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NCT Number: NCT07495059

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

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.

Recruiting

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Key information

Conditions

HIV (Human Immunodeficiency Virus) Acquired Immunodeficiency Syndrome Behavior Blood-Borne Infections Communicable Diseases Continuum of Care Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Social Behavior Social Stigma Stigma Urogenital Diseases Virus Diseases

Age range

16 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Medicine and Pharmacy

Ho Chi Minh City, Vietnam

Location status: Recruiting

Location contact

Do Van Dung, PhD

CONTACT

[email protected]

(+84-28) 3855 9714

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TransAction

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Social support

    Time frame: Baseline, 3-, and 6-months

    Perceived support from family members, peers, service providers, and online resources

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Chunqing Lin, PhD

CONTACT

[email protected]

3107940361

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

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

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Mar 27, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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