Using Bundled Interventions to Improve Health Outcomes for Black Cisgender and Transgender Women: Findings From the Black Women First Initiative

Abstract

Objectives. To examine the effects of replicating a bundled package of evidence-informed interventions on social determinants, HIV health outcomes, and health-related quality of life (HRQoL) for 697 Black cisgender and transgender women with HIV across 12 US sites from 2021 to 2023.

Methods. Women participated in a minimum of 2 interventions. We collected self-reported HRQoL and social determinants via interview at baseline, 6 months, and 12 months. We collected retention in care and viral suppression via medical chart review. We examined effects by gender identity and type and number of bundled interventions received.

Results. In the 12-month postenrollment period, 85.0% of women reached viral suppression and 74.3% were retained in care. Social determinants and HRQoL improved over time. Transgender women had significantly lower odds of retention in care compared with cisgender women (adjusted odds ratio = 0.85; 95% confidence interval = 0.77, 0.93) but an overall higher physical HRQoL score (46.8 vs 40.8). Viral suppression and mental HRQoL did not differ by gender identity.

Conclusions. Using a bundled intervention is a promising approach to reach and provide culturally relevant care for Black women with HIV. (Am J Public Health. 2025;115(S1):S46–S56. https://doi.org/10.2105/AJPH.2025.308019)

The National HIV/AIDS Strategy (NHAS; 2022–2025) identifies Black women as a priority population for the Ending the HIV Epidemic initiative in the United States by 2030.¹ Black/African American women are 16 times more likely to acquire HIV than are White women and account for 55% of HIV-related deaths among all women.² This disparity is rooted in social and structural determinants, such as racism and genderism. These have led to Black/African American populations experiencing higher rates of stigma and discrimination, poverty, food insecurity, housing instability, and unemployment and inequitable access to health services, all of which contribute to poorer HIV health outcomes.^3,4

To reduce HIV inequities, the NHAS Federal Implementation Plan (2022–2025) calls for greater investment in implementation research for the scale-up of evidence-informed and evidence-based interventions to expand quality care and treatment to priority populations.⁵ In 2020, the Health Resources and Services Administration (HRSA), the HIV/AIDS Bureau, Ryan White HIV/AIDS Program Part F Special Projects of National Significance Program, with funding from the Minority HIV/AIDS Fund, launched Improving Care and Treatment Coordination: Focusing on Black Women With HIV (hereafter the “Black Women First Initiative”; 2020–2024) to address these intersectional factors and improve health outcomes for Black women with HIV.

In accordance with the HRSA HIV/AIDS Bureau’s implementation science framework,⁶ the initiative funded 12 US sites to adapt, implement, and evaluate 6 evidence-informed practices as a bundled intervention to improve HIV and other health outcomes.^7,8 The goals of the initiative were to expand the delivery of HIV care and treatment, address sociocultural determinants of health, and ensure that Black women received continuous care and support services in a culturally relevant and responsive manner. The findings of this initiative were intended for replication and scale-up to other Ryan White HIV/AIDS Program providers and communities serving Black women.

We defined a bundled intervention as a group of evidence-informed practices that, when provided as a package, produces better health outcomes than does a single intervention.^8,9 Systematic reviews of bundled interventions and care bundles have been condition or setting specific and suggest effectiveness in preventing and managing conditions such as sepsis, chronic pain, and chronic obstructive pulmonary disorder.^10–13 Few studies have been conducted in outpatient or community settings. Recent studies have focused on multicomponent HIV prevention programs for adolescent girls and young women in 10 countries in sub-Saharan Africa.^14–17 To our knowledge, no studies to date have focused on assessing bundled interventions for HIV care and treatment of Black cisgender and transgender women with HIV.

Our primary study aim was to describe the uptake of bundled interventions and their effect on HIV outcomes and health-related quality of life (HRQoL) for Black women with HIV. Sites were funded based on HRSA’s a priori list of evidence-informed interventions that had demonstrated effectiveness among people with HIV. We hypothesized that different intervention packages are needed for and should be tailored to Black women by their gender identity to improve HIV health outcomes and HRQoL. A previous study of Ryan White HIV/AIDS Program participants found Black transgender women significantly less likely than Black cisgender women to be retained in care and virally suppressed.¹⁸ Our study may help program planners, policymakers, and health care providers to address these disparities, adapt and replicate the use of bundled evidence-informed interventions, and invest resources in HIV and primary health care services that are culturally relevant and meet the needs of all Black women.

