Same-Day PrEP Initiation and Sexual Health for Transgender Women

Summary

Participation Requirements

Description

The overall goal of this study is to evaluate the feasibility and acceptability of same-day F/TAF initiation and characterize F/TAF persistence among trans women taking PrEP. This research will be conducted at the Infectious Diseases Institute, Makerere University in Kampala, Uganda and consists of ...

The overall goal of this study is to evaluate the feasibility and acceptability of same-day F/TAF initiation and characterize F/TAF persistence among trans women taking PrEP. This research will be conducted at the Infectious Diseases Institute, Makerere University in Kampala, Uganda and consists of 3 complementary aims. In Aims 1 and 2, the investigators will assess the feasibility and acceptability of same-day F/TAF initiation and characterize PrEP persistence. In Aim 3, the investigators will use qualitative methods to explore how self-care interventions for sexual health influence prevention choices among trans women and their sexual partners. Study subjects will be accrued using respondent driven sampling (RDS) and enrolled at the study clinic where F/TAF will be initiated same day. Participants will be randomized in a 1:1 ratio to either the intervention arm (quarterly integrated next steps counseling [iNSC] using point-of-care [POC] urine tenofovir [TFV] levels) or the control arm (standard adherence counseling without drug level feedback). In Aim 3, the investigators will use qualitative methods to explore how self-care interventions for sexual health influence prevention choices among trans women and their sexual partners. The overall goal will be to assess whether POC urine testing and iNSC counseling increase PrEP uptake and persistence over 12 months. This study for trans women is guided by the cardinal ethical principles of justice, respect for persons and beneficence. The local trans community will be involved in study design and implementation. Aim 1 : Evaluate the feasibility and acceptability of same-day F/TAF PrEP initiation among African trans women. Approach: The investigators will recruit up to 200 trans women. All study participants who meet study eligibility criteria will be consented and enrolled at the study clinic. Randomization will occur through REDCap. Participants will start PrEP on the day of enrollment and receive F/TAF for 12 months. Free HIV and sexually transmitted infection (STI) testing and treatment will be provided to all participants. Aim 2 : Characterize F/TAF persistence and test the impact of drug level feedback among African trans women taking PrEP. Approach: Using a factorial design within the Aim 1 study, all F/TAF users will be randomized to real-time drug level feedback and adherence counseling using a POC urine TFV lateral-flow immunoassay versus standard counseling alone. Socio-behavioral surveys will assess potential factors influencing adherence, including gender dysphoria and FHT. Aim 3 : Explore how self-care interventions for sexual health influence HIV/STI prevention choices among African trans women and their sexual partners. Approach: To clarify how same-day PrEP initiation, FHT use and self-collection of samples (SCS) for STI testing may influence prevention choices, the investigators will conduct in-depth interviews with participants and their sexual partners to assess perceptions and experiences with same-day PrEP, real-time drug level feedback, use of FHT, SCS, and how self-care interventions could empower trans women to engage in prevention services. Hypothesis: Same-day PrEP initiation will be a feasible and acceptable entryway into PrEP care among trans women.

Tracking Information