Contraception, HIV Infections, STI
Conditions
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.
Interventions
DRUGPrEP
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.
Sponsors
National Institute of Mental Health (NIMH)
Kenyatta National Hospital
Kenya National AIDS & STI Control Programme
Kisumu County Government
University of Washington
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
This a programmatic stepped-Wedge cluster randomized trial
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of women accessing family planning services who are screened for HIV risk | up to 24 months | Measure HIV risk screening completion among women receiving family planning services |
| Proportion of women accessing family planning services who uptake PrEP for HIV prevention | up to 24 months | Measure PrEP initiation among women receiving family planning services |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of family planning clinics that implement PrEP provision | up to 36 months | Measure number of clinics that provide PrEP |
| Proportion of targeted providers who are trained and provide PrEP | up to 24 months | Measure number of providers in family planning clinics who implement PrEP |
| Proportion of core PrEP delivery components delivered per protocol | up to 24 months | Measure fidelity to PrEP delivery procedures in family planning clinics |
| PrEP adherence quantified by tenofovir drug levels in blood | up to 24 months | Measure PrEP adherence among women who initiate PrEP |
| Programmatic costs of providing PrEP in family planning clinics | 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 |
| Develop data tools to expand and support delivery of family planning and HIV prevention services | up to 24 months | Coordinate with key stakeholders to develop and refine data tools and clinical delivery products during project implementation |
| Facilitators and barriers to PrEP implementation | up to 24 months | Mixed methods assessment of clinic readiness and ability to implement PrEP per protocol |
| Proportion of women who remain HIV-negative | up to 24 months | Assess HIV status of women receiving family planning services |
Countries
Kenya
Outcome results
None listed