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

NCT03387462 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 17-228641R01MH109320-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Adherence, Medication; Risk Behavior; Pre-Exposure Prophylaxis; HIV Prevention

Keywords

Adherence; PrEP; HIV Prevention; Truvada; HIV Risk Reduction; Mobile App

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Assessment of Situations and Reasons for Sub-optimal Use of the App

  8 weeks

Study Arms (1)

DOT Diary Optimization Intervention

EXPERIMENTAL

DOT Diary mobile app and Emtricitabine / Tenofovir Disoproxil Oral Tablet

Drug: Emtricitabine / Tenofovir Disoproxil Oral Tablet; Other: DOT Diary mobile app

Interventions

Emtricitabine / Tenofovir Disoproxil Oral Tablet DRUG

Open label daily emtricitabine/tenofovir disoproxil oral tablet

Also known as: Truvada

DOT Diary Optimization Intervention

DOT Diary mobile app OTHER

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

DOT Diary Optimization Intervention

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Self-identify as a man
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Public Health Foundation Enterprises, Inc.: lead
• National Institute of Mental Health (NIMH): collaborator
• San Francisco Department of Public Health: collaborator
• Emory University: collaborator
• AiCure: collaborator

Study Sites (2)

Bridge HIV, San Francisco Department of Public Health

San Francisco, California, 94102, United States

Location

Emory University, School of Public Health

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

• 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.

  PMID: 33044687 RESULT

MeSH Terms

Conditions

Medication Adherence; Risk-Taking

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Susan Buchbinder
• Organization: Bridge HIV, San Francisco Department of Public Health

susan.buchbinder@sfdph.org

628-217-7479

Study Officials

• Susan Buchbinder, MD

  Bridge HIV, San Francisco Department of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Bridge HIV

Study Record Dates

• First Submitted: December 1, 2017
• First Posted: January 2, 2018
• Study Start: February 28, 2018
• Primary Completion: August 30, 2018
• Study Completion: August 30, 2018
• Last Updated: October 27, 2021
• Results First Posted: February 19, 2020

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data are available from publication of the primary results through 3 years.
• Access Criteria: Must have IRB approval.

Locations

US (2)