METHODS

We conducted a prospective, nonrandomized study with a convenience sample of Black women with HIV recruited from San Francisco, California; Atlanta, Georgia (2 sites); Chicago, Illinois; Mandeville and New Orleans, Louisiana; Charlotte, North Carolina; Philadelphia (2 sites) and Chester, Pennsylvania; New York, New York; and Dallas, Texas, all serving priority Ending the HIV Epidemic jurisdictions (Table A, available as a supplement to the online version of this article at http://www.ajph.org). Sites represented HIV primary care clinics (5) and community-based organizations (7). Two sites were Black women–led organizations. Our evaluation framework was guided by Greenhalgh’s conceptual model of diffusion of innovations in health service organizations and Proctor’s for use of implementation strategies and evaluating implementation, service, and client outcomes.^19,20 The study protocol was previously published.⁷

Eligibility criteria included having a previous diagnosis of HIV, being aged 18 years or older, self-identifying as Black or African American, and self-identifying as a cisgender or transgender woman. We recruited participants from internal or external clinic or community partner referrals or review of medical records for women who did not have a primary care visit in the past 6 months or were virally unsuppressed (> 200 copies/mL). We limited the analytic sample to participants who received 2 or more interventions during the study period (Figure 1). We found few differences in demographic characteristics, social determinants of health, or key outcomes between women who did and those who did not have relevant follow-up outcome data (Table B, available as a supplement to the online version of this article at http://www.ajph.org).

FIGURE 1—

Study Population for the Health Resources and Services Administration/Special Projects of National Significance (HRSA/SPNS) Initiative Improving Care and Treatment Coordination: Focusing on Black Women With HIV: 12 US Sites, 2021–2023

Note. The 12 US sites were San Francisco, CA; Atlanta, GA (2 sites); Chicago, IL; Mandeville and New Orleans, LA; Charlotte, NC; Philadelphia (2 sites) and Chester, PA; New York, NY; and Dallas, TX.

We followed participants for 12 months between May 2021 and August 2023. We collected data via interview and medical chart review at baseline, 6 months, and 12 months. Staff documented participant encounters for each intervention domain, including content, duration, modality (individual vs group), and setting (virtual vs in-person). Because we launched the study during the COVID-19 pandemic, most initial informed consent procedures and interviews were conducted virtually, with follow-ups shifting to in-person as pandemic restrictions were lifted at each site. We collected data via REDCap version 13.8.1 (Vanderbilt Institute for Clinical and Translational Research, Nashville, TN).²¹

Intervention Description

Each site selected an intervention bundle that was tailored to their local context. Seven sites engaged Black women with lived experience in this process. Ten sites adapted a peer–patient navigation intervention that provided intensive support for medical and social needs and 6 structured education sessions to improve adherence to HIV care and treatment. Navigators were Black women, and 9 sites included women with HIV. Six sites adapted Red Carpet Care Experience, which was delivered by a team of peers and case managers or licensed social workers and nurses that focused on addressing social needs to improve linkage to and retention in medical care.

Three sites adapted individual or group stigma reduction interventions to support women with accepting and managing HIV. Ten sites implemented trauma-informed care interventions that focused on improving access to and use of behavioral health services via connection to licensed providers, including Black women therapists (4 sites), training and capacity building interventions, or both to ensure that all care team members integrated a trauma-informed approach to service delivery. Five sites adapted self-efficacy interventions to improve engagement in care and viral suppression, and 4 sites implemented individual- or organizational-level interventions (e.g., training staff on screening and referrals) to address intimate partner violence.

Measures

We based primary outcomes on HRSA-defined measures for the HIV care continuum.²² We defined retention in care as 2 visits with an HIV primary care provider, a laboratory test, or both at least 90 days apart in the 12-month postenrollment period. We defined viral suppression as less than 200 copies per milliliter on the last viral load test before enrollment and at each 6-month follow-up.

