Training in mHealth Prevention With MSM
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Feasibility of the JomPrEP app using the percentage of participants that accessed the app
研究概览
简要总结
The investigators will conduct a pilot RCT to evaluate the feasibility and acceptability of the JomPrEP app and examine its preliminary efficacy in improving PrEP cascade compared with the control group.
详细描述
mHealth is a promising and cost-effective strategy to reach stigmatized and hard-to-reach populations and link them to care. Leveraging mHealth reduces individuals' discomfort and distrust of disclosing risk behaviors to providers, providers' low cultural competency for working with individuals of diverse sexual identities, and bypasses barriers to care for marginalized populations, - all features crucial for HIV prevention in MSM in Malaysia. Results from the investigators' studies show Malaysian MSM often do not get HIV tested or initiate PrEP. Mixed methods suggest MSM want these services but prefer a streamlined system to access them that reduces interaction with clinicians where disclosure and perceived judgment occurs. mHealth may overcome these barriers by facilitating prevention services delivery and health decision-making in a confidential, less-stigmatizing, and convenient manner. Overall smartphone growth in Malaysia (63% in 2015 to 89% in 2017), and the investigators' parallel work with MSM indicates that nearly all (>97%) MSM own a smartphone. Findings from qualitative interviews with MSM further indicate preferences for interfacing with 'apps' rather than health professionals as well as local stakeholders indicating strong interest in using such platform to deliver HIV prevention services align with developing culturally tailored mHealth strategies and to engage MSM in virtual communication with providers - all embedded within one app.
To the investigators' knowledge however, no mHealth intervention has been developed to improve access to HIV prevention services in Malaysia. The investigators, therefore, propose to pilot test their new clinic-affiliated app (JomPrEP) to promote HIV testing and PrEP uptake in Malaysian MSM. They will conduct a pilot RCT to evaluate the feasibility and acceptability of the JomPrEP app and examine its preliminary efficacy in improving PrEP cascade compared with the control group.
The investigators will enroll 90 participants who will be randomized (1:1) to receive either the JomPrEP app or the control group and assessed at 3- and 6-months. Randomization will be stratified by ATS use (16% to 24%) and age. They will conduct exit interviews with participants and clinical staff to examine the barriers and facilitators to the app and obtain feedback to further optimize the app.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •HIV-negative MSM
- •Age more than or equal to 18
- •Cis-gender men
- •Condomless sex in the last 30 days
- •Own a smartphone
排除标准
- •Unable to provide informed consent
- •Unable to read and understand English or Bahasa Malaysia
结局指标
主要结局
Feasibility of the JomPrEP app using the percentage of participants that accessed the app
时间窗: 6 months
The investigators will determine the percentage of participants that accessed the app, with ≥60% of participants accessing app as lower threshold. The higher the percentage, the higher the feasibility.
Feasibility of the JomPrEP app using percentages of individuals enrolled
时间窗: 6 months
The investigators will use the percentage of individuals enrolled to determine the feasibility of the JomPrEP app
Acceptability of the JomPrEP app based on the subjective usability measure
时间窗: 6 months
Acceptability will be based on descriptive statistics from the subjective usability measure, with a target mean score of ≥ 50. The higher the score, the higher the acceptability. Minimum score for the scale is 0, highest is 100.
Feasibility of the JomPrEP app using percentages of individuals screened
时间窗: 6 months
The investigators will use the percentage of individuals screened to determine the feasibility of the JomPrEP app
Feasibility of the JomPrEP app using percentages of individuals eligible
时间窗: 6 months
The investigators will use the percentage of individuals eligible to determine the feasibility of the JomPrEP app
Feasibility of the JomPrEP app using percentages of individuals retained
时间窗: 6 months
The investigators will use the percentage of individuals retained to determine the feasibility of the JomPrEP app
Acceptability of the JomPrEP app based on usability concerns identified by participants in qualitative interviews
时间窗: 6 months
Acceptability will be based on analysis of qualitative data which includes usability concerns.
Acceptability of the JomPrEP app based on perceived usefulness of participants assessed in qualitative interviews
时间窗: 6 months
Acceptability will be based on analysis of qualitative data which includes specific areas of perceived usefulness of the app.
Acceptability of the JomPrEP app based on barriers and facilitators identifies by participants in qualitative interviews
时间窗: 6 months
Acceptability will be based on analysis of qualitative data which includes barriers and facilitators.
Acceptability of the JomPrEP app based on refinement feedback identified by participants in qualitative data interviews
时间窗: 6 months
Acceptability will be based on analysis of qualitative data which includes refinement needed to maximize future implementation.
次要结局
- Preliminary Efficacy of the JomPrEP app through dried blood spot testing as PrEP adherence measure(6 months)
- Preliminary Efficacy of the JomPrEP app using the visual analog scale (VAS) to measure PrEP adherence(6 months)
- Preliminary Efficacy of the JomPrEP app using proportion of participants who persist on PrEP(6 months)
研究者
Roman Shrestha
Assistant Professor
University of Connecticut