Mentor Mothers: A Sustainable Family Intervention in South African Townships

Tuberculosis Clinical Trial

Official title:

Mentor Mothers: A Sustainable Family Intervention in South African Townships

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00972699
• Other study ID #: R01MH077553
• Secondary ID: R01MH077553DAHBR
• Status: Completed
• Phase: Phase 2
• First received: September 4, 2009
• Last updated: May 1, 2013
• Start date: July 2008
• Est. completion date: December 2011

Study information

• Verified date: May 2013
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review BoardSouth Africa: Department of HealthSouth Africa: Human Research Ethics CommitteeSouth Africa: Medicines Control CouncilSouth Africa: National Health Research Ethics Council
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Acquired Immune Deficiency Syndrome
• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes
• Tuberculosis

Intervention

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.

Locations

Country	Name	City	State
South Africa	HSRC Sweetwaters Site	Pietermaritzburg	KwaZulu-Natal

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Los Angeles	Human Sciences Research Council, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baby's health status		6 days after birth; 6 months after birth; 12 months after birth	No
Secondary	Maternal adherence: baby's and mother's health.		6 days after birth; 6 months after birth; 12 months after birth	No