<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/NCT02999334</url>
  </required_header>
  <id_info>
    <org_study_id>NR14413-01</org_study_id>
    <nct_id>NCT02999334</nct_id>
  </id_info>
  <brief_title>HIV With Innovative Group Antenatal Care in Two African Countries</brief_title>
  <official_title>HIV With Innovative Group Antenatal Care in Two African Countries</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Illinois at Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Illinois at Chicago</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The quality of antenatal care (ANC) in much of sub-Saharan Africa is constrained by severe&#xD;
      resource and staffing shortages. The investigators adapted and piloted an evidence-based&#xD;
      model of group antenatal care as an innovative way to improve ANC service delivery and&#xD;
      increase health promotion. This pilot will be conducted in Malawi and Tanzania and will&#xD;
      provide data to prepare for a large randomized controlled trial to document the impacts that&#xD;
      group antenatal has on perinatal health outcomes. This study will ultimately inform policy&#xD;
      and practice aimed at improving quality of antenatal care through respectful and&#xD;
      woman-centered care to pregnant women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      More than 90% of women in sub-Saharan Africa use antenatal care (ANC) at least once in&#xD;
      pregnancy. To leverage high attendance rates, most facilities bundle HIV prevention and&#xD;
      prevention of maternal-to-child transmission (PMTCT) with ANC. Unfortunately, the quality of&#xD;
      ANC in sub-Saharan Africa is sharply constrained by severe resource and staffing shortages,&#xD;
      as reflected in numerous &quot;missed opportunities&quot; for PMTCT, clinical service delivery, and&#xD;
      health education. Moreover, job satisfaction among the overburdened providers is low. To&#xD;
      improve ANC quality, the investigators will adapt and pilot an innovative, evidence-based&#xD;
      model of group ANC, an approach that restructures provider time, allowing health facilities&#xD;
      to offer respectful, woman-centered and high quality ANC given the limitations.&#xD;
&#xD;
      In CenteringPregnancy (CP), the only evidence-based model of group ANC, 12 women meet jointly&#xD;
      for two hour antenatal visits, assessing their own weights and blood pressures, meeting&#xD;
      briefly with the provider for individual consultations, and engaging in facilitated health&#xD;
      discussions. Randomized controlled trial (RCT) data from ethnically and socioeconomically&#xD;
      diverse populations in the US demonstrated that CP is highly effective at improving ANC&#xD;
      adherence, provider and client satisfaction, and maternal and child outcomes. In the US, the&#xD;
      successful integration of HIV prevention into the CP model reduced sexually transmitted&#xD;
      infections and increased condom use.&#xD;
&#xD;
      CP has not been implemented with fidelity and tested for efficacy in a low-resource country.&#xD;
      With funding from the Chicago Developmental Center for AIDS Research, the investigators&#xD;
      conducted preliminary work in Malawi and Tanzania which suggested that a CP-based model of&#xD;
      group ANC was feasible and acceptable; both women and providers were excited and energized by&#xD;
      the model. The purpose of this study is to build on this work and: 1) conduct the&#xD;
      developmental work to collaboratively adapt CP materials for use in both countries (sessions,&#xD;
      training guides, and implementation and evaluation strategies); 2) train providers and&#xD;
      pretest activities; and 3) conduct a full-scale randomized pilot. Investigators will work&#xD;
      directly with the Centering Healthcare Institute to implement this CP-based model of group&#xD;
      ANC with fidelity. This study will result in a feasible, acceptable, and sustainable CP-based&#xD;
      model of group ANC adapted for the constraints posed by poorly resourced health systems and&#xD;
      those of the clients they serve. These pilot data will be used to generate retention rates&#xD;
      and effect sizes for an RCT to test the efficacy of a CP-based group ANC model.&#xD;
&#xD;
      Group antenatal care is an innovative paradigm shift in ANC, and this rigorous evaluation of&#xD;
      its impact will expand the limited scientific assessments of reconfigured ANC models and&#xD;
      mother and infant health outcomes in low-resource countries in sub-Saharan Africa. Because&#xD;
      this model was developed and tested in target countries with high HIV prevalence and poor&#xD;
      maternal and neonatal outcomes, it has the potential for broad impacts on maternal and child&#xD;
      health, including PMTCT, in other low resource settings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2013</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">May 2015</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>Adherence to Care</measure>
