<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02214875</url>
  </required_header>
  <id_info>
    <org_study_id>C6-TSA-037</org_study_id>
    <nct_id>NCT02214875</nct_id>
  </id_info>
  <brief_title>Lafiyan Jikin Mata &quot;Excellent Health for Mothers&quot;</brief_title>
  <acronym>LJM</acronym>
  <official_title>Increasing Retention-in-care of HIV Positive Women in PMTCT Services Through Continuous Quality Improvement -Break Through Series in Primary &amp; Secondary Health Care Facilities in Nigeria: A Cluster Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre for Integrated Health Programs, Nigeria</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Federal Ministry of Health, Nigeria</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>World Health Organization</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Foreign Affairs, Trade and Development, Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre for Integrated Health Programs, Nigeria</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to address the research question: Will continuous quality improvement, using&#xD;
      a Break Through Series approach, increase uptake of PMTCT services and retention-in-care of&#xD;
      HIV-infected pregnant women and mothers at six and 12 months postpartum?&#xD;
&#xD;
      Continuous Quality Improvement (CQI) is a health systems intervention to assist programs to&#xD;
      systematically improve services and health outcomes. The Break Through Series (BTS) is a&#xD;
      specific CQI approach is a short-term (6- to 15-month) learning system that brings together&#xD;
      teams from several hospitals or clinics (&quot;collaboratives&quot;) to seek improvement in a focused&#xD;
      topic area through a common process of data sharing and review Primary Objective To assess&#xD;
      whether retention-in-care of HIV-infected women at six (6) months postpartum is higher at&#xD;
      health facilities implementing CQI-BTS approaches than at health facilities not implementing&#xD;
      CQI-BTS approaches.&#xD;
&#xD;
      Secondary Objectives&#xD;
&#xD;
      To assess whether implementation of CQI-BTS initiatives at health facilities increases:&#xD;
&#xD;
        1. Uptake of PMTCT services by HIV-infected pregnant women;&#xD;
&#xD;
        2. Retention-in-care of HIV-infected women at twelve (12) months postpartum;&#xD;
&#xD;
        3. Retention-in-care of HIV-exposed babies at six (6) and twelve (12) months of age;&#xD;
&#xD;
        4. Uptake of a pre-defined, minimum set of integrated RH/PMTCT services by HIV-infected&#xD;
           women in health facilities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Methods/ Study design/ Population/ Interventions Study Design: A cluster randomized&#xD;
      controlled trial in which 32 public primary and secondary health care facilities are&#xD;
      randomized into 16 intervention and 16 control sites. The control sites will receive routine&#xD;
      CIHP support, while the intervention sites will receive structured CQI-BTS interventions.&#xD;
&#xD;
      Study sites Based on pre-set site selection criteria, 32 sites were selected from a total of&#xD;
      241 eligible sites supported by the Centre for Integrated Healthcare Programs (CIHP), to&#xD;
      provide comprehensive HIV care and treatment programs. These sites are at higher levels of&#xD;
      standardized care compared to Government of Nigeria sites where there is minimal&#xD;
      standardization of care. The following criteria were used to select health facilities for the&#xD;
      study;&#xD;
&#xD;
        -  Facility supports ANC/PMTCT services and has capacity to provide ART until 12-18 months&#xD;
           post-partum&#xD;
&#xD;
        -  Onsite delivery of HIV+ women by the facility&#xD;
&#xD;
        -  Provision of postpartum care follow-up for HIV+ women&#xD;
&#xD;
        -  ANC attendance with at least 2 HIV+ women per month for general hospitals and at least 1&#xD;
           per month for primary health care (PHCs)&#xD;
&#xD;
        -  Availability of, at least, two trained community health extension workers&#xD;
&#xD;
        -  Facilities providing PMTCT services for more than six months prior to onset of study&#xD;
&#xD;
      Study Participants:&#xD;
&#xD;
      Participants are HIV-infected pregnant women presenting at study sites for 1st booking at&#xD;
      antenatal clinics with gestational age of 34 weeks or less, ART naive, accept ARV and agree&#xD;
      to remain in care for at least six months post-partum.&#xD;
&#xD;
      Control and Intervention arms:&#xD;
&#xD;
      Individual pregnant women and mothers attending facilities in the control and intervention&#xD;
      arms receive the same routine care that includes a &quot;test and treat&quot; protocol i.e. same day&#xD;
      HIV testing and initiation of triple ARVs (option B) of HIV+ pregnant women. Clients eligible&#xD;
      for lifelong ART based on CD4 count, and/or WHO staging, continue ARVs indefinitely for their&#xD;
