PrEParing Family Planning Clinics to Streamline Integration of HIV Prevention Services for Young Women in Kenya

University of Washington

Status and phase: Enrolling; Phase 4

Conditions: STI; Contraception; HIV Infections

Treatments: Drug: PrEP

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04666792

STUDY00009583

R01MH123267 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This a prospective, open-label implementation project to catalyze integration of HIV prevention and PrEP care services for adolescent girls and young women in family planning clinics in Kenya.

Full description

Investigators will conduct a stepped-wedge cluster-randomized programmatic project to integrate PrEP provision within a combination HIV prevention package in 12 family planning clinics in Kisumu, Kenya- a region with an HIV prevalence of up to 28% among young women. The project will optimize and sustain PrEP delivery with existing family planning staff, supported through training and ongoing technical assistance. The investigators will rigorously evaluate program reach, effectiveness, adoption, implementation, maintenance, and impact using validated implementation science frameworks and how clinics build new efficient delivery systems.

Enrollment: 3,600 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female of reproductive age
• Sexually active
• Able and willing to provide informed consent
• HIV negative, according to national HIV testing algorithm
• Has at least one risk factor for HIV as defined by the Kenya National AIDS and STI Control Program

Exclusion criteria

• Otherwise not eligible based on the above inclusion criteria

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3,600 participants in 1 patient group

PrEP for HIV-1 uninfected for women accessing family planning

Other group

Description:

Women accessing family planning will be assessed for HIV risk and PrEP eligibility. If eligible and willing to initiate PrEP, they will be provided PrEP in accordance with national guidelines as part of their standard of care at the family planning clinic.

Treatment:

Drug: PrEP