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Clinical Trials/NCT02496793
NCT02496793CompletedNot Applicable

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

Elizabeth Glaser Pediatric AIDS Foundation0 sites1,600 target enrollmentStarted: January 1, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
1,600
Primary Endpoint
To measure proportion of women less than 20 weeks gestation at first ANC attendance

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Peer Facilitator and Support Group

Experimental

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.

Intervention: Peer-facilitated community support group (Behavioral)

Standard Care

No Intervention

ANC/PMTCT activities as per standard of care in Zimbabwe

Outcomes

Primary Outcomes

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

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

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

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

Secondary Outcomes

  • Pregnant and postnatal women tested for HIV as a proportion of these women in the community(12 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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