      own health, while those not eligible continue ARV prophylaxis according to the National&#xD;
      guidelines. For the purpose of this study, antenatal clients are seen for their ARV drug&#xD;
      refills until delivery according to the National ANC schedule of appointments. Postpartum,&#xD;
      visits follow the immunization schedule i.e. 6 weeks, 10 weeks, and 14 weeks and thereafter 2&#xD;
      monthly until 12 months. Facilities in the control arm continue to receive routine health&#xD;
      system support from CIHP&#xD;
&#xD;
      Intervention package:&#xD;
&#xD;
      CQI interventions employ rapid cycles of data collection, testing of solutions and review of&#xD;
      changes will be implemented. At each site a Quality Improvement Team (QIT) will be&#xD;
      established from among the local staff. Local Government and State level QI teams will also&#xD;
      be set up to provide oversight function of the health facilities' QI initiatives. The BTS is&#xD;
      a collaborative learning approach conducted quarterly in each study state at a central&#xD;
      location with participants from the intervention sites. The sessions provide opportunity for&#xD;
      teams to learn from each other and to adapt and implement changes using the Plan-Do-Study-Act&#xD;
      (PDSA) model. Driver diagrams will be developed to understand the primary and secondary&#xD;
      drivers for low retention of HIV positive mothers and formulate action plans and indicator&#xD;
      sets to address these. Between the collaborative sessions, specific designated improvement&#xD;
      coaches will follow up site teams at regular intervals via physical site visits and telephone&#xD;
      calls to guide implementation of change ideas. Different site teams will also be encouraged&#xD;
      to communicate with each other through telephone calls and cross-site visits to strengthen&#xD;
      learning and exchange of ideas.&#xD;
&#xD;
      Sample size estimation:&#xD;
&#xD;
      Sample size was calculated using the windows programme for epidemiologists. The CQI-BTS&#xD;
      approach tested within the study would be deemed worthwhile if there is a 20% absolute&#xD;
      increase in retention of mothers at 6 months (e.g. expected retention rate in the control&#xD;
      arm: 40%; expected retention rate in the control arm: 60%). First, the minimum sample size&#xD;
      needed under individual randomization was calculated to detect the desirable difference of&#xD;
      proportions with a level of significance set at 95% (two-sided) and at 80% power. We found&#xD;
      that 94 mother-infant pairs would be needed in each arm under individual randomization.&#xD;
      Second, bearing in mind that this trial will randomize the intervention package under several&#xD;
      clusters, the sample size from a non-cluster randomized trial was inflated by an Inflation&#xD;
      Factor (IF). The IF is calculated as follows: IF = 1 + (m - 1) ro, where m is the size of&#xD;
      each cluster, and ro the internal variability which represents how strongly individuals&#xD;
      within clusters are related to each other. In our case, it is difficult to estimate a priori&#xD;
      this internal variability due to lack of primary data: it is possible that the standardized&#xD;
      structure of the intervention tested within the trial will lead to a relatively low cluster&#xD;
      internal variability; alternatively, because the intervention package depends on the&#xD;
      individual capacity/will of health-care personnel, this may increase the internal variability&#xD;
      across clusters. Hence, we believe it is reasonable to assume a ro value of 0.10, as&#xD;
      recommended by most authors. We set the size of cluster at 20, which gave an inflation factor&#xD;
      of 2.9. Additionally, since this research is being carried out in an operational context, we&#xD;
      allowed for up to 20% of routine data to be incomplete or maternal mortality in pregnancy and&#xD;
      therefore data on retention in care not available for analysis. As a conclusion, a total of&#xD;
      327 mother-infant pairs are needed in each arm. There will be 16 clusters in each arm with a&#xD;
      minimum number of 20 HIV-infected pregnant women per site. A total of 640 pregnant&#xD;
      HIV-infected women will be recruited.&#xD;
&#xD;
      Data management plan:&#xD;
&#xD;
      Primary outcome data is sourced from the local health registers -Data collection and entry&#xD;
      occur weekly in both study arms by research assistants. A monthly review of these data is&#xD;
      conducted by the LJM study team. In addition, process measures are routinely collected to&#xD;
      assess the integrity of implementation of the CQI-BTS intervention.&#xD;
&#xD;
      Primary Outcome: Proportion of HIV+ pregnant women in care 6 months postpartum Source&#xD;
      Document: PMTCT ARV register&#xD;
&#xD;
