Feasibility of an Ingestible Sensor System to Measure PrEP Adherence in YMSM

ConditionHuman Immunodeficiency Virus

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexMale

Age18-24

SponsorHektoen Institute for Medical Research

About this trial

The goal of this study is to evaluate an integrated technology system that confirms ingestion of oral PrEP, monitors adherence both in real-time and longitudinally, and provides visual feedback mechanisms to promote enhanced adherence behaviors.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

PrEP-eligible YMSM

Ages 18-24

Biologically born male

Report interest in PrEP

Disqualifiers

HIV+

Creatinine clearance <60 cc/min)

Allergy to topical adhesive

Acute gastrointestinal symptoms

Trial design

Design model

Crossover

Treatments tested in this trial

Proteus Sensor System
Device
The Proteus Sensor System (PSS) intervention includes 12 weeks of daily FTC/TDF with a weekly text messages transmitted to participants with estimated HIV risk reduction based upon the DBS algorithm.

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: ARM A: Proteus Sensor System (PSS) FirstActive comparator 1 intervention

Group B: ARM B: SOC FirstNo intervention 0 interventions

Trial outcomes

Primary outcomes

Number of HIV-negative YMSM taking part in PSS intervention who adhere to PrEP medication

Time frame

Up to 33 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hektoen Institute for Medical Research

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: