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PLOS One logoLink to PLOS One
. 2020 Oct 1;15(10):e0239190. doi: 10.1371/journal.pone.0239190

Pathways to housing stability and viral suppression for people living with HIV/AIDS: Findings from the Building a Medical Home for Multiply Diagnosed HIV-positive Homeless Populations initiative

Serena Rajabiun 1,*,#, Kendra Davis-Plourde 2,#, Melinda Tinsley 3,, Emily K Quinn 4,, Deborah Borne 5,, Manisha H Maskay 6,, Thomas P Giordano 7,, Howard J Cabral 2,
Editor: Zixin Wang8
PMCID: PMC7529314  PMID: 33001986

Abstract

Background

People with HIV with co-occurring substance use and mental health diagnoses who are unstably housed have poorer outcomes for retention in care and viral suppression. Navigation models are a potential strategy to help this vulnerable population obtain the necessary medical and non-medical services across multiple service systems. The Health Resources and Services Administration’s Special Projects of National Significance: “Building a Medical Home for Multiply-Diagnosed HIV-positive Homeless Populations initiative 2012–2017 found that navigation models may be an effective intervention to support people with HIV with unstable housing improve HIV health outcomes. However, there is limited information about the mechanisms by which this intervention works. In this article, we explore the participant and program factors for achieving stable housing at 6 months and how these factors influence HIV health outcomes.

Methods and findings

This was a prospective study of 471 unstably housed people with HIV enrolled in a navigation intervention across nine sites in the United Stated from 2013–2017. All sites provided HIV primary medical care. Eight sites were located in urban areas and one site served a predominantly rural population. Two sites were federally qualified health centers, three were city or county health departments, one site was a comprehensive HIV/AIDS service organization, and three sites were outpatient or mobile clinics affiliated with a university -based or hospital system. Data were collected via interview and medical chart review at baseline, post 6 and 12 months. Type and dose of navigation activities were collected via a standardized encounter form. We used a path analysis model with housing stability at 6 months as the mediator to examine the direct and indirect effects of participant’s socio-demographics and risk factors and navigation on viral suppression and retention in care at 12 months. Housing stability at 6 months was associated with male gender, younger age, viral suppression at baseline, having a lower risk for opiate use, recent homelessness, lower risk of food insecurity, and a longer length of time living with HIV. Participants who increased self-efficacy with obtaining help by 6 months had significantly higher odds of achieving housing stability. Stable housing, fewer unmet needs, moderate to high risk for opiate use, and viral suppression at baseline had a direct effect on viral suppression at 12 months. The intensity of navigation contact had no direct effect on housing stability and a mixed direct effect on viral suppression. Recent diagnosis with HIV, women, greater social support, increased self-efficacy and higher intensity of navigation contact had a direct effect on improved retention in HIV primary care at 12 months.

Conclusions

In this sample of people with HIV who are experiencing homelessness, housing stability had a significant direct path to viral suppression. Navigation activities did not have a direct effect on the path to housing stability but were directly related to retention in care. These results identify key populations and factors to target resources and policies for addressing the health and social unmet needs of people with HIV to achieve housing stability and HIV health outcomes.

Introduction

For people with HIV having stable, secure, and adequate housing is a significant factor in obtaining appropriate HIV medical care, access and adherence to antiretroviral therapy (ART), achieving viral suppression, and reducing risk of transmission [17]. Even among people with HIV who have access to medical care, housing stability remains a challenge to reaching viral suppression. According to national data from the Ryan White HIV/AIDS Program (RWHAP), the payor of last resort for HIV medical care in the US, 86% of participants with stable housing reached viral suppression compared to 72% of participants who were unstably housed [8]. Interventions that support people with HIV with obtaining stable housing and other social and medical needs are needed for this vulnerable population group.

The Health Resources and Services Administration’s Special Projects of National Significance aimed to address this disparity through the Building a Medical Home for Multiply-Diagnosed HIV-positive Homeless Populations initiative from 2012–2017 (HRSA SPNS Homeless Initiative). Patient navigation models are a potential strategy to help people with HIV who experience homelessness obtain the necessary medical and non-medical services necessary by coordinating and accessing care across multiple services systems [9, 10]. Patient navigators are members of the care team who can provide this intensive service and work with medical and behavior health care providers to provide a seamless system of care. Results from this initiative demonstrated that navigation models were an effective intervention to support people with HIV who experience homelessness achieve more stable housing, improve retention in care, and reach viral suppression [6, 11]. Approximately 60% of SPNS participants were able to achieve temporary or permanent supportive housing. Among those who stabilized their housing, 86% were retained in appropriate HIV care and 77% achieved viral suppression compared to those who remained unstably housed (79% were retained in care and 66% were virally suppressed) in the post intervention period [6].

In addition, the initiative found that for people with HIV experiencing homelessness, the road to continuous housing stability is achievable with sufficient support. Approximately 43% of participants were able to obtain and maintain consistent stable housing up to 12 months post intervention. This finding was statistically significant for persons with mental health disorders [AOR = 1.55; 95% CI = 1.02,2.35; p<0.05] and a history of trauma disorders [AOR = 1.72; 95% CI = 1.22,2.41; p<0.05]. However, persons with recent injection drug use had less consistent housing stability [AOR = 0.41; 95% CI = 019,0.90, p<0.05] [11]. These findings were consistent with other studies, concluding that transitions from homelessness to more stable housing were associated with a reduction in alcohol and illicit drug use and improved mental health status among those exiting incarceration and participating in a care coordination intervention [12].

Despite the promise of navigation models, there is limited information about the mechanisms through which they work to enable people with HIV experiencing homelessness achieve housing stability and improve health outcomes. This study examines the mediating effects of housing stability on HIV health outcomes and the role of patient navigation. We hypothesized that more intensive patient navigation interventions in the first 6 months would lead to housing stability at 6 months post intervention, which in turn would improve retention in HIV medical care and viral suppression at 12 months (Fig 1).

Fig 1. Hypothesized model for pathways from homelessness to housing stability to viral suppression and retention in care for people with HIV.

Fig 1

Materials and methods

Study design and intervention

The HRSA SPNS Homeless Initiative (2012–2017), funded nine intervention sites and one multisite evaluation center to implement and evaluate the effect of patient-centered medical homes (PCMH) on HIV health outcomes among people with HIV experiencing homelessness. All nine sites received Ryan White funds to provide HIV primary medical care at the time of enrollment. Eight sites were located in metropolitan areas and one site served a predominantly rural population. Two sites were federally qualified health centers, three were city or county health departments, one site was a comprehensive HIV/AIDS service organization, and three sites were outpatient or mobile clinics affiliated with a university -based or hospital systems. Common elements for a PCMH across the nine sites included: 1) the use of patient navigators to conduct outreach and provide intensive individual and system coordination to address housing needs and support linkage and retention in HIV medical care; 2) the integration of behavioral health services into HIV primary care; and 3) partnerships with housing providers to obtain housing and housing assistance. Navigators were members of the care team and included peer (people with HIV) and non-peer staff. All navigators were trained in principles of harm reduction, trauma informed care and motivational interviewing techniques. They were distinct from HIV case managers and worked closely with behavioral health HIV medical, and housing providers. Housing assistance included housing search to find a place to live; assist with housing applications with agencies; linkage and coordination with Housing for Opportunities for Persons with HIV/AIDS (HOPWA) and other U.S. Department of Housing and Urban Development (HUD) resources for rental subsidies and housing units; communication and support with landlords; provision of emergency housing stays at hotels or motels for shelter resistant clients; support with finding resources to move in and furnish apartments; and access to transitional living facilities such as residential treatment for substance use disorders. Further details of the intervention have been published elsewhere [6, 9].

The HRSA/SPNS Homeless Initiative enrolled 909 participants across the nine sites. This study included a subsample of 471 SPNS participants with complete available data on our mediator (i.e., stably housed at 6 months) and at least one outcome variable of interest (i.e., retention in care at 12 months and viral suppression at 12 months). Participants gave consent and were enrolled and followed up to 12 months post intervention in a prospective, nonrandomized study across the nine sites from September 2013 through February 2017. Eligibility criteria included people with HIV who (1) were 18 years or older; (2) had a history of or current diagnosis of a substance use or mental health disorder; and (3) were currently homeless or unstably housed as defined by the U.S. Department of Housing and Urban Development (HUD) [13] Literally homeless: lacks a fixed, regular, and adequate nighttime residence; Unstably housed: an individual who has not had a lease, ownership interest, or occupancy agreement in permanent and stable housing with appropriate utilities (e.g. running water, electricity) in the last 60 days; or has experienced persistent housing instability as measured by two moves or more during the preceding 60 days (couch surfing) and can be expected to continue in such status for an extended period of time, or individuals fleeing domestic violence.

Data were collected from participant interviews and medical chart review on socio-demographic factors (e.g., gender, age, race/ethnicity, and education), housing status, incarceration history, mental health diagnoses, substance use risk factors, social support, self-efficacy for getting information, obtaining help and communicating with a physician, and unmet need for services. In addition, participants were assessed on barriers to obtaining HIV primary care including personal, organizational, and structural, as well as physical and mental health-related quality of life via interviews at baseline, and at 6- and 12-months post intervention. Further details of the study intervention, design, and measures are published elsewhere [6].

