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. Author manuscript; available in PMC: 2022 Feb 1.
Published in final edited form as: J Acquir Immune Defic Syndr. 2021 Feb 1;86(2):191–199. doi: 10.1097/QAI.0000000000002548

Embedding a Linkage to Pre-Exposure Prophylaxis (PrEP) Care Intervention in Social Network Strategy and Partner Notification Services: Results from a Pilot Randomized Controlled Trial

Daniel Teixeira da Silva 1,2, Alida Bouris 3,4, Arthi Ramachandran 4, Olivia Blocker 4, Billy Davis 4, James Harris 4, Maria Pyra 4,5, Laura K Rusie 4, Russell Brewer 2,4, Jade Pagkas-Bather 2,4,5, Anna Hotton 4, Jessica P Ridgway 2,4, Moira McNulty 2,4, Ramona Bhatia 6, John A Schneider 2,4,5,7
PMCID: PMC8103968  NIHMSID: NIHMS1690443  PMID: 33109935

Abstract

Background:

Increased pre-exposure prophylaxis (PrEP) uptake among Black men who have sex with men and Black transgender women (BMSM/TW) is needed to end the HIV epidemic. Embedding a brief intervention in network services that engage individuals in HIV transmission networks for HIV/STI testing may be an important strategy to accelerate PrEP uptake.

Setting:

Partner Services PrEP (PS-PrEP) study is a pilot randomized control trial to improve linkage to PrEP care among BMSM/TW presenting for network services in Chicago, IL from 2015 to 2017.

Methods:

BMSM/TW (N=146) aged 18–40 were recruited from network services (partners services and social network strategy services). Intervention participants developed an individualized linkage plan based on the Information-Motivation-Behavioral Skills model and received mini-booster sessions. Control participants received treatment as usual. Socio-demographic, behavioral, and clinical factors were examined at baseline, three- and 12-months post-intervention. Intent-to-treat analyses examined linkage to PrEP care within three months post-intervention (primary outcome). Secondary outcomes were PrEP initiation, time to linkage to PrEP care, and time to PrEP initiation.

Results:

Compared to control participants, a significantly greater proportion of the intervention participants were linked to PrEP care within three months (24% vs. 11%; p=0.04) and initiated PrEP (24% vs. 11%, p=0.05). Among those linked to PrEP care within the study period, intervention participants were linked significantly sooner than control participants (median [interquartile range] days, 26.5 [6.0, 141.8] vs. 191.5 [21.5, 297.0]; p=0.05).

Conclusion:

Study results support the preliminary efficacy of PS-PrEP to improve linkage to PrEP care and PrEP initiation among BMSM/TW.

Keywords: Pre-exposure prophylaxis, HIV, Linkage, Black, Men who have sex with men, Randomized Control Trial

Introduction

Pre-exposure prophylaxis (PrEP) with emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) is over 90% effective in preventing HIV transmission,1 and, in 2012, was approved by the Federal Drug Administration for HIV prevention in the United States (U.S.).1 Despite this advance, HIV in the U.S. continues to disproportionately affect Black men who have sex with men (MSM) and transgender women (TW) (BMSM/TW). From 2012 to 2017, HIV incidence decreased by 14% among White MSM while increasing 3% among BMSM.2 The Centers for Disease Control and Prevention estimates an HIV prevalence of 44.2% among Black TW compared to 6.7% among White TW.3 Despite high levels of willingness to take PrEP,4–7 numerous studies have documented low PrEP uptake among BMSM/TW.6–10 In 2017, 5.9% of PrEP-eligible Black persons aged ≥13 years received a prescription for FTC/TDF compared to 42.1% for Whites.11 Racial inequity is a major driver of HIV incidence in the U.S. and increasing PrEP uptake among BMSM/TW is an urgent priority in most Ending the HIV Epidemic plans throughout local jurisdictions.12–14

Research investigating the delivery of real-world implementation strategies to support PrEP uptake among BMSM/TW in the U.S. is limited.15 A recent review of behavioral interventions to enhance PrEP uptake among BMSM found only seven studies that included BMSM.16 Of those, only one study showed an increase in PrEP adherence but consisted of a primarily White study population, decreasing generalizability to BMSM.16,17 Other open-label studies provide PrEP care at no cost, limiting applicability and relevance to real-world settings.13,18 Thus, there is a lack of evidence-based interventions to support PrEP uptake among BMSM/TW.

