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

NCT07076043 | Recruiting Phase 4 DMC

• 2 other identifiers: KEMRI/SERU/CCR/0361/5052R01MH134681
• Study Type: interventional
• Target: 1,400
• Locations: 1 country
• Sites: 1

Brief Summary

Following on the heels of large implementation science projects that participated in the launch of widespread daily oral PrEP availability, we 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. We will support participating clinics to add dapivirine ring into their existing PrEP services offered to women seeking reproductive health care. Our primary aim will be to determine whether the availability of multiple PrEP products to young women will result in greater frequency of PrEP initiation and persistence.

Conditions

Hiv

Keywords

HIV prevention; PrEP; Adolescent girls and young women; Kenya; stepped wedge cluster randomized trial

Outcome Measures

Primary Outcomes (1)

• PrEP initiation

  Women who start to use PrEP

  From enrolment to 6 months

Secondary Outcomes (1)

• PrEP persistence at 3 months

  From enrolment to 3 months

Other Outcomes (1)

• PrEP persistence at 6 months

  Enrolment to 6 months

Study Arms (2)

Standard of Care PrEP Program

NO INTERVENTION

In the control phase, clinics will offer standard of care PrEP program, which includes daily oral PrEP, for young women.

Multiple Product PrEP Program

ACTIVE COMPARATOR

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.

Drug: Multiple Product PrEP Program

Interventions

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.

Multiple Product PrEP Program

Eligibility Criteria

• Age: 18 Years - 30 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• University of Washington: collaborator
• Kenya Medical Research Institute: collaborator
• National Institute of Mental Health (NIMH): collaborator
• Partners in Health and Research Development: collaborator

Study Sites (1)

Kenya Medical Research Institute and Partners in Health & Research Development

Thika, Kiambu County, Kenya

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Nelly Mugo, MBChB, MMed, MPH

  Kenya Medical Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Renee Heffron, PhD, MPH

CONTACT

205-934-7349; rheffron@uabmc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: July 20, 2025
• Study Start: June 3, 2025
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2029
• Last Updated: July 20, 2025

Record last verified: 2025-07

Locations

KE (1)