All study procedures were approved by local Institutional Review Boards at the nine participating study sites (Chesapeake IRB (PrismHealth NT and Commwell Health), San Diego State University (Family Health Centers), Baylor College of Medicine (Harris Health System), Public Health Division/Multnomah County Health Department Institutional Review Board, County of Los Angeles Public Health & Health Services Institutional Review Board (Pasadena Public Health Department); Ethical & Independent Review Services (San Francisco Department of Public Health); University of Florida Institutional Review Board; and Yale University Institutional Review Board) and the multisite evaluation center at Boston University Medical Campus. The Office of Human Research Protection at the Department of Health and Human Services granted a certificate of confidentiality for the study.

Measures

Our primary outcomes of interest were retention in HIV primary medical care and viral suppression at 12 months. We defined retention in HIV primary care as at least one visit in each of the three consecutive 4-month windows of the 12-month follow-up period [14]. Viral suppression was defined as having a final viral load test result, in the post 6 to 12-month observation period, of less than 200 copies per milliliter. Stably housed was defined as living in a rented or owned room, apartment or home paid for by self or permanent supported housing or subsidized housing through the Housing for Opportunities for Persons with HIV/AIDS (HOPWA) or other federal, state or local subsidy program. We measured housing stability at 6 months into the observation period. Participants who were unstably housed included persons living on the street, in public places, shelters, temporarily living with friends or family (“couch surfing”), or in a motel/hotel paid for by a program.

Navigation activities formed the core of the intervention and were defined as 43 activities across six domains: health care related activities: linking newly diagnosed to first medical appointment, accompanying to HIV medical appointment, follow up with HIV or non-HIV medical appointment; discuss medical appointments and help with obtaining medications. Mental health (mh) or substance use (su) treatment support: collect information about mental health or substance use treatment, accompany to appointments, referrals and assist with making appointments. Housing related activities: assist with housing application for rental assistance and housing units, creating a housing goal plan, accompany to housing appointments, provide assistance with maintaining housing, discuss housing needs. Other social service or transportation assistance activities: assist with obtaining transportation assistance, and assist with obtaining other social service appointments. Educational and emotional support activities: relationship building (checking in with client and providing emotional support), coaching on living skills, assist with disclosure, mentoring on provider interactions, education on treatment adherence, discuss safer sex, help reduce drug use/educate on harm reduction. Employment-related or other practical support activities, such as obtaining legal documents (IDs) food, clothing, job assistance, budgeting/financial planning, legal assistance and cell phones. Navigators completed forms on a daily basis for all encounters made directly with a client either face-to-face, phone or email/text exchange, or if the encounter was made with another health care, housing or other social service provider (“collateral”) on behalf of a client. We defined intervention dose by generating quartiles of the total number of activities overall and by activity type during the first 6 months of the intervention. We then categorized the dose as “low”, “moderate”, “high” or “very high”.

Other covariates included socio-demographics (gender, race/ethnicity, age, education) and risk factors that could affect our mediator or outcome variables. These measures included recent incarceration history in the past 12 months and lifetime trauma history, either physical injury or sexual assault. Food insecurity was assessed with a dichotomized variable whether a person had barely anything to eat in the past 30 days. Substance use risk was measured using the World Health Organization’s Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) and categorized as low, moderate (problem) or high (addictive) risk [15]. Depression risk was measured using the 10-item Center for Epidemiological studies Depression Scale, with a score of 10 or greater indicating moderate to severe depression [16]. Social support was measured using a 5-item scale to measure types of support in the past 4 weeks with higher scores reflecting greater social support [17]. Self-efficacy was measured across 3 domains: ability to get information, obtain help and communicate with a health care provider. Each item was scored on a 10-item scale ranging from 1 =“ not confident at all” to 10 =“ Totally confident” [18]. Number of medical and non-medical service needs were counted and included: food, housing medication assistance, financial assistance, transportation, legal services, employment, mental health treatment, substance use treatment, and dental care. Unmet need for a service was also calculated from the list of reported need for services but unable to obtain during the previous 6 months. Barriers to care included person, organizational and structural barriers to obtaining HIV primary care [19]. Health related quality of life was measured using the Veterans RAND 12-item Health to assess domains of general health perception, physical functioning role limitations attributable to physical and emotional problems, bodily pain, energy, fatigue, social functioning and mental health. Each item is measured on a 5-point scale from “none of time” to “all of the time.” The 12 items are summarized into a physical component summary score (PCS) and mental component summary score (MCS). The summary scores are set to a mean of 50 and standard deviation of 10 for the US general population [20].

Statistical analysis

We conducted a series of univariate analyses for all continuous variables and categorical variables. These included analyses of counts and percentages for categorical variables and means, standard deviations, and quantiles for continuous variables. We also assessed the distribution of continuous variables for potential skewness or extreme values.

Using a path modeling framework, we then examined the mediating effects of housing stability at 6 months with the associations of baseline socio-demographic and risk factors and intervention dose on retention in HIV primary care and viral suppression at 12 months [21]. First, to develop the set of independent variables for our initial path model, we conducted bivariate analyses with housing stability at 6 months, retention in HIV primary care at 12 months, and viral load suppression at 12 months as dependent variables. In these bivariate analyses, independent variables associated with both housing stability and at least one clinical outcome at the 0.15 α-level were included in a subsequent comprehensive logistic path analysis model that we estimated and tested using Mplus version 8.1. Our analyses considered the multi-site design by employing study site as a clustering variable. We included in the path model client characteristics related to length of time chronically homeless and living with HIV since these characteristics could influence our mediator and outcomes of interests. Paths for independent (exogenous) variables with p-values less than 0.15 in tests of association with a mediator or outcome variable in this initial model were included in a subsequent comprehensive path model. A final more parsimonious path model was then computed after removing variables not associated with the mediator or either outcome with p-values greater than or equal to 0.15. We present adjusted odds ratios (AOR), 95% confidence intervals (CI), and p-values from this final path model with adjusted odds ratios and CIs for continuous independent variables computed per standard deviation.

Results

As shown in Table 1, the majority of participants were cisgender men (75.0%), Hispanic/Latinx or African-American/Black (66.0%), aged 31–54 years (71.8%), and one-third had less than a high school education. Approximately 72% were homeless with an average of 6.1 years of being homeless and 34.4% were incarcerated in the past 12 months. Approximately 40% of participants had trauma history due to physical or sexual assault and 80.8% had a diagnosed mental health disorder. Moderate to severe substance use risk was reported in 21% for opioid use, 34.4% for amphetamine use, 41% for alcohol use, and 47.4% for cocaine use. Approximately 36.7% participants had no health insurance. Participants reported multiple barriers to obtaining HIV care and unmet needs for services such as transportation, food, medication assistance, substance use and mental health treatment in addition to housing. The average number of unmet needs for services were 3.4 (SD = 2.3) and average number of barriers to care were 3.2 (SD = 3.1). Approximately 58.2% were food insecure, and 58.8% reported a need for mental health treatment and 38.6% for substance use treatment. With respect to health status, on average participants were living with HIV for 11 years, 48.6% were virally suppressed at baseline, and participants rated their physical health quality of life as 37.9 (SD = 12.2) and mental health-related quality of life as 35.8 (SD = 12.8), nearly 1.5 standard deviations lower than the general population.

Table 1. Participants characteristics and associations with housing stability and HIV health outcomes, HRSA/SPNS Building a Medical Home for Multiply-Diagnosed HIV-positive Homeless Populations initiative from 2013–2017.