      Secondary Outcome 1: Proportion of HIV+ pregnant women initiating ARV prophylaxis or&#xD;
      treatment within 2 weeks of enrolment Source Document: PMTCT HCT register, PMTCT ARV register&#xD;
      and Mother Child Care Form&#xD;
&#xD;
      Secondary Outcome 2: Proportion of HIV+ pregnant women care 12 months postpartum Source&#xD;
      Document: PMTCT ARV register, Mother and Child Care Form&#xD;
&#xD;
      Secondary Outcome 3: Proportion of HIV exposed infants with Dry Blood Spot (DBS) samples&#xD;
      taken at 8 weeks of life Source Document: Child follow up register and Mother Child Care Form&#xD;
&#xD;
      Analysis plan:&#xD;
&#xD;
      Descriptive analyses will be conducted to outline participants' and clusters' baseline&#xD;
      characteristics and outcomes by study arms using frequency tabulations and summary&#xD;
      statistics. Bi-variate analysis will be done to identify potential prognostic factors&#xD;
      confounding the distribution of baseline characteristics among the arms that require&#xD;
      adjustment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 14, 2014</start_date>
  <completion_date type="Actual">June 30, 2017</completion_date>
  <primary_completion_date type="Actual">October 31, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of HIV+ pregnant women in care 6 months postpartum</measure>
    <time_frame>Six months post partum</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of HIV exposed infants with Dry Blood Spot (DBS) samples taken at 6-8 months of life</measure>
    <time_frame>2 months post delivery of exposed infant</time_frame>
    <description>Denominator: Number of HIV exposed infants delivered at facility&#xD;
Numerator: Number of exposed infants whose DBS was taken at 6-8 months of life</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">491</enrollment>
  <condition>Retention</condition>
  <arm_group>
    <arm_group_label>CQI/BTS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental: CQI/BTS&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Facilities in control will continue will routine unstructured, irregular continuous quality improvement. Break Through Collaborative will not be applied to the control facilities.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CQI/BTS</intervention_name>
    <description>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.</description>
    <arm_group_label>CQI/BTS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Facilities in control will continue will routine unstructured, irregular continuous quality improvement. Break Through Collaborative will not be applied to the control facilities.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. They must be pregnant women newly diagnosed for HIV during ANC&#xD;
&#xD;
          2. Clients must present with gestational age of 34weeks or less at ANC enrollment&#xD;
&#xD;
          3. They must accept in principle to take ARVs and remain in care.&#xD;
&#xD;
          4. They must be willing to participate until at least six months postpartum&#xD;
&#xD;
          5. Must be domiciled in the facility coverage area.&#xD;
&#xD;
          6. Previously diagnosed HIV positive pregnant women yet to start ART&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Clients requesting fee/remuneration for participation&#xD;
&#xD;
          2. Positive women already on ART.&#xD;
&#xD;
          3. Unbooked HIV positive pregnant woman coming in labour.&#xD;
&#xD;
          4. Positive pregnant women with gestational age more than 34 weeks.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bolanle Oyeledun, MASTERS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Center for Integrated Health Program(CIHP)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for Integrated Health Program</name>
      <address>
        <city>Abuja</city>
        <state>Federal Capital Territory</state>
        <zip>900288</zip>
        <country>Nigeria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Nigeria</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>February 9, 2021</last_update_submitted>
  <last_update_submitted_qc>February 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre for Integrated Health Programs, Nigeria</investigator_affiliation>
    <investigator_full_name>DR BOLA OYELEDUN</investigator_full_name>
    <investigator_title>Chief Executive Officer</investigator_title>
  </responsible_party>
  <keyword>Retention</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02214875
org study id: C6-TSA-037
nct id: NCT02214875
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
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.
Methods/ Study design/ Population/ Interventions Study Design: A cluster randomized
      controlled trial in which 32 public primary and secondary health care facilities are
      randomized into 16 intervention and 16 control sites. The control sites will receive routine
      CIHP support, while the intervention sites will receive structured CQI-BTS interventions.

