<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/NCT02216734</url>
  </required_header>
  <id_info>
    <org_study_id>RPC526</org_study_id>
    <nct_id>NCT02216734</nct_id>
  </id_info>
  <brief_title>Effects of Facility-based Mother Support Groups on Prevention of mother-to Child Transmission Outcomes in Zimbabwe</brief_title>
  <acronym>EPAZ</acronym>
  <official_title>Effects of Mother Support Groups on Prevention of Mother-To-Child Transmission (PMTCT) Outcomes in Mutare &amp; Makoni Districts, Zimbabwe: A Cluster Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Family AIDS Caring Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>World Health Organization</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Canadian International Development Agency</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Family AIDS Caring Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators hypothesize that a strategy of establishing facility-based mother support&#xD;
      groups (MSGs) for HIV-positive mothers will result in increased retention rates of&#xD;
      HIV-exposed infants in clinic-based PMTCT follow-up systems twelve months post-delivery&#xD;
      compared to clinics that lack MSGs. The study will be conducted in health facilities in rural&#xD;
      Mutare and Makoni health districts in Manicaland province, Zimbabwe. A two-arm cluster&#xD;
      controlled study design will be used in 30 rural clinics randomly assigned to either arm to&#xD;
      compare the effectiveness of MSGs. Arm 1 of the study consists of standard of care whilst arm&#xD;
      2 consists of standard of care together with facility-based MSGs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE To test whether MSGs lead to increased retention of HIV-exposed infants in&#xD;
      PMTCT programmes&#xD;
&#xD;
      SECONDARY OBJECTIVES&#xD;
&#xD;
        1. To assess whether MSGs lead to increased retention of mothers in postnatal HIV follow-up&#xD;
           care&#xD;
&#xD;
        2. To assess whether male participation in PMTCT activities is increased at clinics with&#xD;
           MSGs&#xD;
&#xD;
        3. To assess whether selected maternal and infant health indicators are improved in&#xD;
           HIV-positive mothers and their exposed infants at facilities with MSGs, viz. (1)&#xD;
           Antenatal attendance; (2) Delivery in facilities; (3) Infant immunisation uptake; (4)&#xD;
           Infant feeding methods and nutrition status; (5) Infant nevirapine prophylaxis; (6)&#xD;
           Infant co-trimoxazole prophylaxis; (7) Infant HIV testing; and (8) Family planning&#xD;
           uptake&#xD;
&#xD;
      MOTHER SUPPORT GROUP INTERVENTION MSGs were designed following formative research. A&#xD;
      non-governmental organisation established MSGs by recruiting HIV+ mothers and volunteer&#xD;
      coordinators (MSGCs) prior to commencing enrolment. MSGCs were HIV-positive mothers who were&#xD;
      trained in MSG establishment and maintenance, retention activities and data collection. MSGs&#xD;
      meet each two weeks with the MSGC or health worker facilitating an information session using&#xD;
      a curriculum of eight PMTCT-related topics. MSGCs send standard message reminders to members,&#xD;
      contact non-attending members by phone and inform health workers (HWs) to assist retention.&#xD;
      HWs conduct retention actions of non-attending patients in PMTCT programmes.&#xD;
&#xD;
      SAMPLE SIZE AND RANDOMISATION We excluded from the study low-volume facilities that recorded&#xD;
      booking fewer than 10 HIV-positive antenatal mothers per annum. We randomly selected&#xD;
      facilities in the two study districts to either of the study arms. Based on estimated infant&#xD;
      retention rates for control and intervention arms, we calculated the minimum sample size of&#xD;
      10 HIV-positive mothers to be enrolled at each health facility.&#xD;
&#xD;
      DATA COLLECTION, ANALYSIS AND QUALITY ASSURANCE The study utilizes the existing health&#xD;
      information system (e.g. antenatal care (ANC) Register, Exposed Infant Follow-Up Register,&#xD;
      Anti-retroviral treatment (ART) Register), supplemented by EPAZ study-related data collection&#xD;
      and patient tracking systems. Study staff will work with clinic- and district-level staff to&#xD;
      improve and collect routine and study-specific data. Data will be entered, coded, cleaned and&#xD;
      locked before analyses are made. Data will be analysed on an intention-to-treat basis. A&#xD;
      mobile team of well-trained quality assurance and control study staff will be deployed&#xD;
      throughout the data collection period to ensure quality of the intervention and of data&#xD;
      generated and collected at each study site. A pre-specified proportion of patient visit&#xD;
      records will be reviewed from each site.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">November 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>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>One-year retention rates of HIV-exposed infants in post-natal follow-up</measure>
    <time_frame>12 months postnatal</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>a. Retention rates of HIV-infected mothers</measure>
    <time_frame>12 months postnatal</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>HIV Infection</condition>
  <arm_group>
