- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04666792
PrEParing Family Planning Clinics to Streamline Integration of HIV Prevention Services for Young Women in Kenya
June 2, 2023 updated by: Kenneth K Mugwanya, University of Washington
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Estimated)
3600
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zarna Marfatia
- Phone Number: +12065203866
- Email: zarnam@uw.edu
Study Contact Backup
- Name: John Kinuthia, PhD
- Phone Number: +254-722-799-052
Study Locations
-
-
-
Kisumu, Kenya
- Recruiting
- Kenyatta National Hospital
-
Contact:
- John Kinuthia, MBChB, M.Med., MPH
- Email: kinuthia@uw.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: PrEP for HIV-1 uninfected for women accessing family planning
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of women accessing family planning services who are screened for HIV risk
Time Frame: up to 24 months
|
Measure HIV risk screening completion among women receiving family planning services
|
up to 24 months
|
Proportion of women accessing family planning services who uptake PrEP for HIV prevention
Time Frame: up to 24 months
|
Measure PrEP initiation among women receiving family planning services
|
up to 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PrEP adherence quantified by tenofovir drug levels in blood
Time Frame: up to 24 months
|
Measure PrEP adherence among women who initiate PrEP
|
up to 24 months
|
Proportion of women who remain HIV-negative
Time Frame: up to 24 months
|
Assess HIV status of women receiving family planning services
|
up to 24 months
|
Proportion of family planning clinics that implement PrEP provision
Time Frame: up to 36 months
|
Measure number of clinics that provide PrEP
|
up to 36 months
|
Proportion of targeted providers who are trained and provide PrEP
Time Frame: up to 24 months
|
Measure number of providers in family planning clinics who implement PrEP
|
up to 24 months
|
Proportion of core PrEP delivery components delivered per protocol
Time Frame: up to 24 months
|
Measure fidelity to PrEP delivery procedures in family planning clinics
|
up to 24 months
|
Facilitators and barriers to PrEP implementation
Time Frame: up to 24 months
|
Mixed methods assessment of clinic readiness and ability to implement PrEP per protocol
|
up to 24 months
|
Programmatic costs of providing PrEP in family planning clinics
Time Frame: up to 24 months
|
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
|
Develop data tools to expand and support delivery of family planning and HIV prevention services
Time Frame: up to 24 months
|
Coordinate with key stakeholders to develop and refine data tools and clinical delivery products during project implementation
|
up to 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kenneth Mugwanya, MBChB, MS, PhD, University of Washington
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2021
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
December 8, 2020
First Submitted That Met QC Criteria
December 8, 2020
First Posted (Actual)
December 14, 2020
Study Record Updates
Last Update Posted (Actual)
June 5, 2023
Last Update Submitted That Met QC Criteria
June 2, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Urogenital Diseases
- Genital Diseases
- HIV Infections
Other Study ID Numbers
- STUDY00009583
- R01MH123267 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV Infections
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
University of California, San DiegoUniversity of California, Los Angeles; University of Southern California; California... and other collaboratorsCompleted
-
Gérond'ifRecruiting
-
University of California, DavisCompleted
-
University of California, San DiegoNational Center for Complementary and Integrative Health (NCCIH)CompletedHIV PositiveUnited States
-
University of ChicagoUniversity of Athens; National Development and Research Institutes, Inc.Completed
-
HIV Prevention Trials NetworkNational Institute on Drug Abuse (NIDA); National Institute of Allergy and...CompletedHIV PositiveIndonesia, Ukraine, Vietnam
-
University of ZimbabweCompleted
-
Florida International UniversityCompleted
-
Boston Children's HospitalNational Institute on Minority Health and Health Disparities (NIMHD)Completed
Clinical Trials on PrEP
-
University of UlsterNorthern Ireland Chest Heart and StrokeCompleted
-
Penn State UniversityRecruiting
-
University of WashingtonNational Institute of Allergy and Infectious Diseases (NIAID); Kenyatta National...Completed
-
San Diego State UniversityNational Institute of Mental Health (NIMH); Hennepin Healthcare Research InstituteCompleted
-
Hilary L Surratt, PhDNational Institute on Drug Abuse (NIDA)Active, not recruitingHIV PreventionUnited States
-
University of Illinois at ChicagoNational Institute of Nursing Research (NINR)RecruitingSex Work | Pre-Exposure ProphylaxisUnited States
-
Montefiore Medical CenterNew York State Psychiatric InstituteActive, not recruiting
-
University of California, San FranciscoNational Institute of Nursing Research (NINR); San Francisco Department of...CompletedHIV/AIDSUnited States
-
University of Massachusetts, WorcesterEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsRecruitingPre-Exposure ProphylaxisThailand
-
Columbia UniversityNational Institute of Mental Health (NIMH); Gilead SciencesCompleted