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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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13 June 2023 |
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Main ID: |
NCT02915367 |
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Date of registration:
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16/09/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Monitoring Pre-exposure Prophylaxis for Young Adult Women
MPYA |
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Scientific title:
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Next Generation Real-time Monitoring for PrEP Adherence in Young Kenyan Women |
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Date of first enrolment:
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December 21, 2016 |
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Target sample size:
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348 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02915367 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Kenya
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Contacts
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Name:
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Elizabeth Bukusi |
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Address:
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Telephone:
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Email:
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Affiliation:
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Kenya Medical Research Institute |
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Name:
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Jessica Haberer, MD, MS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Massachussetts General Hospital |
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Name:
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Nelly Mugo |
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Address:
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Telephone:
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Email:
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Affiliation:
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Kenya Medical Research Institute |
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Name:
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Jared Baeten, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Washington |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
24 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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HIV/AIDS
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Adherence
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Intervention(s)
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Behavioral: SMS Reminders
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Primary Outcome(s)
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Enacted Adherence as Measured by Electronic Monitoring at 6 and 24 Months
[Time Frame: up to 2 years follow-up]
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Secondary Outcome(s)
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Number of Participants Reporting High Acceptability of Wisepill Devices for PrEP Adherence Monitoring
[Time Frame: Month 1]
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USD Per Month
[Time Frame: two years]
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Secondary ID(s)
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R01MH109309
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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