Feasibility of an Ingestible Sensor System to Measure PrEP Adherence in YMSM
Initiatives
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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
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- Individuals
Number of participants
- Number of participants
- 100
- Number of participants with biosamples
Access
Availability of data and biosamples
| Data | |
| Biosamples | |
| Other |
Timeline
Young men
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
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men
- Minimum age
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18
- Maximum age
-
24
- Newborns
- Twins
- Countries
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- United States of America
- Ethnic Origin
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- 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
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2017-06
- End Date
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2019-11
- Data sources
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Mobile data collection
- PrEP
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Mobile data collection