Adaptation and Implementation of an Evidence-based Approach to Advance HIV Prevention and Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TransAction.
- Who it may be relevant to
- Registry conditions: HIV (Human Immunodeficiency Virus), Continuum of Care, Stigma. Basic parameters: from 16 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Vietnam
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Interventions
- 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 mes
Primary outcome measures
- Placement on HIV prevention/care continua [Time frame: Baseline, 3-, and 6-months]
Secondary outcome measures (3)
- Self-efficacy [Time frame: Baseline, 3-, and 6-months]
- Social support [Time frame: Baseline, 3-, and 6-months]
- General wellbeing and quality of life [Time frame: Baseline, 3-, and 6-months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Vietnam · 1 center
- University of Medicine and Pharmacy — Ho Chi Minh City
Identifiers
NCT: NCT07495059 · TransAction in Vietnam · 1R34MH139375-01