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

NCT02216734 | Unknown

• 1 other identifier: RPC526
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

The investigators hypothesize that a strategy of establishing facility-based mother support groups (MSGs) for HIV-positive mothers will result in increased retention rates of HIV-exposed infants in clinic-based PMTCT follow-up systems twelve months post-delivery compared to clinics that lack MSGs. The study will be conducted in health facilities in rural Mutare and Makoni health districts in Manicaland province, Zimbabwe. A two-arm cluster controlled study design will be used in 30 rural clinics randomly assigned to either arm to compare the effectiveness of MSGs. Arm 1 of the study consists of standard of care whilst arm 2 consists of standard of care together with facility-based MSGs.

Conditions

HIV Infection

Keywords

HIV/AIDS; Prevention of mother-to-child transmission; Mother support groups; Retention-in-care; Male participation; Anti-retroviral treatment; Infants

Outcome Measures

Primary Outcomes (1)

• One-year retention rates of HIV-exposed infants in post-natal follow-up

  12 months postnatal

Secondary Outcomes (1)

• a. Retention rates of HIV-infected mothers

  12 months postnatal

Study Arms (2)

Mother support groups for HIV+ mothers

EXPERIMENTAL

Facility-based mother support groups (MSGs) for HIV+ mothers. MSGs were established prior to study enrolment. MSGs are facilitated by volunteer mothers. Groups meet every two weeks. Health information is provided by health workers during MSGs. Mothers receive HIV prevention, psychosocial and treatment support, reinforce safe feeding practices, promote linkages with family planning services and support disclosure by HIV+ mothers to partners, male attendance and male HIV treatment. Mothers leave MSGs 6 months postnatally. Volunteer MSG coordinators contact defaulting mothers visits using cell phones; VHWs may conduct home visits to to defaulting MSG members to reduce LTFU;

Behavioral: Mother support groups for HIV+ mothers

Standard of Care Arm

NO INTERVENTION

Standard of Care: Nurses may identify HIV+ mothers lost to follow-up (LTFU); village health workers (VHWs) may conduct home visits to reduce LTFU of HIV+ mothers. LTFU activities are not standardised throughout all Ministry of Health and Child Care facilities.

Interventions

Mother support groups for HIV+ mothers BEHAVIORAL

Facility-based mother support groups (MSGs) for HIV+ mothers. MSGs were established prior to study enrolment. MSGs are facilitated by volunteer mothers. Groups meet every two weeks. Health information is provided by health workers during MSGs. Mothers receive HIV prevention, psychosocial and treatment support, reinforce safe feeding practices, promote linkages with family planning services and support disclosure by HIV+ mothers to partners, male attendance and male HIV treatment. Mothers leave MSGs 6 months postnatally. Volunteer MSG coordinators contact defaulting mothers visits using cell phones; VHWs may conduct home visits to to defaulting MSG members to reduce LTFU;

Mother support groups for HIV+ mothers

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Family AIDS Caring Trust: lead
• World Health Organization: collaborator
• Canadian International Development Agency: collaborator

Study Sites (2)

Family AIDS Caring Trust

Mutare, Manicaland Province, Zimbabwe

RECRUITING

Family AIDS Caring Trust

Mutare, Manicaland Province, Zimbabwe

ENROLLING BY INVITATION

Related Publications (3)

• Cataldo F, Sam-Agudu NA, Phiri S, Shumba B, Cornelius LJ, Foster G. The Roles of Expert Mothers Engaged in Prevention of Mother-to-Child Transmission (PMTCT) Programs: A Commentary on the INSPIRE Studies in Malawi, Nigeria, and Zimbabwe. J Acquir Immune Defic Syndr. 2017 Jun 1;75 Suppl 2:S224-S232. doi: 10.1097/QAI.0000000000001375.

  PMID: 28498193 DERIVED

• Foster G, Orne-Gliemann J, Font H, Kangwende A, Magezi V, Sengai T, Rusakaniko S, Shumba B, Zambezi P, Maphosa T. Impact of Facility-Based Mother Support Groups on Retention in Care and PMTCT Outcomes in Rural Zimbabwe: The EPAZ Cluster-Randomized Controlled Trial. J Acquir Immune Defic Syndr. 2017 Jun 1;75 Suppl 2:S207-S215. doi: 10.1097/QAI.0000000000001360.

  PMID: 28498191 DERIVED

• Foster G, Kangwende A, Magezi V, Maphosa T, Mashapa R, Mukora-Mutseyekwa F, Mushavi A, Rusakaniko S, Shumba B, Zambezi P. Cluster randomized trial on the effect of mother support groups on retention-in-care and PMTCT outcomes in Zimbabwe: study design, challenges, and national relevance. J Acquir Immune Defic Syndr. 2014 Nov 1;67 Suppl 2:S145-9. doi: 10.1097/QAI.0000000000000325.

  PMID: 25310121 DERIVED

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Study Officials

• Geoff Foster, MB BS MRCP

  Ministry of Health and Child Welfare, Zimbabwe

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Geoff Foster, MB BS MRCP

CONTACT

+263772265830; geofffoster53@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2014
• First Posted: August 15, 2014
• Study Start: July 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 15, 2014

Record last verified: 2014-08

Locations

ZI (2)