Adapting Effective mHealth Interventions to Improve Uptake and Adherence of the HIV Pre-exposure Prophylaxis (PrEP) in Thai Young Men Who Have Sex With Men (MSM).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 119
- 试验地点
- 6
- 主要终点
- Intervention Acceptability: System Usability Score
研究概览
简要总结
The goal of this study is to develop and pilot test technology-based interventions to promote Pre-exposure Prophylaxis (PrEP) uptake and adherence among Thai young men who have sex with men (YMSM).
详细描述
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). Motivational Interactive Text Messaging (MTM) will be integrated with MES-PrEP to provide ongoing support to maintain the individual's motivation for behavior change. Both interventions will be developed and refined based upon the inputs from YMSM through focus group discussion and youth advisory board.
The Investigators propose to pilot randomized controlled trial (RCT) to evaluate the feasibility, acceptability, and preliminary efficacy of an intervention combining MES-PrEP and MTM to increase PrEP uptake and adherence among Thai YMSM. Eligible YMSM will be randomized to receive either the intervention plus the standard PrEP counseling or standard PrEP counseling, and followed for 6 months with assessments at baseline, month 1, 3 and 6.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 25 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age 16-25 years old
- •Men who report sex with men in the past 12 months
- •Confirmed HIV-negative status
- •Self-reported evidence of being at-risk for HIV acquisition, including one of the following in the past 6 months:
- •having a sex with an HIV-positive partner
- •having anal sex
- •without using a condom
- •being diagnosed with an STI or
- •having any illicit drug use (e.g., Amphetamine type stimulants)
- •Able to understand, read and speak Thai
- •Either having not started PrEP (Group 1: PrEP naive) or currently on PrEP but not adherent to PrEP (taking ≤3 pills/week) in the past month (Group 2: PrEP users).
排除标准
- •In a mutually monogamous relationship of more than 6 months with a partner who recently tested HIV-negative
- •Have a serious cognitive or psychiatric problem that would compromise ability to provide informed consent
- •currently enrolled in another HIV intervention study
研究组 & 干预措施
MES-PrEP and MTM
Participants in this arm will receive standard PrEP counseling, followed by mHealth interventions to improve PrEP uptake and support PrEP adherence.
干预措施: Standard PrEP Counseling (Behavioral)
MES-PrEP and MTM
Participants in this arm will receive standard PrEP counseling, followed by mHealth interventions to improve PrEP uptake and support PrEP adherence.
干预措施: Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP) (Behavioral)
MES-PrEP and MTM
Participants in this arm will receive standard PrEP counseling, followed by mHealth interventions to improve PrEP uptake and support PrEP adherence.
干预措施: Motivational Interactive Text Messaging (MTM) (Behavioral)
Standard PrEP Counseling
Participants in this arm will receive the standard PrEP counseling.
干预措施: Standard PrEP Counseling (Behavioral)
结局指标
主要结局
Intervention Acceptability: System Usability Score
时间窗: Month 6
System Usability Score (SUS) is a 10-item, Likert scale used to calculate intervention usability. Each item ranges from 0 to 4 (with 4 being the most positive response). For odd-numbered items, the score is calculated by subtracting one from the user response. For even-numbered items, the score is calculated by subtracting the user response from 5. Then sum the total score and multiply that by 2.5. The overall SUS scores range from 0 to 100. A score of \> 50 indicates that the technology-based interventions are acceptable.
Intervention Acceptability: Client Satisfaction Questionnaire
时间窗: Month 6
Client Satisfaction Questionnaire (CSQ-8) is an 8-items, Likert scale measuring the construct of global intervention satisfaction. The total possible composite score range from 8 to 32, with higher scores indicating a greater degree of acceptability.
Intervention Feasibility: Number of responses to text messages
时间窗: Baseline through Month 6
Intervention feasibility will be measured by total number of responses to text messages. Point estimates of \>50% of participants responded to at least one text message is considered as the minimum criteria for feasibility.
Intervention Feasibility: Number of intervention sessions completed
时间窗: Baseline through Month 6
Intervention feasibility will be measured by number of intervention sessions completed. Point estimates of \>50% of participants completed at least one intervention session is considered as the minimum criteria for feasibility.
Intervention Feasibility: Participant retention
时间窗: Baseline through Month 6
Intervention Feasibility will be measured by participants retention rate at Month 6.
PrEP Adherence: Visual analog scale
时间窗: Baseline through Month 6
PrEP adherence will be measured from Young Adult Adherence Interview via computer-assisted self-interview (CASI) survey which contains a visual analog scale (VAS). VAS ranges from 0 to 100, with higher percentage indicating greater adherence to PrEP.
PrEP Adherence: Self-reported adherence
时间窗: Baseline through Month 6
PrEP adherence will be measured from self-reported adherence to PrEP in the past 4 weeks.
PrEP uptake
时间窗: Month 1 through Month 6
PrEP uptake will be measured by the number of PrEP prescription, using a self-report measure (participants reporting if they left the clinic with PrEP) and confirming with clinic records.
PrEP Adherence: Dried blood spots
时间窗: Baseline through Month 6
PrEP adherence will be measured by the level of tenofovir in dried blood spots (DBS). DBS report on 80% Truvada adherence after at least three weeks of regular adherence.
Intervention Acceptability: System Usability Score
时间窗: Month 3
System Usability Score (SUS) is a 10-item, Likert scale used to calculate intervention usability. Each item ranges from 0 to 4 (with 4 being the most positive response). For odd-numbered items, the score is calculated by subtracting one from the user response. For even-numbered items, the score is calculated by subtracting the user response from 5. Then sum the total score and multiply that by 2.5. The overall SUS scores range from 0 to 100. A score of \> 50 indicates that the technology-based interventions are acceptable.
Intervention Acceptability: Client Satisfaction Questionnaire
时间窗: Month 3
Client Satisfaction Questionnaire (CSQ-8) is an 8-items, Likert scale measuring the construct of global intervention satisfaction. The total possible composite score range from 8 to 32, with higher scores indicating a greater degree of acceptability.
次要结局
- PrEP Knowledge(Baseline to Month 6)
- HIV Knowledge(Baseline to Month 6)
- Motivation: Rollnick's Readiness Ruler(Baseline to Month 6)
- HIV Status(Baseline to Month 6)
- Sexually Transmitted Infections (STIs) Diagnosis(Baseline to Month 6)
- Sexual Risk(Baseline to Month 6)
- Motivation: Decisional Balance for PrEP Use(Baseline to Month 6)
- Behavioral Skill(Baseline to Month 6)
研究者
Bo Wang
Professor
University of Massachusetts, Worcester