AEGiS-15IAC: Evaluation of three informed consent processes for a clinical trial on the prevention of mother-to-child transmission of HIV through breastfeeding in Lilongwe, Malawi.

15th International AIDS Conference

Bangkok, Thailand - July 11-16, 2004

Evaluation of three informed consent processes for a clinical trial on the prevention of mother-to-child transmission of HIV through breastfeeding in Lilongwe, Malawi.

Int Conf AIDS 2004 Jul 11-16; 15:(abstract no. WeOrD1247)

Corneli A, Sorenson J, Nkhoma J, Moses A, Zulu C, Chilima J, Bowling JM, Henderson G, Bentley M, Martinson F, Jones D, Ahmed Y, Heilig C, Kazembe P, Jamieson D, van der Horst C
University of North Carolina at Chapel Hill, Chapel Hill, United States

BACKGROUND: Findings from a study conducted in Lilongwe on participation in a clinical trial suggested participants believed medicines have already been tested to be safe and efficacious; they would be assigned to a study arm based on their health needs; and the trial was designed to benefit them. Given that comprehension of these concepts is crucial for participants to give their informed consent, additional research was carried out to evaluate three versions of consent information to determine the amount of cultural modification needed, if any, to enhance understanding.

METHODS: Approximately 300 pregnant women were randomly selected and sequentially allocated to one of three hypothetical consent approaches: (1) the standard-of-care form which is a comparatively short form with simple language, (2) a form which uses culturally-specific information as informed by formative research, (3) counseling cards, an educational method used in Lilongwe, which uses culturally-specific information coupled with drawings. Understanding of research concepts (RC) and study procedures (SP) was assessed directly after delivery.

RESULTS: Preliminary analyses using ANOVA and Tukey's Studentized Range Test suggest understanding of RC and SP differs significantly among the groups (RC = p<.0001; SP = p<.0001), and was significantly higher in both groups 2 and 3 when compared independently to group 1. Although well received by participants, the addition of drawings did not appear to enhance understanding of RC between groups 2 and 3. However, drawings did appear to enhance understanding of SP between these two groups.

CONCLUSIONS: These preliminary analyses suggest that modifying consent information to be culturally specific can enhance understanding. Thus, when writing consent forms for U. S.-funded international research, formative research should be carried out to determine local explanations and methods for enhancing understanding.

Keywords: AEGIS, Informed Consent, Acquired Immunodeficiency Syndrome, Clinical Trials, HIV Seropositivity, Evaluation Studies, Breast Feeding, Mothers, Comprehension, Consent Forms, Research Subjects, HIV Infections, Research, Research Design, Counseling, Ethics Committees, Research, Malawi, Child, Humans, Pregnancy, Female, transmission, prevention & control, ethics, methods

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WeOrD1247