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

• ClinicalTrials.gov Identifier: NCT03771638
• Recruitment Status: Completed
• First Posted: December 11, 2018
• Last Update Posted: April 9, 2021
• Sponsor: Public Health Foundation Enterprises, Inc.
• Collaborators: National Institute of Mental Health (NIMH); San Francisco Department of Public Health; Emory University; AiCure
• Information provided by (Responsible Party): Susan Buchbinder, Public Health Foundation Enterprises, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Adherence, Medication; Risk Behavior; Pre-Exposure Prophylaxis; HIV Prevention	Drug: Emtricitabine / Tenofovir Disoproxil Oral Tablet; Other: DOT Diary mobile app	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized, controlled study
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: DOT Diary Longitudinal Pilot: A Mobile App for Pre-Exposure Prophylaxis Adherence in Young Men
• Actual Study Start Date: February 1, 2019
• Actual Primary Completion Date: April 21, 2020
• Actual Study Completion Date: April 21, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: DOT Diary Intervention; DOT Diary mobile app and Emtricitabine / Tenofovir Disoproxil Oral Tablet (once daily)	Drug: Emtricitabine / Tenofovir Disoproxil Oral Tablet; Open label daily emtricitabine/tenofovir disoproxil oral tablet; Other Name: Truvada; Other: DOT Diary mobile app; 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)	Drug: Emtricitabine / Tenofovir Disoproxil Oral Tablet; Open label daily emtricitabine/tenofovir disoproxil oral tablet; Other Name: Truvada

Outcome Measures

Primary Outcome Measures :

1. Effect of DOT Diary app on PrEP adherence [ Time Frame: 24 weeks ]
   Measurement of PrEP Adherence as measured by TFV-DP in DBS among young MSM initiating PrEP
2. Concordance of TFV-DP and FTC-TP in DBS with adherence measured by DOT Diary app [ Time Frame: 24 weeks ]
   Validation of DOT will focus on concordance between aDOT-based assessments of PrEP adherence by the DOT Diary app with DBS measurements
3. DOT Diary mobile app acceptability [ Time Frame: 24 weeks ]
   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
4. DOT Diary mobile app ease of use [ Time Frame: 24 weeks ]
   Combined descriptive analysis of key attributes of ease of use of DOT Diary over 24 weeks by YMSM on PrEP

Secondary Outcome Measures :

1. PrEP coverage of sexual acts (prevention-effectiveness adherence) as measured by DOT Diary [ Time Frame: 24 weeks ]
   Combined analysis of the probability of coverage of condomless receptive sexual acts in each period with sexual acts treated as trials, and coverage as success.
2. Evaluation of daily use of aDOT components of DOT Diary app [ Time Frame: 24 weeks ]
   Estimation of the average use of aDOT components, as proportion of days on study
3. Evaluation of use of diary components of DOT Diary app [ Time Frame: 24 weeks ]
   Estimation of the average use of diary component of DOT Diary app as proportions of weeks on study.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 35 Years (Adult)
• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Self-identify as a man
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, California

Bridge HIV, San Francisco Department of Public Health

San Francisco, California, United States, 94102

United States, Georgia

Emory University, School of Public Health

Atlanta, Georgia, United States, 30322

Sponsors and Collaborators

Public Health Foundation Enterprises, Inc.

National Institute of Mental Health (NIMH)

San Francisco Department of Public Health

Emory University

AiCure

Investigators

• Principal Investigator: Susan Buchbinder, MD; Bridge HIV, San Francisco Department of Public Health

More Information

• Responsible Party: Susan Buchbinder, Director, Bridge HIV, Public Health Foundation Enterprises, Inc.
• ClinicalTrials.gov Identifier: NCT03771638
• Other Study ID Numbers: 18-25821; 1R01MH109320-01 ( U.S. NIH Grant/Contract )
• First Posted: December 11, 2018
• Last Update Posted: April 9, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Susan Buchbinder, Public Health Foundation Enterprises, Inc.:

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

Additional relevant MeSH terms:

Tenofovir; Emtricitabine; Antiviral Agents; Anti-Infective Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-Retroviral Agents; Anti-HIV Agents