Actively Recruiting
Strengthening Informed Consent for Authentic Participation in Perinatal HIV Research
Led by Columbia University · Updated on 2025-08-14
60
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Strengthening Informed Consent for Authentic Participation in Perinatal HIV Research
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women ages 18-45 years
- Pregnant women or women who have given birth within the past 2 to 6 weeks
You will not qualify if you...
- Unwilling to provide consent
- Severe maternal or infant illness such as tuberculosis or major psychiatric or neurological conditions
- Inability to communicate in English, isiXhosa, or Afrikaans
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Stellenbosch University Wooster Rural Campus
Worcester, Western Cape, South Africa, 6850
Actively Recruiting
Research Team
L
Louise Kuhn, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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