Visual informed consent to help pregnant and recently postpartum women understand infant nutrition participation
Strengthening Informed Consent for Authentic Participation in Perinatal HIV Research
This study will test whether a visual consent form (cartoons, graphics, and simple text) helps pregnant or recently postpartum women better understand the enrollment process for an infant nutrition intervention compared with a standard text-only consent form.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (Worcester, Western Cape) |
| Trial ID | NCT07122960 on ClinicalTrials.gov |
What this trial studies
This randomized sub-study (n=40) is nested within a larger infant nutrition trial in South Africa and compares a visual informed consent form to the usual text-only form. Women aged 18–45 who are pregnant or 2–6 weeks postpartum and considering enrollment in the larger trial will be randomized to receive either the visual or text-only ICF. Immediate and 8-week follow-up qualitative and quantitative data will be collected on knowledge recall, decision conflict, self-rated understanding, self-efficacy, satisfaction, decision regret, and trust in the study team. The visual ICF uses cartoon characters, graphics, and simplified language while covering the same content as the standard consent form.
Who should consider this trial
Good fit: Women aged 18–45 who are pregnant or 2–6 weeks postpartum, able to communicate in English, isiXhosa, or Afrikaans, and considering enrollment in the linked infant nutrition trial.
Not a fit: Women who are unwilling to provide consent, who have severe maternal or infant illness, or who cannot communicate in the three study languages will not be eligible and are unlikely to benefit from this consent intervention.
Why it matters
Potential benefit: If successful, the visual ICF could help women make clearer, more informed decisions about enrolling their infants by improving understanding, satisfaction, and trust.
How similar studies have performed: Prior work using simplified or pictorial consent materials in various settings has sometimes improved participant understanding, but results have been mixed and remain context-dependent.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women ages 18-45 years of age * Pregnant women or women that have recently given birth within the past 2-6 weeks Exclusion Criteria: * 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)
Where this trial is running
Worcester, Western Cape
- Stellenbosch University Wooster Rural Campus — Worcester, Western Cape, South Africa (Recruiting)
Study contacts
- Principal investigator: Louise Kuhn, PhD — Columbia University
- Study coordinator: Louise Kuhn, PhD
- Email: lk24@cumc.columbia.edu
- Phone: 2123052398
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.