Mentor Mothers: A Sustainable Family Intervention in South African Townships

This study has been completed.
Sponsor:
Collaborators:
Human Sciences Research Council
Information provided by (Responsible Party):
Mary Jane Rotheram-Borus, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00972699
First received: September 4, 2009
Last updated: May 1, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Human Immunodeficiency Virus
Acquired Immune Deficiency Syndrome
Tuberculosis
Behavioral: Peer support and mentoring
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Mentor Mothers: A Sustainable Family Intervention in South African Townships

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Baby's health status [ Time Frame: 6 days after birth; 6 months after birth; 12 months after birth ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maternal adherence: baby's and mother's health. [ Time Frame: 6 days after birth; 6 months after birth; 12 months after birth ] [ Designated as safety issue: No ]

Enrollment: 1200
Study Start Date: July 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mentor Mothers Intervention
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
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.
Other Name: Masihambisane
No Intervention: Control
Mothers living with HIV in the standard of care control clinics will receive the Department of Health-delivered PMTCT program.

Detailed Description:

South Africa's HIV/AIDS epidemic, one of the worst in the world, has shown little evidence of decline and is indicative of the urgent need to focus on both preventative and treatment intervention efforts (UNAIDS, 2006). In South Africa, close to one in three women who attend public antenatal clinics are living with HIV (UNAIDS, 2006). In KwaZulu-Natal (KZN) - one of the worst affected provinces - as many as 40% to 60% of pregnant women attending antenatal services are living with HIV (Rochat et al., 2006; Kharsany et al., 2004).

HIV infection in pregnant women raises a number of issues that are not faced by HIV-infected men or non pregnant women (Ojikutu & Stone, 2005) and has particular implications for the successful prevention of mother-to-child transmission (Raisler & Cohn, 2005). Most women learn their HIV status for the first time during antenatal testing, which can be distressing and may introduce or further compound psychological, social and health risks in the antenatal and post natal period (Firn & Norman, 1995; Patel V, Rahman A, Jacob KS, & Hughes M, 2004; Patel, DeSouza, & Rodrigues, 2003; Rochat et al., 2006; Shisana et al., 2005; Stein et al., 2005). Research on the uptake of treatment for HIV indicates that poor mental health and a lack of social support are associated with lowered uptake of HAART (Cook et al., 2006), lowered adherence to anti-retroviral medication (Ammassari, Trotta, Murri, & et al., 2002; DiMatteo, Lepper, & Croghan, 2000; Ickovics et al., 2001; Starace et al., 2002)and increased disease progression (Ickovics et al., 2001).

Fortunately, HIV testing and access to antiretroviral drugs (ARV) to prevent mother-to-child transmission (PMTCT) from HIV positive pregnant women to their babies are currently being scaled up in South Africa (Civil Society HIV and AIDS Congress, 2005; Department of Health, 2005). While the potential exists to cut transmission to babies from mothers living with HIV(MLH), maternal HIV disease has been demonstrated to have negative consequences on maternal mental health and social support and children's emotional, social and developmental outcomes and adjustment - both as a result of chronic HIV illness and as a result of the psychological and social burden of HIV on care giving (Stein et al., 2005; Krebs, Stein, & Rochat, 2005; Stein et al., 2005; Sherr, 2005; Dunn, 2005; Hough, Brumitt, Templin, Saltz, & Mood, 2003).

While PMTCT programs provide the opportunity for women to prevent transmission through medical and feeding interventions, the needs of mothers living with HIV extend well beyond this. The psychosocial challenges facing mothers living with HIV are substantial and, if children are to have positive outcomes, it is necessary to provide mothers living with HIV with the support, skills and knowledge to protect and promote their own health and well-being, that of their babies, and, hopefully, their partners (Rochat et al., 2006; Stein et al., 2005; 2006).

The goal of this randomized trial then is to test an intervention to improve the health and well-being of HIV positive mothers and their babies during pregnancy and the early postpartum period through the implementation of a clinic-based mentor mothers' peer support program(also referred to as Project Masihambisane) and dissemination of health information.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00972699

Locations
South Africa
HSRC Sweetwaters Site
Pietermaritzburg, KwaZulu-Natal, South Africa, 3201
Sponsors and Collaborators
University of California, Los Angeles
Human Sciences Research Council
Investigators
Principal Investigator: Mary Jane Rotheram-Borus, Ph.D. UCLA Semel Institute, Center for Community Health
  More Information

No publications provided by University of California, Los Angeles

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Mary Jane Rotheram-Borus, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00972699     History of Changes
Other Study ID Numbers: R01 MH077553, R01MH077553, DAHBR 9A-ASPA
Study First Received: September 4, 2009
Last Updated: May 1, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board
South Africa: Department of Health
South Africa: Human Research Ethics Committee
South Africa: Medicines Control Council
South Africa: National Health Research Ethics Council

Keywords provided by University of California, Los Angeles:
Human Immunodeficiency Virus
Acquired Immune Deficiency Syndrome
Tuberculosis
Women
Pregnancy
Vertical Transmission of Human Immunodeficiency Virus
South Africa
Low Birth Weight

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Tuberculosis
Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014