NCT02891720Not yet recruiting
Feasibility of an Ingestible Sensor System to Measure PrEP Adherence in YMSM
Source: ClinicalTrials.gov · Last updated 7 Sept 2016 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 29 Aug 2016
- Start date
- Jun 2017
- Primary completion date
- Nov 2018
- Lead sponsor
- Hektoen Institute for Medical Research
- Diseases
- HIV
- NCT number
- NCT02891720
What you commit to
- Study type: Interventional
- Planned participants: 100
- From Jun 2017 to the primary completion date, Nov 2018
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- HIV+
- Allergy to topical adhesive
- History of major GI surgery
Lab values
- Creatinine clearance \<60 cc/min)
Other
- Young men who meet any of the following criteria will be excluded:
- Acute gastrointestinal symptoms
- Presence of an implanted electronic medical device.
Who the study is looking for
- 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.
Age in the registry: 18 years to 24 years · Sex: Male · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.