      Study sites Based on pre-set site selection criteria, 32 sites were selected from a total of
      241 eligible sites supported by the Centre for Integrated Healthcare Programs (CIHP), to
      provide comprehensive HIV care and treatment programs. These sites are at higher levels of
      standardized care compared to Government of Nigeria sites where there is minimal
      standardization of care. The following criteria were used to select health facilities for the
      study;

        -  Facility supports ANC/PMTCT services and has capacity to provide ART until 12-18 months
           post-partum

        -  Onsite delivery of HIV+ women by the facility

        -  Provision of postpartum care follow-up for HIV+ women

        -  ANC attendance with at least 2 HIV+ women per month for general hospitals and at least 1
           per month for primary health care (PHCs)

        -  Availability of, at least, two trained community health extension workers

        -  Facilities providing PMTCT services for more than six months prior to onset of study

      Study Participants:

      Participants are HIV-infected pregnant women presenting at study sites for 1st booking at
      antenatal clinics with gestational age of 34 weeks or less, ART naive, accept ARV and agree
      to remain in care for at least six months post-partum.

      Control and Intervention arms:

      Individual pregnant women and mothers attending facilities in the control and intervention
      arms receive the same routine care that includes a "test and treat" protocol i.e. same day
      HIV testing and initiation of triple ARVs (option B) of HIV+ pregnant women. Clients eligible
      for lifelong ART based on CD4 count, and/or WHO staging, continue ARVs indefinitely for their
      own health, while those not eligible continue ARV prophylaxis according to the National
      guidelines. For the purpose of this study, antenatal clients are seen for their ARV drug
      refills until delivery according to the National ANC schedule of appointments. Postpartum,
      visits follow the immunization schedule i.e. 6 weeks, 10 weeks, and 14 weeks and thereafter 2
      monthly until 12 months. Facilities in the control arm continue to receive routine health
      system support from CIHP

      Intervention package:

      CQI interventions employ rapid 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 local staff. Local Government and State level QI teams will also
      be set up to provide oversight function of the health facilities' QI initiatives. The BTS is
      a collaborative learning approach conducted quarterly in each study state at a central
      location with participants from the intervention sites. The sessions provide opportunity for
      teams to learn from each other and to adapt and implement changes using the Plan-Do-Study-Act
      (PDSA) model. Driver diagrams will be developed to understand the primary and secondary
      drivers for low retention of HIV positive mothers and formulate action plans and indicator
      sets to address these. Between the collaborative sessions, specific designated improvement
      coaches will follow up site teams at regular intervals via physical site visits and telephone
      calls to guide implementation of change ideas. Different site teams will also be encouraged
      to communicate with each other through telephone calls and cross-site visits to strengthen
      learning and exchange of ideas.

