HIV Testing at Family Planning Clinics in Mombasa County, Kenya

NCT02994355 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-11-30

Study results available
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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.

Conditions

Interventions

OTHER

Systems Analysis and Improvement Approach

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)

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH
  • University of Nairobi

    collaborator OTHER
  • Kenyatta National Hospital

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

    collaborator NIH
  • Ministry of Health, Mombasa County

    collaborator OTHER_GOV
  • University of Washington

    lead OTHER

Principal Investigators

  • Raymond S McClelland, MD, MPH · Professor of Medicine, Epidemiology, Global Health

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2019-12-31
Completion
2022-12-31

Countries

  • Kenya

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02994355 on ClinicalTrials.gov