NCT04248790

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at below P25 for not_applicable hiv-infections

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable hiv-infections

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

May 25, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2020

Completed
Last Updated

December 30, 2020

Status Verified

December 1, 2020

Enrollment Period

5 months

First QC Date

January 28, 2020

Last Update Submit

December 28, 2020

Conditions

HIV InfectionsPre-Exposure Prophylaxis

Outcome Measures

Primary Outcomes (3)

  • 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

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

  • Feasibility: data from qualitative interviews

    4 months

Study Arms (1)

Experimental: the mobile App

EXPERIMENTAL

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

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.

Experimental: the mobile App

Eligibility Criteria

Age20 Years - 100 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

National Cheng Kung University Hospital

Tainan, Tainan, 701, Taiwan

Location

Taipei city hospital (Renai Branch)

Taipei, 10629, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 33258793DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Carol Strong, PhD

    National Cheng Kung University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 28, 2020

First Posted

January 30, 2020

Study Start

May 25, 2020

Primary Completion

October 23, 2020

Study Completion

October 23, 2020

Last Updated

December 30, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

TW(3)