Adaptation and Implementation of an Evidence-based Approach to Advance HIV Prevention and Care
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age16+
SponsorUniversity of California, Los Angeles
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
have been involved in intervention adaptation activities previously with the study team
inability to give informed consent/assent
Trial design
Design model
Parallel
Treatments tested in this trial
TransAction
BehavioralImmediately 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: ControlPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline, 3-, and 6-monthsSecondary outcomes
1
Self-efficacy
Self-efficacy in seeking healthcare and social services, as well as self-efficacy in negotiating condom use.
Time frame
Baseline, 3-, and 6-months2
Social support
Perceived support from family members, peers, service providers, and online resources
Time frame
Baseline, 3-, and 6-months3
General wellbeing and quality of life
General wellbing and quality of life will be measured using Short Form-12 and Hospital Anxiety and Depression Scale
Time frame
Baseline, 3-, and 6-monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, Los Angeles
Lead sponsor
University of Medicine and Pharmacy at Ho Chi Minh City
Collaborator
Friends Research Institute, Inc.
Collaborator
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov