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

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

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

Initiatives -
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.
Start Year
2017
End Year
2019
Funding
Hektoen Institute for Medical Research

Design

Study design
Clinical trial cohort

Marker Paper

https://clinicaltrials.gov/ct2/show/NCT02891720

PUBMED

Recruitment

Sources of Recruitment
  • Individuals

Number of participants

Number of participants
100
Number of participants with biosamples

Access

Availability of data and biosamples

Data
Biosamples
Other

Timeline

Population

Inclusion Criteria Young men who meet all of the following criteria are eligible for inclusion: PrEP-eligible YMSM Ages 18-24 Biologically born male Report interest in PrEP Intend to use PrEP for a full 6 month period Eligible to be a PrEP patient at the CORE Center PrEP Clinic Meet one the following sexual risk criteria: Have an HIV-positive sexual partner Had recent bacterial STI Report high numbers of sexual partners Report history of inconsistent or no condom use Report exchange/transactional sex.
Selection Criteria
Gender
men
Minimum age
18
Maximum age
24
Newborns
Twins
Countries
  • United States of America
Ethnic Origin
Health Status
Other criteria
Young men who meet any of the following criteria will be excluded: HIV+ Creatinine clearance <60 cc/min) Allergy to topical adhesive Acute gastrointestinal symptoms History of major GI surgery Presence of an implanted electronic medical device. Subjects who are receiving any of the following medications:Nephrotoxic drugs (e.g., cidofovir, amphotericin, aminoglycosides, dapsone, tacrolimus, foscarnet, ACE inhibitors), all diuretics, drugs that may interfere with TFV excretion (e.g., (Val)ganciclovir, Cyclosporin A, Sirolimus, Antineoplastics), drugs (not including mineral and vitamin supplements) used for treatment of osteoporosis (e.g., alendronate and other bisphosphonates, teriparatide, denosumab, and calcitonin), chronic use of oral or systemic steroids (i.e., daily use for two weeks or more is not allowed), experimental medications that are not Food and Drug Administration (FDA)-approved, and FTC/TDF (Truvada®) received outside of the study

Recruitment

Number of participants

Number of participants
100
Number of participants with biosamples
Data Collection Event
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 behavio
Start Date
2017-06
End Date
2019-11
Data sources
  • Mobile data collection
    • PrEP