Strengthening Informed Consent for Authentic Participation in Perinatal HIV Research

This study evaluates a visual Informed Consent Form (ICF) compared to a standard, text-only ICF as an approach to achieving meaningful consent into a clinical trial. The visual ICF uses cartoon characters, graphics and easy-to-understand text to cover the full content of a standard, text-only ICF. In this study, women who are considering enrollment into a clinical trial of a nutrition intervention for their infants will be randomized to either the visual ICF or to the text-only ICF. Qualitative and quantitative data will be collected immediately after the consent process and 8 weeks later. In addition, women not eligible for enrollment into the infant nutrition trial will be asked questions about their opinions regarding the visual ICF. The overall goal of the sub-study is to inform efforts to improve meaningful consent into clinical trials by evaluating whether the visual ICF improves understanding of the trial.

NCT Number	NCT07122960
Lead Sponsor	Columbia University Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Stellenbosch
Conditions	Consent Form
Enrollment	58 participants
Start Date	2024-09-02
Primary Completion	2025-12-04 (estimated)
Study Completion	2027-07-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-16