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

NCT ID: NCT03771638

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2020-04-21

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.

Detailed Description

In the DOT Diary research project, the AiCure automated directly observed therapy (aDOT) smartphone app has been adapted for use in monitoring and supporting HIV pre-exposure prophylaxis (PrEP) use among young men who have sex with men (YMSM). The aDOT app uses automated directly observed therapy (DOT) that use the smartphone camera and artificial intelligence software to confirm that the right person is taking the right medication at the right time. A sexual diary has been integrated into the aDOT app to assist YMSM in understanding whether they are receiving protection from PrEP for individual sexual episodes, and when it is particularly important to take PrEP (e.g. after a sexual episode). Specifically, the sexual diary allows participants to track sexual encounters, sexual behaviors that occurred in each encounter, and rating characteristics of partners. The app provides a calendar displaying all days in which PrEP medication was taken, and all days in which sexual activity occurred, allowing participants to see coverage of sexual encounters with PrEP. Based on pharmacokinetic and pharmacodynamic data from prior PrEP trials, the app will also indicate the estimated level of protection achieved from PrEP (e.g. low, medium, high), and also provide personalized messages on the additional numbers of doses needed to maximize protection.

In the next stage of app development and assessment, the researchers will conduct the DOT Diary Longitudinal Pilot to assess the impact of the app on PrEP adherence as measured by pharmacokinetic measures of PrEP use (tenofovir diphosphate [TFV-DP] and emtricitabine triphosphate [FTC-TP] levels in dried blood spots [DBS]). The researchers will also assess the concordance of TFV-DP and FTC-TP in DBS with adherence measured by DOT Diary, and the acceptability and ease of use of the app over a longer (24-week) period. This pilot study will allow evaluation and further refinement of the app in preparation for testing in a larger efficacy trial among YMSM at risk for HIV acquisition. The researchers will conduct this pilot protocol among YMSM in Atlanta and San Francisco Bay Area, two metropolitan regions heavily impacted by HIV, yet differing in sociodemographics, as well as in the availability and uptake of HIV prevention services, including PrEP. These diverse research locations will allow collection of data to inform app development among a broad group of YMSM.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

DOT Diary Intervention

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

Group Type: EXPERIMENTAL

Emtricitabine / Tenofovir Disoproxil Oral Tablet

Intervention Type: DRUG

Open label daily emtricitabine/tenofovir disoproxil oral tablet

DOT Diary mobile app

Intervention Type: OTHER

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

DOT Diary Control

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

Group Type: OTHER

Emtricitabine / Tenofovir Disoproxil Oral Tablet

Intervention Type: DRUG

Open label daily emtricitabine/tenofovir disoproxil oral tablet

Interventions

Emtricitabine / Tenofovir Disoproxil Oral Tablet

Open label daily emtricitabine/tenofovir disoproxil oral tablet

Intervention Type: DRUG

DOT Diary mobile app

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

Intervention Type: OTHER

Other Intervention Names

Truvada

Eligibility Criteria

Inclusion Criteria

• 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
• Meets local locator requirements
• Lives, works or plays in Atlanta Metropolitan Area, San Francisco, Alameda, Marin, Contra Costa, Santa Clara, or San Mateo Counties

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

San Francisco Department of Public Health

OTHER_GOV

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: collaborator

AiCure

INDUSTRY

Sponsor Role: collaborator

Public Health Foundation Enterprises, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Susan Buchbinder

Director, Bridge HIV

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susan Buchbinder, MD

Role: PRINCIPAL_INVESTIGATOR

Bridge HIV, San Francisco Department of Public Health

Locations

Bridge HIV, San Francisco Department of Public Health

San Francisco, California, United States

Emory University, School of Public Health

Atlanta, Georgia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39222964 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

1R01MH109320-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

18-25821

Identifier Type: -

Identifier Source: org_study_id