Social network approaches may provide important infrastructure to accelerate PrEP uptake among populations most vulnerable to HIV. Network induction stimulates the dissemination of information and behaviors through established social networks.19 Network induction strategies include network referral services, such as partner notification services (PNS)20 and social network strategy services (SNSS),21 hereafter network services, which can identify individuals in HIV transmission networks who may benefit from PrEP. In 2016, 37% of BMSM/TW presenting for PNS across 59 U.S. health departments received a new diagnosis of HIV.20 Accordingly, health departments have integrated PrEP within PNS.22–24 Similarly, SNSS have been shown to increase HIV testing and diagnosis25,26 and identify BMSM at increased risk for seroconversion.21,27 SNSS have been implemented by health departments alongside PNS27,28 and are promoted by the World Health Organization to increase HIV testing among key populations.28 Given these data, combining linkage to PrEP care interventions with network services may be a promising approach to link BMSM/TW to PrEP care.

We developed the Partner Services PrEP (PS-PrEP) intervention to improve linkage to PrEP care among BMSM/TW presenting for network services. In the current study, BMSM/TW presenting for network services were recruited to receive a brief intervention based on the Information-Motivation-Behavioral Skills (IMB) Model.29 Several studies have found that IMB has robust empirical support for understanding the determinants of PrEP uptake.29–31 Building on this work, a growing number of IMB-based interventions to improve PrEP Continuum of Care outcomes have been developed.32–35 Here, we report the preliminary efficacy results of the PS-PrEP study, a pilot randomized controlled trial to increase PrEP uptake among BMSM/TW at increased risk for HIV seroconversion. The primary outcome was linkage to PrEP care within three months of receiving the intervention. We hypothesized that a higher proportion of participants who received the PS-PrEP intervention would be linked to PrEP care within three months of the intervention compared to those who received treatment as usual.

Methods

Recruitment and Study Population

Recruitment of adult men and TW presenting for network services was conducted between November 2015 and November 2017. PNS are provided through public health departments on a voluntary basis to people diagnosed with sexually transmitted infections (STI), including HIV, and their sex or needle-sharing partners, who are confidentially notified of possible HIV exposure and offered free services, such as HIV testing and counseling.36 SNSS entails enlisting individuals presenting for HIV/STI testing to recruit their social network associates who may be at increased risk for HIV seroconversion or unaware of their HIV status for testing.25,26,37 In the current study, SNSS were implemented in an academic-affiliated community site that offers HIV/STI testing and is co-located with a federally qualified health center (FQHC) that specializes in sexual health. PNS were implemented by the Chicago Department of Public Health (CDPH) in public STI clinics. Individuals receiving network services were offered routine HIV/STI testing, and those who reported being HIV negative were assessed for eligibility.

Inclusion criteria were: (1) assigned male sex at birth; (2) self-identified as Black; (3) aged 18–40 years; (4) reported sex with a man or transgender woman in the past six months; (5) self-reported being HIV seronegative; (6) English speaking; (7) living in the Chicago metropolitan area at least six months of the year; and (8) owning a cell phone and agreeable to text/phone communication. Participants were excluded if they reported taking PrEP in the previous 12 months, planned to move out of the Chicago area within the next 12 months, or were unable to provide informed consent. Figure 1 shows the CONSORT diagram for the study. In total, 357 candidates were assessed for eligibility and a total of N=146 eligible BMSM/TW consented and enrolled. Participants were able to enroll in the study prior to receiving confirmatory HIV test results. If participants were found to be HIV seropositive upon linkage to PrEP care, they were included in the linkage to PrEP care analysis but excluded from the PrEP initiation analysis.

Figure 1:

Figure 1:

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PS-PrEP Study Consort flow diagram

Study Assessments

Data Collection, Randomization, and Masking

Survey data was collected at baseline, three- and 12-months post-intervention by trained interviewing staff using RedCap, a secure online survey software.38 Participants received a $25 cash incentive at each assessment. Following the baseline assessment, participants were randomized using block randomization into one of two groups: PS-PrEP intervention or treatment as usual (TAU). Due to the nature of the intervention, complete blinding of participants, investigators and interventionists was not possible. All protocols were approved by the University of Chicago, CDPH and Howard Brown Health Institutional Review Boards. ClinicalTrials.gov Identifier: NCT02749955.