We measured HRQoL using 2 approaches. First, we adapted the NHAS QoL indicators (i.e., food insecurity, unemployment, unstable housing, and unmet mental health need) focusing on structural and social factors to improve HIV clinical outcomes.²³ Second, we examined physical and mental HRQoL using the Veterans-RAND 12-item scale, which assesses general health perceptions, physical functioning, role limitations, physical and emotional problems, bodily pain, energy fatigue, social functioning, and mental health.²⁴ We measured each item on a 5-point Likert-type scale and summarized them into a physical component score (PCS) and a mental component score (MCS). Summary scores were set to a mean of 50 and SD of 10 for the US general population in 2002.²⁴

Our independent variables were participant’s gender identity and type and number of interventions received as a bundle. We characterized gender identity as cisgender or transgender based on self-reported screening eligibility criteria at the time of participant consent. Further details on variable measurements are described in the file “Methods” (available as a supplement to the online version of this article at http://www.ajph.org). We calculated the type and number of interventions received from participant encounter forms. Given the lack of a standardized protocol for bundled interventions across sites, we were able to assess only the specific type of evidence-informed intervention within a bundle on outcomes. Overall, there were 20 different combinations of bundled interventions selected and implemented across the sites (Table C, available as a supplement to the online version of this article at http://www.ajph.org).

Data Analysis

We conducted univariate and unadjusted bivariate analyses overall and by gender identity for sociodemographics, structural and social factors, and the number and type of interventions received in the bundle. We examined item scale reliability for validated measures, and all Cronbach α coefficients met the minimum acceptability criterion of 0.70. To examine the effects of the bundled interventions, we assessed outcomes from baseline to 6 and 12 months for viral suppression as a binary variable and physical and mental HRQoL as continuous variables, with participants providing up to 2 observations. We assessed retention in care as a binary variable for the 12-month postenrollment period, with 1 observation per participant.

We used generalized estimating equation models with autoregressive working correlations to model these outcomes separately by number and type of interventions (within a 0–6- vs 6–12-month period) adjusted for follow-up timepoint, gender identity, baseline measures, age, and clustering by participant and site as a fixed effect. We computed adjusted odds ratios (AORs) and 95% confidence intervals (CIs) for the binary outcomes and Β coefficients for continuous outcomes. We examined interactions between gender identity, timepoint, and intervention characteristics in each model. We found no significant interactions. We time averaged results for main effects only models that included data from multiple time windows. We achieved statistical significance (P < .05) for results. We used SAS version 9.4 (SAS Institute, Cary, NC) in all analyses.

RESULTS

The average age of participants was 45 years, 9.6% were Hispanic Latina or had racial or ethnic identities in addition to Black, 11.5% were not US born, 57.3% had a high school education or less, 28.0% had caregiving responsibilities, 26.1% were unstably housed, 27.7% were food insecure, 65.3% were unemployed, 33.6% reported symptoms of moderate to severe depression, and 61.6% with a substance use history reported illicit substance use in the past 3 months (Table 1). Participants experienced 6 traumatic events on average in their lifetime and had been living with HIV for 14 years; 6.6% were newly diagnosed in the past 12 months. At baseline, 85.2% had health insurance, 83.9% had seen a primary care provider in the past 6 months, 72.3% were virally suppressed, and both PCS and MCS were at least 1 SD below the standard for a healthy US adult population.²⁴

TABLE 1—

Participant Characteristics and Selected HIV Health Outcomes, Overall and by Gender Identity, for the Health Resources and Services Administration/Special Projects of National Significance (HRSA/SPNS) Initiative Improving Care and Treatment Coordination: Focusing on Black Women With HIV: 12 US Sites, 2021–2023

