Design and Development of a Mobile App to Improve Adherence to Pre-exposure Prophylaxis in Men Who Have Sex With Men

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Design and Development of a Mobile App to Improve Adherence to Pre-exposure Prophylaxis in Men Who Have Sex With Men: A Pilot Study

Conditions
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HIV Infections, Pre-Exposure Prophylaxis

Intervention / Treatment
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* Behavioral: mobile app to improve adherence to PrEP self-management


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Male. 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. Exclusion criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: the mobile App<br>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. | Behavioral: mobile app to improve adherence to PrEP self-management<br>* Access to the mobile app which includes the sex and PrEP diary, information on HIV/STI testing, PrEP reminders and geo-location features.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability | Scores on system usability scale (SUS) for this app at the first month and the fourth month. | 4 months | 
| Feasibility: data based on the app analytics | Frequency of app log-in; Use of app components such as PrEP-taking and sex behavior reports; Duration of app use | 4 months | 
| Efficacy of adherence monitoring | Measuring the Tenofovir (TDF) and Emtricitabine (FTC) drug concentration in dried blood spot (DBS) samples to compare with self-report data | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility: data from qualitative interviews | any technical challenges participants may have encountered; recommendations for the app improvement; users' satisfaction and comfort in using this app | 4 months |