A Protocol for a Cluster Randomized Trial on the Effect of a “feeding buddy” Program on adherence to the Prevention of Mother-To-Child-Transmission Guidelines in a Rural Area of KwaZulu-Natal, South Africa

BACKGROUND: The uptake of prevention of mother-to-child-transmission (PMTCT) services has improved in South Africa but challenges remain, including adherence to the World Health Organization's (WHO) PMTCT recommendations of exclusive breastfeeding (EBF), taking antiretroviral medication (ARV); testing for early infant diagnosis; and reducing stigma. Women who practice EBF for the first 6 months are less likely to transmit HIV to their infants, yet only 7% of women EBF for 6 months in South Africa. Adherence to these recommendations remains challenging because of difficulties relating to disclosure and stigma. To address this challenge, the feeding buddy concept was developed based on studies where ARV buddies have proved effective in providing support for women living with HIV. Buddies have demonstrated a positive effect on providing emotional and social support to adhere to PMTCT guidelines. METHODS: A cluster randomized controlled trial was conducted in 16 selected randomly assigned clinics in uMhlathuze and uMlalazi districts of KwaZulu Natal, South Africa. HIV-positive pregnant women (n = 625) who intended to breastfeed were enrolled at 8 control clinics and 8 intervention clinics. The clinics were stratified on the basis of urban/rural/periurban locale and then randomly allocated to either intervention or control. In the intervention clinics, the mother chose a feeding buddy to be enrolled alongside her. Quantitative interviews with mothers and their chosen buddies took place at enrollment during pregnancy and at routine postdelivery visits at day 3 and weeks 6, 14 and 22. Women in the control clinics were followed using the same evaluation schedule. The trial evaluated the effect of a voluntary PMTCT feeding buddy program on HIV-infected women's adherence to PMTCT recommendations and stigma reduction. The proportion of women exclusively feeding at 5.5 months postpartum was the primary end-point of the trial. In-depth interviews were conducted among a convenience sample of PMTCT counselors, community caregivers, mothers, and buddies from intervention clinics and control clinics to document their overall experiences. DISCUSSION: The information collected in this study could be used to guide recommendations on how to build upon the current South Africa. PMTCT “buddy” strategy and to improve safe infant feeding. The information would be applicable to many other similar resource poor settings with poor social support structures.