Clinical trial NCT03771638: DOT Diary Mobile App for Pre-Exposure Prophylaxis Adherence in Young Men
Official title: DOT Diary Longitudinal Pilot: A Mobile App for Pre-Exposure Prophylaxis Adherence in Young Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Adherence, Medication
Risk Behavior
Pre-Exposure Prophylaxis
HIV Prevention
Keywords: Adherence
PrEP
HIV Prevention
Truvada
HIV Risk Reduction
Mobile App
Lead sponsor: Public Health Foundation Enterprises, Inc.
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: San Francisco Department of Public Health
name: Emory University
name: AiCure
First posted: 2018-12-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled study
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Effect of DOT Diary app on PrEP adherence
timeFrame: 24 weeks
measure: Concordance of TFV-DP and FTC-TP in DBS with adherence measured by DOT Diary app
timeFrame: 24 weeks
measure: DOT Diary mobile app acceptability
timeFrame: 24 weeks
measure: DOT Diary mobile app ease of use
timeFrame: 24 weeks
Secondary outcomes:
measure: PrEP coverage of sexual acts (prevention-effectiveness adherence) as measured by DOT Diary
timeFrame: 24 weeks
measure: Evaluation of daily use of aDOT components of DOT Diary app
timeFrame: 24 weeks
measure: Evaluation of use of diary components of DOT Diary app
timeFrame: 24 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Bridge HIV, San Francisco Department of Public Health
state: California
city: Atlanta
country: United States
facility: Emory University, School of Public Health
state: Georgia
Study officials:
affiliation: Bridge HIV, San Francisco Department of Public Health
name: Susan Buchbinder, MD
role: PRINCIPAL_INVESTIGATOR
References: