Offering multiple PrEP options, including the dapivirine ring, to young women at reproductive health clinics
Multi-product PrEP Delivery to Young Women Seeking Reproductive Health Services and Coverage of HIV Prevention
PHASE4 · University of Alabama at Birmingham · NCT07076043
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.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 1400 (estimated) |
| Ages | 18 Years to 30 Years |
| Sex | Female |
| Sponsor | University of Alabama at Birmingham (other) |
| Locations | 1 site (Thika, Kiambu County) |
| Trial ID | NCT07076043 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Thika, Kiambu County
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hiv, HIV prevention, PrEP, Adolescent girls and young women, Kenya, stepped wedge cluster randomized trial