HIV (Human Immunodeficiency Virus)NCT07495059
Adaptation and Implementation of an Evidence-based Approach to Advance HIV Prevention and Care
A study testing TransAction in people with HIV (Human Immunodeficiency Virus) and Continuum of Care, run by University of California, Los Angeles at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older, men only
- Conditions the study is for
- HIV (Human Immunodeficiency Virus), Continuum of Care, Stigma
- What is being tested?
- TransAction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Mar 2026to 10 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- have been involved in intervention adaptation activities previously with the study team
- inability to give informed consent/assent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
University of Medicine and Pharmacy
Ho Chi Minh City
Do Van Dung, PhD, (+84-28) 3855 9714, Dvdung@ump.edu.vn
About this study
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.
Read the 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.
- Being tested
- TransAction
- Keywords
- HIV, Implementation Science, Continuum of Care
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TransActionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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 Receives: Behavioral: TransAction |
| Control | Placebo comparator | Participants in the control condition will be invited to social events only. Receives: Behavioral: TransAction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3-, and 6-months
Secondary outcomes (3)
Self-efficacy
Self-efficacy in seeking healthcare and social services, as well as self-efficacy in negotiating condom use.
Measured: Baseline, 3-, and 6-months
Social support
Perceived support from family members, peers, service providers, and online resources
Measured: Baseline, 3-, and 6-months
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
Measured: Baseline, 3-, and 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Mar 2026
- Primary completion1 Oct 2026 (estimated)
- Study completion10 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV (Human Immunodeficiency Virus)Studies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- University of Medicine and Pharmacy at Ho Chi Minh City, Friends Research Institute, Inc., National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Chunqing Lin, PhD, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07495059
- Sponsor's protocol ID
- TransAction in Vietnam
- Other IDs
- 1R34MH139375-01
- Status last verified
- Apr 2026
- First submitted
- 17 Mar 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation and Implementation of an Evidence-based Approach to Advance HIV Prevention and Care
- ClinicalTrials.gov ID
- NCT07495059
- Acronym / sponsor ID
- TransAction in Vietnam
- Keywords
- HIV, Implementation Science, Continuum of Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- University of Medicine and Pharmacy at Ho Chi Minh City, Friends Research Institute, Inc., National Institute of Mental Health (NIMH)
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 10 Jan 2027 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: TransActionParticipants 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 comparator | Behavioral: TransActionParticipants in the control condition will be invited to social events only. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- have been involved in intervention adaptation activities previously with the study team
- inability to give informed consent/assent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TransActionImmediately 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. | Behavioural | Control, Intervention |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TransAction in people with HIV (Human Immunodeficiency Virus) and Continuum of Care, run by University of California, Los Angeles at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chunqing Lin, PhD (3107940361, lincq@ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Placement on HIV prevention/care continua (time frame: Baseline, 3-, and 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.