Baseline characteristics Total Stably Housed at 6 Months Virally Suppressed at 12 Months Retained in Care at 12 Months
(N = 471)
N (%) (N = 269)
N (%) (N = 266) (N = 268)
N (%) N (%)
Gender **
    Cisgender male 353 (75.0) 200 (56.8) 197 (75.5) 195 (55.2)
    Cisgender female 100 (21.2) 64 (64.0) 60 (72.3) 64 (64.0)
    Transgender or Other identified 18 (3.8) 5 (27.8) 9 (64.3) 9 (50.0)
Race/ethnicity
    African-American/Black 212 (45.0) 125 (59.0) 124 (73.8) 121 (57.1)
    Hispanic 99 (21.0) 55 (56.1) 59 (77.6) 55 (55.6)
    White 123 (26.1) 74 (60.2) 66 (74.2) 70 (56.9)
    Other (including multiracial) 37 (7.9) 15 (40.5) 17 (68.0) 22 (59.5)
Ages
    30 years or younger 72 (15.3) 48 (67.6) 41 (70.7) 44 (61.1)
    31–54 year 338 (71.8) 188 (55.6) 185 (73.4) 189 (55.9)
    55 years or older 61 (13.0) 33 (54.1) 40 (83.3) 35 (57.4)
Education **
    Less than high school 151 (32.1) 77 (51.3) 85 (73.9) 88 (58.3)
    High school 151 (32.1) 99 (65.6) 85 (72.7) 93 (61.6)
    Beyond high school 168 (35.7) 93 (55.4) 95 (76.0) 86 (51.2)
Housing status—baseline ***
    Homeless 341 (72.4) 167 (49.1) 179 (72.2) 190 (55.7)
    Controlled Environment 41 (8.7) 33 (80.5) 27 (79.4) 25 (61.0)
    Unstably Housed 89 (18.9) 69 (77.5) 60 (79.0) 53 (59.6)
Recent Incarceration (past 12 months) 124 (34.4) 66 (53.2) 62 (66.7) ** 74 (59.7)
Trauma history, lifetime
    Physical injury, harm 205 (43.6) 107 (52.5) * 112 (73.7) 118 (57.6)
    Sexually assaulted 194 (41.5) 116 (59.8) 110 (73.8) 112 (57.7)
Mental Health Diagnosis prior to enrollment 361 (80.8) 201 (55.8) 205 (74.8) 214 (59.3)
Social support score, mean±SD 11.3 ± 5.2 11.8 ± 5.4** 11.6 ± 5.4 11.7 ± 5.5*
Change in social support score, mean±SD 0.6 ± 5.8 0.6 ± 6.0 0.6 ± 6.1 1.1 ± 6.1**
Self-efficacy score, mean±SD
    Getting information 8.8 ± 2.2 8.9 ± 2.1* 8.9 ± 2.1 8.8 ± 2.2
    Obtaining Help 5.7 ± 2.4 5.9 ± 2.4* 5.9 ± 2.4 5.8 ± 2.5
    Communicating with Physician 8.7 ± 2.1 8.7 ± 2.0 8.8 ± 2.0* 8.8 ± 1.9
Change in score, mean±SD
    Getting information 0.1 ± 2.5 0.2 ± 2.3 0.1 ± 2.3 0.3 ± 2.4
    Obtaining Help 0.6 ± 2.7 0.9 ± 2.6*** 0.7 ± 2.5 0.9 ± 2.6**
    Communicating with Physician 0.3 ± 2.5 0.5 ± 2.3* 0.3 ± 2.5 0.3 ± 2.3
No health insurance 172 (36.7) 105 (61.1) 100 (73.0) 100 (58.1)
Food insecurity 274 (58.2) 137 (50.2) *** 140 (69.3)** 151 (55.1)
Food insecurity–need met by 6 months 317 (67.5) 207 (65.5)*** 195 (78.3)*** 190 (59.9)**
Need medication assistance 250 (53.1) 140 (56.2) 138 (75.0) 133 (53.2)*
Medication assistance–need met by 6 months 271 (57.5) 155 (57.4) 158 (77.5)* 160 (59.0)
Need mental health assistance 277 (58.8) 159 (57.6) 152 (72.0) 159 (57.4)
Mental health assistance–need met by 6 months 224 (47.7) 129 (57.9) 127 (75.2) 121 (54.0)
Need substance abuse treatment 182 (38.6) 102 (56.0) 98 (73.7) 94 (51.7)*
Substance abuse treatment–need met by 6 months 342 (72.6) 205 (60.1)** 197 (74.1) 197 (57.6)
Number of unmet needs, mean±SD 3.4 ± 2.3 3.2 ± 2.2* 3.1 ± 2.1*** 3.3 ± 2.2
Number of barriers to care, mean±SD 3.2 ± 3.1 2.9 ± 2.8*** 3.0 ± 3.1*** 3.3 ± 3.0
Moderate/severe risk for substance use
    Alcohol 193 (41.0) 101 (52.3)* 98 (68.5)** 107 (55.4)
    Cocaine 223 (47.4) 120 (53.8) 133 (79.2)** 127 (57.0)
    Opioids 99 (21.0) 48 (48.5)** 59 (80.8) 57 (57.6)
    Amphetamines 162 (34.4) 76 (46.9)*** 81 (71.7) 90 (55.6)
Moderate to severe depressive symptoms (%CES-D≥10) 345 (73.3) 197 (57.3) 193 (74.2) 195 (56.5)
Virally suppressed (HIV-1 RNA<200 copies/mL) at baseline 229 (48.6) 146 (64.0)*** 154 (90.1)*** 132 (57.6)
Health-related quality of life score, mean±SD
    Physical composite score (PCS) 37.9 ± 12.2 38.9 ± 11.8** 38.0 ± 12.1 37.5 ± 12.5
    Mental composite score (MCS) 35.8 ± 12.8 35.8 ± 13.0 36.3 ± 13.2 35.9 ± 12.5
Time living with HIV in years, mean±SD 11.2 ± 9.0 11.5 ± 8.8 11.4 ± 9.3 10.4 ± 8.9**
Years homeless, mean±SD 6.1 ± 8.0 5.3 ± 6.9** 6.2 ± 8.2 5.9 ± 8.1

*p<0.15

**p<0.05

***p<0.01.

Total column results are displayed as n (column percent) for categorical.

Remaining column results are displayed as n (row percent) for categorical.

Socio-demographics, including gender, age, length of time being homeless, length of time living with HIV, social support, self-efficacy, food insecurity, number of unmet needs, number of barriers to care, level of risk for opiate use, intervention dose activities and viral suppression at baseline were selected for the path analysis. Table 1 shows the characteristics of the sample and factors associated with housing stability, retention in care, and viral suppression for the path model.

Table 2 describes the type and intensity of navigation activities by stable housing, viral suppression and retention in care. Overall, higher intensity (dose) of navigation activities were significantly associated with retention in care at 12 months, but there was no significant effect on stable housing or viral suppression. The type of navigation activity varied by housing stability and health outcomes. There was no significant effect of type of navigation activity on achieving stable housing at 6 months. There was some suggestive evidence that participants who received intensive employment and practical support (e.g., obtaining food, clothing, or cell phones) versus moderate employment and practical support had greater housing stability (approximately 56% versus 51%).

Table 2. Type and intensity of navigation activities by stable housing, viral suppression and retention in care.

I Total Stably Housed at 6 Months Virally Suppressed at 12 Months Retained in Care at 12 Months
(N = 471)
N (%)
(N = 269) (N = 266) (N = 268)
N (%) N (%) N (%)
Dose—Overall (0–180 days) ***
    Low (1–11 activities) 116 (24.6) 63 (54.3) 61 (78.2) 52 (44.8)
    Moderate (12–26 activities) 104 (22.1) 59 (57.3) 64 (80.0) 57 (54.8)
    High (27–54 activities) 120 (25.5) 72 (60.0) 71 (71.7) 82 (68.3)
    Very High (55–244 activities) 131 (27.8) 75 (57.3) 70 (69.3) 77 (58.8)
Dose–Healthcare (0–180 days) *** **
    Low (0–2 activities) 136 (28.9) 80 (58.8) 81 (84.4) 71 (52.2)
    Moderate (3–5 activities) 87 (18.5) 44 (50.6) 47 (70.2) 44 (50.6)
    High (6–12 activities) 118 (25.1) 75 (64.1) 72 (78.3) 65 (55.1)
    Very High (13–61 activities) 130 (27.6) 70 (53.9) 66 (64.1) 88 (67.7)
Dose–Mental Health (0–180 days)
    Low (0 activities) 110 (23.4) 62 (56.4) 61 (77.2) 57 (51.8)
    Moderate (1–2 activities) 144 (30.6) 77 (53.9) 84 (79.3) 77 (53.5)
    High (3–6 activities) 88 (18.7) 50 (56.8) 54 (75.0) 51 (58.0)
    Very High (7–43 activities) 129 (27.4) 80 (62.0) 67 (66.3) 83 (64.3)
Dose–Housing (0–180 days) ***
    Low (0–2 activities) 106 (22.5) 60 (57.1) 58 (77.3) 49 (46.2)
    Moderate (3–6 activities) 122 (25.9) 72 (59.0) 71 (77.2) 61 (50.0)
    High (7–12 activities) 94 (20.0) 55 (58.5) 55 (71.4) 63 (67.0)
    Very High (13–81 activities) 149 (31.6) 82 (55.0) 82 (71.9) 95 (63.8)
Dose–Social Services (0–180 days) * **
    Low (0 activities) 142 (30.2) 79 (55.6) 76 (78.4) 66 (46.5)
    Moderate (1 activity) 68 (14.4) 36 (52.9) 38 (80.9) 39 (57.4)
    High (2–5 activities) 140 (29.7) 80 (57.6) 89 (76.7) 92 (65.7)
    Very High (6–33 activities) 121 (25.7) 74 (61.2) 63 (64.3) 71 (58.7)
Dose–Educational & Emotional (0–180 days) **
    Low (0–1 activities) 111 (23.6) 66 (60.0) 67 (83.8) 53 (47.8)
    Moderate (2–5 activities) 129 (27.4) 69 (53.5) 67 (71.3) 75 (58.1)
    High (6–13 activities) 115 (24.4) 69 (60.0) 74 (78.7) 69 (60.0)
    Very High (14–80 activities) 116 (24.6) 65 (56.0) 58 (64.4) 71 (61.2)
Dose–Employment & practical support (0–180 days)
    Low (0 activities) 216 (45.9) 131 (60.9) 123 (77.4) 118 (54.6)
    Moderate (1–2 activities) 113 (24.0) 58 (51.3) 66 (74.2) 63 (55.8)
    High (3–41 activities) 142 (30.2) 80 (56.3) 77 (70.0) 87 (61.3)

*p<0.15

**p<0.05

***p<0.01.

Total column results are displayed as n (column percent) for categorical.

Remaining column results are displayed as n (row percent) for categorical.

There was a significant association between the intensity of health care and education/emotional support activities with viral suppression. Those who received low (84.4%) to high (78.3%) health care support from navigators were virally suppressed compared to participants who received very high intensity of health care activities (64.1%). Similarly, participants who received low (83.8%) or high (78.7%) of education/emotional support were virally suppressed compared to those with very high intensity of education/emotional support (64.4%). Transportation and other social services also were significantly associated with viral suppression for those who received lower intensity (78.4%) and high intensity (76.7%) of services compared to those with very high doses (64.3%).

Finally, higher intensity of health care, housing and social service/transportation activities were significantly associated with retention in care at 12 months. Participants who received higher intensity of health supports (67% vs 52%), housing supports (64% vs 46%) and social service/transportation (59% vs 46%) were retained in care. In summary, the higher intensity of navigation activities in general led to greater retention in care. However, there were no significant effects of navigation on housing stability at 6 months and mixed effects on viral suppression depending on the intensity and type of services provided by the navigator (Table 2).

