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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02496793
Other study ID # EG0090
Secondary ID MRCZ/A/1651
Status Completed
Phase N/A
First received
Last updated
Start date January 2012
Est. completion date June 2013

Study information

Verified date February 2021
Source Elizabeth Glaser Pediatric AIDS Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1600
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Peer-facilitated community support group
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.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Elizabeth Glaser Pediatric AIDS Foundation Ministry of Health and Child Welfare, Zimbabwe, The Children's Investment Fund Foundation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 12 months
Primary 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 12 months
Primary 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 12 months
Primary 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 12 months
Secondary 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 12 months
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