Monitoring birth defects and weight-related pregnancy outcomes with newer HIV medicines
Tsepamo Plus: Expanded Congenital Abnormalities Surveillance with an Emulated Clinical Trial to Evaluate Weight Impact on Birth Outcomes for Newer ART Regimens
This project follows pregnancies in people with HIV to learn how newer HIV drugs and maternal weight affect birth defects and other birth outcomes.
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-11178661 on NIH RePORTER |
What this research studies
If you are pregnant and living with HIV, the project collects information from deliveries and medical records in Botswana to track birth defects and other newborn outcomes linked to specific HIV medicines. Investigators focus on newer drugs such as dolutegravir (DTG) and tenofovir alafenamide (TAF) and examine how baseline maternal weight and weight gain during pregnancy relate to outcomes. The team uses the large Tsepamo surveillance database of over 180,000 deliveries and applies methods that mimic a clinical trial to compare treatments. Results are intended to guide safer treatment choices in settings that rely on a single first-line regimen.
Who could benefit from this research
Good fit: Pregnant people living with HIV (or people of childbearing potential on HIV treatment) receiving newer ART regimens, especially those receiving care at participating hospitals in Botswana or similar settings, are the ideal participants.
Not a fit: People without HIV, those not pregnant, or individuals receiving care outside the participating surveillance sites are unlikely to directly benefit from this project.
Why it matters
Potential benefit: If successful, this work could help doctors choose HIV treatments in pregnancy that lower the risk of birth defects and poor birth outcomes.
How similar studies have performed: Yes—earlier Tsepamo surveillance successfully identified safety signals such as the initial DTG neural tube concern and has produced influential safety data.
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: Shapiro, Roger L — Harvard University D/b/a Harvard School of Public Health
- Study coordinator: Shapiro, Roger L
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.