The final path model (Fig 2) depicts the strength of direct relationships between social determinants of health, housing stability, and subsequent retention in HIV care and viral suppression for all associations with significance level less than 0.15. In the final path analysis, our sample included 471participants with complete data. Table 3 provides all results of the direct relationships of the final path model. We found the path to stable housing at 6 months had a significantly increased likelihood for youth under the age of 30 years (AOR = 2.13 [95% CI 1.09, 4.18]), being virally suppressed at baseline (AOR = 1.56 [95% CI 0.95, 2.55]), longer time living with HIV (AOR = 1.27 [95% CI 1.01, 1.59]), and improved self-efficacy for obtaining help by 6 months (AOR = 1.36 [95% CI 1.06, 1.74]). Those with food insecurity (AOR = 0.57 [95% CI 0.35, 0.91]), moderate to higher risk of opiate use (AOR = 0.59 [95% CI 0.34, 1.03]), being transgender versus cisgender male (AOR = 0.34 [95% CI 0.15, 0.79]), and longer time being homeless (AOR = 0.78 [95% CI 0.66, 0.93]) were significantly less likely to be stably housed at 6 months.

Fig 2. Path model for participant characteristics and navigation activity level on housing stability and HIV health outcomes.

Fig 2

Table 3. Path model logistic regression results for participant characteristics and navigation activity level with housing stability and HIV health outcomes, HRSA/SPNS Building a Medical Home for Multiply diagnosed HIV homeless populations 9 sites in the US, 2013–2017 (n = 471).

AOR (95% CI) p-value
Stably housed at 6M (n = 269)
Navigation Activity level—overall
    Moderate vs low 1.27 (0.70,2.28) 0.428
    High vs low 1.31 (0.61,2.82) 0.484
    Very high vs low 1.43 (0.88,2.35) 0.152
Food insecurity 0.57 (0.35,0.91) 0.019
Age
    30 years or younger versus 31–54 years 2.13 (1.09,4.18) 0.027
    55 years or older versus 31–54 years 0.74 (0.38,1.42) 0.364
Number of years homeless 0.78 (0.66,0.93) 0.008
Number of years with HIV 1.27 (1.01,1.59) 0.046
Social support score 1.19 (0.93,1.53) 0.164
Virally suppressed at baseline 1.56 (0.95,2.55) 0.077
Change in self-efficacy score: Obtaining help 1.36 (1.06,1.74) 0.014
Gender
    Cisgender female versus cisgender male 1.37 (0.79,2.37) 0.266
    Transgender people or other identified versus cisgender male 0.34 (0.15,0.79) 0.012
Number of unmet needs 0.92 (0.80,1.06) 0.223
Number of barriers to care 0.83 (0.66,1.04) 0.107
Moderate/severe risk for substance use: opiates 0.59 (0.34,1.03) 0.063
Retention in HIV Primary care at 12M (n = 268)
Stably housed at 6 months 1.00 (0.68,1.47) 0.998
Navigation Activity level—overall
    Moderate vs low 1.31 (0.51,3.41) 0.575
    High vs low 2.36 (1.11,5.02) 0.026
    Very high vs low 1.57 (0.99,2.48) 0.054
Food insecurity 1.02 (0.66,1.58) 0.913
Ages
    30 years or younger versus 31–54 years 0.96 (0.64,1.46) 0.857
    55 years or older versus 31–54 years 1.13 (0.65,1.97) 0.668
Number of years homeless 0.96 (0.82,1.13) 0.610
Number of years with HIV 0.82 (0.67,1.01) 0.064
Social support score 1.23 (1.10,1.37) <0.001
Virally suppressed at baseline 1.15 (0.80,1.64) 0.457
Change in self-efficacy score: Obtaining help 1.27 (1.05,1.52) 0.011
Gender
    Cisgender female versus cisgender male 1.38 (0.98,1.93) 0.066
    Transgender people or other identified versus cisgender male 0.79 (0.38,1.62) 0.516
Number of unmet needs 0.90 (0.70,1.16) 0.421
Number of barriers to care 1.12 (0.92,1.37) 0.277
Moderate/severe risk for substance use: opiates 0.96 (0.53,1.74) 0.890
Virally Suppressed at 12M (n = 266)
Stably housed at 6 months 2.43 (1.42,4.16) 0.001
Navigation Activity level—overall
    Moderate vs low 0.99 (0.62,1.58) 0.955
    High vs low 0.50 (0.24,1.03) 0.061
    Very high vs low 0.55 (0.36,0.87) 0.010
Food insecurity 0.58 (0.24,1.45) 0.245
Ages
    30 years or younger versus 31–54 years 0.90 (0.45,1.81) 0.760
    55 years or older versus 31–54 years 1.51 (0.75,3.02) 0.247
Number of years homeless 1.02 (0.76,1.39) 0.880
Number of years with HIV 0.90 (0.76,1.07) 0.241
Social support score 0.81 (0.59,1.11) 0.194
Virally suppressed at baseline 4.65 (2.13,10.16) <0.001
Change in self-efficacy score: Obtaining help 0.99 (0.71,1.38) 0.939
Gender
    Cisgender female versus cisgender male 1.01 (0.61,1.68) 0.955
    Transgender people or other identified versus cisgender male 1.17 (0.18,7.69) 0.874
Number of unmet needs 0.65 (0.55,0.77) <0.001
Number of barriers to care 1.00 (0.68,1.49) 0.991
Moderate/severe risk for substance use: opiates 1.98 (1.53,2.57) <0.001

Adjusted odds ratio (AOR) and 95% confidence intervals (CI) for continuous variables are per standard deviation.

Being stably housed at 6 months did not lead to a significantly greater likelihood of being retention in care at 12 months, but it did result in a greater likelihood of viral suppression at 12 months (AOR = 2.43 [95% CI 1.42, 4.16]). Viral suppression at baseline (AOR = 4.65 [95% CI 2.13, 10.16]) and being at moderate to high risk for opiate use (AOR = 1.98 [95% CI 1.53, 2.57]) were also associated with viral suppression at 12 months. Finally, a higher number of unmet needs at baseline (AOR = 0.65 [95% CI 0.55, 0.77]) and higher doses of patient navigation intervention: high versus low (AOR = 0.50 [95% CI 0.24, 1.03] and very high versus low (AOR = 0.55 [95% CI 0.36, 0.87]), were associated with a lower likelihood of viral suppression at 12 months (See Fig 2, Table 3).

Higher intensity of the patient navigation intervention was associated with an increased likelihood of retention in care at 12 months: high versus low dose (AOR = 2.36 [95% CI 1.11, 5.02]); very high versus low dose (AOR = 1.57 [95% CI 0.99, 2.48]). Retention in care was also associated with having greater social support (AOR = 1.23 [95% CI 1.10, 1.37], an increase in self-efficacy score for obtaining help by 6 months (AOR = 1.27 [95% CI 1.05, 1.52]), and for cisgender female versus cisgender male (AOR = 1.38, [95% CI 0.98,1.93]). In addition, longer time living with HIV was associated with a lower likelihood of retention in care (AOR = 0.82 [95% CI 0.67, 1.01]). We found no direct effect of intensity of navigation activities on housing stability at 6 months and interestingly higher doses of navigation activities had a lower odds of viral suppression compared to those who received few contacts with navigators (Fig 2, Table 3).

Discussion

This study examined factors associated with the pathways to housing stability and subsequent retention in care and viral suppression for people with HIV experiencing homelessness who participated in the HRSA/SPNS Homeless Initiative. We hypothesized that a higher dose of patient navigation activities would lead to increased likelihood of housing stability at 6 months, and thus, result in improved retention in care and viral suppression at 12 months post follow-up. While we found that navigation activities directly increased retention in care, there was no direct effect on stable housing. Similar to other studies, we found a direct effect of obtaining housing stability on viral suppression, yet, surprisingly, those with higher doses of patient navigation led to lower odds of viral suppression.

To our knowledge, this is the first study that examines the specific pathways for mechanisms of patient navigation programs to improve housing stability and HIV health outcomes among people with HIV who are unstably housed or homeless. Our results show that the intensity of navigation programs have a positive, direct effect on engaging and retaining this vulnerable population in medical care over time. Specific support for health care, housing, and transportation can lead to better outcomes. This finding highlights the critical role patient navigators can play as part of the care team in reducing barriers to care and keeping people with HIV experiencing homelessness connected to the health care system for continuity of care. Our findings are similar to those of other studies that found that patient navigation has a significant effect on engagement in care for vulnerable people with HIV at risk for homelessness, such as those leaving incarceration and those who have been out of care for more than six months [2225].

Our participants included people with HIV with multiple co-morbidities, such as mental health and substance use disorders. In this sample population, we found initial suggestive evidence that reducing the unmet need for substance use treatment was associated with better housing stability (Table 1), however, there was no association with retention in care nor viral suppression in bivariate analyses. We, therefore, excluded it from the path model due to our selection criteria. Given these results, it is likely that structural effects, due to limited accessibility to substance use treatment and mental health providers, was a perpetual barrier that limited the effectiveness of navigation activities on viral suppression. Other studies have found an indirect effect of mental health coordination on reducing days to enter treatment for addiction services, specifically, as a critical factor for the pathway to addiction services, especially for racial ethnic minorities [26]. Further research is needed to assess how access to substance use and mental health treatment mediate housing stability and subsequent health outcomes.

