Study to Determine Impact of Feeding Buddies on Adherence to WHO PMTCT Guidelines in South Africa

HIV Clinical Trial

Official title: Effect of Feeding Buddies on Adherence to WHO PMTCT Guidelines in South Africa

Status Completed

Clinical Trial Summary

The 2010 revised WHO recommendations to provide antiretroviral (ARV) prophylaxis or treatment to mothers or infants during the breastfeeding period indicate a paradigm shift in prevention of mother-to-child transmission (PMTCT); care; and treatment programming. Yet despite South Africa's adoption of this guidance, myriad challenges currently exist. Confusion in the public health care system related to mixed messaging around safe infant feeding and the provision of—and now withdrawal of—free formula milk have made adherence to exclusive breastfeeding a challenge in South Africa. Cultural, social, and psychological factors influence the ability of women to follow PMTCT guidelines, which include exclusive breastfeeding for six months, adherence to ARV prophylaxis or treatment, and early infant diagnosis. Facility-based interventions alone are often inadequate to effect sustained behavioral changes in the face of multiple contextual factors. Community- and home-based support are needed, yet cost and systems constraints make these infeasible in many PMTCT programs. Some preliminary pilot data suggests that a feeding buddy strategy could fill this gap and provide a home-based support system for the mother. The feeding buddy, who is selected by an HIV-positive pregnant woman to support her in overcoming sociocultural challenges to adhering to various aspects of PMTCT programs, is not an employed health care worker, but rather an individual known to the mother, making the intervention extremely cost-effective, and requiring minimal resources to implement. In the Uthungulu District of KZN the Programme for Appropriate Technologies in Health (PATH) is implementing a programme (Window of Opportunity-WinOp) of improving health of mothers and infants, and the feeding buddy strategy is one of the strategies included in this overall package of care. While this strategy has been encouraged by the South African Department of Health, it has not previously been implemented nor obviously evaluated. In order to scale-up such a programme and justify the human resource costs, it is vital that such a programme be evaluated.

The goal of this proposed research study is therefore to evaluate the effect of the feeding buddy strategy to support mothers to adhere to PMTCT recommendations.

The investigators hypothesize that mothers who choose a feeding buddy will have increased rates of exclusive breastfeeding and adherence to ARV prophylaxis or treatment, as well as improved rates of early infant diagnosis and stigma reduction.

This evaluation will provide valuable information to the Department of Health in terms of choosing best practice models for promoting HIV-free infant survival and optimum health of infants in resource limited settings. The project plans to employ a cluster randomized intervention design and will include 300 mothers and their infants as well as the 300 buddies in the intervention group, as well as 300 mothers in the control group. All participants will be part of the WinOp feeding buddy intervention programme.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV
• PMTCT

• NCT number: NCT02162498
• Study type: Interventional
• Source: PATH
• Status: Completed
• Phase: N/A
• Start date: August 2013
• Completion date: August 2015