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

Hiv Clinical Trial

— FP HIV SCALE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05404958
• Other study ID #: STUDY00014745
• Secondary ID: GRANT13455302
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: March 31, 2027

Study information

• Verified date: March 2024
• Source: University of Washington
• Contact: McKenna Eastment
• Phone: 206-4165074
• Email: mceast[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 31, 2027
• Est. primary completion date: June 28, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hiv

Intervention

Other:
• 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).

Locations

Country	Name	City	State
Kenya	FP Clinics in Mombasa County	Mombasa

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reach HIV counseling	Proportion of FP clients in intervention clinics counseled for HIV out of the total FP clients seen in the clinic	Months 1-12
Primary	Effectiveness HIV counseling	Proportion of FP clients (counseled for HIV out of the total FP clients seen in the clinic in intervention vs control clinics	Months 1-12
Primary	Reach HIV testing	Proportion of FP clients in intervention clinics counseled for HIV out of the total FP clients seen in the clinic	Months 1-12
Primary	Effectiveness HIV testing	Proportion of FP clients tested for HIV out of the total FP clients who should be tested in intervention vs control clinics	Months 1-12
Primary	Reach Linked to HIV care	Proportion of HIV seropositive FP clients who are out of care linked to comprehensive HIV care in intervention clinics out of all HIV seropositive FP clients who are out of care	Months 1-12
Primary	Effectiveness Linked to HIV care	Proportion of HIV-seropositive FP clients who are out of care then linked to comprehensive HIV care out of all HIV-seropositive FP clients who are out of care in intervention vs control clinics	Months 1-12
Primary	Reach Screening and linkage to PrEP	Proportion of HIV seronegative FP clients in intervention clinics screened for PrEP out of all HIV seronegative FP clients; Proportion of HIV seronegative FP clients eligible for PrEP in intervention clinics who are linked to PrEP out of all HIV seronegative FP clients eligible for PrEP	Months 1-12
Primary	Effectiveness Screening and linkage to PrEP	1. Proportion of HIV-seronegative FP clients screened for PrEP out of all HIV-seronegative FP clients in intervention vs control clinics 2. Proportion of HIV-seronegative FP clients who are eligible for PrEP who are linked to PrEP out of all HIV-seronegative FP clients who are eligible for PrEP in intervention vs control clinics 2. Proportion of HIV seronegative FP clients eligible for PrEP in intervention clinics who are linked to PrEP out of all HIV seronegative FP clients eligible for PrEP	Months 1-12
Primary	Adoption	1. Proportion of intervention clinics that participated in the initial training and selected their first micro-intervention	12 months
Primary	Adoption	2. In-depth interviews using the IRLM and CFIR; Administer survey using the ORIC assessment	12 months
Primary	Implementation	1a. Proportion of intervention clinics implementing SAIA with high fidelity; 1b. Proportion of intervention clinics implementing SAIA with low fidelity	12 months
Primary	Implementation	1a. Proportion of intervention clinics implementing SAIA with high fidelity; 1b. Proportion of intervention clinics implementing SAIA with low fidelity	24 months
Primary	Implementation	2. In-depth interviews with FP clinic staff in intervention clinics and county and national personnel using IRLM and CFIR.	12 months and 24 months
Primary	Maintenance	1a. Proportion of FP clinics with sustained maintenance; 1b. Proportion of FP clinics with partial maintenance	12 & 24 months