Improving HIV Outcomes Among African American Transgender Women

Completed · Not applicable

Conditions studied: HIV

In brief

The investigators will conduct a randomized controlled trial to test the efficacy of the mobile HIV behavioral intervention for African American transgender women (Shine). Participants will be 215 trans women recruited by staff of the Trans Women of Color Collective via community events and social media. Participants must : 1) identify as a Black transgender woman using the 2-step method (Step 1: assigned male birth sex, Step 2: current gender identity is female); 2) be aged 18 or older; 3) report risk of HIV transmission in past 3 months (i.e., CAS with a serodiscordant or risky partner AND either \<90% ART adherence or \<5 daily doses of PrEP per week); 4) own a smartphone; and 5) be able to read and speak English. Eligible participants who subsequently provide informed consent will complete two confidential phone-based research surveys at different time points (baseline and 6 months post-baseline) and will be randomly assigned to one of two conditions (Shine or mobile HIV education for transgender women). Participants randomly assigned to the experimental condition will be instructed to text the word "Join" to the Shine study phone number. The intervention will take approximately 1-2 hours, with content delivered over several weeks. Participants randomly assigned to the control condition will be texted a link to a set of videos on healthy HIV-related behaviors for transgender women. These videos cover a variety of topics, including recommended testing frequencies, PrEP, and ART. After randomization, participants will complete the baseline research survey. This survey will assess the primary outcome of composite HIV transmission risk along with several secondary outcomes (individual behavioral components of the composite score; HIV medical care utilization and adherence; HIV testing; PrEP knowledge, interest, and uptake; gender affirmation; well-being; social support; sexual communication). Six months after the baseline research survey, all participants will complete a follow-up research survey assessing the same outcome measures in the baseline research survey. Binomial logistic regression will be the main analytic technique for the primary measure (composite risk for HIV transmission). For the secondary continuous measures, hierarchical linear modeling (HLM) will be used. All models will control for any demographic covariate (e.g., age) that varies at the .2 significance level due to randomization failure at baseline.

Key facts

Study ID
NCT05483686
Run by
ISA Associates, Inc.
People needed
38
Starts
2021-11-16
Expected to finish
2023-01-30
Last updated by the study team
2023-10-16

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: accepted.

You may qualify if…

You may not qualify if…

Where it is running

Full record on ClinicalTrials.gov

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