Improving informed consent materials for mothers and newborns in HIV research
Strengthening informed consent for authentic participation in perinatal HIV research
['FUNDING_R21'] · COLUMBIA UNIVERSITY HEALTH SCIENCES · NIH-11380499
This project uses clear visual consent materials to help breastfeeding mothers, including those living with HIV, understand and decide about joining perinatal research.
Quick facts
| Phase | ['FUNDING_R21'] |
|---|---|
| Study type | Nih_funding |
| Sex | All |
| Sponsor | COLUMBIA UNIVERSITY HEALTH SCIENCES (nih funded) |
| Locations | 1 site (NEW YORK, UNITED STATES) |
| Trial ID | NIH-11380499 on ClinicalTrials.gov |
What this research studies
If I am a new mother, the team will offer simple picture-based consent materials to explain what joining a breastfeeding research study means. Columbia and Stellenbosch researchers will test those visual consent forms inside an ongoing trial of a synbiotic given to breastfeeding mother-infant pairs. Social science and empirical ethics experts will interview mothers, observe consent conversations, and collect feedback to find confusing parts and improve the visuals. Those results will shape a larger future trial and help determine whether visuals can replace standard written consent in this setting.
Who could benefit from this research
Good fit: Breastfeeding mothers and their newborns—including mothers living with HIV—recruited shortly after delivery (typically within the first 4 weeks) are the intended participants.
Not a fit: People not enrolled in perinatal or maternal HIV research (such as non-breastfeeding mothers, older children, or individuals outside the study areas) are unlikely to receive direct benefit from this project.
Why it matters
Potential benefit: Could make consent easier to understand so mothers can give truly informed permission and feel more comfortable taking part in perinatal HIV research.
How similar studies have performed: Visual consent approaches have been used in prior maternal-infant studies and show promise, but more data are needed before replacing written forms.
Where this research is happening
NEW YORK, UNITED STATES
- COLUMBIA UNIVERSITY HEALTH SCIENCES — NEW YORK, UNITED STATES (ACTIVE)
Researchers
- Principal investigator: KUHN, LOUISE — COLUMBIA UNIVERSITY HEALTH SCIENCES
- Study coordinator: KUHN, LOUISE
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.
Conditions: Acquired Immune Deficiency Syndrome Virus, Acquired Immunodeficiency Syndrome Virus