- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02496793
Community-Based Peer Facilitator Intervention (Zimbabwe)
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 Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Collaborators
Investigators
- Principal Investigator: Godfrey J Woelk, PhD, Elizabeth Glaser Pediatric AIDS Foundation
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- EG0090
- MRCZ/A/1651 (Other Identifier: Medical Research Council of Zimbabwe)
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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