South Africa has 5 million persons living with HIV (2.7 million women of childbearing age), the country with the most persons living with HIV (UNAIDS, 2004a). Fortunately, HIV testing and access to antiretroviral drugs (ARV) to prevent mother-to-child transmission (MTCT) of HIV from HIV+ pregnant women and their babies is being scaled up . Yet, 40.7% of pregnant women are HIV seropositive (HIV+) in townships such as those in the KwaZulu-Natal (KZN) Province of South Africa (Department of Public Health, South Africa, 2004). This project is primarily aimed at enhancing the adjustment of children of MLH by improving the health and mental health of MLH which benefits their children, as well as the MLH. The Mothers'Programmes (TMP) is a community based non-government organization, operating in South Africa including the Western and Eastern Cape, KZN, Mpumalanga and Northern Cape Provinces and two other African countries, Ethiopia and Botswana. TMP provides wrap-around preventive social support and educational services for MLH at MTCT clinic sites. The proposed project aims to transform the existing TMP into a theoretically-based, sustainable behavioral prevention program (the Mothers-To-Mothers [M2M] intervention) that will improve the adjustment of MLH and their babies. Rather than design an intervention that then must adapt itself to a delivery vehicle, we will take a delivery vehicle (TMP) and enhance its efficacy by creating the M2M intervention. We propose a two phase project over five years. In Phase 1 over the first year, we will finalize all measures, procedures, recruitment of staff, training protocols, and intervention manuals and strategies. In Phase 2, a quasi-experimental design will be implemented with 1632 MLH at 8 clinics (204 mothers/ clinic). Study clinics will be selected that provide environmental access to these services from two strata (large, peri-urban clinics [4 clinics] &small, rural clinics [4 clinics]). All MLH in 8 clinics (n = 1632) will be randomly assigned by clinic within strata to either: 1) standard care (SC), the health care that is delivered by the province;or 2) an enhanced care intervention condition (Mothers-to- Mothers [M2M]). The M2M intervention will be focused on caring for one's own health, parenting one's baby, maintaining mental health, and reducing transmission. The intervention's impact will be assessed over 15 months in a design that is a blend of an efficacy and effectiveness trial.
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|Rotheram-Borus, Mary-Jane; Richter, Linda; Van Rooyen, Heidi et al. (2011) Project Masihambisane: a cluster randomised controlled trial with peer mentors to improve outcomes for pregnant mothers living with HIV. Trials 12:2|