Strengthening Informed Consent for Authentic Participation in Perinatal HIV Research
Recruiting
N/A
Interventional Study
Consent Form
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 45
- Sex
- Female
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 60 (estimated)
- Sponsor
- Columbia University · Other
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About This Trial
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…
Trial Locations
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Eligibility 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)
* Inabili…
Contacts