Developing mHealth to Promote PrEP Use Among Thai Young Vulnerable Adolescents and Emerging Adults

University of Massachusetts, Worcester

Status: Active, not recruiting

Conditions: Pre-Exposure Prophylaxis

Treatments: Behavioral: Standard PrEP Counseling; Behavioral: Behavioral: Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP); Behavioral: Enhanced YaCool

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05262426

1R21HD107988-01 (U.S. NIH Grant/Contract)

H00023527

Details and patient eligibility

About

The main aim of this study is to develop technology-based interventions to improve HIV pre-exposure prophylaxis (PrEP) uptake and adherence among Thai young transgender women.

Full description

Motivational Enhancement System for Adherence (MESA) is a computer-based motivation invention, based on the Information-Motivation-Behavioral Skills (IMB) model and Motivational Interviewing (MI) principles, used to promote adherence among HIV-positive youth initiating antiretroviral treatment. In this study, the team will adapt and develop MESA to focus on PrEP uptake and adherence, which will be called Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP). YaCool is a mobile application developed to support transgender women self-management of gender and sexual health, including PrEP use.

In Aim 1, the investigators will begin with needs assessment to evaluate intervention efficacy by exploring the barriers and facilitators of PrEP uptake and adherence through in-depth interviews with transgender women and community health workers. The two interventions will be developed and refined based upon the inputs from transgender women through focus group discussion and community advisory board.

In Aim 2, the investigators will conduct a Multiphase Optimization Strategy (MOST) design-based trial to evaluate the feasibility, acceptability, and preliminary efficacy of MES-PrEP and Enhanced YaCool and to determine whether MES-PrEP works better when combined with Enhanced YaCool to improve PrEP use. Eligible transgender women will be randomized to one of the four experimental conditions, and followed for 12 months with assessments at baseline, month 1, 3, 6, 9 and 12.

Enrollment: 145 patients

Sex: Male

Ages: 16 to 29 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Aim 1:

Transgender women participants

Inclusion Criteria:

• Age 16-29 years old
• Male sex at birth
• Self-identifies as woman or transgender women or culturally identifies with the female spectrum
• Confirmed HIV-negative status
• Self-reported recent history of condomless sex in the past 6 months
• Able to understand, read and speak Thai
• Either having not started PrEP (Group 1: PrEP naive), currently on PrEP but not adherent to PrEP (taking ≤3 pills/week) in the past month (Group 2: PrEP users) or currently on PrEP with good adherence (Group 3: PrEP users with good adherence).

Exclusion Criteria:

• Have a serious cognitive or psychiatric problem that would compromise ability to provide informed consent
• Have active suicidal ideation or major mental illness (e.g., untreated psychosis or mania) at the time of interview (patients will be referred for treatment)
• Laboratory or clinical findings that would preclude PrEP initiation (e.g., decreased creatinine clearance)

Healthcare providers

Inclusion Criteria:

• Have at least 1-year experience working with HIV-negative transgender women, including providing PrEP prescription and counseling

Exclusion Criteria:

• None

Aim 2:

Inclusion Criteria:

• Age 16-29 years old
• Male sex at birth
• Self-identifies as woman or transgender women or culturally identifies with the female spectrum
• Confirmed HIV-negative status
• Self-reported recent history of condomless sex in the past 6 months
• Able to understand, read and speak Thai
• Either having not started PrEP (Group 1: PrEP naive), currently on PrEP but not adherent to PrEP (taking ≤3 pills/week) in the past month (Group 2: PrEP users).

Exclusion Criteria:

• Have a serious cognitive or psychiatric problem that would compromise ability to provide informed consent
• Have active suicidal ideation or major mental illness (e.g., untreated psychosis or mania) at the time of interview (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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145 participants in 4 patient groups

Standard PrEP Counseling, MES-PrEP and Enhanced YaCool

Experimental group

Description:

Participants in this arm will receive standard PrEP counseling, followed by two mHealth interventions (MES-PrEP and Enhanced YaCool) to improve PrEP uptake and support PrEP adherence.

Treatment:

Behavioral: Enhanced YaCool

Behavioral: Behavioral: Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP)

Behavioral: Standard PrEP Counseling

Standard PrEP Counseling and MES-PrEP

Experimental group

Description:

Participants in this arm will receive standard PrEP counseling, followed by one mHealth intervention (MES-PrEP) to improve PrEP uptake and support PrEP adherence.

Treatment:

Behavioral: Behavioral: Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP)

Behavioral: Standard PrEP Counseling

Standard PrEP Counseling and Enhanced YaCool

Experimental group

Description:

Participants in this arm will receive standard PrEP counseling, followed by one mHealth intervention (Enhanced YaCool) to improve PrEP uptake and support PrEP adherence.

Treatment:

Behavioral: Enhanced YaCool

Behavioral: Standard PrEP Counseling

Standard PrEP Counseling

Active Comparator group

Description:

Participants in this arm will receive the standard PrEP counseling.

Treatment:

Behavioral: Standard PrEP Counseling