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

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ClinicalTrials.gov Identifier: NCT03771638
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : March 20, 2019
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
San Francisco Department of Public Health
Emory University
AiCure
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Susan Buchbinder, Public Health Foundation Enterprises, Inc.

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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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




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.



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03771638


Contacts
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Contact: Kenneth Coleman, MA 415-437-7443 kenneth.coleman@sfdph.org

Locations
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United States, California
Bridge HIV, San Francisco Department of Public Health Recruiting
San Francisco, California, United States, 94102
Contact: Kenneth Coleman, MA    415-437-7443    kenneth.coleman@sfdph.org   
Principal Investigator: Susan Buchbinder, MD         
Sub-Investigator: Albert Liu, MD, MPH         
United States, Georgia
Emory University, School of Public Health Recruiting
Atlanta, Georgia, United States, 30322
Contact: Aaron Siegler, PhD    404-712-9733    asiegle@emory.edu   
Principal Investigator: Aaron Siegler, PhD         
Sponsors and Collaborators
Public Health Foundation Enterprises, Inc.
National Institute of Mental Health (NIMH)
San Francisco Department of Public Health
Emory University
AiCure
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Susan Buchbinder, MD Bridge HIV, San Francisco Department of Public Health

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Responsible Party: Susan Buchbinder, Director, Bridge HIV, Public Health Foundation Enterprises, Inc.
ClinicalTrials.gov Identifier: NCT03771638     History of Changes
Other Study ID Numbers: 18-25821
1R01MH109320-01 ( U.S. NIH Grant/Contract )
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Tenofovir
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
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