Project Design and Implementation Plan

The purpose of this study is to demonstrate that a broad spectrum Re-Natured® nutrient supplement improves clinical outcomes in HIV patients.

Site - The Rural AIDS and Development Action Research program (RADAR), based in the Limpopo Province of South Africa. This program is a collaboration between the School of Public Health at the University of the Witwatersrand (WITS) in Johannesburg and the London School of Hygiene and Tropical Medicine. It comprises clinical and social intervention research on HIV/AIDS, with an emphasis on developing model approaches that are appropriate and relevant to the rural African context.

Population - Participants will be identified through Voluntary Counselling and Testing (VCT) sites. Those willing to participate will be given detailed information about the study protocol, and signed informed consent will be obtained.

Inclusion Criteria - Adult volunteers who have been pre-counselled, offered HIV tests, found to be infected with the HIV virus, and are to be started on anti-retroviral therapy (ART). Power calculations indicate a study size of 220.

Duration - The study will last 1 year.

Methodology - Patients entering the study will be randomly allocated to the intervention and control groups. The intervention group will regularly receive a Re-Natured® nutrient supplement. This supplement is ‘food type’, and has been manufactured specifically for this study by Grow Company Inc in New Jersey using Grow Nutrients® .

Data Collection & Analysis - Investigation parameters will include, at inception and every 2 months, body mass index (BMI) and, at inception and every 6 months, CD4 count, viral load, serum selenium and a full blood count.

Ethical Considerations - Clearance will be obtained from the Ethics Committee of WITS. Grow Nutrients® are sold throughout the world without restriction in retail outlets as food supplements. The products have full FDA approval in terms of manufacturing quality and they have been sold without restriction in South Africa for the past 15 years. Patient confidentiality will be respected. Should the intervention prove beneficial to the study group, it will be offered to the control group after the study period.

Reporting & Publishing - At the completion of the study and after statistical analysis, the results will be published, submitted for peer review and will be freely available to all interested parties.