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

NCT ID: NCT03387462

Last Updated: 2021-10-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-28

Study Completion Date

2018-08-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Adherence, Medication Risk Behavior Pre-Exposure Prophylaxis HIV Prevention

Keywords

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Adherence PrEP HIV Prevention Truvada HIV Risk Reduction Mobile App

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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DOT Diary Optimization Intervention

DOT Diary mobile app and Emtricitabine / Tenofovir Disoproxil Oral Tablet

Group Type EXPERIMENTAL

Emtricitabine / Tenofovir Disoproxil Oral Tablet

Intervention Type DRUG

Open label daily emtricitabine/tenofovir disoproxil oral tablet

DOT Diary mobile app

Intervention Type OTHER

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

Interventions

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Emtricitabine / Tenofovir Disoproxil Oral Tablet

Open label daily emtricitabine/tenofovir disoproxil oral tablet

Intervention Type DRUG

DOT Diary mobile app

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

Intervention Type OTHER

Other Intervention Names

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Truvada

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

San Francisco Department of Public Health

OTHER_GOV

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role collaborator

AiCure

INDUSTRY

Sponsor Role collaborator

Public Health Foundation Enterprises, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Susan Buchbinder

Director, Bridge HIV

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Susan Buchbinder, MD

Role: PRINCIPAL_INVESTIGATOR

Bridge HIV, San Francisco Department of Public Health

Locations

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Bridge HIV, San Francisco Department of Public Health

San Francisco, California, United States

Site Status

Emory University, School of Public Health

Atlanta, Georgia, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 33044687 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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1R01MH109320-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

17-22864

Identifier Type: -

Identifier Source: org_study_id