Effects of Facility-based Mother Support Groups on Prevention of mother-to Child Transmission Outcomes in Zimbabwe

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02216734
• Date of registration: 12/08/2014
• Prospective Registration: No
• Primary sponsor: Family AIDS Caring Trust
• Public title: Effects of Facility-based Mother Support Groups on Prevention of mother-to Child Transmission Outcomes in Zimbabwe EPAZ
• Scientific title: Effects of Mother Support Groups on Prevention of Mother-To-Child Transmission (PMTCT) Outcomes in Mutare & Makoni Districts, Zimbabwe: A Cluster Randomized Controlled Trial
• Date of first enrolment: July 2014
• Target sample size: 300
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT02216734
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
• Phase: N/A

Countries of recruitment

Zimbabwe

Contacts

• Name: Vhumani Magezi

• Name: Geoff Foster, MB BS MRCP

• Name: Geoff Foster, MB BS MRCP
• Affiliation: Ministry of Health and Child Care, Zimbabwe

Key inclusion & exclusion criteria

Inclusion Criteria:

- Pregnant mothers

- with documented HIV-1 infection attending an antenatal clinic for the current
pregnancy

- Aged 18 years of age or greater

- Attending the clinic with no known intention at the time of enrolment to permanently
migrate outside the catchment area of the clinic for the duration of the study
follow-up period

- Estimated gestational age of 34 weeks or less at time of enrolment

- Willing to have her infant, when born, participate in the study.

- Able and willing to give informed consent to participate

Exclusion Criteria:

- Pregnant mothers with no documented HIV infection

- Under 18 years of age

- Not able or willing to give informed consent to participate

- Estimated gestational age of over 34 weeks when considered for possible enrolment

- Not residing in catchment area of clinic

- Planning to relocate out of the catchment area of the clinic for the duration of
study follow-up period or longer

- Any condition that in the opinion of the investigators would interfere with adherence
to study requirements. Such conditions include mental illness or active drug or
alcohol use or dependence.

- Unwilling for her infant, when born, to participate in the infant component of the
study



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

HIV Infection

Intervention(s)

Behavioral: Mother support groups for HIV+ mothers

Primary Outcome(s)

One-year retention rates of HIV-exposed infants in post-natal follow-up [Time Frame: 12 months postnatal]

Secondary Outcome(s)

a. Retention rates of HIV-infected mothers [Time Frame: 12 months postnatal]

Secondary ID(s)

RPC526

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

World Health Organization

Canadian International Development Agency