    <time_frame>6-8 weeks postpartum</time_frame>
    <description>Two Indicators: Attended 4 (or more) antenatal care visits (yes, no) and the 6-week postnatal visit (yes, no)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Healthy Pregnancy Knowledge Index</measure>
    <time_frame>Enrollment, 32-40 weeks gestation</time_frame>
    <description>14-item true/false questions measured two times in pregnancy and scored as percent correct (range 0-100%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthy Pregnancy Behaviors</measure>
    <time_frame>Enrollment, 32-40 weeks gestation</time_frame>
    <description>Substance use behaviors in the last two months for: tobacco products, alcohol, and marijuana. Two nutritional behaviors were asked about. One was whether or not she ate fruits or vegetables at least 3 times a day for 5 or more days in the past week. The second focused on eating protein at least once a day for 5 or more days in the past week. Measured two times in pregnancy. Three or less of these five behaviors scored as 0 and four or more healthy behaviors were categorized as a 1 (Dichotomous)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevention of Mother-to-Child (PMTCT) Knowledge</measure>
    <time_frame>Enrollment, 32-40 weeks gestation</time_frame>
    <description>4-item PMTCT knowledge index measured two times in pregnancy and scored as 1 if all four were correct and 0 if one or more item was incorrect (Dichotomous)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comprehensive HIV Prevention Knowledge</measure>
    <time_frame>Enrollment, 32-40 weeks gestation</time_frame>
    <description>5-item comprehensive HIV knowledge index measured twice in pregnancy. Scored as 1 if all five items were correctly and 0 if one or more item was incorrect (Dichotomous)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mental Distress</measure>
    <time_frame>Enrollment, 32-40 weeks gestation</time_frame>
    <description>20-item yes/no Self Reporting Questionnaire (SRQ-20) to assess mental distress was measured two times in pregnancy. Validated in multiple countries including Malawi and Tanzania (Range 0-20, baseline α = 0.789; late pregnancy α = 0.848). We dichotomized scores to low (&lt;8 symptoms) and high (≥8), a level used in clinics for referral. (Dichotomous)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pregnancy-Related Empowerment Scale (PRES)</measure>
    <time_frame>32-40 weeks gestation</time_frame>
    <description>The pregnancy-related empowerment scale (PRES) is a 16-item Likert-type scale with items ranging from 1 (strongly disagree) to 4 (strongly agree) that is intended to assess a woman's sense of control over their pregnancy health and health care. Measured once in late pregnancy (Range 16-64, Continuous)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with Care</measure>
    <time_frame>32-40 weeks gestation</time_frame>
    <description>10-item satisfaction with antenatal care index; Measured once in late pregnancy with 5 response options between 1 (poor) and to 5 (excellent) (Range 13-50, Continuous)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Any Adverse Perinatal Event</measure>
    <time_frame>6-8 weeks postpartum</time_frame>
    <description>Fetal demise, stillbirth, neonatal death, preterm birth, low birth weight, or maternal death. None experienced = 0; one or more = 1 (Dichotomous)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">218</enrollment>
  <condition>Prenatal Care</condition>
  <arm_group>
    <arm_group_label>Individual ANC (standard care)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Individual ANC is the standard of care. Women arrive at the clinic and and are provided ANC services on a first come, first serve basis. While waiting women who are present listen to a health lecture. Women then complete laboratory tests, including HIV testing (at the first visit), then meet individually with a midwife for a brief one-on-one physical assessment. Four ANC visits are recommended.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group ANC (intervention)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women in CP-based group antenatal care (intervention) arrive at clinic at the scheduled appointment time and go directly to the group space. The same group of 12 women and the midwife and co-facilitator are present at each session. Women measure and record their own vital signs and weight. Each then has a brief one-on-one assessment with the midwife in the group space room. Instead of health lectures, the group engages in facilitated and interactive discussions using activities. Four ANC visits are recommended.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Group Antenatal Care</intervention_name>
    <description>To examine the effect of type of care on completion of the recommended antenatal and postnatal visits as well as perinatal health outcomes, including knowledge, behaviors, psychosocial well-being, pregnancy-related empowerment, satisfaction with ANC care.</description>