Characteristic	Overall (n = 697), No. (%) or Mean ±SD (Range)	Cisgender (n = 567; 81.3%), No. (%) or Mean ±SD (Range)	Transgender (n = 130; 18.7%), No. (%) or Mean ±SD (Range)
Sociodemographics
Age, y	45 ± 13 (18–77)	47 ± 12 (18–77)	35 ± 9 (18–65)
Race/ethnicity
Non-Hispanic Black/African American	630 (90.4)	525 (92.6)	105 (80.8)
Hispanic/Latina Black	28 (4.0)	18 (3.2)	10 (7.7)
Multiple identities	39 (5.6)	24 (4.2)	15 (11.5)
Where born
US	617 (88.5)	503 (88.7)	114 (87.7)
Outside US	80 (11.5)	64 (11.3)	16 (12.3)
Educational status
< High school	171 (24.6)	137 (24.3)	34 (26.2)
High school or equivalent	227 (32.7)	176 (31.2)	51 (39.2)
> High school	296 (42.7)	251 (44.5)	45 (34.6)
Structural and social factors
Has caregiver responsibilities*	195 (28.0)	184 (32.5)	11 (8.5)
Unemployment
Baseline	450 (65.3)	360 (64.3)	90 (69.8)
After 6 mo	319 (59.7)	274 (61.6)	45 (50.6)
After 12 mo	224 (58.0)	196 (58.2)	28 (57.1)
Housing status instability*
Baseline	181 (26.1)	121 (21.4)	60 (46.9)
After 6 mo	123 (23.2)	89 (20.1)	34 (39.1)
After 12 mo	82 (21.4)	62 (18.5)	20 (41.7)
Any health insurance*	593 (85.2)	505 (89.2)	88 (67.7)
Ever incarcerated*	305 (43.8)	222 (39.2)	83 (63.8)
Food insecurity
Baseline	193 (27.7)	131 (23.1)	62 (47.7)
After 6 mo	110 (20.6)	79 (17.8)	31 (34.8)
After 12 mo	67 (17.5)	53 (15.8)	14 (29.8)
Unmet need for mental health services
Baseline	60 (8.7)	45 (8.0)	15 (11.6)
After 6 mo	30 (5.6)	27 (6.1)	3 (3.4)
After 12 mo	16 (4.2)	14 (4.2)	2 (4.3)
Depression risk
None to minimal	274 (39.8)	231 (40.7)	43 (33.9)
Mild	182 (26.4)	155 (27.3)	27 (21.3)
Moderate	116 (16.8)	86 (15.3)	30 (23.6)
Moderately severe/severe	117 (16.8)	92 (16.2)	27 (20.8)
Current use of illicit substancesa*	302 (61.6)	215 (56.7)	87 (78.4)
Social support score	57 ±17 (12–84)	57 ±17 (12–84)	55 ±17 (12–84)
Trauma events experienced*	6 ±4 (0–16)	6 ±4 (0–16)	8 ±4 (0–16)
Health literacy*	17 ±4 (4–20)	17 ±4 (4–20)	18 ±3 (6–20)
HIV stigma	21 ±9 (13–52)	21 ±9 (13–52)	21 ±9 (13–47)
Discrimination*	5 ±5 (0–21)	4 ±5 (0–21)	8 ±6 (0–21)
Health status
Years living with HIV*	14 ± 10 (0–41)	15 ± 10 (0–41)	10 ± 9 (0–38)
Newly diagnosed, past 12 mo	43 (6.6)	34 (6.4)	9 (7.8)
Viral suppression < 200 copies/ml
Baseline	470 (72.3)	383 (71.1)	87 (78.4)
After 6 mo	473 (85.7)	391 (85.2)	82 (88.2)
After 12 mo	354 (84.3)	309 (84.2)	45 (84.9)
Has seen a primary care provider past 6 mo (baseline)	567 (83.9)	472 (85.0)	96 (78.5)
Retained in care after 12 mob*	472 (74.3)	406 (77.8)	66 (58.4)
Health-related Quality of life*
Physical health component score	40.6 ± 11.6 (3.6–63.6)	39.6 ± 11.8 (3.6–63.6)	45.2 ± 9.4 (12.5–63.2)
Mental health component score	43.7 ± 13.3 (2.8–71.1)	44.5 ± 13.0 (5.5–71.1)	40.1 ± 14.3 (2.8–69.0)

Note. Study sample size was n = 697. The 12 US sites were San Francisco, CA; Atlanta, GA (2 sites); Chicago, IL; Mandeville and New Orleans, LA; Charlotte, NC; Philadelphia (2 sites) and Chester, PA; New York, NY; and Dallas, TX. All models used generalized estimating equations adjusted for site.

^a Measured in past 3 mo among participants who had ever used illicit substances (n = 490; 73.1% of total study sample).

^b 2 appointments with an HIV primary medical care provider or a laboratory test at least 90 d apart after 12 mo.

^*P < .05.

