Clinical trial NCT05404958: Systems Analysis and Improvement Approach to Improve Integration of HIV Prevention and Treatment Services
Official title: Systems Analysis and Improvement Approach to Improve Integration of HIV Prevention and Treatment Services
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hiv
Keywords: HIV prevention and treatment
Family planning
PrEP
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2022-06-03
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a cluster randomized trial enrolling family planning clinics. "Participants" are FP clinics.
Primary purpose: OTHER

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.

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.

FP clinic managers and staff: No exclusion criteria Kenyan public health staff: No exclusion criteria

Primary outcomes:
measure: Reach HIV counseling
timeFrame: Months 1-12
measure: Effectiveness HIV counseling
timeFrame: Months 1-12
measure: Reach HIV testing
timeFrame: Months 1-12
measure: Effectiveness HIV testing
timeFrame: Months 1-12
measure: Reach Linked to HIV care
timeFrame: Months 1-12
measure: Effectiveness Linked to HIV care
timeFrame: Months 1-12
measure: Reach Screening and linkage to PrEP
timeFrame: Months 1-12
measure: Effectiveness Screening and linkage to PrEP
timeFrame: Months 1-12
measure: Adoption
timeFrame: 12 months
measure: Adoption
timeFrame: 12 months
measure: Implementation
timeFrame: 12 months
measure: Implementation
timeFrame: 24 months
measure: Implementation
timeFrame: 12 months and 24 months
measure: Maintenance
timeFrame: 12 & 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mombasa
country: Kenya
facility: FP Clinics in Mombasa County
Study officials:
affiliation: University of Washington
name: McKenna Eastment, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: