Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-27 @ 10:52 PM
Study NCT ID:
NCT07122960
Status:
RECRUITING
Last Update Posted:
2025-08-14
First Post:
2025-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Strengthening Informed Consent for Authentic Participation in Perinatal HIV Research
Sponsor:
Columbia University
Organization:
Study Overview
Official Title:
Strengthening Informed Consent for Authentic Participation in Perinatal HIV Research
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
The overall goal of the study is to inform efforts to improve meaningful consent into clinical trials. The investigators are evaluating whether substituting a visual informed consent form (ICF) for the usual text-only ICF will increase potential participants' understanding of the risks and benefits of research and contribute to more informed participation.
This study is nested within a larger clinical trial of a nutrition intervention for infants underway in South Africa. For this larger trial, a visual ICF was developed that covers the identical content of a standard text-only ICF. For this sub-study (n=40), women who are considering enrollment into this larger study who agree to enroll in the sub-study, will be randomized to either receive the visual ICF or to receive the text-only ICF. Following the decision to either participate or not in the larger trial, women will be interviewed about their knowledge recall of the content of the ICF including concerning the trial goal, the voluntary nature of participation, potential benefits, potential risks, and randomization measured using a mix of true/false/uncertain and likert-type response options. Questions will also be asked about decision conflict, self-rated understanding, self-efficacy, and satisfaction with the informed consent process. Eight weeks later, at one of the follow-up visits in the larger trial, these questions will be repeated to determine knowledge retention and decision regret and trust in the study team. The evaluation includes both quantitative and qualitative data which will be analyzed using standard mixed methods analysis techniques.
In addition, an independent population of women from the same area with infants of the same age but who are not eligible for the larger trial will be enrolled (n=20). For this population, participating in the trial is a hypothetical situation and thus respondents have no direct connection with the study team and thus are less prone to positive bias in responses. Questions will be asked concerning opinions about the visual ICF using a semi-structured, qualitative, think-aloud approach.
This study is nested within a larger clinical trial of a nutrition intervention for infants underway in South Africa. For this larger trial, a visual ICF was developed that covers the identical content of a standard text-only ICF. For this sub-study (n=40), women who are considering enrollment into this larger study who agree to enroll in the sub-study, will be randomized to either receive the visual ICF or to receive the text-only ICF. Following the decision to either participate or not in the larger trial, women will be interviewed about their knowledge recall of the content of the ICF including concerning the trial goal, the voluntary nature of participation, potential benefits, potential risks, and randomization measured using a mix of true/false/uncertain and likert-type response options. Questions will also be asked about decision conflict, self-rated understanding, self-efficacy, and satisfaction with the informed consent process. Eight weeks later, at one of the follow-up visits in the larger trial, these questions will be repeated to determine knowledge retention and decision regret and trust in the study team. The evaluation includes both quantitative and qualitative data which will be analyzed using standard mixed methods analysis techniques.
In addition, an independent population of women from the same area with infants of the same age but who are not eligible for the larger trial will be enrolled (n=20). For this population, participating in the trial is a hypothetical situation and thus respondents have no direct connection with the study team and thus are less prone to positive bias in responses. Questions will be asked concerning opinions about the visual ICF using a semi-structured, qualitative, think-aloud approach.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R21HD115480 | NIH | None | https://reporter.nih.gov/quic… | View |