Strengthening Informed Consent for Authentic Participation in Perinatal HIV Research (NCT07122960) | Clinical Trial Compass
RecruitingNot Applicable
Strengthening Informed Consent for Authentic Participation in Perinatal HIV Research
South Africa60 participantsStarted 2024-09-02
Plain-language 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.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Summed score from the validated Quality of Informed Consent (QUIC) instrument.
Timeframe: Immediately after the consent process (Day 0) and 8 weeks later