NCT02496793

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 14, 2015

Completed
Last Updated

February 8, 2021

Status Verified

February 1, 2021

Enrollment Period

1.4 years

First QC Date

June 24, 2015

Last Update Submit

February 3, 2021

Conditions

HIV-infection/Aids

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (1)

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

    12 months

Study Arms (2)

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.

Behavioral: Peer-facilitated community support group

Standard Care

NO INTERVENTION

ANC/PMTCT activities as per standard of care in Zimbabwe

Interventions

Peer-facilitated community support groupBEHAVIORAL

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.

Peer Facilitator and Support Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant and breastfeeding women who were 18 years of age and above, regardless of HIV status, were eligible to participate in support groups.

You may not qualify if:

  • Women less than 18 years and those who were mentally ill were excluded as they could not give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Godfrey J Woelk, PhD

    Elizabeth Glaser Pediatric AIDS Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2015

First Posted

July 14, 2015

Study Start

January 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

February 8, 2021

Record last verified: 2021-02