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NCT02994355

HIV Testing at Family Planning Clinics in Mombasa County, Kenya

Last Updated: 2023-11-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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HIV

Keywords

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Family planning clinics Implementation Science Systems Analysis and Improvement Approach (SAIA)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Systems Analysis and Improvement Approach

Intervention Type OTHER

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)

Control Clinics

Clinics randomized to the control arm of the study will continue HIV testing as per usual procedures.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Systems Analysis and Improvement Approach

Intervention Type OTHER

Other Intervention Names

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SAIA

Eligibility Criteria

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Inclusion Criteria

* 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

-Clinics providing assent for participation in both the preliminary review and randomizations

Exclusion Criteria

* Clinics planning to be closed during the study period
* Clinics unwilling to be randomized or to participate in the SAIA intervention/approach

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Scott McClelland

Professor, Medicine, Epidemiology, and Global Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raymond S McClelland, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Professor of Medicine, Epidemiology, Global Health

Reference Type DERIVED

PMID: 36471311 (View on PubMed)

Long JE, Eastment MC, Wanje G, Richardson BA, Mwaringa E, Mohamed MA, Sherr K, Barnabas RV, Mandaliya K, Jaoko W, McClelland RS. Assessing the sustainability of the Systems Analysis and Improvement Approach to increase HIV testing in family planning clinics in Mombasa, Kenya: results of a cluster randomized trial. Implement Sci. 2022 Oct 4;17(1):70. doi: 10.1186/s13012-022-01242-3.

Reference Type DERIVED

PMID: 36195890 (View on PubMed)

Eastment MC, Long JE, Wanje G, Richardson BA, Mwaringa E, Sherr K, Barnabas RV, Mandaliya K, Jaoko W, McClelland RS. Qualitative evaluation of the Systems Analysis and Improvement Approach as a strategy to increase HIV testing in family planning clinics using the Consolidated Framework for Implementation Research and the Implementation Outcomes Framework. Implement Sci Commun. 2022 Sep 8;3(1):97. doi: 10.1186/s43058-022-00342-x.

Reference Type DERIVED

PMID: 36076250 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1K24HD088229-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00001851

Identifier Type: -

Identifier Source: org_study_id

HIV Testing at Family Planning Clinics in Mombasa County, Kenya

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Intervention Clinics

Systems Analysis and Improvement Approach

Control Clinics

Interventions

Systems Analysis and Improvement Approach

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

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

University of Washington

Responsible Party

Scott McClelland

Principal Investigators

Raymond S McClelland, MD, MPH

Locations

Alfarooq

Jocham

Junda Dispensary

Junda

Kongowea

Magongo

Marimani

Mbuta

Mikindani

Mlaleo

Mrima

Mvita

Mwakirunge

Mwangaza

Pandya

Roadside

ShikaAdabu

Shukurani

Singawa

St. Thomas

Tudor

Waweni

Wema

Ziwa la ngombe

Countries

References

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.

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.

Bloom DE. 7 billion and counting. Science. 2011 Jul 29;333(6042):562-9. doi: 10.1126/science.1209290.

Kennedy CE, Spaulding AB, Brickley DB, Almers L, Mirjahangir J, Packel L, Kennedy GE, Mbizvo M, Collins L, Osborne K. Linking sexual and reproductive health and HIV interventions: a systematic review. J Int AIDS Soc. 2010 Jul 19;13:26. doi: 10.1186/1758-2652-13-26.

Spaulding AB, Brickley DB, Kennedy C, Almers L, Packel L, Mirjahangir J, Kennedy G, Collins L, Osborne K, Mbizvo M. Linking family planning with HIV/AIDS interventions: a systematic review of the evidence. AIDS. 2009 Nov;23 Suppl 1:S79-88. doi: 10.1097/01.aids.0000363780.42956.ff.

Madon T, Hofman KJ, Kupfer L, Glass RI. Public health. Implementation science. Science. 2007 Dec 14;318(5857):1728-9. doi: 10.1126/science.1150009. No abstract available.

Glasgow RE, Vinson C, Chambers D, Khoury MJ, Kaplan RM, Hunter C. National Institutes of Health approaches to dissemination and implementation science: current and future directions. Am J Public Health. 2012 Jul;102(7):1274-81. doi: 10.2105/AJPH.2012.300755. Epub 2012 May 17.

UNAIDS. The GAP Report. Geneva: Joint United National Programme on HIV/AIDS (UNAIDS), 2014.

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

Other Identifiers

1K24HD088229-01

STUDY00001851