Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jul 16, 2024
Date Accepted: Jul 25, 2024
Jabula Uzibone: Protocol for an Implementation Study of Transgender-Specific Differentiated HIV Service Delivery Models in the South African Public Primary Healthcare System
ABSTRACT
Background:
Almost 60% of transgender people in South Africa are living with HIV, compared with 18% of reproductive age adults. Ending the HIV epidemic will require that key populations, including transgender people, successfully access HIV prevention, treatment, and care. However, transgender people often avoid health services due to facility-based stigma and lack of availability of gender-affirming care. Transgender-specific differentiated service delivery (TG-DSD) may improve engagement and facilitate progress toward HIV elimination. Wits RHI, a renowned South African research institute, established 4 TG-DSD demonstration sites in 2019, with funding support from the US Agency for International Development (USAID). These sites offer unique opportunities to evaluate implementation of TG-DSD and test the effectiveness of TG-DSD on HIV outcomes.
Objective:
The Jabula Uzibone study seeks to assess the implementation, effectiveness, and cost of TG-DSD for viral suppression and prevention-effective adherence.
Methods:
This observational, mixed methods, prospective implementation study collects baseline and 12-month site observation checklists (n=8 sites) and key informant interviews (6/site, n=48) at the 4 TG-DSD sites and 4 standard sites to explore implementation. We will enroll 600 transgender clients at TG-DSD (n=300) and standard (n=300) sites: 200 with HIV on antiretroviral therapy and 100 HIV-negative for each site type. Participants complete interviewer-administered surveys quarterly, and blood is drawn at baseline and 12 months for HIV RNA testing among participants with HIV and tenofovir levels among participants on PrEP. A subset of 30 per site type will also complete in-depth interviews at baseline and 12 months. Within each site type, 15 will be living with HIV and 15 will not. Qualitative analyses will explore aspects of implementation; regression models will compare HIV outcomes (viral suppression and prevention-effective adherence) by site type. Structural equation modeling will test whether HIV outcomes are mediated by stigma and/or gender affirmation. A micro-costing approach will estimate the cost per service user served and per service user successfully treated at TG-DSD relative to standard sites, as well as the budget needed for broader implementation of TG-DSD.
Results:
As of June 28, 2024, 489 transgender participants have been enrolled: 216 are living with HIV and 279 are HIV-negative; 15% (75/489) are gender non-conforming, 15% (72/489) are transgender men, and 70% (342/489) are transgender women. We anticipate baseline enrollment will be complete by August 31, 2024, and the final study visit will take place no later than August 2025.
Conclusions:
Jabula Uzibone will provide actionable data to inform HIV policies and health facility practices in South Africa and generate the first evidence for implementation of TG-DSD in sub-Saharan Africa. Study findings also may inform how other countries could utilize TG-DSD strategies to increase care engagement of transgender people and advance global progress towards HIV elimination goals. Clinical Trial: Not applicable
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