HIV Clinical Trial
Official title:
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
Verified date | November 2023 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria for in-depth interviews: - Adult family planning clinic staff - If staff younger than 18 are encountered, they will be allowed to participate only if they qualify as emancipated minors in Kenya (14 years or older and married or pregnant). - Able to provide written informed consent for in-depth interviews Inclusion criteria for FP clinics in Mombasa: -Clinics providing assent for participation in both the preliminary review and randomizations Exclusion Criteria for FP clinics: - Clinics planning to be closed during the study period - Clinics unwilling to be randomized or to participate in the SAIA intervention/approach |
Country | Name | City | State |
---|---|---|---|
Kenya | Alfarooq | Mombasa | |
Kenya | Jocham | Mombasa | |
Kenya | Junda | Mombasa | |
Kenya | Junda Dispensary | Mombasa | |
Kenya | Kongowea | Mombasa | |
Kenya | Magongo | Mombasa | |
Kenya | Marimani | Mombasa | |
Kenya | Mbuta | Mombasa | |
Kenya | Mikindani | Mombasa | |
Kenya | Mlaleo | Mombasa | |
Kenya | Mrima | Mombasa | |
Kenya | Mvita | Mombasa | |
Kenya | Mwakirunge | Mombasa | |
Kenya | Mwangaza | Mombasa | |
Kenya | Pandya | Mombasa | |
Kenya | Roadside | Mombasa | |
Kenya | ShikaAdabu | Mombasa | |
Kenya | Shukurani | Mombasa | |
Kenya | Singawa | Mombasa | |
Kenya | St. Thomas | Mombasa | |
Kenya | Tudor | Mombasa | |
Kenya | Waweni | Mombasa | |
Kenya | Wema | Mombasa | |
Kenya | Ziwa la ngombe | Mombasa |
Lead Sponsor | Collaborator |
---|---|
University of Washington | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Kenyatta National Hospital, Ministry of Health, Mombasa County, National Institutes of Health (NIH), University of Nairobi |
Kenya,
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* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Eligible (Not Known HIV+) New FP Clients Who Are Tested for HIV in the Months 9-12 of the Study in Intervention and Control Facilities | Months 9-12 of the study | ||
Secondary | Percentage of New FP Clients Who Are Counseled About HIV Testing in the Months 9-12 of the Study in Intervention and Control Facilities, Adjusted for Baseline | Months 9-12 of the study | ||
Secondary | Percentage of New FP Clients Who Are Tested for HIV After Year of Minimal Support | Months 13-24 of the study |
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