Same-Day PrEP Initiation and Sexual Health for Transgender Women

Summary

Transgender women (trans women; assigned male sex at birth but identify as female) are at high risk for HIV infection, and are an important, under-researched population in sub-Saharan Africa. Trans women have a 13 times greater risk of acquiring HIV than adults aged 15-49 years in the general population, and in Africa, trans women have nearly twice the HIV prevalence (25%) of men who have sex with men \[MSM\] (14%). Oral pre-exposure prophylaxis (PrEP) is an effective prevention tool that could change the trajectory of the HIV epidemic among the 25 million trans women globally, yet its use has been suboptimal in this vulnerable population. Same-day PrEP initiation is feasible and acceptable and improves retention in PrEP care in resource-rich settings. Same-day initiation of emtricitabine/tenofovir alafenamide (F/TAF), a new PrEP regimen, has not to our knowledge previously been evaluated as PrEP in African trans women. F/TAF is potentially more efficacious and safer than emtricitabine/tenofovir disoproxil fumarate (F/TDF) as shown in the recent DISCOVER trial. However, concerns about drug-drug interactions between feminizing hormonal therapy (FHT) and PrEP are a key potential adherence barrier for trans women. While PrEP drugs do not lower FHT levels, FHT decreases plasma TFV and (emtricitabine) FTC levels. Little is known about FHT use among African trans women taking F/TAF or how concerns about F/TAF-FHT interactions may influence PrEP adherence. Moreover, interventions to support PrEP adherence in this population are needed. Feedback about PrEP use has been shown to potentially improve PrEP adherence among MSM but has not been utilized among trans women. Key knowledge gaps include: 1) whether same-day PrEP can be successfully implemented for African trans women, 2) the impact of drug-level feedback on PrEP adherence, and 3) how use of FHT may influence PrEP adherence.

To address these questions, this protocol describes a randomized trial to evaluate the feasibility and acceptability of same day initiation of F/TAF PrEP, evaluate impact of drug-level feedback on PrEP adherence and characterize PrEP persistence, and in-depth interviews to explore how self-care interventions for sexual health influence prevention choices among trans women and their sexual partners. This will be the first clinical trial, to our knowledge, to evaluate F/TAF as PrEP for HIV-negative trans women in sub-Saharan Africa.

Conditions

• HIV
• PrEP
• Transgender Women
• Sexually Transmitted Diseases, Bacterial

Interventions

COMBINATION_PRODUCT

Integrated Next Steps Counseling with Real-Time Drug Level Feedback

Integrated next steps counseling with real-time drug level feedback using point-of-care urine tenofovir testing at quarterly visits

Sponsors & Collaborators

• Massachusetts General Hospital

  collaborator OTHER

• Harvard Medical School (HMS and HSDM)

  collaborator OTHER

• University of Washington

  collaborator OTHER

• Makerere University

  lead OTHER

Principal Investigators

• Andrew Mujugira, PhD · Infectious Diseases Institute

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

14 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-11-02

Primary Completion

2023-07-05

Completion

2023-07-05

Countries

• Uganda

Study Locations