Community-Based Peer Facilitator Intervention (Zimbabwe)

February 3, 2021 updated by: Elizabeth Glaser Pediatric AIDS Foundation

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

1600

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Peer Facilitator and Support Group
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.
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.
No Intervention: Standard Care
ANC/PMTCT activities as per standard of care in Zimbabwe

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To measure proportion of women less than 20 weeks gestation at first ANC attendance
Time Frame: 12 months
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
12 months
To measure proportion of pregnant women attending four ANC visits
Time Frame: 12 months
The number of pregnant women attending four ANC visits as a proportion of pregnant women attending any ANC visit
12 months
To measure proportion of HIV exposed babies tested for HIV
Time Frame: 12 months
The number of HIV exposed babies test for HIV as a proportion of the number of HIV exposed babies
12 months
To measure proportion of HIV exposed babies initiated on NVP prophylaxis at birth
Time Frame: 12 months
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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnant and postnatal women tested for HIV as a proportion of these women in the community
Time Frame: 12 months
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Godfrey J Woelk, PhD, Elizabeth Glaser Pediatric AIDS Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

June 24, 2015

First Submitted That Met QC Criteria

July 13, 2015

First Posted (Estimate)

July 14, 2015

Study Record Updates

Last Update Posted (Actual)

February 8, 2021

Last Update Submitted That Met QC Criteria

February 3, 2021

Last Verified

February 1, 2021

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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