    <arm_group_label>Mother support groups for HIV+ mothers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Facility-based mother support groups (MSGs) for HIV+ mothers. MSGs were established prior to study enrolment. MSGs are facilitated by volunteer mothers. Groups meet every two weeks. Health information is provided by health workers during MSGs. Mothers receive HIV prevention, psychosocial and treatment support, reinforce safe feeding practices, promote linkages with family planning services and support disclosure by HIV+ mothers to partners, male attendance and male HIV treatment. Mothers leave MSGs 6 months postnatally. Volunteer MSG coordinators contact defaulting mothers visits using cell phones; VHWs may conduct home visits to to defaulting MSG members to reduce LTFU;</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard of Care: Nurses may identify HIV+ mothers lost to follow-up (LTFU); village health workers (VHWs) may conduct home visits to reduce LTFU of HIV+ mothers. LTFU activities are not standardised throughout all Ministry of Health and Child Care facilities.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mother support groups for HIV+ mothers</intervention_name>
    <description>Facility-based mother support groups (MSGs) for HIV+ mothers. MSGs were established prior to study enrolment. MSGs are facilitated by volunteer mothers. Groups meet every two weeks. Health information is provided by health workers during MSGs. Mothers receive HIV prevention, psychosocial and treatment support, reinforce safe feeding practices, promote linkages with family planning services and support disclosure by HIV+ mothers to partners, male attendance and male HIV treatment. Mothers leave MSGs 6 months postnatally. Volunteer MSG coordinators contact defaulting mothers visits using cell phones; VHWs may conduct home visits to to defaulting MSG members to reduce LTFU;</description>
    <arm_group_label>Mother support groups for HIV+ mothers</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant mothers&#xD;
&#xD;
          -  with documented HIV-1 infection attending an antenatal clinic for the current&#xD;
             pregnancy&#xD;
&#xD;
          -  Aged 18 years of age or greater&#xD;
&#xD;
          -  Attending the clinic with no known intention at the time of enrolment to permanently&#xD;
             migrate outside the catchment area of the clinic for the duration of the study&#xD;
             follow-up period&#xD;
&#xD;
          -  Estimated gestational age of 34 weeks or less at time of enrolment&#xD;
&#xD;
          -  Willing to have her infant, when born, participate in the study.&#xD;
&#xD;
          -  Able and willing to give informed consent to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant mothers with no documented HIV infection&#xD;
&#xD;
          -  Under 18 years of age&#xD;
&#xD;
          -  Not able or willing to give informed consent to participate&#xD;
&#xD;
          -  Estimated gestational age of over 34 weeks when considered for possible enrolment&#xD;
&#xD;
          -  Not residing in catchment area of clinic&#xD;
&#xD;
          -  Planning to relocate out of the catchment area of the clinic for the duration of study&#xD;
             follow-up period or longer&#xD;
&#xD;
          -  Any condition that in the opinion of the investigators would interfere with adherence&#xD;
             to study requirements. Such conditions include mental illness or active drug or&#xD;
             alcohol use or dependence.&#xD;
&#xD;
          -  Unwilling for her infant, when born, to participate in the infant component of the&#xD;
             study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Geoff Foster, MB BS MRCP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ministry of Health and Child Welfare, Zimbabwe</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Geoff Foster, MB BS MRCP</last_name>
    <phone>+263772265830</phone>
    <email>geofffoster53@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Family AIDS Caring Trust</name>
      <address>
        <city>Mutare</city>
        <state>Manicaland</state>
        <country>Zimbabwe</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vhumani Magezi</last_name>
      <phone>+2632061648</phone>
      <email>vhumani@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Family AIDS Caring Trust</name>
      <address>
        <city>Mutare</city>
        <state>Manicaland</state>
        <country>Zimbabwe</country>
      </address>
    </facility>
    <status>Enrolling by invitation</status>
  </location>
  <location_countries>
    <country>Zimbabwe</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>August 13, 2014</last_update_submitted>
  <last_update_submitted_qc>August 13, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HIV/AIDS</keyword>
  <keyword>Prevention of mother-to-child transmission</keyword>
  <keyword>Mother support groups</keyword>
  <keyword>Retention-in-care</keyword>
  <keyword>Male participation</keyword>
  <keyword>Anti-retroviral treatment</keyword>
  <keyword>Infants</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <!-- 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/NCT02216734
org study id: RPC526
nct id: NCT02216734
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The investigators hypothesize that a strategy of establishing facility-based mother support
      groups (MSGs) for HIV-positive mothers will result in increased retention rates of
      HIV-exposed infants in clinic-based PMTCT follow-up systems twelve months post-delivery
      compared to clinics that lack MSGs. The study will be conducted in health facilities in rural
      Mutare and Makoni health districts in Manicaland province, Zimbabwe. A two-arm cluster
      controlled study design will be used in 30 rural clinics randomly assigned to either arm to
      compare the effectiveness of MSGs. Arm 1 of the study consists of standard of care whilst arm
      2 consists of standard of care together with facility-based MSGs.
PRIMARY OBJECTIVE To test whether MSGs lead to increased retention of HIV-exposed infants in
      PMTCT programmes

