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
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|Condition or disease||Intervention/treatment||Phase|
|Human Immunodeficiency Virus Acquired Immune Deficiency Syndrome Tuberculosis||Behavioral: Peer support and mentoring||Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||1200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Mentor Mothers: A Sustainable Family Intervention in South African Townships|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
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.
- Baby's health status [ Time Frame: 6 days after birth; 6 months after birth; 12 months after birth ]
- Maternal adherence: baby's and mother's health. [ Time Frame: 6 days after birth; 6 months after birth; 12 months after birth ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00972699
|HSRC Sweetwaters Site|
|Pietermaritzburg, KwaZulu-Natal, South Africa, 3201|
|Principal Investigator:||Mary Jane Rotheram-Borus, Ph.D.||UCLA Semel Institute, Center for Community Health|
|Responsible Party:||Mary Jane Rotheram-Borus, Principal Investigator, University of California, Los Angeles|
|Other Study ID Numbers:||
R01MH077553 ( U.S. NIH Grant/Contract )
R01MH077553 ( U.S. NIH Grant/Contract )
|First Posted:||September 7, 2009 Key Record Dates|
|Last Update Posted:||May 3, 2013|
|Last Verified:||May 2013|
Human Immunodeficiency Virus
Acquired Immune Deficiency Syndrome
Vertical Transmission of Human Immunodeficiency Virus
Low Birth Weight
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Gram-Positive Bacterial Infections
Bacterial Infections and Mycoses
Immune System Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
RNA Virus Infections
Slow Virus Diseases