The findings that the intensity of navigation activities did not have a significant direct effect on housing stability and resulted in a lower odds of viral suppression, surprised us. Our findings suggest that given the high level of unmet multiple needs in this population, patient navigation addressed those needs first before housing stability could be directly achieved. Our study found that navigators provided an intensive amount of time on a variety of activities in addition to housing assistance including education about HIV treatment, managing disclosure and coaching on living skills as well as supporting employment related services, skills development, and providing practical support such as help with transportation, phones, clothing, and food. Similar to addressing substance use and mental health treatment, the structural factors of housing affordability and availability could not be addressed solely via the intensive work by patient navigators working with individual participants in a time-limited intervention of 6–12 months.

Finally, while navigation programs alone are not the magic bullet for reaching viral suppression, they addressed the intermediate factors in the pathway to promoting housing stability and retention in care, specifically for recently diagnosed people with HIV. Our population had multiple unmet needs in addition to stable housing including food, obtaining medications, substance use, and mental health treatment. Patient navigators may have spent more time addressing these priority unmet needs, and therefore had less time to devote to education and counseling on adherence to treatment. We found significant mixed effects of dose of education activities on viral suppression: those with very high doses (14–80 contacts) of education were less likely to be virally suppressed compared to those who received low to high doses (1–13 contacts) (Table 2). We could not tease out the specific educational topics or activities that made an impact or examine how sessions were delivered across sites. Our model also did not explore other factors that patient navigation activities could affect such as relationships with health care providers, stigma, and personal beliefs and attitudes towards addressing HIV that may impact reaching viral suppression. Further research on the effects of patient navigation models on these factors is warranted.

However, our findings signal other important elements for navigation programs that affect housing stability and viral suppression in this population. HRSA SPNS participants with moderate or high risk for opiate use were more likely to achieve viral suppression regardless of the person’s ability to be stably housed. The HRSA SPNS intervention used mobile, interdisciplinary teams to address housing, behavioral health and medical care to help ensure people with HIV who were homeless had access to HIV medications and treatment and achieve viral suppression. These interdisciplinary teams of clinicians and navigators could be a key step in supporting a person’s readiness to enter longer-term treatment at a health care facility or to become stably housed [27].

Limitations

Our path analysis was dependent on a convenience sample of people with HIV experiencing homelessness. While we had fewer than 10% of missing data on outcome variables, we cannot rule out the possibility of selection bias on the outcomes for viral suppression and housing stability due to the nonrandomized, prospective study design. To address this bias, we conducted an attrition analysis of the characteristics of participants in this path analysis (n = 471) to those study participants lost to follow up by 12 months (n = 438). We found no differences on socio-demographics (age, race/ethnicity, gender and education), However this study sample were less likely to be chronically homeless (72% vs 78%), more likely to obtain food (67% vs 23%) and reported fewer unmet social and medical needs (3.4 vs 3.7), lower proportion of high risk for cocaine use (47% vs 57%) and slightly higher mental health functioning (35.8 vs 33. 8) [S1 Table].

Second, we only included those with permanent stable housing at 6 months as our mediator and did not consider other types of temporary or transitional housing models or perceptions of housing security. Studies have found that other dimensions are important to include in measuring housing stability such as perception of security, safety, and quality of the housing [28]. It was beyond the scope of the study to capture how the HRSA SPNS intervention affected these dimensions of housing stability, which might subsequently impact retention in care or viral suppression.

Our measurement of patient navigation dose was driven by the data and we chose to divide intensity of contact into quartiles of “low”, “moderate”, “high” and “very high”. We did not explore participant characteristics that may be related to each level of intensity, which could account for the direct effect of the intervention on retention in care and viral suppression. Further research in the area is needed to understand if specific characteristics are related to the intervention dose.

Finally, we collected data on housing status and other enabling and risk factors (food security, opiate risk, self-efficacy) via self-report in interviews and intervention dose at 6 months to see the impact on clinical outcomes at 12 months. Because some of these factors were measured at the same time, it could account for some of the null effects on stable housing as some of these other variables are serving as mediator effects. Further studies should explore the temporality of these factors on housing status and subsequent clinical outcomes.

Despite the above limitations, these findings highlight the potential impact for the scope and practice of the navigation activities and the need for greater resources to support system coordination in working with people with HIV who experience homelessness. First, prioritizing the needs and developing a person-centered care plan to address and monitor the progress with addressing multiple needs is important. As part of the medical home, the HRSA/SPNS interventions worked with an interdisciplinary team to create a coordinated plan for addressing medical and social needs including housing. Our path analysis revealed specific populations who benefitted from the intervention, such as youth under the age of 30, women, recently diagnosed, and persons with high risk for opiate use. Other populations, such as transgender people, were less likely to obtain stable housing. While our transgender population was a small percentage, our findings highlight a need to provide culturally appropriate training for staff in better response to the needs of transgender people and also serve as an advocate with housing providers and landlords to reduce possible stigma and discrimination.

Second, the model revealed key indicators associated with stable housing, retention in care, and viral suppression, such as increased social support and improved self-efficacy with obtaining help. Providing training and supervision to patient navigation staff on how to discuss, motivate, and support clients and provide services that promote client self-efficacy in this area could lead to better housing and HIV care outcomes.

Finally, there is a greater need for system coordination to address the accessibility and affordability of housing, access to employment, substance use, and mental health treatment. It was beyond the scope of this study to examine or measure the level of system coordination on housing and HIV health outcomes, however, this would be an important next step in understanding how barriers to care are reduced and housing stability may be improved.

Conclusions

In summary, we found in the sample of people with HIV experiencing homelessness participating in a navigation intervention, housing stability was a significant direct pathway for viral suppression. Population groups varied in the pathway to housing stability and health outcomes. Youth, and people with HIV who were more recently homeless were more likely to achieve stable housing. Women and people who were newly diagnosed with HIV had a greater odds of being retained in care, and people with HIV with a moderate to high risk of opiate use were more like to achieve viral suppression. Transgender persons and those experiencing high food insecurity were less likely to reach housing stability and subsequent improvements in HIV health outcomes. Navigation activities did not have a direct effect on the pathway to housing stability, but they were directly related to retention in care. The results identify key populations and factors to target resources for social interventions and policies to achieve improved housing stability and HIV health outcomes.

Supporting information

S1 Table. Study sample attrition analysis, HRSA/SPNS Building a Medical Home for Multiply-Diagnosed HIV-positive Homeless Populations initiative from 2013–2017.

(DOCX)

Acknowledgments

The authors wish to thank all the intervention and evaluation staff, care coordinators, patient navigators and clients who participated in the HRSA/SPNS Building a Medical Home for multiply diagnosed HIV-positive homeless populations Initiative and the following study group members:

Serena Rajabiun, PhD, Sara S. Bachman PhD, Howard Cabral, PhD, Jane Fox, MPH, Emily K. Quinn, MA, Mariana Sarango, MPH, Carmen Avalos, MD, Alexander de Groot, MPH, Karen Fortu, MPH, Kerrin Gallagher, MPH, Boston University; Barbara Cocci, MSW, Carole Hohl, PA-C, Sandy Sheble-Hall, BSN, Boston Health care for the Homeless Program.

Manisha H. Maskay, PhD, Nicole Chisolm, MPH, Ben Calloway, LMSW, Prism Health North Texas.

Bahby Banks, PhD, MPH, Ayodele Gomih PhD, MSPH, Lisa McKeithan, MS,CRC Commwell Health.

Verna Gant, MBA, Family Health Centers of San Diego; Amy Pan PhD, San Diego State University.

Tom Giordano, MD, MPH, Jessica Davila, PhD, Baylor College of Medicine; Nancy Miertschin, MPH, Siavash Pasalar, PhD, Harris Health System.

Jo Ann Davich, BA, Multnomah County Health Department.

Angelica Palmeros, MSW, Matt Feaster, MPH, Pasadena Public Health Department.

Deborah Borne, MD, MSW, Janell Tryon, MPH, San Francisco Department of Public Health; Kate Franza, Asian & Pacific Islander Wellness Center.

Mobeen H. Rathore, MD, Kendall Guthrie, M Div, University of Florida Center for HIV/AIDS, Research, Education & Service (UF CARES).

Frederick Altice, MD, MA, Ruthanne Marcus, PhD, Mary L. Powell, DNP, PMHNP-BC, Yale University AIDS Program; Silvia Moscariello, MBA, Liberty Community Services.

Melinda Tinsley, MA, Pamela Belton, Thelma Iheanyichukwu, MHA,Chau Nguyen, MPH, Corliss Heath, PhD, MPH, Health Resources and Services Administration, HIV/AIDS Bureau.

Data Availability

The data underlying the results presented in the study are available upon request from the Biostatistics and Epidemiology Data Coordinating Center. Due to the sensitive nature of the data and as required by the Boston University Medical Campus Institutional Review Board (IRB). datasets are stored for up to seven years from the close of the study, and thus with this project through 2025. Data requests can be sent to Boston University’s Biostastics & Epidemiology Data Analytics Center (BEDAC) @ bedacprp@bu.edu. This request will be sent to the study’s Publications & Dissemination Committee, which consists of the Principal Investigators from each local study sites, the multisite evaluation center at Boston University and HRSA. As Principal Investigator for the multisite evaluation center I will manage the approval process, in accordance with our policy and guidelines Once a data request is approved by the P & D committee, BEDAC will work with the requesting party to create a dataset for processing fee.

