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Completed

NCT Number: NCT04248790

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

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).

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Pre-exposure Prophylaxis RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

20 year–100 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng Kung University Hospital, Tainan, Taiwan

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mobile app to improve adherence to PrEP self-management

Behavioral

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

Primary outcomes

  1. Usability

    Time frame: 4 months

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

  2. Feasibility: data based on the app analytics

    Time frame: 4 months

    • Frequency of app log-in;
    • Use of app components such as PrEP-taking and sex behavior reports;
    • Duration of app use

  3. Efficacy of adherence monitoring

    Time frame: 4 months

    Measuring the Tenofovir (TDF) and Emtricitabine (FTC) drug concentration in dried blood spot (DBS) samples to compare with self-report data

Secondary outcomes

  1. Feasibility: data from qualitative interviews

    Time frame: 4 months

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

Sponsors and collaborators

Lead sponsor

National Cheng Kung University

Other

Collaborators

  • National Cheng-Kung University Hospital
  • National Tsing Hua University
  • Taipei Veterans General Hospital, Taiwan

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 30, 2020
Registry last updated
Dec 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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