NCT07495059

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Mar 2026Jan 2027

Study Start

First participant enrolled

March 1, 2026

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2027

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

March 17, 2026

Last Update Submit

April 15, 2026

Conditions

Keywords

HIV, Implementation Science, Continuum of Care

Outcome Measures

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.

    Baseline, 3-, and 6-months

Secondary Outcomes (3)

  • Self-efficacy

    Baseline, 3-, and 6-months

  • Social support

    Baseline, 3-, and 6-months

  • General wellbeing and quality of life

    Baseline, 3-, and 6-months

Study Arms (2)

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

Behavioral: TransAction

Control

PLACEBO COMPARATOR

Participants in the control condition will be invited to social events only.

Behavioral: TransAction

Interventions

TransActionBEHAVIORAL

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.

ControlIntervention

Eligibility Criteria

Age16 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsbeing male at birth and currently self-identified as a trans women
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Medicine and Pharmacy

Ho Chi Minh City, Vietnam

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeSocial Stigma

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSocial BehaviorBehavior

Central Study Contacts

Chunqing Lin, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor-in-Residence

Study Record Dates

First Submitted

March 17, 2026

First Posted

March 27, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

January 10, 2027

Last Updated

April 21, 2026

Record last verified: 2026-04

Locations