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Community-Based Peer Facilitator Intervention (Zimbabwe)

Primary Purpose

HIV-infection/Aids

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Peer-facilitated community support group
Sponsored by
Elizabeth Glaser Pediatric AIDS Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for HIV-infection/Aids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Pregnant and breastfeeding women who were 18 years of age and above, regardless of HIV status, were eligible to participate in support groups.

Exclusion Criteria:

  • Women less than 18 years and those who were mentally ill were excluded as they could not give informed consent.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Peer Facilitator and Support Group

    Standard Care

    Arm Description

    Peer-facilitated community support group is the experimental intervention. The intervention tested in this study involved using trained peer facilitators to create demand for and retention within the ANC/PMTCT program.The peer facilitators were volunteer women from the community, who had recently been through the ANC process themselves and could speak about their experience(s). the support group meetings was to develop skills and generate self-efficacy for the women to be able to take actions such as routine antenatal and postnatal clinic attendance using participatory learning techniques. The peer facilitators were provided with job aids which outlined key points for the various educational sessions.

    ANC/PMTCT activities as per standard of care in Zimbabwe

    Outcomes

    Primary Outcome Measures

    To measure proportion of women less than 20 weeks gestation at first ANC attendance
    The number of women attending first ANC attendance at 20 weeks gestation as a proportion of all women attending first ANC attendance at any age of gestation
    To measure proportion of pregnant women attending four ANC visits
    The number of pregnant women attending four ANC visits as a proportion of pregnant women attending any ANC visit
    To measure proportion of HIV exposed babies tested for HIV
    The number of HIV exposed babies test for HIV as a proportion of the number of HIV exposed babies
    To measure proportion of HIV exposed babies initiated on NVP prophylaxis at birth
    The number of HIV exposed babies initiated on NVP prophylaxis at birth as a proportion of the number of HIV exposed babies tested for HIV at birth

    Secondary Outcome Measures

    Pregnant and postnatal women tested for HIV as a proportion of these women in the community
    The number of pregnant and postnatal women tested for HIV as a proportion of the number of pregnant and postnatal women estimated to have HIV in the community

    Full Information

    First Posted
    June 24, 2015
    Last Updated
    February 3, 2021
    Sponsor
    Elizabeth Glaser Pediatric AIDS Foundation
    Collaborators
    Ministry of Health and Child Welfare, Zimbabwe, The Children's Investment Fund Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02496793
    Brief Title
    Community-Based Peer Facilitator Intervention (Zimbabwe)
    Official Title
    A Community Randomized Study to Evaluate the Effect of a Community-Based Peer Facilitator Intervention on Prevention of Maternal to Child Transmission (PMTCT) of HIV Program Outcomes in Zimbabwe
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2012 (undefined)
    Primary Completion Date
    June 2013 (Actual)
    Study Completion Date
    June 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Elizabeth Glaser Pediatric AIDS Foundation
    Collaborators
    Ministry of Health and Child Welfare, Zimbabwe, The Children's Investment Fund Foundation

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The goal of this community randomized operations research study was to evaluate the effect of a peer-facilitated community support group intervention on uptake of maternal and neonatal child health (MNCH) and PMTCT services and on adherence outcomes in Zimbabwe.
    Detailed Description
    To increase uptake of, and retention within maternal and child health/prevention of maternal-to-child HIV transmission (MCH/PMTCT) services, the investigators conducted a community-based peer facilitator intervention study in Hurungwe District of Zimbabwe. Using a paired community randomized design, 16 health facility-linked communities were randomly allocated to the intervention or control condition, with a total of approximately 1,600 pregnant and lactating women, (100 women in each community), recruited into the study. In the intervention communities, 24 trained peer facilitators (3 in each community) using participatory educational approaches were encouraging women to form antenatal and post-natal groups, and to utilize and adhere to MCH/PMTCT services and recommendations. Peer facilitators, by the definition of this project, were women from the community who were peers to pregnant and lactating women; who had recently been through the process themselves and could speak to their experience. A key activity of the community-based peer facilitators was the encouragement of the formation of women into groups, and the participation of these women into antenatal care (ANC), prevention of maternal to child transmission (PMTCT), and postnatal care (PNC) programs. The group process was enable solidarity and support among the women at the vulnerable times of pregnancy and lactation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV-infection/Aids

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1600 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Peer Facilitator and Support Group
    Arm Type
    Experimental
    Arm Description
    Peer-facilitated community support group is the experimental intervention. The intervention tested in this study involved using trained peer facilitators to create demand for and retention within the ANC/PMTCT program.The peer facilitators were volunteer women from the community, who had recently been through the ANC process themselves and could speak about their experience(s). the support group meetings was to develop skills and generate self-efficacy for the women to be able to take actions such as routine antenatal and postnatal clinic attendance using participatory learning techniques. The peer facilitators were provided with job aids which outlined key points for the various educational sessions.
    Arm Title
    Standard Care
    Arm Type
    No Intervention
    Arm Description
    ANC/PMTCT activities as per standard of care in Zimbabwe
    Intervention Type
    Behavioral
    Intervention Name(s)
    Peer-facilitated community support group
    Intervention Description
    Support groups were composed of up to 20 women from community. Peer facilitator facilitated a total of 6 groups of a maximum of 20 women each. Women were exposed to 8 two hour sessions. Facilitators gave activities in support of MCH/PMTCT. Group met twice a month for four months. The support group meetings took place in the community at a convenient location for those attending (e.g. village meeting point, churches, schools or individual households). With local support through community leaders, the intervention involved trained peer facilitators working with pregnant and post-partum women to form ANC and PNC support groups through which they will present information on general maternal and child health and PMTCT specific topics using participatory learning and problem-solving approaches.
    Primary Outcome Measure Information:
    Title
    To measure proportion of women less than 20 weeks gestation at first ANC attendance
    Description
    The number of women attending first ANC attendance at 20 weeks gestation as a proportion of all women attending first ANC attendance at any age of gestation
    Time Frame
    12 months
    Title
    To measure proportion of pregnant women attending four ANC visits
    Description
    The number of pregnant women attending four ANC visits as a proportion of pregnant women attending any ANC visit
    Time Frame
    12 months
    Title
    To measure proportion of HIV exposed babies tested for HIV
    Description
    The number of HIV exposed babies test for HIV as a proportion of the number of HIV exposed babies
    Time Frame
    12 months
    Title
    To measure proportion of HIV exposed babies initiated on NVP prophylaxis at birth
    Description
    The number of HIV exposed babies initiated on NVP prophylaxis at birth as a proportion of the number of HIV exposed babies tested for HIV at birth
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Pregnant and postnatal women tested for HIV as a proportion of these women in the community
    Description
    The number of pregnant and postnatal women tested for HIV as a proportion of the number of pregnant and postnatal women estimated to have HIV in the community
    Time Frame
    12 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Pregnant and breastfeeding women who were 18 years of age and above, regardless of HIV status, were eligible to participate in support groups. Exclusion Criteria: Women less than 18 years and those who were mentally ill were excluded as they could not give informed consent.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Godfrey J Woelk, PhD
    Organizational Affiliation
    Elizabeth Glaser Pediatric AIDS Foundation
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Community-Based Peer Facilitator Intervention (Zimbabwe)

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