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

NCT02891720 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2016-09-07

No results posted yet for this study

Summary

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.

Conditions

  • Human Immunodeficiency Virus

Interventions

DEVICE

Proteus Sensor System

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.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Hektoen Institute for Medical Research

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
24 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-30
Primary Completion
2018-11-30
Completion
2019-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02891720 on ClinicalTrials.gov