The PS-PrEP Intervention

The PS-PrEP intervention consisted of a 60-minute face-to-face session with a social work interventionist (SWI) who guided participants through four components based on the IMB model.31 In the first component, the SWI provided interactive education on HIV and PrEP. Building on this content, the SWI used motivational interviewing techniques39 to assess participant’s intrinsic motivation to reduce HIV risk and engage in PrEP care. A motivational scale was used to facilitate a conversation on HIV risk reduction, and the participant and SWI completed a pros and cons worksheet40 to guide a discussion on enacting change. In the third component, the SWI and participant developed a Linkage Roadmap, a personalized plan to navigate linkage to PrEP care. Adapted from the Life Steps intervention,41,42 the Linkage Roadmap included a plan to: (1) identify a primary care physician or medical home for PrEP care; (2) review the PrEP appointment schedule; (3) manage barriers to care engagement and medication adherence, including stigma, provider communication, transportation, and side-effects; and (4) develop skills to maintain a daily medication schedule.41,42 After completing the Linkage Roadmap, participants received a comprehensive list of PrEP care providers in Chicago. In an optional fourth component, the SWI completed problem-solving exercises with participants who identified significant barriers in their Linkage Roadmap and/or decided not to engage in PrEP care linkage.

Participants received up to four mini-booster sessions via phone or text message from the SWI until they were linked to PrEP care or up to 12 weeks post-intervention. The mini-boosters served to check-in with participants about experiences getting linked to PrEP care, answer questions, review the Linkage Roadmap, and problem-solve difficulties enacting the Linkage Roadmap.

Control condition

The control group received TAU, which included a brief risk assessment, referral for additional STI testing and provision of HIV prevention programing, including PrEP care, by community-based or CDPH staff.

Measures

Socio-demographic factors

Socio-demographic measures included Latinx identity, gender identity, sexual orientation, educational achievement, employment status and health insurance coverage.

Psychosocial characteristics

Depression was assessed with the Brief Symptom Inventory-18; those with a depression subscale T-score > 62 were categorized as having depression (0=no, 1=yes).43 A single item assessed binge drinking, i.e., ≥ 5 alcoholic drinks on the same occasion, in the past three months. Heavy marijuana use was categorized as smoking or ingesting marijuana ≥ 4 times per week or < 4 times per week or never. A binary variable for illicit substance use based on affirmative responses to using any other illicit substance to get high or buzzed in the preceding three months.

PrEP awareness and HIV risk perception

PrEP awareness was assessed with a single yes-no question: “Before today, have you heard about pre-exposure prophylaxis (PrEP)?”44 Perception of risk of HIV infection was assessed by two items that asked participants about how likely they are to get infected with HIV (0=almost zero to 5=very large) and how concerned they are about becoming HIV infected (0=not concerned to 5=extremely concerned).45

HIV serostatus and STIs

HIV and STI testing were completed according to agency protocols. Active syphilis infection was defined as an RPR titer > 1:8. Genital and extragenital gonorrhea and chlamydia, syphilis and HIV infections were abstracted from participant’s electronic medical record (EMR) through release of information and data sharing Memorandums of Understanding with PrEP providing clinics and service programs.

Outcome measures

The primary outcome was linkage to PrEP care, which was defined as having at least one outpatient clinic visit within three months of the baseline session (e.g., linkage window) where PrEP was discussed with a PrEP prescriber regardless of whether PrEP was initiated. Secondary outcomes included PrEP initiation within the linkage window and within the study period, as well as linkage to PrEP care, time to linkage to PrEP care, and time to PrEP initiation within the study period. PrEP initiation was defined as receiving a prescription for FTC/TDF. We abstracted visit data from the EMR and evaluated three-month survey results to evaluate linkage to care within the linkage window (e.g., primary outcome) and PrEP initiation within the linkage window. All other outcomes were measured by abstracting clinic data from the EMR.

