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Mentor Mothers: A Sustainable Family Intervention in South African Townships

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ClinicalTrials.gov Identifier: NCT00972699
Recruitment Status : Completed
First Posted : September 7, 2009
Last Update Posted : May 3, 2013
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Human Sciences Research Council
Information provided by (Responsible Party):
Mary Jane Rotheram-Borus, University of California, Los Angeles

Tracking Information
First Submitted Date  ICMJE September 4, 2009
First Posted Date  ICMJE September 7, 2009
Last Update Posted Date May 3, 2013
Study Start Date  ICMJE July 2008
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2009)
Baby's health status [ Time Frame: 6 days after birth; 6 months after birth; 12 months after birth ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2009)
Maternal adherence: baby's and mother's health. [ Time Frame: 6 days after birth; 6 months after birth; 12 months after birth ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mentor Mothers: A Sustainable Family Intervention in South African Townships
Official Title  ICMJE Mentor Mothers: A Sustainable Family Intervention in South African Townships
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Human Immunodeficiency Virus
  • Acquired Immune Deficiency Syndrome
  • Tuberculosis
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Peer support and mentoring
  • No Intervention: Control
    Mothers living with HIV in the standard of care control clinics will receive the Department of Health-delivered PMTCT program.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 1, 2013)
1200
Original Estimated Enrollment  ICMJE
 (submitted: September 4, 2009)
1632
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE South Africa
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00972699
Other Study ID Numbers  ICMJE R01MH077553( U.S. NIH Grant/Contract )
R01MH077553 ( U.S. NIH Grant/Contract )
DAHBR 9A-ASPA
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mary Jane Rotheram-Borus, University of California, Los Angeles
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE
  • National Institute of Mental Health (NIMH)
  • Human Sciences Research Council
Investigators  ICMJE
Principal Investigator: Mary Jane Rotheram-Borus, Ph.D. UCLA Semel Institute, Center for Community Health
PRS Account University of California, Los Angeles
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP