Mentor Mothers: A Sustainable Family Intervention in South African Townships

NCT00972699 | Completed Phase 2 DMC

• 2 other identifiers: R01MH077553DAHBR 9A-ASPA
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test a mother-to-mother intervention during pregnancy and after delivery with Mothers Living with HIV (MLH)in South Africa. We hypothesize that the intervention will enhance the adjustment of the children of MLH by improving the health and mental health of MLH which benefits their children, as well as the MLH.

Conditions

Human Immunodeficiency Virus; Acquired Immune Deficiency Syndrome; Tuberculosis

Keywords

Human Immunodeficiency Virus; Acquired Immune Deficiency Syndrome; Tuberculosis; Women; Pregnancy; Vertical Transmission of Human Immunodeficiency Virus; South Africa; Low Birth Weight

Outcome Measures

Primary Outcomes (1)

• Baby's health status

  6 days after birth; 6 months after birth; 12 months after birth

Secondary Outcomes (1)

• Maternal adherence: baby's and mother's health.

  6 days after birth; 6 months after birth; 12 months after birth

Study Arms (2)

Mentor Mothers Intervention

EXPERIMENTAL

In the intervention arm, participants will receive the Department of Health-delivered Prevention of Mother to Child Transmission (PMTCT) program plus the Project Masihambisane mentor mothers support program. HIV positive mentor mothers, who have been through the PMTCT program, will be recruited and trained to deliver the intervention to pregnant mothers living with HIV.

Behavioral: Peer support and mentoring

Control

NO INTERVENTION

Mothers living with HIV in the standard of care control clinics will receive the Department of Health-delivered PMTCT program.

Interventions

Peer support and mentoring BEHAVIORAL

The intervention will be delivered in 4 non consecutive visits during pregnancy and 4 visits post-partum. The sessions will be delivered to mothers living with HIV on the days of their health care appointments either individually or in groups that can accommodate up to 30 mothers living with HIV. The intervention will focus on enhancing the mother-baby relationship through increasing the health of the mother and baby, maintaining the mother's mental health, and reducing HIV transmission.

Also known as: Masihambisane

Mentor Mothers Intervention

Eligibility Criteria

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

You may qualify if:

• years or older, pregnant, and HIV+
• Enrolled in the PMTCT program at the study site clinic
• Receiving medical care from study site clinic
• Residing in study area for duration of study
• No psychosis, neurological damage, or IQ less than 70, as judged by an interviewer in consultation with a clinical supervisor
• Ability to give informed consent as judged by an interviewer

You may not qualify if:

• Less than 18 years, or not pregnant, or not HIV+
• Not enrolled in the PMTCT program at the study site clinic
• Not receiving medical care from study site clinic
• Not residing in study area for duration of study
• Psychosis, neurological damage, or IQ less than 70, as judged by an interviewer in consultation with a clinical supervisor
• Clinical provider (nurse or physician) believes it is not in the best interest of the MLH
• Unable to give informed consent

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute of Mental Health (NIMH): collaborator
• Human Sciences Research Council: collaborator

Study Sites (1)

HSRC Sweetwaters Site

Pietermaritzburg, KwaZulu-Natal, 3201, South Africa

Location

Related Publications (8)

• Christodoulou J, Rotheram-Borus MJ, Bradley AK, Tomlinson M. Home Visiting and Antenatal Depression Affect the Quality of Mother and Child Interactions in South Africa. J Am Acad Child Adolesc Psychiatry. 2019 Dec;58(12):1165-1174. doi: 10.1016/j.jaac.2019.03.016. Epub 2019 Mar 26.

  PMID: 30926571 DERIVED

• Rotheram-Borus MJ, Tomlinson M, Roux IL, Stein JA. Alcohol Use, Partner Violence, and Depression: A Cluster Randomized Controlled Trial Among Urban South African Mothers Over 3 Years. Am J Prev Med. 2015 Nov;49(5):715-725. doi: 10.1016/j.amepre.2015.05.004. Epub 2015 Jul 29.

  PMID: 26231855 DERIVED

• Richter L, Rotheram-Borus MJ, Van Heerden A, Stein A, Tomlinson M, Harwood JM, Rochat T, Van Rooyen H, Comulada WS, Tang Z. Pregnant women living with HIV (WLH) supported at clinics by peer WLH: a cluster randomized controlled trial. AIDS Behav. 2014 Apr;18(4):706-15. doi: 10.1007/s10461-014-0694-2.

  PMID: 24469222 DERIVED

• Rotheram-Borus MJ, Richter LM, van Heerden A, van Rooyen H, Tomlinson M, Harwood JM, Comulada WS, Stein A. A cluster randomized controlled trial evaluating the efficacy of peer mentors to support South African women living with HIV and their infants. PLoS One. 2014 Jan 22;9(1):e84867. doi: 10.1371/journal.pone.0084867. eCollection 2014.

  PMID: 24465444 DERIVED

• van Heerden A, Norris S, Tollman S, Richter L, Rotheram-Borus MJ. Collecting maternal health information from HIV-positive pregnant women using mobile phone-assisted face-to-face interviews in Southern Africa. J Med Internet Res. 2013 Jun 10;15(6):e116. doi: 10.2196/jmir.2207.

  PMID: 23748182 DERIVED

• Rotheram-Borus MJ, le Roux IM, Tomlinson M, Mbewu N, Comulada WS, le Roux K, Stewart J, O'Connor MJ, Hartley M, Desmond K, Greco E, Worthman CM, Idemundia F, Swendeman D. Philani Plus (+): a Mentor Mother community health worker home visiting program to improve maternal and infants' outcomes. Prev Sci. 2011 Dec;12(4):372-88. doi: 10.1007/s11121-011-0238-1.

  PMID: 21850488 DERIVED

• Hartley M, Tomlinson M, Greco E, Comulada WS, Stewart J, le Roux I, Mbewu N, Rotheram-Borus MJ. Depressed mood in pregnancy: prevalence and correlates in two Cape Town peri-urban settlements. Reprod Health. 2011 May 2;8:9. doi: 10.1186/1742-4755-8-9.

  PMID: 21535876 DERIVED

• Rotheram-Borus MJ, Richter L, Van Rooyen H, van Heerden A, Tomlinson M, Stein A, Rochat T, de Kadt J, Mtungwa N, Mkhize L, Ndlovu L, Ntombela L, Comulada WS, Desmond KA, Greco E. Project Masihambisane: a cluster randomised controlled trial with peer mentors to improve outcomes for pregnant mothers living with HIV. Trials. 2011 Jan 4;12:2. doi: 10.1186/1745-6215-12-2.

  PMID: 21205302 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Tuberculosis

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Study Officials

• Mary Jane Rotheram-Borus, Ph.D.

  UCLA Semel Institute, Center for Community Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 4, 2009
• First Posted: September 7, 2009
• Study Start: July 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 3, 2013

Record last verified: 2013-05

Locations

ZA (1)