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NCT Number: NCT07076043

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

Following on the heels of large implementation science projects that participated in the launch of widespread daily oral PrEP availability, investigators will launch and study the integration of novel PrEP products - beginning with the dapivirine ring- into existing PrEP programs that reach women seeking reproductive health care at health facilities in Kenya. Intervention delivery will be launched among 12 participating clinics with approximately 1400 AGYW seeking reproductive health services and counseled about PrEP through a stepped wedge cluster randomized trial. investigators will support participating clinics to add dapivirine ring into their existing PrEP services offered to women seeking reproductive health care. The primary aim of the study will be to determine whether the availability of multiple PrEP products to young women will result in greater frequency of PrEP initiation and persistence.

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Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Kenya Medical Research Institute and Partners in Health & Research Development

Thika, Kiambu County, Kenya

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multiple Product PrEP Program

Drug

In the intervention phase, clinics will offer a multi-product PrEP program, which includes daily oral PrEP and other forms of PrEP that are available. To start, the dapivirine vaginal ring will be included among the other forms of PrEP that are available. Others will be added as they become available in Kenya.

Routine Oral PrEP

Drug

Daily oral PrEP

Primary outcomes

  1. PrEP initiation

    Time frame: From enrolment to 6 months

    Women who start to use PrEP

Secondary outcomes

  1. PrEP persistence at 3 months

    Time frame: From enrolment to 3 months

    Women who continue to use PrEP 3 months since they initiated PrEP

Other outcomes

  1. PrEP persistence at 6 months

    Time frame: Enrolment to 6 months

    Women who continue to use PrEP 6 months since they initiated PrEP

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Kenya Medical Research Institute
  • National Institute of Mental Health (NIMH)
  • University of Washington

Registry information

Acronym: PrEMIA

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Jul 20, 2025
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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