Statistical Analysis
Primary analysis.

All analyses were completed using R Statistical Software (R Version 3.5.2).46 Due to the pilot nature of the study, statistical significance was set at p ≤ 0.05. The study recruitment goal was 150 participants based on 80% power and two-sided alpha of 0.05, assuming linkage to PrEP care in the control group of 8% and PS-PrEP intervention group of 25%. To evaluate baseline equivalence across treatment groups, we first conducted chi-square or Fisher’s exact tests for categorical variables and Wilcoxon rank-sum tests for continuous variables. We calculated the cumulative incidence of STIs and compared difference between groups by estimating Risk Ratios (RR). In order to ensure that previous engagement in care at the FQHC co-located with the community site did not influence our results, we also compared the proportion of participants in each group who had non-PrEP clinic visits at the FQHC in the six months prior to baseline.

For the primary outcome, an intent-to-treat analysis using chi-square tests was performed to evaluate the preliminary efficacy of the PS-PrEP intervention on linkage to PrEP care within the linkage window. We also completed a sensitivity analysis excluding participants who were diagnosed with HIV after baseline or who moved away from Chicago after baseline.

Secondary analysis.

Intent-to-treat analysis was also completed for secondary outcomes. We examined treatment effects on the time to linkage to PrEP care and time to PrEP initiation within the study period by using Wilcoxon rank-sum tests, and on the proportion linked to PrEP care within the study period and the proportion initiated PrEP within the linkage window by using chi-square tests. Time to PrEP initiation analysis was limited to participants linked to care.

Results

Descriptive characteristics.

A total of 136 participants were included in the primary analysis (Figure 1 and Table 1). The study population was predominantly younger (median = 25.9 years, interquartile range [IQR] = 22.5, 28.5), gay-identified (62%) Black men and transgender women with a high school education (92%) and health insurance (83%). There were no significant differences in sociodemographic factors between study groups. At baseline, perception of HIV risk or PrEP awareness did not differ significantly between groups. Almost all participants (97%) were aware of PrEP and 68% were moderately or extremely concerned about seroconverting; however, only 8% thought their chance of becoming HIV seropositive was large or very large. There was no significant difference between groups in non-PrEP clinic visits at the co-located FQHC six-months prior to the study (8% vs. 6%; p=0.74)

Table 1:

Baseline characteristics of study participants, PS-PrEP 2015–2018, Chicago

Study Population (n = 136) Control Group (n = 65) Intervention Group (n = 71) Test Statistic* p value*
Median age in years (Interquartile range) 25.9 (22.5, 28.5) 25.9 (23.3, 28.4) 25.7 (21.9, 28.8) W = 2480 0.45
Latinx Ethnicity (%) 8 (6) 5 (8) 3 (3) N/A 0.48
Transgender or queergender identity (%) 10 (7) 5 (8) 5 (7) N/A 1.00
Sexual orientation (%) N/A 0.11
Straight 2 (1) 1 (2) 1 (1)
Gay 85 (62) 44(68) 41 (58)
Bisexual 44 (32) 20 (31) 24 (34)
Queer 5 (4) 0 (0) 5 (7)
Education (%) 2.3 (3 df) 0.52
Some high school 11 (8) 6 (9) 5 (7)
High school 41 (30) 17 (26) 24 (34)
Some college† 68 (50) 32 (49) 36 (51)
Bachelor’s or higher 16 (12) 10 (16) 6 (9)
Employment (%) 4.6 (3 df) 0.21
Full-time 54 (40) 31 (48) 23 (32)
Part-time 36 (26) 13 (20) 23 (32)
Unemployed 35 (26) 17 (26) 18 (25)
Other 11 (8) 4 (6) 7 (10)
Health Insurance (%) 113 (83) 57 (88) 56 (79) 1.9 (1 df) 0.17
Depression (%) 20 (15) 12 (18) 8 (11) 1.4 (1 df) 0.24
Binge drank alcohol (%) 32 (24) 15 (23) 17 (24) 0.0 (1 df) 0.91
Heavy marijuana use†† (%) 55 (40) 28 (43) 27 (38) 0.4 (1 df) 0.55
Illicit substance use (%) 17 (12) 7 (11) 10 (14) 0.3 (1 df) 0.56
Sexually transmitted infections (%) 13 (10) 5 (8) 8 (11) 0.5 (1 df) 0.48
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*

Wilcoxon rank-sum test (test statistic = W) for continuous variables, Fisher’s exact test (no test statistic) for categorical variables with N ≤ 5, and Chi-square test (df = degrees of freedom) categorical variables with N > 5.

