N/A
N=348
Monitoring Pre-exposure Prophylaxis for Young Adult Women
HIV/AIDS · Adherence
Bottom Line
View on ClinicalTrials.gov: NCT02915367 ↗Enrolled (actual)
348
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcome: Primary: Enacted Adherence as Measured by Electronic Monitoring at 6 and 24 Months — 40.2; 36.8; 27.0; 26.6 percentage of adherence
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SMS Reminders (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Enacted Adherence as Measured by Electronic Monitoring at 6 and 24 Months |
40.2; 36.8; 27.0; 26.6 | — |
| SECONDARY Number of Participants Reporting High Acceptability of Wisepill Devices for PrEP Adherence Monitoring |
141; 142 | 0.93 |
| SECONDARY USD Per Month |
12.64; 7.57; 7.69; 2.76 | — |
Summary
Next generation real-time monitoring for PrEP adherence in young Kenyan women
Eligibility Criteria
Inclusion Criteria
- HIV-uninfected (as determined by Kenya national testing algorithms)
- Wanting to start PrEP with an initial recommendation of 6 months of use
- Clinically safe to receive PrEP, in accordance with Centers for Disease Control and Prevention (CDC) guidelines:
- Creatinine clearance >60 mL/min
- Not infected with hepatitis B
- No other medical condition that in the discretion of the site investigator would make participation unsafe or complicate the goals of the study
- Sexually active (defined as vaginal or anal sex) within the last 3 months
- At high risk for HIV infection based on a validated risk score of >5 or being in an HIV serodiscordant relationship
- Not pregnant
- Owns a personal cell phone (not shared) compatible with study protocols and the ability to charge it
- Ability to send a text message
- Intending to stay in the area for at least the next year
- Willing to use study criteria
Exclusion Criteria
- Unable to provide consent
- Breast-feeding (PrEPis not currently approved for use during breast-feeding)
- Concurrent participation in another research study that may influence adherence to PrEP and/or interfere with the procedures of this study.
Data sourced from ClinicalTrials.gov (NCT02915367). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.