    <arm_group_label>Group ANC (intervention)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Physically and mentally competent pregnant women over the age of 16 attending&#xD;
             antenatal care&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Less than 16 years of age&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Crystal L Patil, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Illinois at Chicago</affiliation>
  </overall_official>
  <results_reference>
    <citation>Patil CL, Abrams ET, Klima C, Kaponda CP, Leshabari SC, Vonderheid SC, Kamanga M, Norr KF. CenteringPregnancy-Africa: a pilot of group antenatal care to address Millennium Development Goals. Midwifery. 2013 Oct;29(10):1190-8. doi: 10.1016/j.midw.2013.05.008. Epub 2013 Jul 19.</citation>
    <PMID>23871278</PMID>
  </results_reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 11, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>December 16, 2016</last_update_submitted>
  <last_update_submitted_qc>December 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Illinois at Chicago</investigator_affiliation>
    <investigator_full_name>Crystal L. Patil, PhD</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Group healthcare models</keyword>
  <keyword>Antenatal care</keyword>
  <keyword>Prenatal care</keyword>
  <keyword>Perinatal health</keyword>
  <keyword>CenteringPregnancy</keyword>
  <keyword>sub-Saharan Africa</keyword>
  <keyword>Malawi</keyword>
  <keyword>Tanzania</keyword>
  <keyword>Pregnancy</keyword>
  <patient_data>
    <sharing_ipd>No</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/NCT02999334
org study id: NR14413-01
nct id: NCT02999334
lead sponsor: 
has dmc: No
The quality of antenatal care (ANC) in much of sub-Saharan Africa is constrained by severe
      resource and staffing shortages. The investigators adapted and piloted an evidence-based
      model of group antenatal care as an innovative way to improve ANC service delivery and
      increase health promotion. This pilot will be conducted in Malawi and Tanzania and will
      provide data to prepare for a large randomized controlled trial to document the impacts that
      group antenatal has on perinatal health outcomes. This study will ultimately inform policy
      and practice aimed at improving quality of antenatal care through respectful and
      woman-centered care to pregnant women.
More than 90% of women in sub-Saharan Africa use antenatal care (ANC) at least once in
      pregnancy. To leverage high attendance rates, most facilities bundle HIV prevention and
      prevention of maternal-to-child transmission (PMTCT) with ANC. Unfortunately, the quality of
      ANC in sub-Saharan Africa is sharply constrained by severe resource and staffing shortages,
      as reflected in numerous "missed opportunities" for PMTCT, clinical service delivery, and
      health education. Moreover, job satisfaction among the overburdened providers is low. To
      improve ANC quality, the investigators will adapt and pilot an innovative, evidence-based
      model of group ANC, an approach that restructures provider time, allowing health facilities
      to offer respectful, woman-centered and high quality ANC given the limitations.

      In CenteringPregnancy (CP), the only evidence-based model of group ANC, 12 women meet jointly
      for two hour antenatal visits, assessing their own weights and blood pressures, meeting
      briefly with the provider for individual consultations, and engaging in facilitated health
      discussions. Randomized controlled trial (RCT) data from ethnically and socioeconomically
      diverse populations in the US demonstrated that CP is highly effective at improving ANC
      adherence, provider and client satisfaction, and maternal and child outcomes. In the US, the
      successful integration of HIV prevention into the CP model reduced sexually transmitted
      infections and increased condom use.

      CP has not been implemented with fidelity and tested for efficacy in a low-resource country.
      With funding from the Chicago Developmental Center for AIDS Research, the investigators
      conducted preliminary work in Malawi and Tanzania which suggested that a CP-based model of
      group ANC was feasible and acceptable; both women and providers were excited and energized by
      the model. The purpose of this study is to build on this work and: 1) conduct the
      developmental work to collaboratively adapt CP materials for use in both countries (sessions,
      training guides, and implementation and evaluation strategies); 2) train providers and
      pretest activities; and 3) conduct a full-scale randomized pilot. Investigators will work
      directly with the Centering Healthcare Institute to implement this CP-based model of group
      ANC with fidelity. This study will result in a feasible, acceptable, and sustainable CP-based
      model of group ANC adapted for the constraints posed by poorly resourced health systems and
      those of the clients they serve. These pilot data will be used to generate retention rates
      and effect sizes for an RCT to test the efficacy of a CP-based group ANC model.