†

Some college, associate’s or technical school.

††

≥ 4 times per week.

There were 35 STIs diagnosed during the study period among 27 participants, of which 13 were diagnosed at baseline. The cumulative incidence of any STI diagnosis among the study population was 26 per 100 person-years and was not significantly different between groups (RR 1.08, 95% CI: 0.56–2.11). Six participants were diagnosed with HIV after completing the baseline survey, two of which were linked to PrEP care and received their diagnosis at their first clinic visit. There were no HIV seroconversions after PrEP initiation. One participant moved out of Chicago after being linked to PrEP care. The six participants diagnosed with HIV after the baseline survey and the participant who moved out of Chicago were excluded from the secondary analysis.

Intervention completion rates.

The initial 60-minute face-to-face session was completed by 97% of participants. Not all participants in the intervention group completed all four booster sessions. Due to changes in contact information and client preference, the SWI utilized Facebook messages and emails in addition to calls and texts to deliver booster sessions. During the linkage window, 67% (n=48) received a median (IQR) of 3.0 (1.0, 4.0) booster sessions and 13% (n=9) received more than four booster sessions (max=11).

Primary and secondary outcomes.

Linkage to PrEP care and PrEP initiation outcomes are described in Table 2. Analysis of the EMR clinic data demonstrated that, compared to control group participants, a significantly greater proportion of participants who received the PS-PrEP intervention were linked to PrEP care within the linkage window (24% vs. 11%; p=0.04). In the intervention group, 82% (n=14) of those linked to care within the linkage window and 86% (n=12) of those who initiated PrEP within the linkage window received at least 1 booster session. Among those linked to PrEP care within the study period, participants who received the PS-PrEP intervention were linked to PrEP care significantly sooner (median [IQR] days, 26.5 [6.0, 141.8] days vs. 191.5 [21.5, 297.0] days; p=0.05) than were participants in the control group.

Table 2:

Linkage to PrEP care and PrEP initiation outcomes of the PS-PrEP study, 2015–2018, Chicago.

Study Population (N = 136) n (%) or Med (IQR) Control group (n = 65) n (%) or Med (IQR) Intervention group (n = 71) n (%) or Med (IQR) Test Statistic p-value
Initiated PrEP within linkage window‡, † 21 (15) 7 (11) 14 (20) 2.1 (1 df) 0.15
Linked to PrEP care within linkage window‡ 24 (18) 7 (11) 17 (24) 4.1 (1 df) 0.04
Initiated PrEP within study period‡, † 41 (32) 17 (27) 24 (37) 1.3 (1 df) 0.25
Linked to PrEP care within study period‡ 46 (34) 20 (31) 26 (37) 0.5 (1 df) 0.47
Days to PrEP care linkage within study period‡, †† 61.0 (9.8, 258.8) 191.5 (21.5, 297.0) 26.5 (6.0, 141.8) W = 349.5 0.05
Days to PrEP initiation within study period‡, †, †† 93.0 (9.0, 287.0) 209.0 (20.0, 327.0) 61.0 (6.0, 253.0) W = 244 0.30
Initiated PrEP within linkage window‡‡, † 23 (18) 7 (11) 16 (24) 3.8 (1 df) 0.05
Linked to PrEP care within linkage window‡‡ 28 (21) 9 (14) 19 (27) 3.5 (1 df) 0.06
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Notes: Med = Median; IQR = interquartile range; linkage window = 3 months after baseline; study period = 12 months after baseline.

*

Wilcoxon rank-sum test (test statistic = W) for continuous variables, and chi-square test (df = degrees of freedom) for categorical variables.

‡

Clinic data abstracted from the electronic medical record.

‡‡

Self-reported 3-month survey data.

