Management and Optimization of Nutrition, Antenatal, Reproductive, Child Health & HIV Care

NCT02626351 | Completed DMC

• 1 other identifier: EuropeAid/134286/L/ACT/ZA
• Study Type: interventional
• Target: 3,172
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the impact of a quality improvement (QI) intervention on maternal and child healthcare services in seven primary healthcare (PHC) clinics, in a rural setting of KwaZulu-Natal, South Africa.

Conditions

Pregnancy; HIV

Keywords

postnatal

Outcome Measures

Primary Outcomes (2)

• Proportion of HIV-infected pregnant women who are on ART and have received an HIV VL test

  At study mid-point and study end (approximately 20 months)

• Proportion of women who are HIV-uninfected at first ANC HIV test with a repeat antenatal HIV test

  At study mid-point and study end (approximately 20 months)

Secondary Outcomes (12)

• Proportion of HIV-infected pregnant women who have HIV virologic suppression

  At study mid-point and study end (approximately 20 months)

• Uptake of exclusive breastfeeding

  At study mid-point and study end (approximately 20 months)

• Uptake of contraception

  At study mid-point and study end (approximately 20 months)

• Proportion of HIV-infected women initiated on ART during pregnancy/breastfeeding (PMTCT)

  At study mid-point and study end (approximately 20 months)

• Number of participants with knowledge of early infant feeding

  At study mid-point and study end (approximately 20 months)

Study Arms (2)

Receiving/ received QI intervention

EXPERIMENTAL

A clinic which is presently receiving the Intensive Phase of the QI intervention, or is in the Maintenance Phase

Other: Quality Improvement

Not yet received QI intervention

ACTIVE COMPARATOR

A clinic which has not yet received the QI intervention

Other: Baseline data collection (active comparator)

Interventions

Quality Improvement OTHER

In a stepped wedge fashion all 7 PHC clinics will receive QI one by one (exception: the two smallest clinics will be rolled into one step). Each step is of 2 months' duration. The study will commence with baseline data collection across all clinics, before the first randomised clinic receives the QI intervention. The QI intervention involves the following activities at each clinic: \[1\] Situational Analysis: assessment of clinic needs and gaps in processes that influence the specified study endpoints; \[2\] Intensive Intervention Phase (2 months): the clinic QI team (healthcare facility staff) with support of CRH QI mentors maps clinic processes and establishes priorities for process improvements through identification of bottlenecks, root-causes and commence plan-do-study-act (PDSA) cycles; \[3\] Maintenance Phase (duration varies for each clinic based on stepped wedge study design): clinic processes are further improved through iterative PDSA cycles; \[4\] Follow up.

Receiving/ received QI intervention

Baseline data collection (active comparator) OTHER

Endpoint data collection only

Not yet received QI intervention

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Currently postpartum: immediately post delivery OR 3-6 days postpartum OR 6 weeks postpartum; AND
• Lives in Africa Centre Demographic Surveillance Area (DSA); AND/OR
• Attended antenatal care (ANC) or postnatal care (PNC) in study intervention clinics

You may not qualify if:

• Below 18 years of age;
• Not postpartum;
• Does not live within Africa Centre DSA; AND
• Did not attend ANC or PNC at study intervention clinics

Sponsors & Collaborators

• University of KwaZulu: lead

Study Sites (1)

Africa Centre for Population Health

Mtubatuba, KwaZulu-Natal, 3935, South Africa

Location

Related Publications (18)

• Bardfield J, Agins B, Palumbo M, Wei AL, Morris J, Marston B; Cotrimoxazole Qi Group. Improving rates of cotrimoxazole prophylaxis in resource-limited settings: implementation of a quality improvement approach. Int J Qual Health Care. 2014 Dec;26(6):613-22. doi: 10.1093/intqhc/mzu085. Epub 2014 Oct 21.

  PMID: 25335758 BACKGROUND

• Barron P, Pillay Y, Doherty T, Sherman G, Jackson D, Bhardwaj S, Robinson P, Goga A. Eliminating mother-to-child HIV transmission in South Africa. Bull World Health Organ. 2013 Jan 1;91(1):70-4. doi: 10.2471/BLT.12.106807. Epub 2012 Nov 19.

  PMID: 23397353 BACKGROUND

• Doherty T, Chopra M, Nsibande D, Mngoma D. Improving the coverage of the PMTCT programme through a participatory quality improvement intervention in South Africa. BMC Public Health. 2009 Nov 5;9:406. doi: 10.1186/1471-2458-9-406.

  PMID: 19891775 BACKGROUND

• Kim YM, Banda J, Kanjipite W, Sarkar S, Bazant E, Hiner C, Tholandi M, Reinhardt S, Njobvu PD, Kols A, Benavides B. Improving performance of Zambia Defence Force antiretroviral therapy providers: evaluation of a standards-based approach. Glob Health Sci Pract. 2013 Aug 14;1(2):213-27. doi: 10.9745/GHSP-D-13-00053. eCollection 2013 Aug.

