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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

Must not have

Does not speak English

History of Crohn's disease or ulcerative colitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after month 2 visit

Awards & highlights

No Placebo-Only Group

Pivotal 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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not speak English.

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I have a history of Crohn's disease or ulcerative colitis.

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I have had gastric bypass surgery or have a bowel stricture.

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I have had cancer or radiation treatment in my stomach area before.

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I am not willing to use the DPS or Beiwe app.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Correlation of PrEP Adherence with Digital Phenotyping Patterns

PrEP Adherence Patterns

Secondary study objectives

Acceptability of DPS and Digital Phenotyping App

Correlation of PrEP Adherence with DBS Concentrations

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 / 8Eligibility criteria met