CompletedNot Applicable

Monitoring Pre-exposure Prophylaxis for Young Adult Women

Kenya348 participantsStarted 2016-12-21

Plain-language summary

Next generation real-time monitoring for PrEP adherence in young Kenyan women

Who can participate

Age range

18 Years – 24 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Enacted Adherence as Measured by Electronic Monitoring at 6 and 24 Months

Timeframe: up to 2 years follow-up

Trial details

NCT IDNCT02915367

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-03-20

Results submitted2021-11-09

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