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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 is a NA study that has completed, run by ISA Associates. The registered enrollment target is 38 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05483686
The ClinicalTrials.gov registry entry for NCT05483686 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ISA Associates, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Control is the first listed.
NCT05483686 reports 0 study locations.
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.
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