← Back to Search

Digital Pill + Smartphone Intervention for HIV Prevention in Substance Users (PrEPSteps Trial)

Phase 3
Waitlist Available
Led By Peter R 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
On PrEP or initiating PrEP
Age 18 or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up three month study visit
Awards & highlights

PrEPSteps Trial Summary

This trial will test a new smartphone intervention for people taking PrEP, a daily pill to prevent HIV. The intervention will provide real-time feedback on pill-taking and offer counseling for people who miss doses.

Who is the study for?
This trial is for HIV-negative, cisgender men who have sex with men (MSM), aged 18 or older, using or starting PrEP to prevent HIV. They must own a smartphone, have moderate to severe non-alcohol substance use disorder and missed doses of PrEP. Excluded are those allergic to digital pill components, non-English speakers, HIV positive individuals, people with certain GI conditions or abnormal liver function.Check my eligibility
What is being tested?
The study tests a new system called PrEPSteps that uses a 'digital pill'—a capsule with sensors—to monitor if patients take their medication (PrEP). Participants will either use the digital pill alone or combined with the PrEPSteps program on their smartphones for three months to see which helps them stick to their treatment plan better.See study design
What are the potential side effects?
There may be potential side effects from Truvada used in PrEP such as nausea, headache, stomach pain and weight loss. The digital pill contains gelatin, silver and zinc; participants should not join if they're allergic to these substances.

PrEPSteps Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am currently on PrEP or starting it soon.
Select...
I am 18 years old or older.
Select...
I have missed 2 or more PrEP doses in a week several times over the last 3 months.
Select...
I am a cisgender man who has sex with men.

PrEPSteps Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one and three month study visits
This trial's timeline: 3 weeks for screening, Varies for treatment, and one and three month study visits for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Interventional procedure
Feasibility of the adherence intervention qualitative and quantitive questionnaire
Secondary outcome measures
Acceptability of the digital pill
Potential of PrEPsteps to improve adherence
Other outcome measures
Accuracy of digital pill compared to pill counts and dried blood spot for adherence

Side effects data

From 2016 Phase 4 trial • 48 Patients • NCT01529749
20%
Hepatitis C
20%
Sexual transmitted diseases
10%
Post lumbar puncture headache
10%
Abdominal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
FTC/TDF+MK-0518+Losartan
EFV/FTC/TDF + Losartan
FTC/TDF + MK-0518
EFV/FTC/TDF

PrEPSteps Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PrEPstepsExperimental Treatment3 Interventions
Participants receive the digital pills with Truvada, plus the PrEPsteps intervention that is programmed at the randomization study visit (Study Visit 2). Participants will use PrEPsteps and the digital pill to measure Truvada adherence for months 1-3.
Group II: ControlActive Control2 Interventions
Participants receive digital pills with Truvada alone. Participants will use digital pills with Truvada for months 1-3.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Digital pill
2018
Completed Phase 4
~20
Truvada
2016
Completed Phase 4
~6920

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,599 Previous Clinical Trials
11,462,478 Total Patients Enrolled
The Fenway InstituteOTHER
14 Previous Clinical Trials
2,791 Total Patients Enrolled
Gilead SciencesIndustry Sponsor
1,077 Previous Clinical Trials
836,914 Total Patients Enrolled

Frequently Asked Questions

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

For what medical conditions is PrEPsteps most often prescribed?

"While PrEPsteps is most commonly used to treat human immunodeficiency virus type 1 (hiv-1), it can also be taken as a prophylactic measure against hiv transmission and hiv infections more broadly."

Answered by AI

Could you please tell us what other similar PrEPsteps studies have been done in the past?

"At this time, 100 clinical trials for PrEPsteps are ongoing with 31 in Phase 3. Most of these trials are based in Boylston, Massachusetts; however, there are 1,581 total locations running these trials."

Answered by AI

Would you be able to tell me if this clinical trial is currently open to new participants?

"This is an ongoing clinical trial, which was initially posted on 20th June 2019 as per information on clinicaltrials.gov. The most recent update was on 12th May 2022."

Answered by AI
~1 spots leftby May 2024