      SECONDARY OBJECTIVES

        1. To assess whether MSGs lead to increased retention of mothers in postnatal HIV follow-up
           care

        2. To assess whether male participation in PMTCT activities is increased at clinics with
           MSGs

        3. To assess whether selected maternal and infant health indicators are improved in
           HIV-positive mothers and their exposed infants at facilities with MSGs, viz. (1)
           Antenatal attendance; (2) Delivery in facilities; (3) Infant immunisation uptake; (4)
           Infant feeding methods and nutrition status; (5) Infant nevirapine prophylaxis; (6)
           Infant co-trimoxazole prophylaxis; (7) Infant HIV testing; and (8) Family planning
           uptake

      MOTHER SUPPORT GROUP INTERVENTION MSGs were designed following formative research. A
      non-governmental organisation established MSGs by recruiting HIV+ mothers and volunteer
      coordinators (MSGCs) prior to commencing enrolment. MSGCs were HIV-positive mothers who were
      trained in MSG establishment and maintenance, retention activities and data collection. MSGs
      meet each two weeks with the MSGC or health worker facilitating an information session using
      a curriculum of eight PMTCT-related topics. MSGCs send standard message reminders to members,
      contact non-attending members by phone and inform health workers (HWs) to assist retention.
      HWs conduct retention actions of non-attending patients in PMTCT programmes.

      SAMPLE SIZE AND RANDOMISATION We excluded from the study low-volume facilities that recorded
      booking fewer than 10 HIV-positive antenatal mothers per annum. We randomly selected
      facilities in the two study districts to either of the study arms. Based on estimated infant
      retention rates for control and intervention arms, we calculated the minimum sample size of
      10 HIV-positive mothers to be enrolled at each health facility.

      DATA COLLECTION, ANALYSIS AND QUALITY ASSURANCE The study utilizes the existing health
      information system (e.g. antenatal care (ANC) Register, Exposed Infant Follow-Up Register,
      Anti-retroviral treatment (ART) Register), supplemented by EPAZ study-related data collection
      and patient tracking systems. Study staff will work with clinic- and district-level staff to
      improve and collect routine and study-specific data. Data will be entered, coded, cleaned and
      locked before analyses are made. Data will be analysed on an intention-to-treat basis. A
      mobile team of well-trained quality assurance and control study staff will be deployed
      throughout the data collection period to ensure quality of the intervention and of data
      generated and collected at each study site. A pre-specified proportion of patient visit
      records will be reviewed from each site.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: One-year retention rates of HIV-exposed infants in post-natal follow-up
time frame: 12 months postnatal
measure: a. Retention rates of HIV-infected mothers
time frame: 12 months postnatal
arm group label: Mother support groups for HIV+ mothers
arm group type: Experimental
description: Facility-based mother support groups (MSGs) for HIV+ mothers. MSGs were established prior to study enrolment. MSGs are facilitated by volunteer mothers. Groups meet every two weeks. Health information is provided by health workers during MSGs. Mothers receive HIV prevention, psychosocial and treatment support, reinforce safe feeding practices, promote linkages with family planning services and support disclosure by HIV+ mothers to partners, male attendance and male HIV treatment. Mothers leave MSGs 6 months postnatally. Volunteer MSG coordinators contact defaulting mothers visits using cell phones; VHWs may conduct home visits to to defaulting MSG members to reduce LTFU;
arm group label: Standard of Care Arm
arm group type: No Intervention
description: Standard of Care: Nurses may identify HIV+ mothers lost to follow-up (LTFU); village health workers (VHWs) may conduct home visits to reduce LTFU of HIV+ mothers. LTFU activities are not standardised throughout all Ministry of Health and Child Care facilities.
intervention type: Behavioral
intervention name: Mother support groups for HIV+ mothers
description: Facility-based mother support groups (MSGs) for HIV+ mothers. MSGs were established prior to study enrolment. MSGs are facilitated by volunteer mothers. Groups meet every two weeks. Health information is provided by health workers during MSGs. Mothers receive HIV prevention, psychosocial and treatment support, reinforce safe feeding practices, promote linkages with family planning services and support disclosure by HIV+ mothers to partners, male attendance and male HIV treatment. Mothers leave MSGs 6 months postnatally. Volunteer MSG coordinators contact defaulting mothers visits using cell phones; VHWs may conduct home visits to to defaulting MSG members to reduce LTFU;
arm group label: Mother support groups for HIV+ mothers
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Geoff Foster, MB BS MRCP
role: Principal Investigator
affiliation: Ministry of Health and Child Welfare, Zimbabwe
last name: Geoff Foster, MB BS MRCP
phone: +263772265830
email: geofffoster53@gmail.com
facility: 
status: Recruiting
contact: 
facility: 
status: Enrolling by invitation
country: Zimbabwe
responsible party type: Sponsor
mesh term: HIV Infections