Management and Optimization of Nutrition, Antenatal, Reproductive, Child Health & HIV Care - Full Text View

Purpose

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.

Condition	Intervention
Pregnancy HIV	Other: Quality Improvement Other: Baseline data collection (active comparator)


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Health Services Research
Official Title:	Optimizing the Delivery of Maternal and Child Health Services to Strengthen the Primary Health Care System in Rural South Africa

Resource links provided by NLM:

MedlinePlus related topics: Children's Health HIV/AIDS

U.S. FDA Resources

Further study details as provided by University of KwaZulu:

Primary Outcome Measures:

Proportion of HIV-infected pregnant women who are on ART and have received an HIV VL test [ Time Frame: 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 [ Time Frame: At study mid-point and study end (approximately 20 months) ]

Secondary Outcome Measures:

Proportion of HIV-infected pregnant women who have HIV virologic suppression [ Time Frame: At study mid-point and study end (approximately 20 months) ]
Uptake of exclusive breastfeeding [ Time Frame: At study mid-point and study end (approximately 20 months) ]
Uptake of contraception [ Time Frame: At study mid-point and study end (approximately 20 months) ]
Proportion of HIV-infected women initiated on ART during pregnancy/breastfeeding (PMTCT) [ Time Frame: At study mid-point and study end (approximately 20 months) ]
Number of participants with knowledge of early infant feeding [ Time Frame: At study mid-point and study end (approximately 20 months) ]
Number of participants with knowledge of available contraception [ Time Frame: At study mid-point and study end (approximately 20 months) ]
Number of participants with knowledge of HIV [ Time Frame: At study mid-point and study end (approximately 20 months) ]
Subjective experience: patient satisfaction with services [ Time Frame: At study mid-point and study end (approximately 20 months) ]
Subjective experience: provider job satisfaction and motivation [ Time Frame: At study mid-point and study end (approximately 20 months) ]
Proportion of infant HIV PCR positivity among HIV-exposed infants (HEI) [ Time Frame: At study mid-point and study end (approximately 20 months) ]
Proportion of HEI receiving nevirapine prophylaxis [ Time Frame: At study mid-point and study end (approximately 20 months) ]
Proportion of participants enrolled at delivery attending 6-week postnatal visit [ Time Frame: At study mid-point and study end (approximately 20 months) ]
As a measure of retention in care at 6 weeks postpartum


Estimated Enrollment:	6000
Study Start Date:	July 2015
Estimated Study Completion Date:	March 2017
Estimated Primary Completion Date:	March 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Receiving/ received QI intervention A clinic which is presently receiving the Intensive Phase of the QI intervention, or is in the Maintenance Phase	Other: Quality Improvement 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.
Active Comparator: Not yet received QI intervention A clinic which has not yet received the QI intervention	Other: Baseline data collection (active comparator) Endpoint data collection only

Arms

Assigned Interventions

Experimental: Receiving/ received QI intervention

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

Other: Quality Improvement

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.

Active Comparator: Not yet received QI intervention

A clinic which has not yet received the QI intervention

Other: Baseline data collection (active comparator)

Endpoint data collection only

Show Detailed Description

Eligibility


Ages Eligible for Study:	18 Years to 50 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02626351

Contacts


Contact: Manisha N Yapa, FRACP, MPH	+27 35 550 7500 ext 7636	myapa@africacentre.ac.za

Locations


South Africa
Africa Centre for Population Health	Recruiting
Mtubatuba, KwaZulu-Natal, South Africa, 3935
Contact: Suzette Grobler, Grant Manager +27 35 550 7500

Sponsors and Collaborators

University of KwaZulu

Investigators


Principal Investigator:	Till Barnighausen, MD, ScD	Africa Centre for Population Health, University of KwaZulu-Natal

More Information

Publications:

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.

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.

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.

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.

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

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.

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

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

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

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

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

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.

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

WHO publications (2015). Consolidated Guidelines on HIV Testing Services. Available at: http://www.who.int/hiv/pub/guidelines/hiv-testing-services/en/

Zaidi J, Grapsa E, Tanser F, Newell ML, Bärnighausen 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.


Responsible Party:	University of KwaZulu
ClinicalTrials.gov Identifier:	NCT02626351 History of Changes
Other Study ID Numbers:	EuropeAid/134286/L/ACT/ZA
Study First Received:	October 23, 2015
Last Updated:	December 9, 2015

Keywords provided by University of KwaZulu:


postnatal

ClinicalTrials.gov processed this record on July 14, 2017

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