Thailand HIV and Stigma Reduction Study

Official title

Optimizing Mobile Interventions to Overcome Stigma and Promote HIV Prevention

Overview

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 vulnerable emerging adults (18-29 years).

Interventions

• Behavioral Mobile Healthy Choices (mHC)
  mHC is a four-session, 20-minute, motivational interviewing-based intervention, which will be delivered on the CIAS platform. It will be tailored to participants' responses given during the interaction in the intervention. In the first two sessions, the (virtual) counselor will motivate participants to overcome stigma and utilize HIV prevention services by using tailored motivational interviewing strategies, develop an individualized change goal based on their readiness, and provide cognitive be
• Behavioral Finding Respect and Ending Stigma around HIV (FRESH)
  FRESH content includes six 10-15 minute sessions with interactive, culturally sensitive multimedia modules, which will be delivered on the CIAS platform. The content will aim to improve self-efficacy, reduce intersectional stigmas and promote HIV preventative behaviors. The sessions will occur within three months after baseline.
• Behavioral Standard PrEP Counseling
  All participants will receive one-on-one, face to face counseling from focusing on sexual and behavioral risk assessment for HIV/STIs, risk reduction, and HIV prevention. For those not on PrEP, the sessions will focus on risk perception, awareness of PrEP, and facilitators and barriers to PrEP access. For those on PrEP, the sessions will focus on adherence. The counseling will be provided at baseline, 3 months, and 6 months.

Primary outcome measures

• Intervention Acceptability: System Usability Score (SUS) [Time frame: Month 3, Month 6]
• Intervention Acceptability: Exit Interview [Time frame: Month 3]
• Intervention Feasibility: Participant retention [Time frame: Baseline through Month 6]
• Intervention Feasibility: Number of FRESH sessions viewed [Time frame: Baseline through Month 6]
• Intervention Feasibility: Number of mHC sessions completed [Time frame: Baseline through Month 6]
• PrEP Uptake: Self-report [Time frame: Month 3, Month 6]
• PrEP Adherence: Visual analog scale [Time frame: Baseline, Month 3, and Month 6]
• PrEP Adherence: Self-Reported Adherence [Time frame: Baseline, Month 3, and Month 6]
• PrEP Adherence: DBS testing [Time frame: Baseline, Month 3, and Month 6]
• HIV testing uptake: Self-report [Time frame: Baseline, Month 3, and Month 6]

Secondary outcome measures (12)

• Empowerment [Time frame: Baseline, Month 3, and Month 6]
• Information: HIV Knowledge [Time frame: Baseline, Month 3, and Month 6]
• Information: PrEP Knowledge [Time frame: Baseline, Month 3, and Month 6]
• Motivation: Rollnick's Readiness Ruler [Time frame: Baseline, Month 3, and Month 6]
• Motivation: Decisional Balance for Problem Behavior [Time frame: Baseline, Month 3, and Month 6]
• Behavioral Skills [Time frame: Baseline, Month 3, and Month 6]
• HIV [Time frame: Baseline, Month 3, and Month 6]
• STI [Time frame: Baseline and Month 6]
• Sexual Risk [Time frame: Baseline, Month 3, and Month 6]
• Adaptive coping [Time frame: Baseline, Month 3, and Month 6]
• Resilience [Time frame: Baseline, Month 3, and Month 6]
• Substance use: Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) [Time frame: Baseline, Month 3, and Month 6]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Factorial

Masking

Open label

Primary purpose

Prevention

Study locations

Thailand · 3 centers

• Institute of HIV Research and Innovation — Bangkok
• Rainbow Sky Association of Thailand — Bangkok
• SWING Foundation — Bangkok

Identifiers

NCT: NCT06576648 · STUDY00001982 · R34MH134682-01A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