Thailand Transgender Women Stigma Study

University of Massachusetts, Worcester

Status: Enrolling

Conditions: Pre-Exposure Prophylaxis

Treatments: Behavioral: Standard PrEP Counseling; Behavioral: Finding Respect and Ending Stigma around HIV (FRESH); Behavioral: Mobile Healthy Choices (mHC)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06576648

STUDY00001982

R34MH134682-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This project will develop a multi-component, technology-delivered intervention designed to reduce HIV and intersectional stigma and improve the use of HIV pre-exposure prophylaxis (PrEP) among HIV-negative Thai, young transgender women (18-29 years).

Enrollment: 154 estimated patients

Sex: Male

Ages: 18 to 29 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Aim 1 (Formative Research and Beta-Testing) Transgender women

Inclusion Criteria:

• Ages between 18 and 29 years
• Male sex at birth
• Self-identifies as women, transgender women or culturally identifies with the female spectrum
• Laboratory-confirmed HIV-negative status
• Self-reported recent history of condomless sex
• Able to understand, read and speak Thai
• Either not started PrEP or currently on PrEP but not adherent (taking ≤3 pills/week) in the past month.

Exclusion Criteria:

• Have a serious cognitive or psychiatric problem compromising ability to provide informed consent
• Have active suicidal ideation or major mental illness at the time of interview (these patients will be referred for treatment)
• Laboratory or clinical findings that would preclude PrEP initiation (e.g., decreased creatinine clearance)
• Currently enrolled in another HIV intervention study.

Healthcare providers Inclusion criteria

• Age 18 or above
• Has provided HIV prevention or treatment services for TGW for at least one year Exclusion criteria
• None

Aim 2 (Pilot RCT) Transgender women Inclusion criteria

• Ages between 18 and 29 years
• Male sex at birth
• Self-identifies as women, transgender women or culturally identifies with the female spectrum
• Laboratory-confirmed HIV-negative status
• Self-reported recent history of condomless sex
• Able to understand, read and speak Thai
• Either not started PrEP or currently on PrEP but not adherent (taking ≤3 pills/week) in the past month.

Exclusion criteria

• Have a serious cognitive or psychiatric problem compromising ability to provide informed consent
• Have active suicidal ideation or major mental illness at the time of interview (these patients will be referred for treatment)
• Laboratory or clinical findings that would preclude PrEP initiation (e.g., decreased creatinine clearance)
• Currently enrolled in another HIV intervention study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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154 participants in 4 patient groups

Standard PrEP counseling, mHC, and FRESH content

Experimental group

Description:

Participants in this arm will receive standard PrEP counseling, followed by four mHC sessions and six FRESH sessions to reduce stigma and increase utilization of HIV prevention services.

Treatment:

Behavioral: Mobile Healthy Choices (mHC)

Behavioral: Finding Respect and Ending Stigma around HIV (FRESH)

Behavioral: Standard PrEP Counseling

Standard PrEP counseling and mHC

Experimental group

Description:

Participants in this arm will receive standard PrEP counseling, followed by four mHC sessions to reduce stigma and increase utilization of HIV prevention services.

Treatment:

Behavioral: Mobile Healthy Choices (mHC)

Behavioral: Standard PrEP Counseling

Standard PrEP counseling and FRESH content

Experimental group

Description:

Participants in this arm will receive standard PrEP counseling, followed by six FRESH sessions to reduce stigma and increase utilization of HIV prevention services.

Treatment:

Behavioral: Finding Respect and Ending Stigma around HIV (FRESH)

Behavioral: Standard PrEP Counseling

Standard PrEP counseling

Experimental group

Description:

Participants in this arm will receive the standard PrEP counseling.

Treatment:

Behavioral: Standard PrEP Counseling