Systems Analysis and Improvement Approach to Improve Integration of HIV Prevention and Treatment Services

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

East and Southern Africa is home to 6.2% of the world's population but includes 54% of all people living with HIV (PLWH). In this region, three out of five PLWH are women, and there is a particularly high burden of HIV amongst adolescent girls and young women (AGYW). Over half of African women use family planning (FP) services. Integration of HIV prevention and treatment with FP services holds promise for supporting progress toward the UNAIDS 95-95-95 targets for testing, treatment, and prevention. Nonetheless, integration of even basic HIV prevention and treatment services into FP clinics remains low and how best to integrate these services is still unknown. In a previous trial, the Systems Analysis and Improvement Approach (SAIA), was an effective implementation strategy for improving HIV counseling and testing in a small selection of FP clinics in Mombasa County, Kenya when delivered by research staff. SAIA incorporates a cascade analysis tool, sequential process flow mapping, and cycles of micro-intervention development, implementation, and assessment to improve a care cascade. More data is needed to understand if SAIA is effective for also improving linkage to HIV care and screening and linkage to pre-exposure prophylaxis (PrEP) in FP clinics when SAIA is delivered at scale by Kenyan public health workforce. The first objective of this study is to conduct a cluster-randomized trial evaluating the effectiveness of SAIA versus control (usual procedures with no specific intervention) for increasing HIV counseling, testing, linkage to HIV care, and screening and linkage to PrEP in new FP clients and new and returning AGYW clients. There will be a particular focus on the HIV prevention and treatment of AGYW in this study and any AGYW presenting for FP care will be prioritized. Quantitative and qualitative data will be analyzed using the RE-AIM framework to evaluate the program's Reach, Effectiveness, Adoption, Implementation, and Maintenance. To understand how SAIA could be integrated into national Ministry of Health policies and programs, activity-based costing will be conducted to estimate the budget and program impacts of SAIA, scaled to a County level, from a Ministry of Health perspective. It is hypothesized that compared to control, SAIA will be effective at increasing HIV counseling, HIV testing, linkage to HIV care, and screening and linkage to PrEP for new FP clients and all new and returning AGYW FP clients when delivered at scale by Kenyan public health staff. The implementation evaluation, costing, and budget impact analysis will establish a road map for national-level implementation, positioning Kenya as a global leader in integrating FP/HIV services.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: t
View:

‣ FP clinics:

• All FP clinics that receive County-supplied FP products will be eligible to participate.

‣ FP clinic managers and staff:

• Any FP clinic manager that is 18 years and older is eligible to be interviewed. -These clinic managers can be male or female.

‣ Kenyan public health staff:

⁃ Any Kenyan public health staff that is 18 years and older is eligible to be interviewed.

⁃ These public health staff can be male or female.

Locations
Other Locations
Kenya
FP Clinics in Mombasa County
RECRUITING
Mombasa
Contact Information
Primary
McKenna Eastment
mceast@uw.edu
206-4165074
Time Frame
Start Date: 2024-03-14
Estimated Completion Date: 2027-10-01
Participants
Target number of participants: 40
Treatments
Experimental: Intervention clinics that implement the Systems Analysis and Improvement Approach
Mombasa County public health staff will facilitate SAIA
No_intervention: Usual procedures
Related Therapeutic Areas
Sponsors
Leads: University of Washington
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This content was sourced from clinicaltrials.gov