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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 belowSelect...
I am 18 years old or older.
Select...
I am a cisgender male.
Select...
I am a man who has sex with men.
Select...
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
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.
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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
Research Study Groups:
This trial has the following groups:- Group 1: Digital Pills and Beiwe
Awards:
This trial has 2 awards, including:- 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.
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
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