SmartSteps: A Context-Aware, PrEP Adherence Intervention for Individuals With Substance Use Disorder

Sponsor

Fenway Community Health (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05378399

Collaborator

Brigham and Women's Hospital (Other), Gilead Sciences (Industry)

Enrollment

Location

Arm

22.7

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a single-arm, observational study of HIV-negative MSM with substance use disorder. Those who meet pre-screening criteria will attend a Screening Visit (Visit 1), where the informed consent process will be conducted and study eligibility will be confirmed. Eligible participants will attend three additional visits over the course of the study - the Enrollment Visit (Visit 2), Month 1 Visit (Visit 3), and Month 2 Visit (Visit 4). Participants will take one PrEP digital pill per day, for 60 days total, while using the digital pill system (DPS) and Beiwe, a digital phenotyping app. On nonadherent days, participants will receive brief surveys prompting them to report the reasons for their missed dose, as well as their engagement in substance use and sexual activity. Timeline followback will be conducted at the Month 1 and Month 2 Visits to understand the context of any nonadherence. Qualitative user experience exit interviews and dried blood spots (DBS) will be conducted at the Month 2 Visit.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections Substance Use Adherence, Medication Adherence, Treatment	Drug: Descovy or Truvada Device: ID-Cap System Device: Beiwe	Phase 3

Detailed Description

This study will develop a dataset of annotated smartphone usage in the context of PrEP adherence and nonadherence. In order to understand smartphone context, the investigators will utilize a digital pill system (DPS) to measure real-time PrEP ingestion events. Eligibility will be confirmed during the Screening Visit (Visit 1). During the Enrollment Visit (Visit 2), participants will complete a baseline quantitative assessment (e.g., sociodemographics, sexual history, attitudes about technology), receive training on the operation of the DPS and Beiwe, and will ingest their first digital pill dose under observation by study staff. Participants will be instructed to take one PrEP pill once daily while using the DPS and Beiwe app for 60 days. Participants will return for a study visit at the end of month one (Visit 3) for a refill of digital pills. Following a 24-hour period which no PrEP ingestion is detected by the DPS, participants will receive a brief online substance use and sexual risk survey, which will inform specific contexts of nonadherence. At the Month 1 Visit (Visit 3) and Month 2 Visit (Visit 4), timeline followback discussions will be conducted to better understand the context of any PrEP nonadherence events detected by the DPS, and phenotypic data collected by the Beiwe app, during the prior 30 days. At the Month 2 (Visit 4), the investigators will administer a blood draw for dried blood spot (DBS) testing to measure participants' PrEP adherence and compare it against adherence detected by the DPS. To gain insight into user experiences operating the DPS and Beiwe app as part of the study, the investigators will conduct the semi-structured qualitative exit interviews with participants at Month 2 (Visit 4).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

SmartSteps: A Context-Aware, Pre-Exposure Prophylaxis Adherence Intervention for Individuals With Substance Use Disorder

Anticipated Study Start Date :

Oct 10, 2022

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Aug 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Digital Pills and Beiwe Participants will take one PrEP digital pill per day, for 60 days total, while using the ID-Cap digital pill system and Beiwe digital phenotyping app.	Drug: Descovy or Truvada Descovy or Truvada prescribed with digital pills for PrEP Device: ID-Cap System Digital pills overencapsulating Descovy or Truvada for PrEP Other Names: digital pill Device: Beiwe Digital phenotyping app

Arm

Intervention/Treatment

Experimental: Digital Pills and Beiwe

Participants will take one PrEP digital pill per day, for 60 days total, while using the ID-Cap digital pill system and Beiwe digital phenotyping app.

Drug: Descovy or Truvada

Descovy or Truvada prescribed with digital pills for PrEP

Device: ID-Cap System

Digital pills overencapsulating Descovy or Truvada for PrEP

Other Names:

digital pill

Device: Beiwe

Digital phenotyping app

Outcome Measures

Primary Outcome Measures

PrEP Adherence Patterns [After Month 2 Visit]
Percentage adherence to PrEP and adherence patterns over the course of 60 days, as detected by the ID-Cap digital pill system (DPS).
Correlation of PrEP Adherence with Digital Phenotyping Patterns [After Month 2 Visit]
Comparison of digital phenotyping data, as detected by Beiwe, on PrEP-adherent versus PrEP-nonadherent days, as detected by the digital pill system (DPS).

Secondary Outcome Measures

Correlation of PrEP Adherence with DBS Concentrations [After Month 2 Visit]
Correlation of PrEP adherence patterns, as detected by the digital pill system (DPS), with tenofovir diphosphate concentrations in dried blood spots (DBS).
Acceptability of DPS and Digital Phenotyping App [After Month 2 Visit]
User acceptance of and willingness to interact with the digital pill system (DPS) and Beiwe digital phenotyping app, as assessed via qualitative exit interviews.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18 or older
Cisgender male
Has sex with men
HIV negative
On PrEP or initiating PrEP (including switching from 2-1-1 or "on-demand" PrEP dosing to once-daily dosing)
Moderate risk score on ASSIST substance use screener (11-26 for alcohol, 4-26 for all other substances) or higher
Qualifying laboratory testing for PrEP: Cr clearance in past 3 months, HBV vaccination, liver function tests
Owns a smartphone with Android or iOS