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

National Cheng Kung University35 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

HIV Infections Pre-Exposure Prophylaxis

Interventions

mobile app to improve adherence to PrEP self-managementBEHAVIORAL

Access to the mobile app which includes the sex and PrEP diary, information on HIV/STI testing, PrEP reminders and geo-location features.

Eligibility

Sex: MALEMin age: 20 YearsMax age: 100 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (3)

National Cheng Kung University Hospital

Tainan, Tainan, Taiwan

Taipei city hospital (Renai Branch)

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Outcomes

Primary Outcomes

Usability

Scores on system usability scale (SUS) for this app at the first month and the fourth month.

Time frame: 4 months

Feasibility: data based on the app analytics

1. Frequency of app log-in; 2. Use of app components such as PrEP-taking and sex behavior reports; 3. Duration of app use

Time frame: 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

Time frame: 4 months

Secondary Outcomes

Feasibility: data from qualitative interviews

1. any technical challenges participants may have encountered; 2. recommendations for the app improvement; 3. users' satisfaction and comfort in using this app

Time frame: 4 months

Data from ClinicalTrials.gov

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