†

PrEP initiation analysis excluding the six participants who tested seropositive after study enrollment and the one participant who moved out of Chicago (n = 129; control group N = 63; intervention group N = 66).

††

Among participants linked to PrEP care within the study period.

One-hundred and eight (79%) participants complete the three-month follow-up survey. Analysis of the three-month survey data demonstrated that, compared to control group participants, a significantly greater proportion of participants who received the PS-PrEP intervention initiated PrEP (11% vs 25%; p=0.05). There was no significant difference in self-reported linkage to care at three-months. A significantly smaller proportion of participants who completed the three-month follow-up survey had depression, compared to those who did not (Supplemental Table 3). The sensitivity analysis did not demonstrate significant differences in linkage to PrEP care outcomes between groups but did demonstrate the same significant PrEP initiation outcomes (Supplemental Table 1 and Supplemental Table 2).

Discussion

We investigated the preliminary efficacy of PS-PrEP to increase linkage to PrEP care among BMSM/TW accessing network services. Compared to the control group, we found that a significantly higher proportion of BMSM/TW who received the PS-PrEP intervention were linked to PrEP care and initiated PrEP within the three-month linkage window. We also found a lower median time for linkage to PrEP care over the 12-month study period between the intervention and control groups. Our results demonstrate that the PS-PrEP intervention can increase PrEP uptake among BMSM/TW presenting for network services. PS-PrEP offers a novel approach to achieving health equity and eliminating HIV transmission among BMSM/TW, the two populations most impacted by HIV47 and least likely to be engaged in PrEP care in the U.S.48

While BMSM/TW who received the PS-PrEP intervention had improved outcomes, linkage to PrEP care and PrEP initiation remained low across our study population. At the three-month follow-up, the most common reason for not attending a scheduled PrEP care appointment was being busy (data not shown), which suggests competing needs and priorities. Although most participants were concerned about HIV, very few thought they were at risk for HIV infection. Low self-perceived risk of HIV infection has previously been identified as a barrier to PrEP care among BMSM49 and may have influenced our results. Other identified barriers to PrEP uptake among BMSM include racism,50 stigma,13,50,51 mistrust in medical care,50,51 concern about side-effects,13 cost13,18 and insurance status.52 Some barriers, such as stigma, side effects, low-risk perception and insurance status, were addressed in the PS-PrEP intervention. However, barriers such as mistrust in medical care51 and racism50 were not directly addressed. At baseline 10% of participants reported not knowing where they would sleep every night, 30% reported spending time in jail or a juvenile detention facility, and 33% reported not feeling safe walking in their neighborhood (results available from first author). Housing instability, criminal legal system involvement and exposure to community violence is prevalent among BMSM/TW in Chicago,53 and may have contributed to limiting PrEP uptake among our study population. Lastly, depression and substance use were prevalent among our study population. Depression has been associated with increased PrEP uptake among BMSM,10,49 but the association between substance use and PrEP uptake has been less clear.54–56 Future research should elucidate the role of structural barriers, racism, medical mistrust, depression, and substance use in PrEP-related decision-making among BMSM/TW.

HIV testing was not required for enrollment in the PS-PrEP study. There were six participants who were diagnosed with HIV, of whom two were diagnosed when they presented for PrEP care. Participation in PrEP linkage to care programs may require HIV testing;22,57 however, successful same-day start PrEP programs do not complete confirmatory HIV testing prior to starting PrEP.58–61 Similar to the PS-PrEP study, a concurrent CDPH intervention (PrEPLine) also included clients who self-reported negative HIV status.24 Confirmatory HIV testing may be an unnecessary barrier to linkage to PrEP care. Our results indicate that PrEP linkage programs may also need to be prepared to provide HIV care to people found to have newly seroconverted.

Implementation of the PS-PrEP intervention provides useful insights into how future programs may successfully integrate behavioral interventions into network services. The face-to-face component was highly acceptable and completed by 97% of participants in the intervention group. Booster session completion, however, was less than originally planned, with two-thirds of the intervention group completing at least one mini-booster. Participant cell phone information was often inaccurate or out-of-date, which likely contributed to limited fidelity to this component of the protocol. Program staff addressed this issue by utilizing other methods to contact participants, such as through private Facebook and email communication. Most participants in the intervention group who were linked to PrEP care or initiated PrEP within the linkage window received booster sessions, which suggests that boosters were an important component of the PS-PrEP intervention. Additional qualitative research with BMSM/TW to examine which components of the intervention may be more acceptable and/or appropriate are needed.

