AzTrials
AzTrials

HIV InfectionsNCT04248790

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

A study testing mobile app to improve adherence to PrEP self-management in people with HIV Infections and Pre-Exposure Prophylaxis, run by National Cheng Kung University at 3 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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). Read more about this study

Who is it for?
Ages 20 to 100 years, men onlyHealthy volunteers can take part
Conditions the study is for
HIV Infections, Pre-Exposure Prophylaxis
What is being tested?
mobile app to improve adherence to PrEP self-management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
3 sitesTaiwan
Study dates
25 May 2020to 23 Oct 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 100 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country.

Taiwan3 sites

  • National Cheng Kung University Hospital

    Tainan, Tainan, 701

  • Taipei city hospital (Renai Branch)

    Taipei, 10629

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

About this study

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

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).

Read the 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.

Being tested
mobile app to improve adherence to PrEP self-management
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mobile app to improve adherence to PrEP self-managementBehavioural

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

Study groups in NCT04248790
Study groupRoleWhat they receive
Experimental: the mobile AppExperimentalParticipants 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.
Receives: Behavioral: mobile app to improve adherence to PrEP self-management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Usability

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

    Measured: 4 months

  2. 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

    Measured: 4 months

  3. 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

    Measured: 4 months

Secondary outcomes (1)

  1. 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

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2020
  2. Study start25 May 2020
  3. Primary completion23 Oct 2020
  4. Study completion23 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04248790
Sponsor's protocol ID
TaiwanUPrEPU
Other IDs
MOST 108-2636-B-006-004
Status last verified
Dec 2020
First submitted
28 Jan 2020
Last updated
30 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33258793

Questions about this trial

What is this clinical trial studying?

A study testing mobile app to improve adherence to PrEP self-management in people with HIV Infections and Pre-Exposure Prophylaxis, run by National Cheng Kung University at 3 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Usability (time frame: 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04248790, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in