Developing a MHealth HIV Prevention Intervention for Transgender Women (Phase 1 and 2)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Feasibility of the MyLink2Care app using percentages of individuals enrolled
研究概览
简要总结
This study aims to inform the development of an acceptable and usable smartphone app for transgender women (TGW) in Malaysia to deliver an integrated HIV prevention intervention that incorporates screening and guidance for HIV testing and pre-exposure prophylaxis compared to treatment as usual.
详细描述
This study aims to inform the development of an acceptable and usable smartphone app for transgender women (TGW) in Malaysia to deliver an integrated HIV prevention intervention that incorporates screening and guidance for HIV testing and pre-exposure prophylaxis (PrEP) compared to treatment as usual.
A new clinic-affiliated app (to be called MyLink2Care) will be developed (by adapting an existing app) and tested to deliver an integrated HIV prevention intervention that incorporates tailored HIV prevention and gender affirming care (GAC) services to TGW in Malaysia. The specific aims of the study include:
- Aim 1: Guided by the modified IM Adapt model, an existing mobile app will be adapted, expanded, and refined. Focus groups will be conducted with TGW (n=20) and clinical stakeholders (n=10) to theater test the existing app to develop an interactive prototype of the MyLink2Care app (alpha version), which will undergo usability testing (N=10), followed by full development of the app (beta version).
- Aim 2 Conduct beta testing of the fully developed version of the MyLink2Care app (N=15) to assess its usability and acceptability.
- Aim 3: Assess preliminary feasibility and acceptability of the MyLink2Care app within a pilot, randomized controlled trial, compared with treatment as usual for engagement in the HIV prevention cascade (N=50).
Together, these aims will address multilevel barriers to HIV testing and PrEP uptake in Malaysian TGW. Feasibility is high based on the investigators extensive experience with HIV prevention in TGW, theory-guided behavioral interventions, mHealth expertise, and longstanding work in Malaysia.
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
- •Identify as a transgender woman
- •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 MyLink2Care 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 MyLink2Care app
Feasibility of the MyLink2Care 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 MyLink2Care app
Acceptability of the MyLink2Care 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
Feasibility of the MyLink2Care 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 MyLink2Care app
Feasibility of the MyLink2Care 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 MyLink2Care app
Acceptability of the MyLink2Care 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 MyLink2Care 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.
Feasibility of the MyLink2Care 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.
Acceptability of the MyLink2Care 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 MyLink2Care 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.
次要结局
- Preliminary Efficacy of the MyLink2Care app using proportion of participants who persist on PrEP(6 months)
- Preliminary Efficacy of the MyLink2Care app through dried blood spot (DBS) testing as PrEP adherence measure(3 months)
- Preliminary Efficacy of the MyLink2Care app through DBS testing as PrEP adherence measure(6 months)
- Preliminary Efficacy of the MyLink2Care app using the visual analog scale (VAS) to measure PrEP adherence(6 months)