Improving how HIV treatments and birth outcomes are tracked during pregnancy
Methodology: Developing Reporting Criteria for Pregnancy Surveillance Cohorts and New Techniques for Supporting Target Trials
This project improves how information about HIV medicines taken in pregnancy is collected and reported so safety issues can be spotted sooner for pregnant people and their babies.
Quick facts
| Grant type | P01 program project |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Harvard University D/b/a Harvard School of Public Health NIH-funded |
| Lab location | 1 site (Boston, United States) |
| Project ID | NIH-11178664 on NIH RePORTER |
What this research studies
The work builds on the Tsepamo birth outcomes surveillance program in Botswana that has followed thousands of pregnant people living with HIV. The team will keep collecting detailed information about antiretroviral (ARV) exposures in pregnancy and refine rules for when and how to report potential safety signals. Researchers will test statistical monitoring methods, create guidance for reporting from unplanned analyses, and develop ways to compare (benchmark) surveillance findings with results from randomized trials. The project also works to combine evidence from different pregnancy surveillance sources to give clearer answers about medication safety.
Who could benefit from this research
Good fit: Ideal candidates are pregnant people living with HIV who are part of birth-outcome surveillance programs (such as Tsepamo in Botswana) or could contribute data to similar surveillance efforts.
Not a fit: People who are not pregnant, who do not have HIV, or who need immediate treatment changes for their own care are unlikely to receive direct clinical benefits from this methodological project.
Why it matters
Potential benefit: If successful, this could lead to earlier, more reliable detection of safety problems with HIV drugs in pregnancy and clearer guidance for treatment choices.
How similar studies have performed: The Tsepamo program has previously reported important pregnancy-safety findings, but the specific reporting criteria, sequential monitoring methods, and formal benchmarking approaches proposed here are new refinements.
Where this research is happening
Boston, United States
- Harvard University D/b/a Harvard School of Public Health — Boston, United States (Active)
Researchers
- Principal investigator: Swanson, Sonja Alsemgeest — Harvard University D/b/a Harvard School of Public Health
- Study coordinator: Swanson, Sonja Alsemgeest
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.