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Lafiyan Jikin Mata "Excellent Health for Mothers" (LJM)

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ClinicalTrials.gov Identifier: NCT02214875
Recruitment Status : Unknown
Verified August 2014 by DR BOLA OYELEDUN, Centre for Integrated Health Programs, Nigeria.
Recruitment status was:  Recruiting
First Posted : August 12, 2014
Last Update Posted : August 12, 2014
Sponsor:
Collaborators:
Federal Ministry of Health, Nigeria
World Health Organization
Foreign Affairs, Trade and Development, Canada
Information provided by (Responsible Party):
DR BOLA OYELEDUN, Centre for Integrated Health Programs, Nigeria

Brief Summary:

This study aims to address the research question: Will continuous quality improvement, using a Break Through Series approach, increase uptake of PMTCT services and retention-in-care of HIV-infected pregnant women and mothers at six and 12 months postpartum?

Continuous Quality Improvement (CQI) is a health systems intervention to assist programs to systematically improve services and health outcomes. The Break Through Series (BTS) is a specific CQI approach is a short-term (6- to 15-month) learning system that brings together teams from several hospitals or clinics ("collaboratives") to seek improvement in a focused topic area through a common process of data sharing and review Primary Objective To assess whether retention-in-care of HIV-infected women at six (6) months postpartum is higher at health facilities implementing CQI-BTS approaches than at health facilities not implementing CQI-BTS approaches.

Secondary Objectives

To assess whether implementation of CQI-BTS initiatives at health facilities increases:

  1. Uptake of PMTCT services by HIV-infected pregnant women;
  2. Retention-in-care of HIV-infected women at twelve (12) months postpartum;
  3. Retention-in-care of HIV-exposed babies at six (6) and twelve (12) months of age;
  4. Uptake of a pre-defined, minimum set of integrated RH/PMTCT services by HIV-infected women in health facilities.

Condition or disease Intervention/treatment Phase
Retention Other: CQI/BTS Other: Control Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 640 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Increasing Retention-in-care of HIV Positive Women in PMTCT Services Through Continuous Quality Improvement -Break Through Series in Primary & Secondary Health Care Facilities in Nigeria: A Cluster Randomized Controlled Trial
Study Start Date : July 2014
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CQI/BTS

Experimental: CQI/BTS

CQI/BTS interventions will be applied through rapid structured cycles of data collection, testing of solutions and review of changes will be done. At each site, Quality Improvement Teams (QIT) will be established among facility staff. Local Government/State QI teams will provide oversight function of facility based QI initiatives. Break Through Collaborative Series (BTS) will hold quarterly in each study state at a central location with participants from intervention sites. Sessions will provide opportunity for teams to learn from each other; adapt and implement changes using the Plan-Do-Study-Act (PDSA) model. Process indicators will be used to measure quality improvement from the intervention sites and collaboratives.

Other: CQI/BTS
Application of CQI/BTS interventions through employing rapid structured cycles of data collection, testing of solutions and review of changes will be implemented. At each site a Quality Improvement Team (QIT) will be established from among the facility staff. Local Government and State level QI teams will provide oversight function of the health facilities' QI initiatives. BTS as a collaborative learning approach will be conducted quarterly in each study state at a central location with participants from the intervention sites. The sessions will provide opportunity for teams to learn from each other and to adapt and implement changes using the Plan-Do-Study-Act (PDSA) model.

Control
Facilities in control will continue will routine unstructured, irregular continuous quality improvement. Break Through Collaborative will not be applied to the control facilities.
Other: Control
Facilities in control will continue will routine unstructured, irregular continuous quality improvement. Break Through Collaborative will not be applied to the control facilities.




Primary Outcome Measures :
  1. Proportion of HIV+ pregnant women in care 6 months postpartum [ Time Frame: Six months post partum ]
    Denominator= Total number of HIV + pregnant women enrolled to participate in the study Numerator= Total number of HIV + pregnant women retained at six months postpartum


Secondary Outcome Measures :
  1. Proportion of HIV exposed infants with Dry Blood Spot (DBS) samples taken at 6-8 months of life [ Time Frame: 2 months post delivery of exposed infant ]

    Denominator: Number of HIV exposed infants delivered at facility

    Numerator: Number of exposed infants whose DBS was taken at 6-8 months of life




Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. They must be pregnant women newly diagnosed for HIV during ANC
  2. Clients must present with gestational age of 34weeks or less at ANC enrollment
  3. They must accept in principle to take ARVs and remain in care.
  4. They must be willing to participate until at least six months postpartum
  5. Must be domiciled in the facility coverage area.
  6. Previously diagnosed HIV positive pregnant women yet to start ART

Exclusion Criteria:

  1. Clients requesting fee/remuneration for participation
  2. Positive women already on ART.
  3. Unbooked HIV positive pregnant woman coming in labour.
  4. Positive pregnant women with gestational age more than 34 weeks.

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): NCT02214875


Contacts
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Contact: Bolanle Oyeledun, MASTERS +2348099675455 Boyeledun@cihpng.org, bolanle3@gmail.com
Contact: Frank Oronsaye, MASTERS +2348099675463 Foronsaye@cihpng.org

Locations
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Nigeria
Center for Integrated Health Program Recruiting
Abuja, Federal Capital Territory, Nigeria, 900288
Contact: Bolanle Oyeledun, MASTERS    +2348099675455    Boyeledun@cihpng.org, bolanle3@gmail.com   
Contact: Frank Oronsaye, MASTERS    +2348099675463    Foronsaye@cihpng.org   
Principal Investigator: Bolanle Oyeledun, MASTERS         
Sponsors and Collaborators
Centre for Integrated Health Programs, Nigeria
Federal Ministry of Health, Nigeria
World Health Organization
Foreign Affairs, Trade and Development, Canada
Investigators
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Principal Investigator: Bolanle Oyeledun, MASTERS Center for Integrated Health Program(CIHP)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: DR BOLA OYELEDUN, Chief Executive Officer, Centre for Integrated Health Programs, Nigeria
ClinicalTrials.gov Identifier: NCT02214875     History of Changes
Other Study ID Numbers: C6-TSA-037
First Posted: August 12, 2014    Key Record Dates
Last Update Posted: August 12, 2014
Last Verified: August 2014
Keywords provided by DR BOLA OYELEDUN, Centre for Integrated Health Programs, Nigeria:
Retention