In addition, the PS-PrEP study was designed to be integrated into CDPH PNS and target clients presenting for HIV testing at public STI clinics. However, most enrolled study participants were recruited from SNSS. Over the study period, CDPH implemented PrEPLine, a low-threshold phone-based linkage to PrEP care intervention at public STI clinics.24 Clinic clients were recruited directly to the in-house intervention.24 Consequently, nearly all the participants enrolled in the current study were recruited via SNSS. Our results revealed barriers at the individual, e.g., consistent cell phone numbers, and settings levels to implementing the PS-PrEP intervention in different clinical sites. Formal metrics or methods examining implementation science were beyond the scope of the study. Future studies may benefit from incorporating an implementation science component guided by existing models35,62–64 in order to promote linkage to PrEP care for BMSM/TW into routine network services across diverse contexts.

These results should be interpreted in the context of the study limitations. A small number of Black TW were enrolled in the study, thus limiting our ability to determine preliminary efficacy specifically among this subgroup of participants. The study population is likely subject to selection bias as candidate participants were identified when presenting for HIV or STI testing via network services. BMSM/TW not engaged in HIV or STI testing may represent an even higher risk population than those in the present study. In addition, while the initial design was to integrate PS-PrEP into CDPH PNS, most participants were recruited from a community site providing HIV and STI testing via SNSS21 that is co-located with an FQHC specializing in sexual health.65 Co-location52 of the community site and FQHC in the same building may not be available in other contexts. To compare to real-world settings, the control group received TAU rather than time matched sessions, which limited interpretation of how separate components of PS-PrEP impacted outcomes. Lastly, Illinois expanded Medicaid in 2014, prior to the current study, which likely contributed to the high rate of health insurance among participants. Thus, the PS-PrEP intervention may require health insurance assistance if implemented in states that have not expanded Medicaid. In the current study, there was staff turnover across study sites and changes in participant cell phone numbers over time. These issues have been documented in prior research.66–68 Thus, our results demonstrate a real-world implementation of the PS-PrEP intervention, which may be subject to similar limitations in other settings. Although clinic data was overwhelmingly from the largest PrEP provider in Chicago, it was limited to a single FQHC network, and 21% of participants did not complete the three-month follow-up survey. As such, we may have underestimated linkage to PrEP care. A larger trial of the PS-PrEP intervention is necessary to fully evaluate the effect of the PS-PrEP intervention on linkage to PrEP care at a population level.

Racial inequity is a major driver of the HIV epidemic in the U.S. Prevention of HIV transmission with PrEP is a central component of eliminating HIV in the U.S.14 and lower uptake of PrEP among BMSM/TW could worsen racial inequity in HIV incidence.12,13 Network services are effective in identifying BMSM/TW at increased risk for seroconversion,20,21,27 and are promising strategies to accelerate PrEP uptake. To our knowledge, the PS-PrEP study is one of the first efficacious network service linkage to PrEP care interventions tailored to BMSM/TW. PS-PrEP significantly increased PrEP uptake among BMSM/TW, but linkage to PrEP care and PrEP initiation remained low. Future studies utilizing the PS-PrEP strategy may further improve PrEP outcomes by addressing structural barriers, racism and medical mistrust, as well as adapting booster sessions to facilitate continued engagement between PrEP care clinics and participants.

Supplementary Material

1

Acknowledgments:

This study was funded by the National Institute of Mental Health (1R34MH104058-01). The authors would like to thank the study participants, as well as the staff at Howard Brown Health, the Chicago Department of Public Health and the University of Chicago. R. Brewer’s time was supported by a grant from NIMH (R21MH121187). This publication was made possible with help from the Third Coast Center for AIDS Research (CFAR), an NIH funded center (P30 AI117943).

Funding: This study was funded by the National Institute of Mental Health (1R34MH104058-01). ClinicalTrials.gov Identifier: NCT02749955.

Footnotes

Author conflicts of interest: none

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