Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 18 to 30 Women only

Offering multiple PrEP options, including the dapivirine ring, to young women at reproductive health clinics

Official title: Multi-product PrEP Delivery to Young Women Seeking Reproductive Health Services and Coverage of HIV Prevention

Run by University of Alabama at Birmingham · NCT07076043 · Data updated 2026-11-12

This program will try offering both daily oral PrEP and the dapivirine vaginal ring to women aged 18–30 who come for reproductive health services to see if more start and keep using HIV prevention.

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Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years to 30 Years
SexWomen only
Enrollment1400 (estimated)
SponsorUniversity of Alabama at Birmingham
Academic / other
Locations1 site (Thika, Kiambu County)
StatusRecruiting
StartedJune 3, 2025
Main results expectedDecember 30, 2028
Study endsDecember 30, 2029
Registry record updatedJuly 22, 2026
Trial IDNCT07076043 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Women aged 18 to 30 who are seeking reproductive health services at one of the participating clinics in Kiambu County, can consent, and can speak Kiswahili or English are the intended participants.

Probably not a fit

People younger than 18 or older than 30, those not attending participating clinics, those unwilling or unable to consent, or individuals with medical contraindications to PrEP products may not benefit from this program.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This stepped-wedge cluster randomized program will roll out a multi-product PrEP delivery model across 12 health clinics in Kiambu County, Kenya, enrolling about 1,400 adolescent girls and young women seeking reproductive health services. Clinics will be supported to add the dapivirine vaginal ring alongside existing daily oral PrEP services, and implementation will be staggered so sites transition from standard care to the multi-product offering over time. The primary outcome is whether making multiple PrEP products available increases initiation and persistence of HIV prevention among participants. Data will be collected during routine clinic visits and follow-up to compare uptake and continuation before and after the intervention at each site.

Why it matters

Potential benefit: If successful, offering multiple PrEP options could increase uptake and longer-term use of HIV prevention among young women, lowering their risk of acquiring HIV.

How similar studies have gone: Widespread rollout of daily oral PrEP has shown real-world benefit and the dapivirine ring demonstrated protective effects in prior trials, but integrating multiple PrEP products into routine reproductive health services using a stepped-wedge design is less commonly tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria for Adolescent Girls and Young Women seeking reproductive health services:

Age ≥18 years and ≤30years. Seeking a reproductive health service from one of the project facilities (reproductive health services include but are not limited to family planning, maternal and child health, postnatal care).

AGYW receiving reproductive health-related services through OPD, or other departments are eligible. AGYW receiving reproductive health-related services through other departments are eligible.

Willing and able to partake in an informed consent process. Able to speak and read in Kiswahili or English.

Where it's running

  • Kenya Medical Research Institute and Partners in Health & Research Development
    Thika, Kiambu County, Kenya
    Recruiting

Study contacts

  • Principal investigator: Nelly Mugo, MBChB, MMed, MPH — Kenya Medical Research Institute
  • Study coordinator: Renee Heffron, PhD, MPH
  • Email: rheffron@uabmc.edu
  • Phone: 205-934-7349

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.