DOT Diary Mobile App for Pre-Exposure Prophylaxis Adherence in Young Men

NCT03771638 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 18-258211R01MH109320-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

The researchers are working with a technology company, AiCure, to develop a smartphone app, DOT Diary, which combines two drug adherence strategies. DOT Diary reminds people when it is time to take their medication, and uses motion-sensing technology to visually and automatically confirm the pill was swallowed. The goal of this study is to assess the impact of the app on adherence to HIV pre-exposure prophylaxis (PrEP) for the prevention of HIV.

Conditions

Adherence, Medication; Risk Behavior; Pre-Exposure Prophylaxis; HIV Prevention

Keywords

Adherence; PrEP; HIV Prevention; Truvada; HIV Risk Reduction; Mobile App

Outcome Measures

Primary Outcomes (4)

• Effect of DOT Diary App on PrEP Adherence

  Measurement of PrEP Adherence as measured by TFV-DP level \>=700 fmol/punch in DBS among young MSM initiating PrEP

  24 weeks

• Concordance of TFV-DP and FTC-TP in DBS With Adherence Measured by DOT Diary App

  As a measure of concordance between DBS measurements and aDOT-based assessments of PrEP adherence: Number of specimens with \< 700 fmol/punch or \>= 700 fmol/punch agreement with number of participants reporting PrEP use \< 4 days/week or 4-7 days/week at weeks 6, 12, 18, 24

  6, 12, 18, 24 weeks

• DOT Diary Mobile App Acceptability

  Combined descriptive analysis of key attributes of acceptability of DOT Diary over 24 weeks by YMSM on PrEP, in order to identify potential improvements to the app to maximize acceptability. This was measured using the System Usability Scale, with minmum value of 0 and maximum value of 100. This is a scale that uses a 10-item questionnaire with a 5-point Likert scale from strongly agree to strongly disagree. Scores are summed and the final score is multiplied by 2. Higher scores mean a better outcome.

  24 weeks

• DOT Diary Mobile App Ease of Use

  Descriptive analysis of key attribute of ease of use of DOT Diary over 24 weeks by YMSM on PrEP. Participants were asked if the DOT Diary app was easy to use and answered using a Likert Scale from 1= Strongly disagree, 2= Disagree, 3= Neutral, 4= Agree, 5= Strongly agree. A higher score indicates a better outcome.

  24 weeks

Secondary Outcomes (1)

• PrEP Coverage of Sexual Acts (Prevention-effectiveness Adherence) as Measured by DOT Diary

  6, 12, 18, 24 weeks

Study Arms (2)

DOT Diary Intervention

EXPERIMENTAL

DOT Diary mobile app and Emtricitabine / Tenofovir Disoproxil Oral Tablet (once daily)

Drug: Emtricitabine / Tenofovir Disoproxil Oral Tablet; Other: DOT Diary mobile app

DOT Diary Control

OTHER

Standard of care for Emtricitabine / Tenofovir Disoproxil Oral Tablet (once daily)

Drug: Emtricitabine / Tenofovir Disoproxil Oral Tablet

Interventions

Emtricitabine / Tenofovir Disoproxil Oral Tablet DRUG

Open label daily emtricitabine/tenofovir disoproxil oral tablet

Also known as: Truvada

DOT Diary Control; DOT Diary Intervention

DOT Diary mobile app OTHER

DOT Diary mobile application for tracking medication adherence and sexual activities.

DOT Diary Intervention

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Self-identify as a man
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Self-identifies as a man
• Age 18-35 at enrollment
• Reports having insertive or receptive anal sex with a man or trans woman in the past 12 months and one or more of the following criteria in the last 12 months:
• Any condomless anal sex outside of a mutually monogamous relationship with an HIV-negative partner
• Two or more anal sex partners
• Self-reported sexually transmitted infection (STI; gonorrhea, chlamydia, syphilis)
• Having a known HIV-positive sexual partner
• HIV-negative as determined by a negative 4th generation HIV test at screening and negative rapid 4th generation test at enrollment
• Willing to initiate PrEP
• Eligible to take PrEP
• Creatinine clearance ≥60 ml/min as estimated by Cockcroft-Gault equation at screening
• Hepatitis B surface antigen (HBsAg) negative
• Willing and able to provide written informed consent
• Able to read and speak English
• Smartphone ownership compatible with DOT Diary app

You may not qualify if:

• PrEP use within the past 4 months (PrEP naive participants will be prioritized)
• Any reactive HIV test at screening or enrollment
• Signs or symptoms of acute HIV infection at screening or enrollment
• History of pathological bone fracture not related to trauma
• Taking nephrotoxic medications
• History of participation in the active arm of an HIV vaccine trial
• In a mutually monogamous sexual relationship with an HIV-negative partner for the past 12 months
• Unable to commit to study participation for 24 weeks
• Any medical, psychiatric, or social condition or other responsibilities that, in the judgment of the investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Sponsors & Collaborators

• Public Health Foundation Enterprises, Inc.: lead
• National Institute of Mental Health (NIMH): collaborator
• San Francisco Department of Public Health: collaborator
• Emory University: collaborator
• AiCure: collaborator

Study Sites (2)

Bridge HIV, San Francisco Department of Public Health

San Francisco, California, 94102, United States

Location

Emory University, School of Public Health

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

• Velloza J, Liu AY, Katz AWK, van der Straten A, Siegler AJ, Scott H, Wilde G, Lockard A, Christie RH, Buchbinder SP. Acceptability of an automated directly observed therapy (DOT) application for PrEP adherence support among young men who have sex with men: a qualitative exploration. AIDS Care. 2024 Nov;36(11):1704-1718. doi: 10.1080/09540121.2024.2397133. Epub 2024 Sep 2.

  PMID: 39222964 DERIVED

MeSH Terms

Conditions

Medication Adherence; Risk-Taking

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Susan Buchbinder
• Organization: Bridge HIV, San Francisco Department of Public Health

susan.buchbinder@sfdph.org

628.217.7479

Study Officials

• Susan Buchbinder, MD

  Bridge HIV, San Francisco Department of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Bridge HIV

Model Details: Randomized, controlled study

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 11, 2018
• Study Start: February 1, 2019
• Primary Completion: April 21, 2020
• Study Completion: April 21, 2020
• Last Updated: July 3, 2025
• Results First Posted: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)