HIV Testing at Family Planning Clinics in Mombasa County, Kenya

NCT02994355 | Completed Results

• 2 other identifiers: STUDY000018511K24HD088229-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 24

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.

Conditions

HIV

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• Percentage of New FP Clients Who Are Tested for HIV After Year of Minimal Support

  Months 13-24 of the study

Study Arms (2)

Intervention Clinics

EXPERIMENTAL

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

Control Clinics

NO INTERVENTION

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

Interventions

Systems Analysis and Improvement Approach 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)

Also known as: SAIA

Intervention Clinics

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Washington: lead
• National Institutes of Health (NIH): collaborator
• University of Nairobi: collaborator
• Kenyatta National Hospital: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Ministry of Health, Mombasa County: collaborator

Study Sites (24)

Alfarooq

Mombasa, Kenya

Location

Jocham

Mombasa, Kenya

Location

Junda Dispensary

Mombasa, Kenya

Location

Junda

Mombasa, Kenya

Location

Kongowea

Mombasa, Kenya

Location

Magongo

Mombasa, Kenya

Location

Marimani

Mombasa, Kenya

Location

Mbuta

Mombasa, Kenya

Location

Mikindani

Mombasa, Kenya

Location

Mlaleo

Mombasa, Kenya

Location

Mrima

Mombasa, Kenya

Location

Mvita

Mombasa, Kenya

Location

Mwakirunge

Mombasa, Kenya

Location

Mwangaza

Mombasa, Kenya

Location

Pandya

Mombasa, Kenya

Location

Roadside

Mombasa, Kenya

Location

ShikaAdabu

Mombasa, Kenya

Location

Shukurani

Mombasa, Kenya

Location

Singawa

Mombasa, Kenya

Location

St. Thomas

Mombasa, Kenya

Location

Tudor

Mombasa, Kenya

Location

Waweni

Mombasa, Kenya

Location

Wema

Mombasa, Kenya

Location

Ziwa la ngombe

Mombasa, Kenya

Location

Related Publications (20)

• WHO, UNFPA, IPPF, UNAIDS, UCSF. Sexual and reproductive health and HIV linkages: evidence review and recommendations. Geneva: 2009.

  BACKGROUND

• UNAIDS. Global Report: UNAIDS Report on the Global AIDS Epidemic 2013. Geneva: 2013.

  BACKGROUND

• 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.

  BACKGROUND

• Uganda Bureau of Statistics, MEASURE DHS. Uganda demographic and health survey. 2011.

  BACKGROUND

• 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.

  BACKGROUND

• Oberzaucher N, Baggaley R. HIV voluntary counselling and testing: a gateway to prevention and care. Geneva, Switzerland: UNAIDS, 2002 June, 2002.

  BACKGROUND

• 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.

  BACKGROUND

• National AIDS/STD Control Programme MoPHaS. Guidelines for HIV testing and counselling in Kenya. Nairobi: NASCOP, 2008.

  BACKGROUND

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

  PMID: 21798935 BACKGROUND

• Hogan MC, Foreman KJ, Naghavi M, Ahn SY, Wang M, Makela SM, Lopez AD, Lozano R, Murray CJ. Maternal mortality for 181 countries, 1980-2008: a systematic analysis of progress towards Millennium Development Goal 5. Lancet. 2010 May 8;375(9726):1609-23. doi: 10.1016/S0140-6736(10)60518-1. Epub 2010 Apr 9.

  PMID: 20382417 BACKGROUND

• Lozano R, Wang H, Foreman KJ, Rajaratnam JK, Naghavi M, Marcus JR, Dwyer-Lindgren L, Lofgren KT, Phillips D, Atkinson C, Lopez AD, Murray CJ. Progress towards Millennium Development Goals 4 and 5 on maternal and child mortality: an updated systematic analysis. Lancet. 2011 Sep 24;378(9797):1139-65. doi: 10.1016/S0140-6736(11)61337-8. Epub 2011 Sep 19.

  PMID: 21937100 BACKGROUND

• Lindegren ML, Kennedy CE, Bain-Brickley D, Azman H, Creanga AA, Butler LM, Spaulding AB, Horvath T, Kennedy GE. Integration of HIV/AIDS services with maternal, neonatal and child health, nutrition, and family planning services. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD010119. doi: 10.1002/14651858.CD010119.

  PMID: 22972150 BACKGROUND

• 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.

  PMID: 20642843 BACKGROUND

• 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.

  PMID: 20081392 BACKGROUND

• 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.

  PMID: 18079386 BACKGROUND

• 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.

  PMID: 22594758 BACKGROUND

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

  BACKGROUND

• Thomas D, Wanje G, Eastment MC, McClelland RS, Mwaringa E, Patta S, Jaoko W, Kinuthia J, Abubakar A, Sherr K, Barnabas RV. The cost of implementing the Systems Analysis and Improvement Approach for a cluster randomized trial integrating HIV testing into family planning services in Mombasa County, Kenya. BMC Health Serv Res. 2022 Dec 5;22(1):1480. doi: 10.1186/s12913-022-08828-z.

  PMID: 36471311 DERIVED

• 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.

  PMID: 36195890 DERIVED

• 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.

  PMID: 36076250 DERIVED

Limitations and Caveats

First, increases in HTC could not be independently verified through direct observation of HIV counseling sessions or through increases in consumption of HIV testing commodities. Second, due to collinearity, it was not possible to adjust for baseline differences in HIV testing as planned for this analysis. Lastly, this intervention focused on HIV testing, and did not extend to additional steps in the HIV prevention and care cascades.

Results Point of Contact

• Title: Dr. R. Scott McClelland
• Organization: University of Washington

mcclell@uw.edu

+206-543-4278

Study Officials

• Raymond S McClelland, MD, MPH

  Professor of Medicine, Epidemiology, Global Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Medicine, Epidemiology, and Global Health

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 15, 2016
• Study Start: June 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2022
• Last Updated: November 30, 2023
• Results First Posted: November 9, 2022

Record last verified: 2023-11

Locations

KE (24)