      Group antenatal care is an innovative paradigm shift in ANC, and this rigorous evaluation of
      its impact will expand the limited scientific assessments of reconfigured ANC models and
      mother and infant health outcomes in low-resource countries in sub-Saharan Africa. Because
      this model was developed and tested in target countries with high HIV prevalence and poor
      maternal and neonatal outcomes, it has the potential for broad impacts on maternal and child
      health, including PMTCT, in other low resource settings.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Adherence to Care
time frame: 6-8 weeks postpartum
description: Two Indicators: Attended 4 (or more) antenatal care visits (yes, no) and the 6-week postnatal visit (yes, no)
measure: Healthy Pregnancy Knowledge Index
time frame: Enrollment, 32-40 weeks gestation
description: 14-item true/false questions measured two times in pregnancy and scored as percent correct (range 0-100%)
measure: Healthy Pregnancy Behaviors
time frame: Enrollment, 32-40 weeks gestation
description: Substance use behaviors in the last two months for: tobacco products, alcohol, and marijuana. Two nutritional behaviors were asked about. One was whether or not she ate fruits or vegetables at least 3 times a day for 5 or more days in the past week. The second focused on eating protein at least once a day for 5 or more days in the past week. Measured two times in pregnancy. Three or less of these five behaviors scored as 0 and four or more healthy behaviors were categorized as a 1 (Dichotomous)
measure: Prevention of Mother-to-Child (PMTCT) Knowledge
time frame: Enrollment, 32-40 weeks gestation
description: 4-item PMTCT knowledge index measured two times in pregnancy and scored as 1 if all four were correct and 0 if one or more item was incorrect (Dichotomous)
measure: Comprehensive HIV Prevention Knowledge
time frame: Enrollment, 32-40 weeks gestation
description: 5-item comprehensive HIV knowledge index measured twice in pregnancy. Scored as 1 if all five items were correctly and 0 if one or more item was incorrect (Dichotomous)
measure: Mental Distress
time frame: Enrollment, 32-40 weeks gestation
description: 20-item yes/no Self Reporting Questionnaire (SRQ-20) to assess mental distress was measured two times in pregnancy. Validated in multiple countries including Malawi and Tanzania (Range 0-20, baseline α = 0.789; late pregnancy α = 0.848). We dichotomized scores to low (<8 symptoms) and high (≥8), a level used in clinics for referral. (Dichotomous)
measure: Pregnancy-Related Empowerment Scale (PRES)
time frame: 32-40 weeks gestation
description: The pregnancy-related empowerment scale (PRES) is a 16-item Likert-type scale with items ranging from 1 (strongly disagree) to 4 (strongly agree) that is intended to assess a woman's sense of control over their pregnancy health and health care. Measured once in late pregnancy (Range 16-64, Continuous)
measure: Satisfaction with Care
time frame: 32-40 weeks gestation
description: 10-item satisfaction with antenatal care index; Measured once in late pregnancy with 5 response options between 1 (poor) and to 5 (excellent) (Range 13-50, Continuous)
measure: Any Adverse Perinatal Event
time frame: 6-8 weeks postpartum
description: Fetal demise, stillbirth, neonatal death, preterm birth, low birth weight, or maternal death. None experienced = 0; one or more = 1 (Dichotomous)
arm group label: Individual ANC (standard care)
arm group type: No Intervention
description: Individual ANC is the standard of care. Women arrive at the clinic and and are provided ANC services on a first come, first serve basis. While waiting women who are present listen to a health lecture. Women then complete laboratory tests, including HIV testing (at the first visit), then meet individually with a midwife for a brief one-on-one physical assessment. Four ANC visits are recommended.
arm group label: Group ANC (intervention)
arm group type: Experimental
description: Women in CP-based group antenatal care (intervention) arrive at clinic at the scheduled appointment time and go directly to the group space. The same group of 12 women and the midwife and co-facilitator are present at each session. Women measure and record their own vital signs and weight. Each then has a brief one-on-one assessment with the midwife in the group space room. Instead of health lectures, the group engages in facilitated and interactive discussions using activities. Four ANC visits are recommended.
intervention type: Behavioral
intervention name: Group Antenatal Care
description: To examine the effect of type of care on completion of the recommended antenatal and postnatal visits as well as perinatal health outcomes, including knowledge, behaviors, psychosocial well-being, pregnancy-related empowerment, satisfaction with ANC care.
arm group label: Group ANC (intervention)
criteria: 
gender: Female
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Crystal L Patil, PhD
role: Principal Investigator
affiliation: University of Illinois at Chicago
citation: Patil CL, Abrams ET, Klima C, Kaponda CP, Leshabari SC, Vonderheid SC, Kamanga M, Norr KF. CenteringPregnancy-Africa: a pilot of group antenatal care to address Millennium Development Goals. Midwifery. 2013 Oct;29(10):1190-8. doi: 10.1016/j.midw.2013.05.008. Epub 2013 Jul 19.
PMID: 23871278
responsible party type: Principal Investigator
investigator affiliation: University of Illinois at Chicago
investigator full name: Crystal L. Patil, PhD
investigator title: Associate Professor
sharing ipd: No