Adaptation and Implementation of an Evidence-based Approach to Advance HIV Prevention and Care
2 other identifiers
interventional
80
1 country
1
Brief Summary
Transgender women in the intervention condition will attend TransAction individual risk reduction sessions; skill building and open group support sessions, and social events between baseline and 3-month assessment. Transgender women participants in the control condition will be invited to social events only.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2026
CompletedFirst Submitted
Initial submission to the registry
March 17, 2026
CompletedFirst Posted
Study publicly available on registry
March 27, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 10, 2027
April 21, 2026
April 1, 2026
7 months
March 17, 2026
April 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Placement on HIV prevention/care continua
An ordinal outcome from 1) HIV+; not taking ART; 2) HIV+; taking ART but not virally suppressed (including no viral load test in the last 6 months); 3) HIV+; taking ART and virtually suppressed; 4) HIV-, not having regular HIV testing; 5) HIV-, having regular HIV testing but not taking PrEP; and 6) HIV-; currently on PrEP. A higher value indicates better placement in HIV prevention/care continua.
Baseline, 3-, and 6-months
Secondary Outcomes (3)
Self-efficacy
Baseline, 3-, and 6-months
Social support
Baseline, 3-, and 6-months
General wellbeing and quality of life
Baseline, 3-, and 6-months
Study Arms (2)
Intervention
EXPERIMENTALParticipants in the intervention condition will attend individual risk reduction sessions; skill building and open group support sessions, and social events between baseline and 3-month assessment
Control
PLACEBO COMPARATORParticipants in the control condition will be invited to social events only.
Interventions
Immediately following the baseline, participants in the intervention condition will be invited to participate in the individual and group sessions, with topics around reducing HIV risk behaviors, regular HIV/CD4/viral load testing, ART/PrEP uptake and adherence, and family/social support, all to be completed within three months. All participants, including those in both intervention and control conditions, will be invited to two social events to disseminate health information, HIV prevention messages, and foster social support in a festive, party-style atmosphere.
Eligibility Criteria
You may qualify if:
- years of age or older
- being male at birth and currently self-identified as a TW
- currently living in Ho Chi Minh City adjacent areas and having no plans to move out of the areas in the next 6 months - have the cognitive capacity to participate in study activities as judged by the study recruiter.
You may not qualify if:
- have been involved in intervention adaptation activities previously with the study team
- inability to give informed consent/assent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Medicine and Pharmacy
Ho Chi Minh City, Vietnam
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor-in-Residence
Study Record Dates
First Submitted
March 17, 2026
First Posted
March 27, 2026
Study Start
March 1, 2026
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
January 10, 2027
Last Updated
April 21, 2026
Record last verified: 2026-04