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DOT Diary Optimization Pilot

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ClinicalTrials.gov Identifier: NCT03387462
Recruitment Status : Completed
First Posted : January 2, 2018
Last Update Posted : September 7, 2018
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 understand people's experiences using this new app while taking 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 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  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: DOT Diary Optimization Pilot
Actual Study Start Date : February 28, 2018
Actual Primary Completion Date : August 30, 2018
Actual Study Completion Date : August 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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 Name: Truvada

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




Primary Outcome Measures :
  1. DOT Diary mobile app acceptability [ Time Frame: 8 weeks ]
    Combined descriptive analysis of key attributes of acceptability of DOT Diary over 8 weeks by MSM on PrEP, in order to identify potential improvements to the app to maximize acceptability

  2. DOT Diary mobile app ease of use [ Time Frame: 8 weeks ]
    Combined descriptive analysis of key attributes of ease of use of DOT Diary over 8 weeks by MSM on PrEP

  3. Quality of execution of the DOT and sexual diary components of DOT Diary by young MSM on PrEP [ Time Frame: 8 weeks ]
    Combined descriptive analysis of the quality of execution of the DOT and sexual diary components of DOT Diary by young MSM on PrEP, based on qualitative and quantitative feedback from participants, in order to identify potential improvements to the app to maximize quality of execution

  4. Persistence of use of the DOT and sexual diary components of DOT Diary by young MSM on PrEP [ Time Frame: 8 weeks ]
    Combined descriptive analysis persistence of use of the DOT and sexual diary components of DOT Diary by young MSM on PrEP based on qualitative and quantitative feedback from participants


Secondary Outcome Measures :
  1. Participant preferences for feedback on non-use or self-reported dosing [ Time Frame: 8 weeks ]
    Combined analysis of participant preferences for feedback on non-use or self-reported dosing that over-rides the DOT Diary app

  2. Assessment of situations and reasons for sub-optimal use of the app [ Time Frame: 8 weeks ]
    Combined analysis of situations and reasons for sub-optimal use of the app, for the purpose of app optimization

  3. PrEP Adherence measured by dried blood spots (DBS) [ Time Frame: 8 weeks ]
    Preliminary assessment of overall PrEP adherence by tenofovir diphosphate levels in dried blood spots (DBS) among young MSM using the DOT Diary app



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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 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.

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): NCT03387462


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
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Susan Buchbinder, MD Bridge HIV, San Francisco Department of Public Health

Responsible Party: Susan Buchbinder, Director, Bridge HIV, Public Health Foundation Enterprises, Inc.
ClinicalTrials.gov Identifier: NCT03387462     History of Changes
Other Study ID Numbers: 17-22864
1R01MH109320-01 ( U.S. NIH Grant/Contract )
First Posted: January 2, 2018    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
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
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