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Strengthening Informed Consent for Authentic Participation in Perinatal HIV Research

Active Not RecruitingNA

Sponsor: Columbia University

Conditions: Consent Form

Interventions: Visual ICF, Text-only ICF

Countries: South Africa

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to 45 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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)
* Inability to communicate in one of the three languages (English, isiXhosa, or Afrikaans)

Locations (1)

Worcester, Western Cape, South Africa