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HIV Testing at Family Planning Clinics in Mombasa County, Kenya

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ClinicalTrials.gov Identifier: NCT02994355
Recruitment Status : Active, not recruiting
First Posted : December 15, 2016
Last Update Posted : October 15, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
University of Nairobi
Kenyatta National Hospital
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Ministry of Health, Mombasa County
Information provided by (Responsible Party):
Scott McClelland, University of Washington

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.


Condition or disease Intervention/treatment Phase
HIV Other: Systems Analysis and Improvement Approach Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Clinics
Clinics randomized to the intervention will be introduced to the Systems Analysis and Improvement Approach (SAIA) to understand barriers to HIV testing in family planning clinics. Sequential process flow mapping will be used to highlight areas for improvement and then specific interventions will be implemented for the clinics with the goal of increasing HIV testing rates.
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)
Other Name: SAIA

No Intervention: Control Clinics
Clinics randomized to the control arm of the study will continue HIV testing as per usual procedures.



Primary Outcome Measures :
  1. Change in proportion of eligible (not known HIV+) new FP clients who are tested for HIV at baseline and after intervention [ Time Frame: Baseline and then following 12 months of SAIA training ]

Secondary Outcome Measures :
  1. Change in proportion of new FP clients who are counseled about HIV testing at baseline and after intervention [ Time Frame: Baseline and then following 12 months of SAIA training ]
  2. Change in proportion of new FP clients who are counseled about HIV testing at baseline, after intervention, and after year of minimal support [ Time Frame: Baseline, following 12 months of SAIA training and then additional year of minimal study support ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02994355


Locations
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Kenya
Alfarooq
Mombasa, Kenya
Jocham
Mombasa, Kenya
Junda Dispensary
Mombasa, Kenya
Junda
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, Kenya
Sponsors and Collaborators
University of Washington
National Institutes of Health (NIH)
University of Nairobi
Kenyatta National Hospital
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Ministry of Health, Mombasa County
Investigators
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Principal Investigator: Raymond S McClelland, MD, MPH Professor of Medicine, Epidemiology, Global Health

Publications:
WHO, UNFPA, IPPF, UNAIDS, UCSF. Sexual and reproductive health and HIV linkages: evidence review and recommendations. Geneva: 2009.
UNAIDS. Global Report: UNAIDS Report on the Global AIDS Epidemic 2013. Geneva: 2013.
National Department of Health South Africa, Medical Research Council South Africa, Human Sciences Research Council South Africa. South African demographic and health survey (SADHS). 2003.
Uganda Bureau of Statistics, MEASURE DHS. Uganda demographic and health survey. 2011.
Central Statistical Office Zambia, Ministry of Health Zambia, Tropical Diseases Research Centre Zambia, University Teaching Hospital Virology Laboratory Zambia, University of Zambia, The DHS Program II. Zambia Demographic and Health Survey 2013-14: Preliminary Report. Rockville, MD: 2014 September 2014.
Oberzaucher N, Baggaley R. HIV voluntary counselling and testing: a gateway to prevention and care. Geneva, Switzerland: UNAIDS, 2002 June, 2002.
Kenya National Bureau of Statistics, Ministry of Health Kenya, National AIDS Control Council, Kenya Medical Research Institute, National Council for Population and Development Kenya. Kenya Demographic and Health Survey 2014: Key Indicators. Nairobi, Kenya: 2015 March 2015.
National AIDS/STD Control Programme MoPHaS. Guidelines for HIV testing and counselling in Kenya. Nairobi: NASCOP, 2008.
UNAIDS. The GAP Report. Geneva: Joint United National Programme on HIV/AIDS (UNAIDS), 2014.

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Responsible Party: Scott McClelland, Professor, Medicine, Epidemiology, and Global Health, University of Washington
ClinicalTrials.gov Identifier: NCT02994355     History of Changes
Other Study ID Numbers: STUDY00001851
1K24HD088229-01 ( U.S. NIH Grant/Contract )
First Posted: December 15, 2016    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Scott McClelland, University of Washington:
Family planning clinics
Implementation Science
Systems Analysis and Improvement Approach (SAIA)