Funding Statement

This study was funded by U.S. Department of Health and Human Services, Health Resources and Services Administration under grant #U90HA24974.

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Decision Letter 0

Dario Ummarino

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4 Feb 2020

PONE-D-19-29536

Pathways to housing stability and viral suppression for people living with HIV/AIDS: Findings from the Building a Medical Home for Multiply Diagnosed HIV positive Homeless Populations Initiative

PLOS ONE

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

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Reviewer #1: No

Reviewer #2: Partly

Reviewer #3: Partly

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2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: I Don't Know

Reviewer #3: Yes

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Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

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Reviewer #2: Yes

Reviewer #3: Yes

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5. Review Comments to the Author

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Reviewer #1: The submitted manuscript describes an analysis of the effect of patient navigation on people living with HIV (PLWH) who are homeless and are diagnosed with co-occurring substance abuse or mental health disorders. Participants were part of one of the Health Resources and Services Administration’s Special Projects of National Significance: “Building a Medical Home for Multiply-Diagnosed HIV-positive Homeless Populations Initiative 2012-2017 (HRSA SPNS Homeless Initiative), which found that navigation models may be an effective intervention to support people who experience homelessness achieve more stable housing, improve retention in care, and reach viral suppression. However, little is known about the mechanisms by which patient navigation interventions work to help people achieve stable housing and subsequently improve health outcomes. This study was set out to examine participant and program factors for achieving stable housing at 6 months and how these factors influenced retention in care and viral suppression at 12 months. In total 700 unstably housed PLWH enrolled in the patient navigation intervention across nine sites in the United Stated from 2013-2017. A path analysis model with housing stability at 6 months as the mediator was used to examine the direct and indirect effects of participant’s socio-demographics and risk factors and patient navigation on viral suppression and retention in care at 12 months. Significant effects of patient navigation intensity on retention in care outcomes at 12 months are reported, however patient navigation intensity was not associated with housing stability at 6 months and was negatively associated with viral load suppression at 12 months. While the manuscript provides critical data for our understanding of the underlying mechanisms impacting housing stability and HIV outcomes among this vulnerable population, several inconsistencies across the paper need to be addressed before publication can be considered.

Specific comments:

• Instead of “people with HIV” would use more established and accepted acronym “PLWH” (people living with HIV)

• Figure 1 and 2 – legends are missing

• Figure 1 – need to elaborate on enabling factors (predictors) – “socio-demographic” does not seem to capture all

• A brief description of the 9 study sites would be helpful

• Results are inconsistent across abstract, tables, text – for example abstract states that being male was associated with housing stability at 6 months, however tables indicate being female was associated with housing stability. This inconsistency also impacts the conclusions of this manuscript.

• Regarding depression instrument used – not clear which depression screening instrument was used – short form or long form!?

• One of the more surprising findings is not discussed sufficiently, namely the negative association of patient navigation intensity and VL suppression – maybe patients struggling with VL suppression were given more resources/attention!? However, this also warrants a more detailed description on how patient navigation was provided in this population.

• References are very few, which is surprising given the body of literature by HL Cooper and O Galarraga.

Reviewer #2: Paper Ref. PONE-D-19-29536

Paper title: Pathways to housing stability and viral suppression for people living with HIV/AIDS: Findings from the Building a Medical Home for Multiply Diagnosed HIV positive Homeless Populations Initiative

Overview

This is an interesting study carried out in socially and economically excluded people such as people living with HIV and experiencing homelessness. The study tested the factors associated with housing stability at 6-month of follow-up and HIV viral suppression status and retention in care at 12 months follow up. The study also explored the mediating role of housing stability status at 6 month on the HIV viral suppression status and retention in care at 12 months follow up. The authors found that some individual-related factors were associated with housing stability at the 6th month of follow-up, which in turn have a positive effect on viral suppression at 12 months of follow-up. They also found that the intensity of the navigator-related activities has a negative impact on viral suppression at the 12th month of follow-up.

Overall, I find that this study provides an important insight into the role of archiving housing stability on health-related outcomes such as HIV viral suppression. These findings also support the need to enhance and provide access to housing and health and social support services for people experiencing homelessness with or without comorbid mental and physical health-related problems. However, I have the below comments to the authors, which could improve the quality of the paper before it can be accepted for publication.

Abstract

1. Please define in short what a navigator model is.

2. Please state what those nine sites involved in the study were, as it will provide a better study contextual background for potential readers are were.

3. In the abstract, some dot marks are missing (i.e., lines 44 and 56).

4. Line 69, the avocation for policies, should not only be limited to clinical intervention and policies. It should also include social interventions and policy to address both the health and social unmet needs (lack of access to housing) of these population groups.

Introduction

1. Please elaborate more on the idea behind the statement “housing stability is an area that still needs progress.”

2. In lines 86 to 90, you summarized the already known effect of housing stability on appropriate HIV care retention and viral suppression in your study sample. Thus, you should state clearly how this new study differs from that one, especially as you also looked at the effect of housing stability on HIV care retention and viral suppression.

3. Line 99. It would be helpful to describe what a navigator model is.

4. The objectives of the study should state clearly the mediating effect of housing stability on health-related outcomes.

5. Relating to the follow-up period, (lines 102, 103) considering that the HRSA SPNS Homeless Initiative lasted from 2012 to 2017, why the analyses were only focused on the first year of follow-up, rather than over the 5 year follow-up period. These should be acknowledged and explained.

Methods

1. You stated that the HRSA SPNS was carried out in nine sites, could you please provide information on which were those nine study sites? This will help to give more background to the study and help the reader to interpret the findings based on the study context.

2. Line 116, define or characterize who the patient navigators were. It will help to understand the nature and dynamics of the intervention.

3. Please expand more on what specific housing-related services the navigator program gives to the participants (line 119). Does it include access to housing accommodation? Rent supplements?

4. Line 119, how many participants were initially enrolled?

5. Line 123. Please, expand more on the criteria used to define the unstably housed status.

6. “Unmet need for services” (line 128), is it referring to social or health services? Or both?

7. Inline 133, you stated that 700 participants were included. However, for the final path analysis, you only included 471 participants. Please state the actual number of participants included, and or whether you used different samples for some analyses. If you final sample was 471 participants, please provide information on potential clinical and demographic differences between these 471 and those excluded from the analyses.

8. Measures: As I said before. One of the main questions is: why did you only carry out the study analyses on the first-year follow-up period and not over the five-year follow-up period? As the housing stability status and intervention doses during the first six-month of follow-up could vary from those of the 6 to 12-month follow-up, impacting the outcome analyzed. Thus, it is important to explain why you did not also consider those measures for the 6 to 12 months period. As for some people experiencing homelessness, it is hard to achieve housing stability in a short period, even when access to housing is facilitated. Also, those people having higher intervention doses during the 6 to 12 months may have archived better health-related outcomes. I understand that this is a pathway analysis; however, there are statistical tools to perform longitudinal pathway analyses using time-varying mediators (See: Zheng et al. Longitudinal Mediation Analysis with Time-varying Mediators and Exposures, with Application to Survival Outcomes. J Causal Inference. 2017;5(2). pii: 20160006. VanderWeele et al. Mediation analysis with time varying exposures and mediators. J R Stat Soc Series B Stat Methodol. 2017; 79(3): 917–938)

9. In the measure subsection, the definition and operationalization of all co-variates considered in the analyses should be described.

10. Lines 155-158. It would be more informative, to describe some examples of specific mental health, housing, social, transportation-related activities that are included in these six program domains.

11. Relating to intervention dose, did you explore its effect by grouping those related to health care supportive services vs non-health related supportive services? As by considering all into one variable may hide the potential positive effect of health-related intervention activities on the HIV viral suppression outcome. Also, the intervention dose for the health-, housing-, social service-, education-, and employment-related areas may have a distinct effect on the outcome analyzed.

12. What about the access to pharmacological viral-related treatment. Does this population have access to the existing effective HIV treatments? Do you have any information about it? If not, this is an essential limitation of the Intervention program that should be acknowledged.

Results

1. In table 1. Those all covariates you presented should be described in the Methods section (as I previously commented). In addition, you could explore the dose of health-related services (health care, mental health care) and the dose of non-health related services (housing, social services, education and employment) on the analyzed health outcomes outcome.

2. Line 220. As said before, the actual number of participants included in the study should be clearly stated. As if for some analyses, you used one sample, and for others, you used a smaller sample, somehow, you are analysis two population groups. Considering present a consistent sample (N=471) and describe any potential differences with the sample of participants who were not included in the final analyses.

Discussion

1. 281. Please expand what a patient navigator actor(s) is/are. His may help the understanding of the potential reader who is providing these kinds of services or activities. Expand the background of these programs.

2. Line 921. Please elaborate on what unmet needs you are referring to (social, mental, physical health, emotional, or all of these).

3. Line 305. Could you comment on whether the navigation-housing related activities also facilitate immediate access to housing? This can be one of the explanations of why the dose of activities was not related to housing stability and viral suppression. For example, the Housing First programs have shown to be effective in helping people to reach housing stability in short and long-term periods. People experiencing homelessness have complex and multidimensional health, social, and emotional unmet needs, which require strong evidence-based interventions and permanent support to observe changes in different dimensions. However, the immediate access to housing without mental, substance use or other social requirements should be provided and should be advocated, rather than wait until those complex needs are addressed before a person could access to stable housing. Thus, could you restate what you are suggesting on line 305/306?

