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

HIV Infections Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04248790
• Other study ID #: TaiwanUPrEPU
• Secondary ID: MOST 108-2636-B-
• Status: Completed
• Phase: N/A
• Start date: May 25, 2020
• Est. completion date: October 23, 2020

Study information

• Verified date: December 2020
• Source: National Cheng Kung University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 23, 2020
• Est. primary completion date: October 23, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections
• Pre-Exposure Prophylaxis

Intervention

Behavioral:
• mobile app to improve adherence to PrEP self-management
Access to the mobile app which includes the sex and PrEP diary, information on HIV/STI testing, PrEP reminders and geo-location features.

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University Hospital	Tainan City	Tainan
Taiwan	Taipei city hospital (Renai Branch)	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (4)

Lead Sponsor	Collaborator
National Cheng Kung University	National Cheng-Kung University Hospital, National Tsing Hua University, Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Usability	Scores on system usability scale (SUS) for this app at the first month and the fourth month.	4 months
Primary	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
Primary	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	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