Strengthening Informed Consent for Authentic Participation in Perinatal HIV Research

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: t
View:

• Women ages 18-45 years of age

• Pregnant women or women that have recently given birth within the past 2-6 weeks

Locations
Other Locations
South Africa
Stellenbosch University Wooster Rural Campus
RECRUITING
Worcester
Contact Information
Primary
Louise Kuhn, PhD
lk24@cumc.columbia.edu
2123052398
Time Frame
Start Date: 2024-09-02
Estimated Completion Date: 2026-07-31
Participants
Target number of participants: 60
Treatments
Experimental: Visual Informed Consent Form (ICF)
Active_comparator: Text-only Informed Consent Form
Related Therapeutic Areas
Sponsors
Leads: Columbia University
Collaborators: University of Stellenbosch, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This content was sourced from clinicaltrials.gov