Clinical trial NCT04248790: Design and Development of a Mobile App to Improve Adherence to Pre-exposure Prophylaxis in Men Who Have Sex With Men
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Pre-Exposure Prophylaxis
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
Collaborators: name: National Cheng-Kung University Hospital
name: Taipei Veterans General Hospital, Taiwan
name: National Tsing Hua University
First posted: 2020-01-30
Enrollment: 35
Sex: MALE
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Usability
timeFrame: 4 months
measure: Feasibility: data based on the app analytics
timeFrame: 4 months
measure: Efficacy of adherence monitoring
timeFrame: 4 months
Secondary outcomes:
measure: Feasibility: data from qualitative interviews
timeFrame: 4 months
Other outcomes:
Locations:
city: Tainan City
country: Taiwan
facility: National Cheng Kung University Hospital
state: Tainan
city: Taipei
country: Taiwan
facility: Taipei city hospital (Renai Branch)
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: National Cheng Kung University
name: Carol Strong, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Strong C, Wu HJ, Tseng YC, Yuan CW, Yu YF, Liao JC, Chen YW, Hung YC, Li CW, Huang PH, Ko NY, Ku SW. Mobile App (UPrEPU) to Monitor Adherence to Pre-exposure Prophylaxis in Men Who Have Sex With Men: Protocol for a User-Centered Approach to Mobile App Design and Development. JMIR Res Protoc. 2020 Dec 1;9(12):e20360. doi: 10.2196/20360.