Consent FormNCT07122960
Strengthening Informed Consent for Authentic Participation in Perinatal HIV Research
A study testing Visual ICF and Text-only ICF in people with Consent Form, run by Columbia University at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Consent Form
- What is being tested?
- Visual ICF and Text-only ICF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSouth Africa
- Study dates
- 2 Sep 2024to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women ages 18-45 years of age
- Pregnant women or women that have recently given birth within the past 2-6 weeks
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Stellenbosch University Wooster Rural Campus
Worcester, Western Cape, 6850
About this study
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.
Read the 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.
- Conditions
- Consent Form
- Being tested
- Visual ICF, Text-only ICF
- Keywords
- Consent process
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual ICFOther
This visual ICF fully represents all the content of the standard, text-only ICF using cartoon characters, graphics and easy text.
Text-only ICFOther
Text-only ICF
| Study group | Role | What they receive |
|---|---|---|
| Visual Informed Consent Form (ICF) | Experimental | Not described Receives: Other: Visual ICF |
| Text-only Informed Consent Form | Active comparator | Not described Receives: Other: Text-only ICF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summed score from the validated Quality of Informed Consent (QUIC) instrument.
The QUIC measures knowledge recall. The summed score of 10 knowledge items comprising key concepts of informed consent will be calculated. The scores range between 0 and 22 with higher scores indicating higher knowledge.
Measured: Immediately after the consent process (Day 0) and 8 weeks later
Secondary outcomes (2)
Self-rated Understanding
Six item self-rated assessment of understanding, which extends beyond knowledge recall to assess comprehension and ability to assimilate information. Scores range between 0-12 with higher scores indicating better understanding.
Measured: Immediately after consent process (Day 0)
Decision Regret Scale
Validated measure with 5 items assessing attitudes about the decision making outcome. The possible score ranges are 0-10 with higher scores indicating less regret.
Measured: 8 weeks after consent process
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start2 Sep 2024
- Primary completion4 Dec 2025
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Consent FormStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Stellenbosch
- Responsible party
- Principal investigator, Louise Kuhn, Columbia University
- Investigators
- Louise Kuhn, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122960
- Sponsor's protocol ID
- AAAV1833
- Other IDs
- 1R21HD115480
- Status last verified
- Jul 2026
- First submitted
- 8 Aug 2025
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening Informed Consent for Authentic Participation in Perinatal HIV Research
- ClinicalTrials.gov ID
- NCT07122960
- Acronym / sponsor ID
- AAAV1833
- Conditions
- Consent Form
- Keywords
- Consent process
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Stellenbosch
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 4 Dec 2025 (actual)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 14 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visual Informed Consent Form (ICF) | Experimental | Other: Visual ICF |
| Text-only Informed Consent Form | Active comparator | Other: Text-only ICF |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women ages 18-45 years of age
- Pregnant women or women that have recently given birth within the past 2-6 weeks
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual ICFThis visual ICF fully represents all the content of the standard, text-only ICF using cartoon characters, graphics and easy text. | Other | Visual Informed Consent Form (ICF) |
| Text-only ICFText-only ICF | Other | Text-only Informed Consent Form |
Primary outcome
Summed score from the validated Quality of Informed Consent (QUIC) instrument.
Time frame: Immediately after the consent process (Day 0) and 8 weeks later
The QUIC measures knowledge recall. The summed score of 10 knowledge items comprising key concepts of informed consent will be calculated. The scores range between 0 and 22 with higher scores indicating higher knowledge.
2 secondary outcomes
Self-rated Understanding
Time frame: Immediately after consent process (Day 0)
Decision Regret Scale
Time frame: 8 weeks after consent process
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
Related trials for Consent Form
Recruiting
Effectiveness of Large Language Model for Anaesthesia and Procedural Consent
Consent Forms, Anesthesia
Not yet recruitingObservational study
Effect of Visual Aids Added to Informed Consent on Patient Understanding and Anesthesia Awareness
Anesthesia, Surgical Patients
Recruiting
Post-market Clinical Follow-up Study of NEMOST V2
Scoliosis Neuromuscular, Scoliosis Idiopathic
Recruiting
Achieving Chronic Care equiTy by leVeraging the Telehealth Ecosystem
Diabetes
Not yet recruitingPhase 2
Envafolimab Combined With Axitinib as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma
Advanced Renal Cell Carcinoma (aRCC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louise Kuhn, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual ICF and Text-only ICF in people with Consent Form, run by Columbia University at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Summed score from the validated Quality of Informed Consent (QUIC) instrument. (time frame: Immediately after the consent process (Day 0) and 8 weeks later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.