Investigating the impact of modern antiretroviral treatments on birth outcomes and congenital abnormalities.
Tsepamo Plus: Expanded Congenital Abnormalities Surveillance with an Emulated Clinical Trial to Evaluate Weight Impact on Birth Outcomes for Newer ART Regimens
This study is looking at how newer HIV treatments, especially those with dolutegravir and tenofovir alafenamide, impact pregnancy and the health of babies, and it aims to help doctors give better advice to pregnant women taking these medications.
Quick facts
| Grant type | P01 program project |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Harvard School of Public Health NIH-funded |
| Lab location | 1 site (Boston, United States) |
| Project ID | NIH-10914851 on NIH RePORTER |
What this research studies
This research focuses on understanding how newer antiretroviral treatments, particularly those containing dolutegravir and tenofovir alafenamide, affect pregnancy outcomes and the risk of congenital abnormalities. It builds on the Tsepamo Study, which has monitored over 180,000 deliveries in Botswana, to gather critical safety data. The study aims to evaluate the relationship between maternal weight gain and birth outcomes, particularly in relation to neural tube defects. By expanding surveillance and analyzing data from diverse maternal weight groups, the research seeks to provide more tailored treatment guidelines for pregnant women on ART.
Who could benefit from this research
Good fit: Ideal candidates for this research include pregnant women in Botswana who are receiving or considering antiretroviral treatment.
Not a fit: Patients who are not pregnant or those who are not receiving antiretroviral treatment may not benefit from this research.
Why it matters
Potential benefit: If successful, this research could lead to improved safety guidelines for antiretroviral treatments during pregnancy, ultimately enhancing birth outcomes for mothers and their babies.
How similar studies have performed: Previous studies, including the Tsepamo Study, have successfully identified safety concerns related to antiretroviral treatments in pregnancy, indicating that this research builds on established findings.
Where this research is happening
Boston, United States
- Harvard School of Public Health — Boston, United States (Active)
Researchers
- Principal investigator: Shapiro, Roger L — 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.