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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02626351
Recruitment Status : Completed
First Posted : December 10, 2015
Last Update Posted : August 17, 2017
Sponsor:
Information provided by (Responsible Party):
University of KwaZulu

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.

Condition or disease Intervention/treatment Phase
Pregnancy HIV Other: Quality Improvement Other: Baseline data collection (active comparator) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3172 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Stepped wedge trial: therefore all clusters receive intervention, in randomised sequence.
Masking: Single (Care Provider)
Masking Description: Masking was only until randomisation status identified at the start of each intervention step.
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
Actual Study Start Date : July 15, 2015
Actual Primary Completion Date : January 26, 2017
Actual Study Completion Date : January 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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) ]
  2. 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 :
  1. Proportion of HIV-infected pregnant women who have HIV virologic suppression [ Time Frame: At study mid-point and study end (approximately 20 months) ]
  2. Uptake of exclusive breastfeeding [ Time Frame: At study mid-point and study end (approximately 20 months) ]
  3. Uptake of contraception [ Time Frame: At study mid-point and study end (approximately 20 months) ]
  4. Proportion of HIV-infected women initiated on ART during pregnancy/breastfeeding (PMTCT) [ Time Frame: At study mid-point and study end (approximately 20 months) ]
  5. Number of participants with knowledge of early infant feeding [ Time Frame: At study mid-point and study end (approximately 20 months) ]
  6. Number of participants with knowledge of available contraception [ Time Frame: At study mid-point and study end (approximately 20 months) ]
  7. Number of participants with knowledge of HIV [ Time Frame: At study mid-point and study end (approximately 20 months) ]
  8. Subjective experience: patient satisfaction with services [ Time Frame: At study mid-point and study end (approximately 20 months) ]
  9. Subjective experience: provider job satisfaction and motivation [ Time Frame: At study mid-point and study end (approximately 20 months) ]
  10. Proportion of infant HIV PCR positivity among HIV-exposed infants (HEI) [ Time Frame: At study mid-point and study end (approximately 20 months) ]
  11. Proportion of HEI receiving nevirapine prophylaxis [ Time Frame: At study mid-point and study end (approximately 20 months) ]
  12. 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



Information from the National Library of Medicine

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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

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): NCT02626351


Locations
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South Africa
Africa Centre for Population Health
Mtubatuba, KwaZulu-Natal, South Africa, 3935
Sponsors and Collaborators
University of KwaZulu
Investigators
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Principal Investigator: Till Barnighausen, MD, ScD Africa Centre for Population Health, University of KwaZulu-Natal
Publications:
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
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
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/

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of KwaZulu
ClinicalTrials.gov Identifier: NCT02626351    
Other Study ID Numbers: EuropeAid/134286/L/ACT/ZA
First Posted: December 10, 2015    Key Record Dates
Last Update Posted: August 17, 2017
Last Verified: December 2015
Keywords provided by University of KwaZulu:
postnatal