4. Line 312. Could you extend more of which additional supportive services will increase the housing stability and better HIV-related outcomes in these populations? Example, Housing First interventions or other evidence-based initiatives.

5. Line 319. Are the mixed effects of education activities on viral suppression presented somewhere on the manuscript? If not, it would be great to include them in the results section or supplemental information.

6. Limitation: Did the study participants have access to HIV pharmacological HIV treatment as part of the navigator intervention activities? If not, it is a significant limitation as it can influence the lack of positive effect of the intervention dose on HIV viral suppression.

End of comments

Reviewer #3: This paper reports findings from a SPNS project on patient navigation at medical homes around the US. The authors conducted a path analysis to assess whether housing stability at six months mediated the relationship between baseline individual demographic and clinical characteristics and retention in care or viral suppression at 12 months. This analysis addresses important issues about whether navigation services and housing stability influence HIV medical outcomes and for whom they work. More literature on this topic would be valuable and of broad interest. This paper has several issues, some of which are serious, and all of which are amenable to changes:

1. The abstract is missing at least three periods, e.g., “…and reach viral suppression However, there is…”

2. Navigation and models of it are not described in the Intro and should be.

3. Line 93, “statistically significant”: Please clarify what was tested that was significant.

4. Lines 115-119: So intervention sites were primary care providers? Are the three mentioned characteristics what also define a medical home? A general working definition of “medical home” is warranted.

5. Lines 134-135: Although it may be in other sources, please in this paper clarify how retention and suppression at 12 months were defined (both the time range for the care/VL and the data source), particularly because you have more people suppressed than retained in care, which is a bit counter to the standard continuum of care.

6. Table 1: In column headers, please add what the percents are. For example, the “Total” column clearly has column percents – please expand headers to make the other percents easier to interpret.

7. Table 1: Please add a total row.

8. Table 1: Can you comment in the results about how so many more people are virally suppressed than retained in care at 12 months? For example, for males, 74% were suppressed and only 53% retained in care. Seems unusual – or maybe your column headers were switched?

9. Table 1: I suggest using the same groupings but different labels for your gender variable. For example, “Cisgender man,” “Cisgender woman,” and “Transgender or another gender identity.” This avoids male/female terms for gender and the suggestion that transgender persons don’t identify with a binary gender.

10. Lines 298-334: Numerous points in the discussion seem to reveal your bias that patient navigation must be effective. For example, “…was a perpetual barrier that limited the effectiveness of navigation activities” (line 298-299), “patient navigation is required to address those needs first before housing stability can be directly achieved” (lines 304-306), “other important elements for patient navigation that affect housing stability and viral suppression” (lines 327-238), and “mobile interdisciplinary teams of clinicians and patient navigators are a key step” (line 332-333). More data on patient navigation would be very useful in the literature, so your focus is appreciated. But it would be more convincing if you wrote as though you didn’t have this bias and patient navigation could, possibly, be ineffective at the things you failed to prove in your analysis. Most importantly, provision of navigation activities isn’t randomized, so the people struggling the most (with a range of things, including those that make achieving housing stability and your medical outcomes difficult) may be offered the most help. Your second Limitations paragraph (lines 346-351) almost addresses this, but not quite, and should. It also seems like there should be a citation out there that you could call on about this apparent paradox, that dose of services and good outcomes are not necessarily correlated.

11. Line 332: “Across” instead of “crossed”?

12. Lines 328-329: Unclear how this sentence relates to the rest of the paragraph – what do you make of this finding?

13. Line 331: First time mentioning “peer” – introduce and define in Intro.

14. Lines 332-333: Would be helpful to mention this care/treatment delivery mode in Intro or Methods. Unclear which aspect(s) of this care/treatment delivery mode influences outcomes. The team was mobile, and it was also a clinician and navigator. Was the peer / navigation aspect of the team truly impactful? From this analysis, it seems that we can’t say.

15. Line 358: “Of” instead of “for”?

16. Lines 384-385: I don’t think your written Results section supports this statement, e.g., for transgender or food-insecure persons. Would be helpful to clarify which “benefit” is being discussed and also to ensure that any results important enough to highlight in Conclusions are written in the Results section.

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Reviewer #1: No

Reviewer #2: No

Reviewer #3: No

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PLoS One. 2020 Oct 1;15(10):e0239190. doi: 10.1371/journal.pone.0239190.r002

Author response to Decision Letter 0


4 May 2020

Response to Reviewer 1

• HRSA’s policy for written communications, including manuscripts requires that we use “people with HIV” and avoid using acronyms such as “PLWH”.

• We have added appropriate titles and legends to Figures 1 and 2. Figure 1 visually depicts our framework for the study. The title was somehow omitted when embedded in the manuscript and now has been added. In Figure 2, there is no legend associated with the path model. However, we revised the Figure to avoid acronyms such as “AOR” and changed to “adjusted odds ratio”.

• The abstract has been revised to ensure consistency with the tables and the manuscript. Table 1 shows the unadjusted bivariate analysis that select the criteria variables for the final path analysis. In unadjusted analyses, gender was a significant factor associated with being stably housed at 6 months and retention in care and therefore, included in the final analytic model. Male gender is the reference group and our findings indicate that transgender persons were significantly less likely to be stably housed at 6 months compared to males, while females were more likely to be retained in care at 12 months compared to males. The abstract has been revised to exclude the reporting of the unadjusted bivariate analyses and only include the findings from the final path model.

• Depression screening: we have updated the methods section to include that we used the short form 10-item Centers for Epidemiologic Studies-Depression Scale.

• Findings related to patient navigation and viral suppression: Thank you for your comment about the surprising negative finding that persons who received higher doses of patient navigation were less likely to be virally suppressed in the final analysis. We have provided more detail in the methods and discussion section about how patient navigation was conducted based on the findings in Tables 1 and 2 and the final path analysis in Figure 2. We hypothesize that patients with whom patient navigators were providing a greater frequency of contact and variety of support services (health care, behavioral health support, other social service needs) had other priority needs. We separated our initial Table 1 into two tables: Table 1: Sociodemographic and health characteristics of the study sample and Table 2: Type and Intensity of Navigation Activities by Housing and Health Outcomes. Our findings in Table 2 show that navigators provided a significant amount of health care related services which included education and support with medications. One of the limitations of our study is that we did not collect data on whether patient navigators specifically observed patients taking medications which would more directly lead to viral suppression. It was also beyond the scope of this study to tease out if participants who received navigation support with obtaining medications had also received directly observed therapy compared to those who did not have better viral suppression. Our encounter form for navigators only documented “assist with obtaining medications”. This is an area for further study.

• Thank you for the suggestion to review the studies published by HL Cooper and O Galarraga. We conducted a specific literature review to focus on people experiencing homelessness and HIV. We added the relevant studies from Galarraga and other recently published in 2018.

Reviewer 2

• For the abstract we added a definition of patient navigator and a description of the sites to give more context for the study (lines 29-30). In addition, we added a dot marks when appropriate. Thank you for these edits.

• In line 54 we revised the sentence to mention that interventions address the unmet social and health needs for this population and not only biomedical interventions.

• Introduction: We revised the section to elaborate that while there is ample evidence that unstable housing affects HIV health outcomes, evidence is needed on the types of interventions and policies and the mechanisms of how they address housing instability and health outcomes. We also revised this section so it clearly addresses the gap in the research: examining how patient navigation can affect housing stability and viral suppression and if there is a direct pathway.

o Added a description of a navigator model (lines 69-71).

o Added the objective of the study to clearly state that we are examining the mediating effect of housing stability on health-related outcomes (lines 86-89).

o The analyses for this study use outcomes based on HRSA core indicators of viral suppression at 12 months and retention in care at 12 months. Therefore, participants were enrolled in the study and followed for a minimum of 12 months and sites were required to collect data on participants at least to 12 months post enrollment.

• Methods: We added more description about location and organizational settings for the nine sites. We had cited the original study which provides this background information to save on word count. We also added more description about the patient navigation model and the types of services, specifically housing services that were provided. Our encounter form collected information about housing search, accompaniment to housing support services and rental assistance, emergency housing services for motel stays; move in support. Our program intervention did not directly provide rental assistance but more navigators helped to connect participants to these programs including housing vouchers and other subsidy programs.

o Line 111: we revised to state that across the project 909 participants were enrolled and this study focuses on the subsample with 471 with complete housing and HIV health outcome data up to 12-month post intervention.

o Line 116: Our criteria used to define “unstably housing status” is based on HUD’s definition of homelessness and unstable housing. We have provided the citation and updated the manuscript to include that description.

o Unmet need for services includes both social and other non-medical needs as well as medical needs (lines 168-171)

o We have updated our analysis to only focus on the sample with complete data n=471. We have also included a statement about the difference between this sample and those enrolled (n=438) (See line 456 -462) who did not have complete data on housing stability or health outcomes due to being lost to follow up at 6 or 12 months. We found the samples to be similar on sociodemographic variables (age, race/ethnicity, gender, education) but our final analytic sample had fewer social and medical unmet needs and barriers to care, and fewer chronically homeless persons compared to the overall samples with incomplete data (n=438). We have also included a table in the Supplementary Information section describing these differences.

o Statistical Analyses (lines 178-193): Thank you for this suggestion and citation. Our main objective of the study was to examine housing stability as a mediator on health outcomes. Therefore, we wanted to see if achieving housing stability and dose of patient navigation at 6 months led to better outcomes at 12 months. We used current standard software for path analysis, M-plus, that can incorporate time varying mediation. We realize that it is challenging to achieve housing stability in 6 months. We wanted, however, to examine intervention effects that occurred prior to our outcomes to better understand the potential mechanisms of action of the intervention. If our intervention and outcomes were occurring at the same time point (12 months) it would be more difficult for us to tease out the intervention mechanism.

o Measures lines 135-196: we have included more information and description about all our measures. We had included a citation to a previous published study that has all the measures defined to save on word count. However, this section is now updated per the reviewer’s suggestion to include all the measures and appropriate citations.

o Navigation activities lines 143-158: We have included more description of the activities provided under each program domain.

o Comment #11 on intervention dose: Our goal in this paper was to explore the global effects of patient navigation and dose on housing stability and health outcomes. It was beyond the scope of the paper to examine the types of activities. We wanted to keep the paper focus to the questions of overall dose. We are planning to do a more in-depth exploration for patient navigation activities in this population in the future.

o Pharmacological viral treatment: We did not collect information on the specific pharmacologic treatments. This paper focuses on navigation and linkage to housing and HIV health outcomes: retention and viral suppression.

