Clinical trial NCT02496793: 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
Overall status: COMPLETED
Phase: NA
Conditions: HIV-infection/Aids
Lead sponsor: Elizabeth Glaser Pediatric AIDS Foundation
Sponsor class: OTHER
Collaborators: name: Ministry of Health and Child Welfare, Zimbabwe
name: The Children's Investment Fund Foundation
First posted: 2015-07-14
Enrollment: 1600
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: To measure proportion of women less than 20 weeks gestation at first ANC attendance
timeFrame: 12 months
measure: To measure proportion of pregnant women attending four ANC visits
timeFrame: 12 months
measure: To measure proportion of HIV exposed babies tested for HIV
timeFrame: 12 months
measure: To measure proportion of HIV exposed babies initiated on NVP prophylaxis at birth
timeFrame: 12 months
Secondary outcomes:
measure: Pregnant and postnatal women tested for HIV as a proportion of these women in the community
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Elizabeth Glaser Pediatric AIDS Foundation
name: Godfrey J Woelk, PhD
role: PRINCIPAL_INVESTIGATOR
References: