# Botswana-Harvard School of Public Health AIDS Initiative Partnership CTU

> **NIH NIH UM1** · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · 2020 · $2,310,807

## Abstract

DESCRIPTION (provided by applicant):
This proposal is to establish an AIDS research Clinical Trials Unit (CTU) at the Botswana-Harvard
School of Public Health AIDS Initiative Partnership (BHP) in Botswana. The CTU would conduct a fully
integrated program for conducting AIDS clinical trials in three programmatic areas: vaccines, therapy,
and prevention research. These areas of emphasis would coincide with trials conducted by the HIV
Vaccine Trials Network (HVTN), the Adult AIDS Clinical Trials Group (AACTG), and the International
Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT). Trials are already conducted at
BHP under the auspices of HVTN and AACTG.
The Botswana CTU would include three Clinical Research Sites (CRSs). These would be: (1) the
Gaborone-based HIV Vaccine Trial Unit (HVTU) CRS; (2) the Gaborone-based Prevention and
Treatment Trial (PTT) CRS, which would do both prevention (IMPAACT) and treatment (AACTG) trials;
and (3) the Molepolole-based Prevention and Treatment Trial (PTT) CRS which would also do both
prevention (IMPAACT) and treatment (AACTG) trials. This organizational structure is designated as
such because vaccine trials would be done only in Gaborone, and the HVTU CRS facility is separate
from the PTT CRS facility in Gaborone.
The combined resources of the BHP have major expertise in clinical trial research, extensive facilities,
and a large and diversified population of potential volunteers for the conduct of Phase I, Phase II, and
Phase III trials. We plan to enroll at least 20 subjects in each of the three sites for each respective area
of emphasis during the first six months of the award, and have already enrolled much larger numbers
on an annual basis in all three areas. Procedures to assure ethical review, clinical oversight, informed
consent, government and institutional approvals, and community relations are described. The proposed
PI for the CTU, Dr. M. Essex, and the proposed heads for the three CRSs, Drs. T. Villafana, I. Thior,
and W. Wester would provide both intellectual and administrative leadership.

## Key facts

- **NIH application ID:** 9825494
- **Project number:** 5UM1AI069456-14
- **Recipient organization:** HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH
- **Principal Investigator:** MYRON E ESSEX
- **Activity code:** UM1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $2,310,807
- **Award type:** 5
- **Project period:** 2007-02-01 → 2020-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9825494

## Citation

> US National Institutes of Health, RePORTER application 9825494, Botswana-Harvard School of Public Health AIDS Initiative Partnership CTU (5UM1AI069456-14). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9825494. Licensed CC0.

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