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

NCT ID: NCT05404958

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-14
• Study Completion Date: 2027-10-01

Brief 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.

Detailed Description

AIM 1: To conduct a cluster-randomized trial evaluating the effectiveness of SAIA versus control (usual procedures) for increasing HIV counseling, testing, linkage to care, and screening and linkage to PrEP in new FP clients and new and returning AGYW clients. Quantitative and qualitative data will be analyzed using the RE-AIM framework (21).

1a) Reach: Proportion of intervention arm health facility clients' reached with the intervention

1b) Effectiveness: Compare the effectiveness of SAIA vs. control for increasing rates of HIV counseling, testing, linkage to care, and screening and linkage to PrEP in new FP clients and new and returning AGYW clients

1c) Adoption: Proportion of clinics adopting SAIA; adoption determinants identified using the Implementation Research Logic Model (IRLM) (22) and Organizational Readiness for Implementing Change (ORIC) scale (23)

1d) Implementation: Proportion of FP clinics implementing SAIA with high fidelity at 12 months and at 24 months; barriers and facilitators of implementation at scale by County DOH personnel will be explored using constructs from the Consolidated Framework for Implementation Research (CFIR) and the IRLM (24)

1e) Maintenance: Proportion of FP clinics maintaining SAIA at 12 months and 24 months after introduction AIM 2: To estimate the incremental cost and budget and program impacts of SAIA from a County DOH perspective. We will conduct activity-based costing and develop budget impact scenarios based on SAIA's adoption.

Conditions

Hiv

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intervention clinics that implement the Systems Analysis and Improvement Approach

Mombasa County public health staff will facilitate SAIA

Group Type: EXPERIMENTAL

Systems Analysis and Improvement Approach (SAIA)

Intervention Type: OTHER

What is SAIA? It is a 5-step cycle that is repeated every 4-6 weeks for continuous quality improvement, implemented by Kenyan public health workforce and FP clinic staff, and monitored by Mombasa DOH.

Step 1: Understanding the cascade from FP clinic enrollment to HIV testing to linkage to treatment and prevention services.

Step 2: Use process mapping to identify modifiable bottlenecks. Step 3: Define and implement workflow adaptations to eliminate modifiable bottlenecks.

Step 4: Monitor change in performance. Step 5: Repeat the analysis and improvement cycle (steps 1-4).

Usual procedures

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Systems Analysis and Improvement Approach (SAIA)

What is SAIA? It is a 5-step cycle that is repeated every 4-6 weeks for continuous quality improvement, implemented by Kenyan public health workforce and FP clinic staff, and monitored by Mombasa DOH.

Step 1: Understanding the cascade from FP clinic enrollment to HIV testing to linkage to treatment and prevention services.

Step 2: Use process mapping to identify modifiable bottlenecks. Step 3: Define and implement workflow adaptations to eliminate modifiable bottlenecks.

Step 4: Monitor change in performance. Step 5: Repeat the analysis and improvement cycle (steps 1-4).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

FP clinics:

• Any clinics that are expected to close within the next year at the time of study initiation
• 12 facilities that participated as SAIA intervention facilities in our small-scale trial where the intervention was led by research staff.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

McKenna Eastment

Assistant Professor: Department of Medicine, Division of Allergy & Infectious Diseases

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

McKenna Eastment, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

FP Clinics in Mombasa County

Mombasa, , Kenya

Site Status: RECRUITING

Countries

Kenya

Central Contacts

McKenna Eastment

Role: CONTACT

mceast@uw.edu

206-4165074

Facility Contacts

George Wanje

Role: primary

Other Identifiers

GRANT13455302

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY00014745

Identifier Type: -

Identifier Source: org_study_id