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Antiretroviral Therapy
Digital Pill System for HIV/AIDS Medication Adherence (NextGen Trial)
Phase 3
Waitlist Available
Led By Peter Chai, MD, MMS
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 1 study visit
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Summary
This trial will investigate a digital pill system to measure adherence to HIV meds & PrEP. A wrist-worn Reader will be tested for usability.
Who is the study for?
This trial is for adults over 18 with HIV and an undetectable viral load for the past 6 months, or those who are HIV negative and on PrEP. Participants must own a smartphone and meet specific health criteria like kidney function tests.
What is being tested?
The study is testing a new wrist-worn Reader as part of a digital pill system to track how well people with HIV stick to their ART medication (Biktarvy) and how HIV-negative individuals adhere to their PrEP regimen (Truvada).
What are the potential side effects?
While this trial focuses on adherence monitoring rather than drug effects, Biktarvy may cause side effects like headache, diarrhea, nausea; Truvada can lead to kidney issues, bone pain, or liver problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 1 study visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 1 study visit
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acceptability of Next-Generation ID-Cap System, via Qualitative Interviews
Acceptability of Next-Generation ID-Cap System, via System Usability Scale
Correlation of PrEP/ART Adherence with DBS Concentrations and Pill Counts
+1 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: PrEP ParticipantsExperimental Treatment2 Interventions
Participants will ingest one Truvada digital pill as PrEP per day, for 30 days total, while using the next-generation Reader and ID-Cap System.
Group II: ART ParticipantsExperimental Treatment2 Interventions
Participants will ingest one Biktarvy digital pill as ART per day, for 30 days total, while using the next-generation Reader and ID-Cap System.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Next-generation Reader and ID-Cap System
2023
Completed Phase 3
~20
Truvada for pre-exposure prophylaxis (PrEP)
2023
Completed Phase 3
~20
Biktarvy for antiretroviral therapy (ART)
2023
Completed Phase 3
~20
Find a Location
Who is running the clinical trial?
The Fenway InstituteOTHER
14 Previous Clinical Trials
2,846 Total Patients Enrolled
Brigham and Women's HospitalLead Sponsor
1,670 Previous Clinical Trials
11,878,251 Total Patients Enrolled
Fenway Community HealthLead Sponsor
34 Previous Clinical Trials
5,831,605 Total Patients Enrolled
Peter Chai, MD, MMSPrincipal InvestigatorBrigham and Women's Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been taking Biktarvy for at least 6 months.I have a history of Crohn's disease or ulcerative colitis.I am not willing to use a daily pill organizer.I have been taking Truvada for PrEP for at least 30 days.I do not speak English.I am 18 years old or older.I have had a gastric bypass or have a bowel stricture.I am 18 years old or older.I have been diagnosed with HIV.I have had cancer or radiation treatment in my stomach area.I have had cancer or radiation treatment in my abdomen.I am not willing to use a drug pump system.I have a history of Crohn's disease or ulcerative colitis.I have had a gastric bypass or have a bowel stricture.
Research Study Groups:
This trial has the following groups:- Group 1: ART Participants
- Group 2: PrEP Participants
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.