# Methodology: Developing Reporting Criteria for Pregnancy Surveillance Cohorts and New Techniques for Supporting Target Trials

> **NIH NIH P01** · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · 2022 · $59,121

## Abstract

The Tsepamo birth outcomes surveillance study has accrued many thousands of women living with HIV from
Botswana. The Tsepamo Plus study (Project 1) will continue to collect ARV exposures in pregnancy which are
rarely studied with high precision. Because Tsepamo can provide high precision when there is much uncertainty
about safety in pregnancy and Botswana typically rolls out new ARVs before other African countries, Tsepamo
may be the first to report on novel safety signals. This in turn makes Tsepamo highly influential in the
understanding of adverse ARV effects in pregnancy. Moreover, surveillance data alone can and should be used
to inform personal, clinical, or societal decision-making, especially when randomized trials are too costly,
unethical, or not timely enough. The objectives of this proposal are to evaluate methodologies and provide
guidance on methods for making best use of Tsepamo data and similar studies. Specifically, we aim to create
guidance on when to publicly report on safety signals based on unplanned analyses; evaluate the statistical
properties of various group sequential methods; develop and implement methods to benchmark results from
Tsepamo with results from a randomized trial; and develop and improve triangulation strategies within
pregnancy-related surveillance data.

## Key facts

- **NIH application ID:** 10495248
- **Project number:** 5P01HD107670-02
- **Recipient organization:** HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH
- **Principal Investigator:** SONJA ALSEMGEEST SWANSON
- **Activity code:** P01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $59,121
- **Award type:** 5
- **Project period:** 2021-09-24 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10495248

## Citation

> US National Institutes of Health, RePORTER application 10495248, Methodology: Developing Reporting Criteria for Pregnancy Surveillance Cohorts and New Techniques for Supporting Target Trials (5P01HD107670-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10495248. Licensed CC0.

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