Design and Development of a Mobile App to Improve Adherence to Pre-exposure Prophylaxis in Men Who Have Sex With Men: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 3
- 主要终点
- Efficacy of adherence monitoring
研究概览
简要总结
This study is testing feasibility and acceptability of a theoretically based mobile application (app), UPrEPU, to increase adherence to pre-exposure prophylaxis (PrEP) among men who have sex with men (MSM) to prevent human immunodeficiency virus (HIV).
详细描述
This study aims to develop an effective mobile application (app), UPrEPU to recognize the factors and decisions that affect PrEP adherence in high-risk populations to improve PrEP adherence. Key components of the app include a sex/PrEP diary using ecological momentary assessment to facilitate accurate data collection; PrEP taking reminder; HIV and sexually transmitted infections (STI) testing information and reminders; HIV and PrEP information and videos; geo-location.
After eligible PrEP candidates agree to participate in the study, we will ask participants to install the app. Then, we will begin to collect their sexual diary and PrEP taking log via ecological momentary assessment. Participants will also complete monthly assessments. The monthly follow-up will test HIV/STI and drug concentration. The participants will be interviewed for difficulties when they use our app and giving feedback on it.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Aged 20 or above.
- •Resides in Taiwan and able to understand, read, and speak Mandarin Chinese.
- •Remains HIV negative prior to and during the study period.
- •The results of the laboratory tests are eligible to initiate PrEP.
- •Currently taking PrEP or willing to initiate PrEP.
- •Reports having 4 times or above anal sex with men in the past month.
- •Owns an Android or Apple operating system (iOS) smartphone and willing to download the study app.
- •Willing to wear the device we provided during the study period.
排除标准
- •With abnormal kidney function (creatinine clearance rate ≦ 60 mL/minute).
- •Currently on medication that might interact with PrEP, such as drugs contain lamivudine in the pre-PrEP assessment.
研究组 & 干预措施
Experimental: the mobile App
Participants in the intervention arm will receive access to all the app capabilities. The app features include information on HIV testing locations, sex and PrEP diary and reminder of taking PrEP.
干预措施: mobile app to improve adherence to PrEP self-management (Behavioral)
结局指标
主要结局
Efficacy of adherence monitoring
时间窗: 4 months
Measuring the Tenofovir (TDF) and Emtricitabine (FTC) drug concentration in dried blood spot (DBS) samples to compare with self-report data
Usability
时间窗: 4 months
Scores on system usability scale (SUS) for this app at the first month and the fourth month.
Feasibility: data based on the app analytics
时间窗: 4 months
1. Frequency of app log-in; 2. Use of app components such as PrEP-taking and sex behavior reports; 3. Duration of app use
次要结局
- Feasibility: data from qualitative interviews(4 months)
研究者
Carol Strong
Associate Professor
National Cheng Kung University