Compared with cisgender women, transgender women were significantly younger (35 vs 47 years), had multiple racial or ethnic identities (19.2% vs 7.4%), were unstably housed (46.9% vs 21.4%), and had higher proportions of a history of incarceration (63.8% vs 39.2%) and food insecurity (47.7% vs 23.1%). Transgender women also reported significantly more traumatic events and experiences with discrimination, fewer years living with HIV, and lower mental HRQoL. Cisgender women reported higher proportions of caregiving responsibilities (32.5% vs 8.5%) and lower scores of health literacy (17 vs 18) and physical HRQoL (39.6 vs 45.2). There were no significant differences in stigma, social support, being newly diagnosed, having seen a provider, or viral suppression rates between cisgender and transgender women (Table 1).

Number and Type of Interventions Received

Most participants received peer–patient navigation (88.1%) and trauma-informed care (54.8%), and 43.9% received up to 4 interventions (Table 2). On average, participants had 26 encounters, for a total average of 17 hours during the 12-month postenrollment period. A higher proportion of transgender women received peer–patient navigation (97.7% vs 85.9%) and self-efficacy interventions (51.5% vs 42.9%). A higher proportion of cisgender women received stigma reduction (16.4% vs 6.9%), intimate partner violence (12.5% vs 6.9%), and trauma-informed care interventions (56.3% vs 48.5%). On average, cisgender women had more encounters (29 vs 12) and longer duration (19 vs 10 hours) across all encounters than did transgender women.

TABLE 2—

Description of Bundled Interventions by Type and Number of Interventions Received, Overall and by Gender Identity for the Health Resources and Services Administration/Special Projects of National Significance (HRSA/SPNS) Initiative Improving Care and Treatment Coordination: Focusing on Black Women With HIV: 12 US Sites, 2021–2023

	Overall (n = 697), No. (%) or Mean ±SD	Cisgender (n = 567; 81.3%), No. (%) or Mean ±SD	Transgender (n = 130; 18.7%), No. (%) or Mean ±SD
Average duration across all encounters, h	17 ±18	19 ±19	10 ±13
Intervention (No. sites)
Peer–patient navigation (10)	614 (88.1)	487 (85.9)	127 (97.7)
Trauma-informed carea (10)	382 (54.8)	319 (56.3)	63 (48.5)
Red Carpet Care (6)	248 (35.6)	200 (35.3)	48 (36.9)
Self-efficacy (5)	310 (44.5)	243 (42.9)	67 (51.5)
Addressing IPV (4)	80 (11.5)	71 (12.5)	9 (6.9)
Stigma reduction (3)	102 (14.6)	93 (16.4)	9 (6.9)
No. interventions received
2	391 (56.1)	318 (56.0)	73 (56.2)
3	270 (38.7)	219 (38.6)	51 (39.2)
4	36 (5.2)	30 (5.3)	6 (4.6)
No. encounters	26 ±32	29 ±34	12 ±13

Note. Study sample size was n = 697. IPV = intimate partner violence. The 12 US sites were San Francisco, CA; Atlanta, GA (2 sites); Chicago, IL; Mandeville and New Orleans, LA; Charlotte, NC; Philadelphia (2 sites) and Chester, PA; New York, NY; and Dallas, TX.

^a 7 sites included an intervention component as part of trauma-informed care with linkage to a behavioral health therapist.

Changes in HIV Outcomes and Quality of Life

Although 74.3% of participants were retained in care, transgender women were significantly less likely to be retained than were cisgender women (58.4% vs 77.8%; AOR = 0.86; 95% CI = 0.77, 0.96; Table 1; Table D, part a, available as a supplement to the online version of this article at http://www.ajph.org). Women who received trauma-informed care were more likely to be retained in care than were those who did not (AOR = 1.09; 95% CI = 1.03, 1.15). Women who received 4 interventions were also more likely to be retained than were those who received 2 interventions (AOR = 1.11; 95% CI = 1.03, 1.19; Table D, parts a and b).

