Thailand HIV and Stigma Reduction Study

Официальное название

Optimizing Mobile Interventions to Overcome Stigma and Promote HIV Prevention

Обзор

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).

Вмешательства

• Поведенческое 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
• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

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

Вторичные конечные точки (12)

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

Критерии участия

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

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Таиланд · 3 центра

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

Идентификаторы

NCT: NCT06576648 · STUDY00001982 · R34MH134682-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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