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NCT05483686 · ClinicalTrials.gov registry record · NA
Improving HIV Outcomes Among African American Transgender Women
A NA study, sponsored by ISA Associates.
- Completed
- Registry status
- NA
- Development phase
- 38
- Enrollment target
NCT05483686: Completed NA study, sponsored by ISA Associates.
NCT05483686 is a NA study that has completed, run by ISA Associates. The registered enrollment target is 38 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05483686, a NA study, has completed, sponsored by ISA Associates.
- COMPLETED
- Registry status
- NA
- Development phase
- 38 participants
- Enrollment target
Study Summary
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 com
Primary Outcome
Percentage of participants with a composite risk for HIV score of 1. The composite risk for HIV score combines participants' use of and adherence to biomedical and behavioral strategies over the past month into a binary indicator (0, 1) of HIV acquisition or transmission risk. 0 indicates some HIV transmission risk and 1 indicates no HIV transmission risk.
Interventions
- BEHAVIORAL Control
- BEHAVIORAL Shine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2021-11-16 |
| Est. Completion | 2023-01-30 |
| Phase | NA |
What the finished NCT05483686 record still lists
NCT05483686 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Control is the first listed.
NCT05483686 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05483686 about?
NCT05483686 is a clinical study titled "Improving HIV Outcomes Among African American Transgender Women". 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 m...
What is the current status of trial NCT05483686?
This trial is currently completed. It is a NA study. The enrollment target is 38 participants. The study started on 2021-11-16. Estimated completion is 2023-01-30.
What interventions are being tested in trial NCT05483686?
The interventions under investigation include: Control (BEHAVIORAL), Shine (BEHAVIORAL).
Who is sponsoring clinical trial NCT05483686?
This trial is sponsored by ISA Associates, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05483686's enrollment target sits among peer trials
38 1538th of 2000 higher than 461 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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