Strengthening informed consent for authentic participation in perinatal HIV research

Project Summary The field of maternal-infant HIV research has been especially attuned to the challenges of attaining authentic informed consent in low-literacy populations affected by a condition that still carries social stigma. Our teams at Columbia University Irving Medical Center (CUIMC), New York and Stellenbosch University, South Africa have been undertaking research in maternal and child populations affected by HIV in South Africa over the past several years. For three recent studies, we partnered with a local company to develop visual informed consent forms (ICF) with the goal of strengthening the consent process. Yet we require additional data before entirely replacing the standard written consent with the visual consent approach in future trials. Here we propose a pragmatic evaluation of the current visual informed consent along with formative research. This data will collectively inform a visual consent approach to be tested in a subsequent R01-level clinical trial. For this R21 study, we propose to partner with a social science expert in empirical ethics from RTI International to evaluate one of the currently used visual ICFs in an NICHD-funded clinical trial (R01HD105492). The clinical trial is testing the efficacy of a synbiotic supplement to reduce infant morbidity and improve growth in 210 breastfeeding mother-infant dyads, including mothers living with and without HIV. Dyads are recruited post- delivery and consented before the infant is 4 weeks of age. The trial is underway in the Breede Valley, an agricultural area in the Western Cape Province, South Africa. For Aim 1, we propose to prospectively evaluate the visual ICF among 40 women living with HIV considering enrollment into our trial. We will randomize 40 new potential participants to receive either the visual ICF at the initial informed consent visit (n=20) or to receive the text only ICF (n=20). Data will be collected via mixed methods to explore knowledge and decision conflict or regret immediately after the consent process and 8 weeks later. For Aim 2, a concurrent evaluation will be conducted among 20 women living with HIV determined to be ineligible for the trial. Aim 2 will include concept and usability testing of the visual ICF using a semi-structured, qualitative, think-aloud approach. Based on the study data, the multidisciplinary study team will develop recommendations for the use of participant-centered, low-literacy approaches to replace standard text-only ICFs in maternal-child health and HIV research conducted with vulnerable populations. The outcome of this project will lead to our next study, where we will develop and test a standalone visual consent form that is designed to replace a text only consent form in a randomized trial. The long-term goal is to inform efforts to improve meaningful consent into studies and contribute to greater inclusivity in clinical research.