• Discussion: We have revised the manuscript to give more understanding about patient navigation and who the patients are and the types of services provided. We have also included more description of the unmet needs, both non-medical and medical.

o Line 309-319: We have revised this section and commented on whether navigation activities facilitate immediate access to housing. In table 3 our logistic regression shows that navigation dose at any level led to greater odds of housing stability, although there was no significant difference between those who received a lower dose versus those who received a higher dose. We more clearly explain that our navigators provided multiple services and it is difficult to tease out if one type of service made a difference on housing stability (see Table 1). In bivariate analyses, types of services seemed to more related to health outcomes viral suppression and health care support and access to housing and retention in care.

• Line 218-235: We have revised to include a description based on bivariate analyses that health care related services and educational and emotional support are more likely to impact viral suppression. There was no one type of service (Table 2) that was more related to housing stability, as it appears all activity was related although we did not find a significant association. This could be attributed to the short term of 6 months time frame that we investigated.

• Line 319: Yes, we included the mixed effects of educational support on viral suppression in the manuscript. Please see lines 226-228.

• Limitations: Yes, participants had access to pharmacological treatment. Although we did not collect data on their specific medications—this was a patient center medical home and the role of the navigator was to connect participants to HIV medical care (a prescribing provider) and housing

Reviewer 3:

• Comments #1 & 2: We have revised the abstract and edited for appropriate punctuation such as removing or adding extra periods per the Reviewers 2 & 3 suggestions.

• Comment #3: We have updated the introduction to provide more detailed description of Navigation models.

• Comment #3: Line 69-71, the test for statistical significance has been added

• Comment # 4: Lines 99-102: A general definition of the medical home intervention is included.

• Comment #5: Lines 135-138: The definition for retention in care and viral suppression are defined under measures in the methods section of the paper. The time for both measures is at 12 months post intervention and we have added a citation for both measures. The viral suppression measure is the standard measure used by HRSA. Retention in care has several definitions we have selected to use the one recommended in the paper by Mugavero. From our perspective this definition would seem important for continuity of care for people with HIV who are experiencing homelessness and a co-morbid condition such as mental health and/or substance use.

• Comments # 6 & #7 on Table 1: We have revised the table to include row percentages per the reviewer’s suggestion. In addition, we have clearly labelled all Column headers to include N (%).

• Comment # 8: Thank you for your question about our finding that there was a higher percentage of participants virally suppressed (75%) vs retained in care (for males 75% were virally suppressed and 55% were retained in care). We hypothesize this is attributable to the fact that some of our sites had medical home teams that were “mobile” with a physician, navigator, nurse and/or social worker. Some participants were seen by a prescribing health care provider in the community, were followed up with their antiretroviral medication consistently, and then connected with a four walls clinic such as community health center (with which many of these mobile teams were affiliated or had partnerships). Furthermore, we used a conservative definition of retention in care in which a person had to be seen at the clinic at least two appointment 90 days apart in a 12-month period. Some participants may have only been seen at 6 months and then could have received their ART prescription for 6 months. Unfortunately, we were not able to obtain from chart review the date of last prescription. We only had information if they had a recent prescription documented in their chart (yes/no).

• Comment # 9: We have updated the Gender variable in Table 1 to include the titles: “cis male” and “b cisgender female”.

• Comment #10: lines # 324-336: The manuscript has been revised to more neutral language and we removed the perceived bias towards patient navigation activities. In addition, we have expanded discussion in the second paragraph about the lack of randomization in the study. Unfortunately, we were not able to find a citation about the higher need patients needing the most help and struggling to achieve housing stability and viral suppression.

• Comment #11: The sentence has been revised to say “across” instead of “crossed”. Thank you for finding this error.

• Comments #12-14: This section has been revised to remove any reference to peer navigation models so as not to speculate differences with this model versus other navigation models since it was not the scope of the paper. The scope of this paper was to examine dose of navigation activities and a future paper will examine the team composition.

• Comment #15: The sentence has been changed from “for” to “of”.

• Comment #16. The results section (lines 254-255) indicate the findings for transgender and food insecure persons.

Thank you for the detailed review of our manuscript and the opportunity to make revisions. We look forward to the opportunity to publish our study in PLoS ONE.

Attachment

Submitted filename: Response to Reviewers-4-2020.docx

Decision Letter 1

Laramie Smith

11 Jun 2020

PONE-D-19-29536R1

Pathways to housing stability and viral suppression for people living with HIV/AIDS: Findings from the Building a Medical Home for Multiply Diagnosed HIV positive Homeless Populations Initiative

PLOS ONE

Dear Dr. Rajabiun,

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Additional Editor Comments (if provided):

Dear Serena,

Many thanks for your detailed response to the reviewers comments. I believe this paper is positioned to make important contributions to the field.

From my read there is only one minor issue that could enhance the contributions of the publication in its current form. I believe R2 had asked for a legend in Figure 2, but that a bit more specificity may have helped in their request. I believe this figure presents the heart of this manuscript, and readers, like me may want to jump right to the figure to understand what the study found before they read all of the study methods. I would recommend that the figure legend be expanded on, in addition to specifying how results are presented. Specifically, it is not clear in the figure what H and VH are referring too. Figure 1 lets me know this is your patient navigation intervention dose, but if I'm just looking at Figure 2 I miss that this is (a) intervention dose, and (b) what the intervention dose is (i.e. patient navigation).

Could you, for example, label that box PN Dose: H: High v. Low -- VH: Very High v. Low, and then in the legend spell out that PN = Patient Navigation, PN Low dose: (give brief description of this dose), PN High dose: (give brief description of this dose), PN Very High dose: (give brief description of this dose)? That way a reader has all the information they need to interpret this figure in one spot. I think this minor revision will substantially help the interpretability of study findings.

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PLoS One. 2020 Oct 1;15(10):e0239190. doi: 10.1371/journal.pone.0239190.r004

Author response to Decision Letter 1


12 Jul 2020

We have updated Figure 2 to include a legend with a description of the patient navigation dose. We hope this addresses the editor's comments and makes the diagram more easily interpreted for the reader.

In response to an email dated 7/2/2020, a revised version of the manuscript has been uploaded with the file name "Manuscript 7-20" which is laid out in Portrait orientation not landscape with one-inch margins on all sides. Please advise if further changes are necessary.

Attachment

Submitted filename: Response to Reviewers-4-2020.docx

Decision Letter 2

Zixin Wang

2 Sep 2020

Pathways to housing stability and viral suppression for people living with HIV/AIDS: Findings from the Building a Medical Home for Multiply Diagnosed HIV positive Homeless Populations Initiative

PONE-D-19-29536R2

Dear Dr. Rajabiun,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

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Kind regards,

Zixin Wang, PhD.

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments:

Acceptance letter

Zixin Wang

15 Sep 2020

PONE-D-19-29536R2

Pathways to housing stability and viral suppression for people living with HIV/AIDS: Findings from the Building a Medical Home for Multiply Diagnosed HIV positive Homeless Populations Initiative

Dear Dr. Rajabiun:

I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department.

If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org.

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Thank you for submitting your work to PLOS ONE and supporting open access.

Kind regards,

PLOS ONE Editorial Office Staff

on behalf of

Professor Zixin Wang

Academic Editor

PLOS ONE

Associated Data

    This section collects any data citations, data availability statements, or supplementary materials included in this article.

    Supplementary Materials

    S1 Table. Study sample attrition analysis, HRSA/SPNS Building a Medical Home for Multiply-Diagnosed HIV-positive Homeless Populations initiative from 2013–2017.

    (DOCX)

    Attachment

    Submitted filename: Response to Reviewers-4-2020.docx

    Attachment

    Submitted filename: Response to Reviewers-4-2020.docx

    Data Availability Statement

    The data underlying the results presented in the study are available upon request from the Biostatistics and Epidemiology Data Coordinating Center. Due to the sensitive nature of the data and as required by the Boston University Medical Campus Institutional Review Board (IRB). datasets are stored for up to seven years from the close of the study, and thus with this project through 2025. Data requests can be sent to Boston University’s Biostastics & Epidemiology Data Analytics Center (BEDAC) @ bedacprp@bu.edu. This request will be sent to the study’s Publications & Dissemination Committee, which consists of the Principal Investigators from each local study sites, the multisite evaluation center at Boston University and HRSA. As Principal Investigator for the multisite evaluation center I will manage the approval process, in accordance with our policy and guidelines Once a data request is approved by the P & D committee, BEDAC will work with the requesting party to create a dataset for processing fee.


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