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

University of California, Los Angeles (UCLA)

Status: Enrolling

Conditions: HIV (Human Immunodeficiency Virus); Stigma; Continuum of Care

Treatments: Behavioral: TransAction

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07495059

1R34MH139375-01 (U.S. NIH Grant/Contract)

TransAction in Vietnam

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: Male

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

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

Treatment:

Behavioral: TransAction

Control

Placebo Comparator group

Description:

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

Treatment:

Behavioral: TransAction