CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 24 enrolled
Drug / intervention
Systems Analysis and Improvement Approachother
Likely dose
Not stated in record
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Search/NCT02994355
NCT02994355N/ACompleted

HIV Testing at Family Planning Clinics in Mombasa County, Kenya: A Cluster-Randomized Trial Comparing the Systems Analysis and Improvement Approach (SAIA) to Usual Procedures

University of Washington·interventional·Posted Dec 15, 2016·Updated Nov 30, 2023

In Brief

A clinical study evaluating Systems Analysis and Improvement Approach for HIV. Completed, enrolled 24 participants across 24 sites.

Detailed Summary

Location: Family Planning Clinics in Mombasa County, Kenya Introduction: Integration of HIV treatment and prevention with family planning (FP) services is a promising approach for optimizing delivery of comprehensive healthcare for HIV-positive women, as well as prevention services for those who are negative. In Mombasa County, the USAID-supported AIDS Population and Health Integrated Assistance II Program revised the FP Clinic Register to capture HIV testing in 2008. However, the rate of HIV testing in FP clinics remains low. Our overarching objective is to assess the effectiveness, costs, and budget impact of implementing the systems analysis and improvement approach (SAIA) to increase HIV testing in FP clinics in Mombasa County. Methods: The investigators aim to conduct a cluster-randomized trial comparing the effect of the SAIA approach versus usual procedures on rates of HIV testing in first-time attendees at 20 intervention versus 20 control FP clinics in Mombasa County. The investigators will compare HIV testing rates for first-time FP clinic attendees in SAIA intervention versus control facilities after an additional year, during which FP clinics in the intervention arm will be encouraged to continue to use the SAIA tools with minimal support from the study team as the Mombasa County Ministry of Health will take ownership of implementation. Lastly, the investigators aim to estimate the incremental cost and budget impact of applying SAIA versus standard of care using an activity-based approach. Anticipated Results: The investigators anticipate that SAIA will produce significant and sustained improvement in HIV-testing rates in first-time FP clinic attendees in intervention clinics compared to control facilities. The use of a rigorous study design will provide strong evidence to guide integration of HIV testing into FP services in a wide range of settings. The inclusion of costing and budget impact analyses will assist policy makers in reaching informed decisions about implementation. Anticipated Conclusion: By addressing the crucial first step in the linkage of HIV and FP services, this research holds considerable promise for improving women's health by opening the gateway to HIV care and prevention.

Study Details

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedDec 15, 2016
Enrollment StartJun 1, 2018
Primary CompletionDec 31, 2019
Study CompletionDec 31, 2022
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 9.5 years ago

Interventions

Systems Analysis and Improvement Approachother

1. Understanding the cascade from FP clinic enrollment to HIV testing 2. Use process mapping to identify modifiable bottlenecks 3. Define and implement workflow adaptations to eliminate modifiable bottlenecks 4. Monitor change in performance 5. Repeat the analysis and improvement cycle (steps 1-4)