Viral suppression improved from 72.3% of participants at baseline to 84.3% at 12 months (Table 1). There were no significant differences by gender identity. Women who participated in the stigma reduction intervention had increased odds of viral suppression during the 12-month postenrollment period compared with women who did not participate in this intervention (AOR = 2.06; 95% CI = 1.01, 4.20). We found no significant effect of the number of interventions received on viral suppression (Table D, parts a and b). However, averaging over time windows, we found that those who received no intervention in a window were 3 times more likely to be virally suppressed in that window than were those who received 2 interventions (AOR = 3.10; 95% CI = 1.13, 8.48), indicating women with few encounters were clinically stable. In a further subanalysis, we found that these women were also more likely to have been suppressed at baseline and to have maintained viral suppression (Table E, available as a supplement to the online version of this article at http://www.ajph.org). Among women who were not virally suppressed at baseline (n = 94), 65% were suppressed by 6 months after enrollment (Table E).

Physical and mental health–related HRQoL scores (PCS, MCS) improved over time (Figure 2; PCS = 40.6–41.6; MCS = 43.7–46.7); participants with the lowest baseline scores experienced the greatest increase over time. Compared with cisgender women, transgender women had significantly higher PCS (45.2 vs 39.6) and lower MCS (40.1 vs 44.5) on average, and only PCS was significantly more likely to improve for transgender women (b = 3.28; 95% CI = 1.56, 5.01). There were no differences in improvements in MCS by gender identity. The number of interventions received did not significantly affect MCS or PCS (Table D).

FIGURE 2—

Changes in Physical and Mental Health-Related Quality of Life, Overall and by Gender Identity, and by (a) Physical Component Score (PCS) and (b) Mental Component Score (MCS) for the Health Resources and Services Administration/Special Projects of National Significance (HRSA/SPNS) Initiative Improving Care and Treatment Coordination: Focusing on Black Women With HIV: 12 US Sites, 2021–2023

Note. Study sample size was n = 697. The 12 US sites were San Francisco, CA; Atlanta, GA (2 sites); Chicago, IL; Mandeville and New Orleans, LA; Charlotte, NC; Philadelphia (2 sites) and Chester, PA; New York, NY; and Dallas, TX.

Women who received peer–patient navigation had significantly higher improvement in MCS from baseline than did those who did not receive the intervention (b = 1.99; 95% CI = 0.00, 3.99), whereas those who did not receive an intimate partner violence intervention had significant improvements in MCS compared with those who did (b = −3.59; 95% CI = −1.09, −2.28). Women who did not participate in a stigma reduction intervention had significantly higher improvement in physical HRQoL scores than did those who did participate in the intervention (b = −3.2; 95% CI = −6.03, −0.35; Table D, part a).

Participants also had improvements in structural and social determinants over time (Table 1). In the 12-month postenrollment period, food insecurity (27.7% to 17.5%), unstable housing (26.1% to 21.4%), unemployment (65.3% to 58.0%), and unmet needs (8.7% to 4.2%) decreased. We observed no significant differences by gender identity.

DISCUSSION

Our results suggest that providing a bundle of 2 or more interventions is a promising strategy to address the multiple needs of and improve viral suppression and HRQoL for Black women with HIV, regardless of gender identity. Although viral suppression did not differ by gender identity, transgender women had significantly lower rates of retention in HIV care than did cisgender women. It may be that transgender women are engaged with non-HIV primary care and, given that they are virally suppressed, place a lower priority on consistent HIV care. It could also signal that HIV primary care providers need to be more culturally responsive to the non-HIV needs of transgender women, such as support for accessing hormone treatment housing and employment.²⁵ In either case, further investigation is warranted to reach and successfully engage Black transgender women with HIV.

We also found that transgender women had higher physical HRQoL and lower mental HRQoL scores than did cisgender women despite improvements over time. In addition, transgender women had fewer encounters and time in the interventions compared with cisgender women. This may be related to more lifetime traumatic events experienced, higher rates of discrimination, or increased stress related to finding stable housing and employment compared with cisgender women. Given that transgender women were younger and more recently diagnosed with HIV than were cisgender women, they may need greater mental and emotional support during this time in their lives.²⁶

Approximately half of participants experienced substance use and mental health disorders, which can affect retention in care. Trauma-informed care was associated with increased retention in care, contributing to evidence of its importance in care settings and in integrating HIV and behavioral health services.²⁷ Using this approach ensures that staff create an environment that is safe and friendly to build trust with Black women to consistently engage in care and treatment.^28–31

We also found that integrating a focused stigma reduction intervention tailored to Black women is essential for supporting viral suppression. Three sites incorporated stigma reduction interventions using culturally adapted materials and narrative storytelling with a safe space for women to share their lived experiences and generate solutions for improving their own health and well-being.