      Sample size estimation:

      Sample size was calculated using the windows programme for epidemiologists. The CQI-BTS
      approach tested within the study would be deemed worthwhile if there is a 20% absolute
      increase in retention of mothers at 6 months (e.g. expected retention rate in the control
      arm: 40%; expected retention rate in the control arm: 60%). First, the minimum sample size
      needed under individual randomization was calculated to detect the desirable difference of
      proportions with a level of significance set at 95% (two-sided) and at 80% power. We found
      that 94 mother-infant pairs would be needed in each arm under individual randomization.
      Second, bearing in mind that this trial will randomize the intervention package under several
      clusters, the sample size from a non-cluster randomized trial was inflated by an Inflation
      Factor (IF). The IF is calculated as follows: IF = 1 + (m - 1) ro, where m is the size of
      each cluster, and ro the internal variability which represents how strongly individuals
      within clusters are related to each other. In our case, it is difficult to estimate a priori
      this internal variability due to lack of primary data: it is possible that the standardized
      structure of the intervention tested within the trial will lead to a relatively low cluster
      internal variability; alternatively, because the intervention package depends on the
      individual capacity/will of health-care personnel, this may increase the internal variability
      across clusters. Hence, we believe it is reasonable to assume a ro value of 0.10, as
      recommended by most authors. We set the size of cluster at 20, which gave an inflation factor
      of 2.9. Additionally, since this research is being carried out in an operational context, we
      allowed for up to 20% of routine data to be incomplete or maternal mortality in pregnancy and
      therefore data on retention in care not available for analysis. As a conclusion, a total of
      327 mother-infant pairs are needed in each arm. There will be 16 clusters in each arm with a
      minimum number of 20 HIV-infected pregnant women per site. A total of 640 pregnant
      HIV-infected women will be recruited.

      Data management plan:

      Primary outcome data is sourced from the local health registers -Data collection and entry
      occur weekly in both study arms by research assistants. A monthly review of these data is
      conducted by the LJM study team. In addition, process measures are routinely collected to
      assess the integrity of implementation of the CQI-BTS intervention.

      Primary Outcome: Proportion of HIV+ pregnant women in care 6 months postpartum Source
      Document: PMTCT ARV register

      Secondary Outcome 1: Proportion of HIV+ pregnant women initiating ARV prophylaxis or
      treatment within 2 weeks of enrolment Source Document: PMTCT HCT register, PMTCT ARV register
      and Mother Child Care Form

      Secondary Outcome 2: Proportion of HIV+ pregnant women care 12 months postpartum Source
      Document: PMTCT ARV register, Mother and Child Care Form

      Secondary Outcome 3: Proportion of HIV exposed infants with Dry Blood Spot (DBS) samples
      taken at 8 weeks of life Source Document: Child follow up register and Mother Child Care Form

      Analysis plan:

      Descriptive analyses will be conducted to outline participants' and clusters' baseline
      characteristics and outcomes by study arms using frequency tabulations and summary
      statistics. Bi-variate analysis will be done to identify potential prognostic factors
      confounding the distribution of baseline characteristics among the arms that require
      adjustment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Proportion of HIV+ pregnant women in care 6 months postpartum
time frame: Six months post partum
description: 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
measure: 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
description: Denominator: Number of HIV exposed infants delivered at facility
Numerator: Number of exposed infants whose DBS was taken at 6-8 months of life
arm group label: CQI/BTS
arm group type: Experimental
description: 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.
arm group label: Control
arm group type: Other
description: Facilities in control will continue will routine unstructured, irregular continuous quality improvement. Break Through Collaborative will not be applied to the control facilities.
intervention type: Other
intervention name: CQI/BTS
description: 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.
arm group label: CQI/BTS
intervention type: Other
intervention name: Control
description: Facilities in control will continue will routine unstructured, irregular continuous quality improvement. Break Through Collaborative will not be applied to the control facilities.
arm group label: Control
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Bolanle Oyeledun, MASTERS
role: Principal Investigator
affiliation: Center for Integrated Health Program(CIHP)
facility: 
country: Nigeria
responsible party type: Principal Investigator
investigator affiliation: Centre for Integrated Health Programs, Nigeria
investigator full name: DR BOLA OYELEDUN
investigator title: Chief Executive Officer
sharing ipd: Undecided