  PMID: 25276534 BACKGROUND

• Maman D, Huerga H, Mukui I et al (2015). Most Breastfeeding Women with High Viral Load Are Still Undiagnosed in Sub-Saharan Africa. Conference on Retroviruses and Opportunistic Infections. Abstract number 32. Available at: http://www.croiconference.org/sessions/most-breastfeeding-women-high-viral-load-are-still-undiagnosed-sub-saharan-africa

  BACKGROUND

• Mwaniki MK, Vaid S, Chome IM, Amolo D, Tawfik Y; Kwale Improvement Coaches. Improving service uptake and quality of care of integrated maternal health services: the Kenya Kwale District improvement collaborative. BMC Health Serv Res. 2014 Sep 21;14:416. doi: 10.1186/1472-6963-14-416.

  PMID: 25240834 BACKGROUND

• Massyn N, Day C, Peer N et al eds (2013/14). District Health Barometer Durban: Health Systems Trust; October 2014.

  BACKGROUND

• Mutiso P, Simba M, Towett R et al (2014). Effective monitoring of HIV prevention: re-testing HIV-negative clients. 20th International AIDS Conference, Melbourne Australia. Abstract number WEPE178. Available at: http://pag.aids2014.org/abstracts.aspx?aid=7817

  BACKGROUND

• Statistics South Africa (2014). Mid-Year Population Estimates. Available at: http://www.statssa.gov.za/publications/P0302/P03022014.pdf

  BACKGROUND

• UNFPA South Africa (2014). Sexual and Reproductive Health. Available at: http://countryoffice.unfpa.org/southafrica/2011/11/24/4255/reproductive_health_and_hiv/

  BACKGROUND

• UNICEF (2012). UNICEF and WHO welcome South Africa's efforts to protect and support breastfeeding. Available at: http://www.unicef.org/southafrica/media_10469.html

  BACKGROUND

• Webster PD, Sibanyoni M, Malekutu D, Mate KS, Venter WD, Barker PM, Moleko W. Using quality improvement to accelerate highly active antiretroviral treatment coverage in South Africa. BMJ Qual Saf. 2012 Apr;21(4):315-24. doi: 10.1136/bmjqs-2011-000381.

  PMID: 22438327 BACKGROUND

• WHO publications (2014). Global Update on the Health Sector Response to HIV. Available at http://www.who.int/hiv/pub/progressreports/update2014/en/

  BACKGROUND

• Consolidated Guidelines on HIV Testing Services: 5Cs: Consent, Confidentiality, Counselling, Correct Results and Connection 2015. Geneva: World Health Organization; 2015 Jul. Available from http://www.ncbi.nlm.nih.gov/books/NBK316021/

  PMID: 26378328 BACKGROUND

• Zaidi J, Grapsa E, Tanser F, Newell ML, Barnighausen T. Dramatic increase in HIV prevalence after scale-up of antiretroviral treatment. AIDS. 2013 Sep 10;27(14):2301-5. doi: 10.1097/QAD.0b013e328362e832.

  PMID: 23669155 BACKGROUND

• Yapa HM, De Neve JW, Chetty T, Herbst C, Post FA, Jiamsakul A, Geldsetzer P, Harling G, Dhlomo-Mphatswe W, Moshabela M, Matthews P, Ogbuoji O, Tanser F, Gareta D, Herbst K, Pillay D, Wyke S, Barnighausen T. The impact of continuous quality improvement on coverage of antenatal HIV care tests in rural South Africa: Results of a stepped-wedge cluster-randomised controlled implementation trial. PLoS Med. 2020 Oct 7;17(10):e1003150. doi: 10.1371/journal.pmed.1003150. eCollection 2020 Oct.

  PMID: 33027246 DERIVED

• Yapa HM, Drayne R, Klein N, De Neve JW, Petoumenos K, Jiamsakul A, Herbst C, Pillay D, Post FA, Barnighausen T. Infant feeding knowledge and practice vary by maternal HIV status: a nested cohort study in rural South Africa. Int Breastfeed J. 2020 Sep 1;15(1):77. doi: 10.1186/s13006-020-00317-5.

  PMID: 32873311 DERIVED

• Chetty T, Yapa HMN, Herbst C, Geldsetzer P, Naidu KK, De Neve JW, Herbst K, Matthews P, Pillay D, Wyke S, Barnighausen T; MONARCH study team. The MONARCH intervention to enhance the quality of antenatal and postnatal primary health services in rural South Africa: protocol for a stepped-wedge cluster-randomised controlled trial. BMC Health Serv Res. 2018 Aug 8;18(1):625. doi: 10.1186/s12913-018-3404-3.

  PMID: 30089485 DERIVED

MeSH Terms

Interventions

Quality Improvement

Intervention Hierarchy (Ancestors)

Engineering; Technology, Industry, and Agriculture; Quality of Health Care; Health Services Administration

Study Officials

• Till Barnighausen, MD, ScD

  Africa Centre for Population Health, University of KwaZulu-Natal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Masking was only until randomisation status identified at the start of each intervention step.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stepped wedge trial: therefore all clusters receive intervention, in randomised sequence.

Study Record Dates

• First Submitted: October 23, 2015
• First Posted: December 10, 2015
• Study Start: July 15, 2015
• Primary Completion: January 26, 2017
• Study Completion: January 30, 2017
• Last Updated: August 17, 2017

Record last verified: 2015-12

Locations

ZA (1)