Clinical trial NCT04666792: PrEParing Family Planning Clinics to Streamline Integration of HIV Prevention Services for Young Women in Kenya
Official title: PrEParing Family Planning Clinics to Streamline Integration of HIV Prevention Services for Young Women in Kenya
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: HIV Infections
Contraception
STI
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Kenyatta National Hospital
name: Kenya National AIDS & STI Control Programme
name: Kisumu County Government
First posted: 2020-12-14
Enrollment: 3600
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This a programmatic stepped-Wedge cluster randomized trial
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of women accessing family planning services who are screened for HIV risk
timeFrame: up to 24 months
measure: Proportion of women accessing family planning services who uptake PrEP for HIV prevention
timeFrame: up to 24 months
Secondary outcomes:
measure: PrEP adherence quantified by tenofovir drug levels in blood
timeFrame: up to 24 months
measure: Proportion of women who remain HIV-negative
timeFrame: up to 24 months
measure: Proportion of family planning clinics that implement PrEP provision
timeFrame: up to 36 months
measure: Proportion of targeted providers who are trained and provide PrEP
timeFrame: up to 24 months
measure: Proportion of core PrEP delivery components delivered per protocol
timeFrame: up to 24 months
measure: Facilitators and barriers to PrEP implementation
timeFrame: up to 24 months
measure: Programmatic costs of providing PrEP in family planning clinics
timeFrame: up to 24 months
measure: Develop data tools to expand and support delivery of family planning and HIV prevention services
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Kenyatta National Hospital
Study officials:
affiliation: University of Washington
name: Kenneth Mugwanya, MBChB, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mugwanya KK, Matemo D, Scoville CW, Beima-Sofie KM, Meisner A, Onyango D, Mugambi M, Feutz E, Grabow C, Barnabas R, Weiner B, Baeten JM, Kinuthia J; FP Plus Team. Integrating PrEP delivery in public health family planning clinics: a protocol for a pragmatic stepped wedge cluster randomized trial in Kenya. Implement Sci Commun. 2021 Dec 11;2(1):135. doi: 10.1186/s43058-021-00228-4.