Clinical trial NCT02994355: HIV Testing at Family Planning Clinics in Mombasa County, Kenya
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: Family planning clinics
Implementation Science
Systems Analysis and Improvement Approach (SAIA)
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: University of Nairobi
name: Kenyatta National Hospital
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Ministry of Health, Mombasa County
First posted: 2016-12-15
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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.

Detailed description: 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. The need for integration of services is evident in Africa, which bears a disproportionate burden of HIV, high birth rates, and maternal mortality. A high and increasing proportion of African women use FP services, making this a potentially efficient venue for reaching them.

Testing for HIV is the gateway to care and prevention. Integrating HIV testing into FP clinics could open this essential gateway, decreasing stigma associated with seeking HIV testing while reducing costs. The antenatal setting provides a useful example. In many African countries, testing for HIV in antenatal clinics (ANCs) has become routine. Diagnosis of HIV during pregnancy has paved the way to substantial reductions in mother-to-child transmission of HIV and AIDS-related deaths in women of reproductive age. These achievements demonstrate the feasibility and impact of wide-scale HIV testing through existing reproductive health services. In contrast to ANCs, integration of HIV testing into FP services remains at a formative stage in much of Africa. Recent reviews support the feasibility of integrating these services, but invariably conclude that additional research is needed.

In Kenya, the National AIDS and STD Control Program (NASCOP) states that the FP clinic is a setting in which, "Failure to offer HIV testing and counseling is unacceptable, and will be considered negligent." However, there has been almost no operational assessment of HIV testing in Kenyan FP clinics. 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, and the County has requested our assistance in addressing this prevention gap. Colleagues at the University of Washington Department of Global Health have developed a systems analysis and performance enhancement approach, using industrial and systems engineering techniques, that the investigators believe will be useful in this setting. The overarching objective is to assess the effectiveness, costs, and budget impact of implementing this systems analysis and improvement approach (SAIA) to increase HIV testing in FP clinics in Mombasa County. The investigators specific aims are as follows:

AIM 1: 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 12 intervention versus 12 control FP clinics in Mombasa County, Kenya.

HYP 1: After one year of study team support implementing SAIA vs. usual procedures, a higher proportion of first-time FP clinic attendees will be tested for HIV at intervention compared to control facilities

AIM 2: To determine whether the SAIA training results in a lasting effect, 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. The Mombasa County Ministry of Health will take ownership of implementation during this phase.

HYP 2: After an additional year with minimal support from the study team, there will continue to be significantly higher rates of HIV testing in first-time FP clinic attendees at intervention compared to control facilities.

AIM 3: To estimate the incremental cost and budget impact of applying SAIA versus standard of care. Using an activity-based approach, the investigators will perform a costing analysis, estimating cost per new HIV diagnosis, both during active support from the study team and after a period without active support. The investigators will also estimate cost to scale up, and conduct a budget impact analysis from a Department of Health (DOH) perspective.

Expected Outcome and Significance:

The investigators anticipate that the SAIA approach 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 to evaluate this scalable approach 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. 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. Preliminary data on linkage to care and prevention services will inform development of future grant proposals.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Months 9-12 of the study
Secondary outcomes:
measure: 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
timeFrame: Months 9-12 of the study
measure: Percentage of New FP Clients Who Are Tested for HIV After Year of Minimal Support
timeFrame: Months 13-24 of the study
Other outcomes:
Locations:
city: Mombasa
country: Kenya
facility: Alfarooq
city: Mombasa
country: Kenya
facility: Jocham
city: Mombasa
country: Kenya
facility: Junda Dispensary
city: Mombasa
country: Kenya
facility: Junda
city: Mombasa
country: Kenya
facility: Kongowea
city: Mombasa
country: Kenya
facility: Magongo
city: Mombasa
country: Kenya
facility: Marimani
city: Mombasa
country: Kenya
facility: Mbuta
city: Mombasa
country: Kenya
facility: Mikindani
city: Mombasa
country: Kenya
facility: Mlaleo
city: Mombasa
country: Kenya
facility: Mrima
city: Mombasa
country: Kenya
facility: Mvita
city: Mombasa
country: Kenya
facility: Mwakirunge
city: Mombasa
country: Kenya
facility: Mwangaza
city: Mombasa
country: Kenya
facility: Pandya
city: Mombasa
country: Kenya
facility: Roadside
city: Mombasa
country: Kenya
facility: ShikaAdabu
city: Mombasa
country: Kenya
facility: Shukurani
city: Mombasa
country: Kenya
facility: Singawa
city: Mombasa
country: Kenya
facility: St. Thomas
city: Mombasa
country: Kenya
facility: Tudor
city: Mombasa
country: Kenya
facility: Waweni
city: Mombasa
country: Kenya
facility: Wema
city: Mombasa
country: Kenya
facility: Ziwa la ngombe
Study officials:
affiliation: Professor of Medicine, Epidemiology, Global Health
name: Raymond S McClelland, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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