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
| Condition(s) | Consent Form |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 effort |
| Who can participate | 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) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Columbia University |
| Locations | Worcester, Western Cape, South Africa |
| Start date | 2024-09-02 |
| NCT ID | NCT07122960 |
| Official listing | https://clinicaltrials.gov/study/NCT07122960 |