Adaptation and Implementation of an Evidence-based Approach to Advance HIV Prevention and Care

April 15, 2026 updated by: Chunqing Lin, PhD, University of California, Los Angeles
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

80 transgender women will be randomized to either an intervention condition (receiving all TransAction activities) or a control condition (being invited to TransAction social events only). We will evaluate outcomes such as advancement along the HIV prevention/care continua, sexual risks, substance use, self-efficacy in services seeking, social support, stigma, general well-being, and quality of life at baseline, 3-month, and 6-month follow-ups. Furthermore, we will assess implementation outcomes such as fidelity, adaptation, feasibility, acceptability, and sustainability through implementation documentation, investigator evaluation, and survey/focus groups with peer facilitators and TW participants.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Chunqing Lin, PhD
  • Phone Number: 3107940361
  • Email: lincq@ucla.edu

Study Locations

  • Vietnam
      • Ho Chi Minh City, Vietnam
        • Recruiting
        • University of Medicine and Pharmacy
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 16 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.

Exclusion Criteria:

  • have been involved in intervention adaptation activities previously with the study team
  • inability to give informed consent/assent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Participants 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
Behavioral: TransAction
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.
Placebo Comparator: Control
Participants in the control condition will be invited to social events only.
Behavioral: TransAction
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Placement on HIV prevention/care continua
Time Frame: Baseline, 3-, and 6-months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-efficacy
Time Frame: Baseline, 3-, and 6-months
Self-efficacy in seeking healthcare and social services, as well as self-efficacy in negotiating condom use.
Baseline, 3-, and 6-months
Social support
Time Frame: Baseline, 3-, and 6-months
Perceived support from family members, peers, service providers, and online resources
Baseline, 3-, and 6-months
General wellbeing and quality of life
Time Frame: Baseline, 3-, and 6-months
General wellbing and quality of life will be measured using Short Form-12 and Hospital Anxiety and Depression Scale
Baseline, 3-, and 6-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

National Institute of Mental Health (NIMH)
University of Medicine and Pharmacy at Ho Chi Minh City
Friends Research Institute, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

January 10, 2027

Study Registration Dates

First Submitted

March 17, 2026

First Submitted That Met QC Criteria

March 21, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TransAction in Vietnam
  • 1R34MH139375-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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