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Completed

NCT Number: NCT02496793

Community-Based Peer Facilitator Intervention (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.

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Key information

Conditions

HIV-infection/Aids Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Peer-facilitated community support group

Behavioral

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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  1. 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

Sponsors and collaborators

Lead sponsor

Elizabeth Glaser Pediatric AIDS Foundation

Other

Collaborators

  • Ministry of Health and Child Welfare, Zimbabwe
  • The Children's Investment Fund Foundation

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 14, 2015
Registry last updated
Feb 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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