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Antiretroviral Therapy

SmartSteps Intervention for HIV Prevention (SmartSteps Trial)

Phase 3

Recruiting

Led By Peter R Chai, MD MMS

Research Sponsored by Fenway Community Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 or older

Cisgender male

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after month 2 visit

Awards & highlights

SmartSteps Trial Summary

This trial is testing a new way to give people PrEP, the HIV prevention medication, to see if it helps them stay on the medication and if it has any side effects.

Who is the study for?

This trial is for HIV-negative cisgender men who have sex with men and struggle with substance use, scoring moderate to high on a substance use screener. They must be 18 or older, own a smartphone, and either be on PrEP (HIV prevention medication) or starting it. Excluded are those with certain gastrointestinal conditions, allergies to digital pill components or PrEP, unwillingness to use the study's digital tools, non-English speakers, or those with specific medical histories.Check my eligibility

What is being tested?

The SmartSteps study observes how well individuals adhere to their daily PrEP regimen using a digital pill system and an app called Beiwe over two months. It aims to understand adherence patterns by sending surveys on days when doses are missed and collecting data about substance use and sexual activity.See study design

What are the potential side effects?

Possible side effects may include reactions related to the medications Descovy or Truvada such as nausea, headache, stomach pain; also potential issues from using the ID-Cap System like discomfort swallowing pills. The Beiwe app does not have physical side effects but may raise privacy concerns.

SmartSteps Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am a cisgender male.

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I am a man who has sex with men.

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I am currently on PrEP or starting it soon.

SmartSteps Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after month 2 visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after month 2 visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and after month 2 visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Correlation of PrEP Adherence with Digital Phenotyping Patterns

PrEP Adherence Patterns

Secondary outcome measures

Acceptability of DPS and Digital Phenotyping App

Correlation of PrEP Adherence with DBS Concentrations

SmartSteps Trial Design

1Treatment groups

Experimental Treatment

Group I: Digital Pills and BeiweExperimental Treatment3 Interventions

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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Fenway Community HealthLead Sponsor

34 Previous Clinical Trials

5,291,921 Total Patients Enrolled

Brigham and Women's HospitalLead Sponsor

1,609 Previous Clinical Trials

11,470,287 Total Patients Enrolled

2 Trials studying Substance Abuse

94 Patients Enrolled for Substance Abuse

Gilead SciencesIndustry Sponsor

1,082 Previous Clinical Trials

842,713 Total Patients Enrolled

Media Library

Substance Abuse Research Study Groups: Digital Pills and Beiwe

Substance Abuse Clinical Trial 2023: Descovy or Truvada Highlights & Side Effects. Trial Name: NCT05378399 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the regulatory status of Descovy and Truvada?

"Descovy and Truvada have both undergone Phase 3 clinical trials, meaning that there is data supporting both drugs' efficacy and safety. Consequently, our team has rated their safety at a 3."

Answered by AI

Are people still being recruited to participate in this research?

"The clinical trial in question is no longer recruiting patients, as evidenced by the clinicaltrials.gov website. This particular trial was posted on October 10th, 2022 and was last edited on August 18th, 2022. There are, however, 927 other trials that are still recruiting patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Peter R Chai 2022. "SmartSteps: A Context-Aware, PrEP Adherence Intervention for Individuals With Substance Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05378399.

All > Substance Abuse > Truvada