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Cartoon consent forms could help mothers better understand HIV research

NCT ID NCT07122960

Knowledge-focused Sponsor: Columbia University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This study tests whether a visual informed consent form—using cartoons, graphics, and simple text—helps women better understand a clinical trial compared to a standard text-only form. Participants are pregnant women or new mothers considering enrollment in a nutrition trial for their infants. Researchers will measure knowledge recall and self-rated understanding right after the consent process and again 8 weeks later. The goal is to improve how informed consent is obtained in perinatal HIV research.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, visual consent forms could improve how well participants understand clinical trials, leading to more informed and meaningful consent.
What could go wrong
This is a small, early-stage study focused on understanding, not on a treatment. The visual form may not improve understanding significantly, and results may not apply to other settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

58 people

The number who actually took part.

Started

Sep 2024

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Consent form

Contacts and locations

Locations

  • Stellenbosch University Wooster Rural Campus

    Worcester, Western Cape, 6850, South Africa