Strengthening Informed Consent for Authentic Participation in Perinatal HIV Research

NCT07122960 | Recruiting

• 2 other identifiers: AAAV18331R21HD115480
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Consent Form

Keywords

Consent process

Outcome Measures

Primary Outcomes (1)

• Summed score from the validated Quality of Informed Consent (QUIC) instrument.

  The QUIC measures knowledge recall. The summed score of 10 knowledge items comprising key concepts of informed consent will be calculated. The scores range between 0 and 22 with higher scores indicating higher knowledge.

  Immediately after the consent process (Day 0) and 8 weeks later

Secondary Outcomes (2)

• Self-rated Understanding

  Immediately after consent process (Day 0)

• Decision Regret Scale

  8 weeks after consent process

Study Arms (2)

Visual Informed Consent Form (ICF)

EXPERIMENTAL

Other: Visual ICF

Text-only Informed Consent Form

ACTIVE COMPARATOR

Other: Text-only ICF

Interventions

Visual ICF OTHER

This visual ICF fully represents all the content of the standard, text-only ICF using cartoon characters, graphics and easy text.

Visual Informed Consent Form (ICF)

Text-only ICF OTHER

Text-only ICF

Text-only Informed Consent Form

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women ages 18-45 years of age
• Pregnant women or women that have recently given birth within the past 2-6 weeks

You may not qualify if:

• Unwilling to provide consent
• Severe maternal or infant illness (e.g. tuberculosis, major psychiatric or neurological conditions)
• Inability to communicate in one of the three languages (English, isiXhosa, or Afrikaans)

Sponsors & Collaborators

• Columbia University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• University of Stellenbosch: collaborator

Study Sites (1)

Stellenbosch University Wooster Rural Campus

Worcester, Western Cape, 6850, South Africa

RECRUITING

Study Officials

• Louise Kuhn, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Louise Kuhn, PhD

CONTACT

2123052398; lk24@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Epidemiology

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 14, 2025
• Study Start: September 2, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: August 14, 2025

Record last verified: 2025-08

Locations

ZA (1)