We found evidence that peer–patient navigation had a significant role in improving mental HRQoL, regardless of gender identity. Other studies have shown that both cisgender and transgender women value settings that build community among women to reduce isolation and provide an opportunity to learn from each other.³² Having a safe space and staff members with similar lived experiences are important for culturally responsive, whole-person, and inclusive care that improves HIV health outcomes.³³

Research has documented the importance of designing and implementing interventions and policies to address these social and structural determinants among Black populations with HIV.^34,35 Our findings contribute to this evidence by highlighting the positive effect of bundled interventions on addressing social determinants and structural barriers to health, including experiencing food insecurity, homelessness, unemployment, and unmet mental health needs.

To our knowledge, this is the first study to examine the delivery of 2 or more interventions for improving care and treatment of people with HIV. The DREAMS (Determined, Resilient, Empowered, AIDS-free, Mentored, and Safe) initiative in 10 sub-Saharan African countries uses multilayer interventions for HIV prevention and integrating components to improve educational and employment opportunities for adolescent girls and young women at risk for HIV. Similarly, our study emphasized the importance of addressing both HIV outcomes and the social determinants that improve women’s HRQoL.

Limitations

This was a prospective study with a convenience sample of Black women. Future research with comparison groups is warranted to examine the effectiveness of bundled interventions on HIV health outcomes and HRQoL. Although we recruited and enrolled a large and diverse population of Black women, the findings may not be generalizable to other Black women with HIV. The study was launched during the COVID-19 pandemic, and women enrolled were those who site staff were able to reach and provide with virtual technology support, including telephones, computers, and Internet access. Thus, our findings may be biased given that some women were more or less likely to engage in a virtual space.

There was variability in the adaptation of the bundled interventions. Sites selected their bundled interventions across the 6 domains, and the lack of standardization across the 12 sites made comparisons for effectiveness of specific care bundles challenging. Future research is needed on the sequencing of interventions and the inputs needed, especially staffing models. In efforts to standardize the interventions, we used implementation strategies, including training and coaching sessions, to build skills and ensure consistency when adapting interventions. We also collected qualitative data to capture implementation barriers and facilitators for future analysis. Elucidating the mechanisms of bundled interventions and their effect on specific outcomes is important for sustainability and scale-up.

Finally, bundled interventions were time limited and required adaptations to recruitment and implementation owing to the COVID-19 pandemic. Participants in other multilayer interventions were followed an average of 31.5 months compared with 12 months in this initiative.^7,16 A longer duration of services is needed for Black women with HIV, who have intersectional social and behavioral health needs.

Despite these limitations, our findings highlight the initiative’s foundational framework for the meaningful involvement of individuals who identify as Black women. Most sites created advisory boards of cisgender and transgender women and actively engaged them in the design and implementation of the bundled services. Many of the staff, including clinicians, were also Black cisgender and transgender women. This may indicate that it is not the specific bundle of services that is offered that is essential. Our findings identified key elements for reaching and engaging Black women with HIV: (1) employing staff and engaging community partners who reflect the women served; (2) consistently screening for structural and unmet social service needs (e.g., food, housing, employment); and (3) integrating social, behavioral, and medical services either on-site or with community partners to encourage women to easily access needed mental health services and other forms of peer support.

Public Health Implications

For the health care system to reach Black women, addressing their psychosocial and economic needs is paramount in addition to treating HIV. System-wide changes are necessary to increase access to resources to improve economic, housing, and employment stability and to reduce intersectional barriers to care rooted in racism, sexism, and discrimination. The NHAS’s focus on physical health, mental and emotional health, hunger and food insecurity, homelessness, and unemployment is critical to these efforts. At an organizational level, care teams need better tools for screening and connecting women to employment, housing, food, and mental health services and to community organizations. Integrating trauma-informed approaches and having team members include Black women with lived experience will aid in decreasing stigma associated with HIV and improve health outcomes for Black women with HIV.³⁶

Conclusions

Providing bundled interventions that offer stigma reduction, education, and navigational support with HIV care and behavioral health and social needs using a trauma-informed approach can improve HIV outcomes and HRQoL for Black women with HIV.