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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04666792
• Other study ID #: STUDY00009583
• Secondary ID: R01MH123267
• Status: Recruiting
• Phase: Phase 4
• Start date: March 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2023
• Source: University of Washington
• Contact: Zarna Marfatia
• Phone: +12065203866
• Email: zarnam[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3600
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Contraception
• HIV Infections
• STI

Intervention

Drug:
• PrEP
A fixed-dose, oral co-formulation of emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) is the approved and preferred regimen for HIV-1 prevention in Kenya and the United States. The World Health Organization (WHO) recommends TDF-containing medications as PrEP, which includes TDF combined with FTC as well as potentially TDF alone and TDF combined with lamivudine (or 3TC, a medication closely related to FTC). Any TDF-containing medications that align with WHO and Kenya national guidelines for PrEP will be used. PrEP medication will come from clinic stocks.

Locations

Country	Name	City	State
Kenya	Kenyatta National Hospital	Kisumu

Sponsors (5)

Lead Sponsor	Collaborator
University of Washington	Kenya National AIDS & STI Control Programme, Kenyatta National Hospital, Kisumu County Government, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of women accessing family planning services who are screened for HIV risk	Measure HIV risk screening completion among women receiving family planning services	up to 24 months
Primary	Proportion of women accessing family planning services who uptake PrEP for HIV prevention	Measure PrEP initiation among women receiving family planning services	up to 24 months
Secondary	PrEP adherence quantified by tenofovir drug levels in blood	Measure PrEP adherence among women who initiate PrEP	up to 24 months
Secondary	Proportion of women who remain HIV-negative	Assess HIV status of women receiving family planning services	up to 24 months
Secondary	Proportion of family planning clinics that implement PrEP provision	Measure number of clinics that provide PrEP	up to 36 months
Secondary	Proportion of targeted providers who are trained and provide PrEP	Measure number of providers in family planning clinics who implement PrEP	up to 24 months
Secondary	Proportion of core PrEP delivery components delivered per protocol	Measure fidelity to PrEP delivery procedures in family planning clinics	up to 24 months
Secondary	Facilitators and barriers to PrEP implementation	Mixed methods assessment of clinic readiness and ability to implement PrEP per protocol	up to 24 months
Secondary	Programmatic costs of providing PrEP in family planning clinics	Conduct micro-costing, cost-effectiveness, and budget impact analyses to estimate the programmatic costs of providing PrEP in family planning clinics	up to 24 months
Secondary	Develop data tools to expand and support delivery of family planning and HIV prevention services	Coordinate with key stakeholders to develop and refine data tools and clinical delivery products during project implementation	up to 24 months