DOT Diary Optimization Pilot: A Pilot Study to Optimize the DOT Diary App to Measure PrEP Adherence

DOT Diary (D2): Developing a Mobile App With Combined Automated DOT and Daily Sexual Diary for Monitoring and Improving PrEP Adherence: DOT Diary Optimization Pilot

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 understand people's experiences using this new app while taking HIV pre-exposure prophylaxis (PrEP) for the prevention of HIV.

Study Overview

• Status: Completed
• Conditions: Risk Behavior; HIV Prevention; Adherence, Medication; Pre-Exposure Prophylaxis
• Intervention / Treatment: Drug: Emtricitabine / Tenofovir Disoproxil Oral Tablet; Other: DOT Diary mobile app

Detailed Description

In the DOT Diary research project, the AiCure 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).

In the next stage of app development, the researchers are conducting this study to identify areas of the app that require refinement to maximize the acceptability and ease of use of the DOT adherence monitoring app. The researchers will assess overall acceptability and ease of use of the integrated DOT Diary (D2) app over an 8 week period.The goal of this pilot study will be to refine and optimize the app for further testing in a larger and longer pilot study 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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94102
      • Bridge HIV, San Francisco Department of Public Health
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University, School of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Self-identifies as a man
• Age 18-35 at enrollment

• Reports having anal sex with a man or trans woman in the past 12 months and one or more of the following criteria in the past 12 months:

  • Any condomless anal sex (not in a mutually monogamous relationship with an HIV-negative partner)
  • Two or more anal sex partners
  • Self-reported 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
• Currently taking PrEP or interested in initiating 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
• Meets local locator requirements

Exclusion Criteria:

• 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
• Does not live, work or play in Atlanta Metropolitan Area, San Francisco, Alameda, Marin, Contra Costa, Santa Clara, or San Mateo Counties
• Unable to commit to study participation for 8 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: DOT Diary Optimization Intervention; DOT Diary mobile app and Emtricitabine / Tenofovir Disoproxil Oral Tablet	Drug: Emtricitabine / Tenofovir Disoproxil Oral Tablet; Open label daily emtricitabine/tenofovir disoproxil oral tablet; Other Names: Truvada; Other: DOT Diary mobile app; DOT Diary mobile application for tracking medication adherence and sexual activities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DOT Diary Mobile App Acceptability	System Usability Scale (SUS) is a 10 item questionnaire with 5 response options: strongly disagree to strongly agree. These are scored 0-4. The scores are then summed up (making sure all positive responses -- increased usability -- are given the higher scores). The final score is multiplied by 2.5 Possible scores are from 0-100, with maximal usability achieving the higher score. Although the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ranking.	8 weeks
DOT Diary Mobile App Ease of Use	5-point Likert scale (1=strongly disagree that app is easy to use; 5=strongly agree that app is easy to use) on a single question of the key attribute of ease of use of DOT Diary over 8 weeks by MSM on PrEP.	8 weeks
Adherence and Persistence of Use of the DOT and Sexual Diary Components of DOT Diary by Young MSM on PrEP	Adherence and Persistence of use of the DOT and sexual diary components of DOT Diary by young MSM on PrEP is measured by the percentage of doses taken with visual confirmation of pill ingestion	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Situations and Reasons for Sub-optimal Use of the App	Combined analysis of situations and reasons for sub-optimal use of the app, for the purpose of app optimization	8 weeks

Collaborators and Investigators

• Sponsor: Public Health Foundation Enterprises, Inc.
• Collaborators: National Institute of Mental Health (NIMH); Emory University; San Francisco Department of Public Health; AiCure
• Investigators: Principal Investigator: Susan Buchbinder, MD, Bridge HIV, San Francisco Department of Public Health

Publications and helpful links

General Publications

• Liu AY, Laborde ND, Coleman K, Vittinghoff E, Gonzalez R, Wilde G, Thorne AL, Ikeguchi E, Shafner L, Sunshine L, van der Straten A, Siegler AJ, Buchbinder S. DOT Diary: Developing a Novel Mobile App Using Artificial Intelligence and an Electronic Sexual Diary to Measure and Support PrEP Adherence Among Young Men Who Have Sex with Men. AIDS Behav. 2021 Apr;25(4):1001-1012. doi: 10.1007/s10461-020-03054-2. Epub 2020 Oct 12.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 28, 2018
• Primary Completion (ACTUAL): August 30, 2018
• Study Completion (ACTUAL): August 30, 2018

Study Registration Dates

• First Submitted: December 1, 2017
• First Submitted That Met QC Criteria: December 21, 2017
• First Posted (ACTUAL): January 2, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 27, 2021
• Last Update Submitted That Met QC Criteria: October 8, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Adherence; PrEP; Truvada; HIV Prevention; Mobile App; HIV Risk Reduction
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Tenofovir; Emtricitabine
• Other Study ID Numbers: 17-22864; 1R01MH109320-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: If requested, will share summary participant data with all identifying information removed.
• IPD Sharing Time Frame: Data are available from publication of the primary results through 3 years.
• IPD Sharing Access Criteria: Must have IRB approval.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• 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