# Leadership and Operations Center (LOC): Microbicide Trials Network

> **NIH NIH UM1** · MAGEE-WOMEN'S RES INST AND FOUNDATION · 2021 · $3,164,556

## Abstract

The objective of this application is to request an extension of the Microbicide Trials Network (MTN)
due to delays in completion of studies related to the COVID-19 pandemic. MTN was established in
2006 and is supported by NIAID, NICHD and NIMH. It is comprised of a Leadership and Operations Center
(LOC); a Laboratory Center (LC) and a Statistical and Data Management Center (SDMC). The aims of the
MTN are to bring to regulatory licensure the vaginal microbicide products; conduct regulatory studies of the
most promising rectal microbicide products; provide administration, fiscal, evaluation, and governance;
provide laboratory support and training in order to perform immunologic, virologic, and pharmacologic
testing; implement and oversee data collection and management as necessary for successful
implementation of clinical trials; collaborate with other NIH-sponsored HIV clinical trials networks to
harmonize methods; faci litate collaboration with external stakeholders; provide training and mentorship to
junior investigators; engage with communities and stakeholders regarding HIV prevention technologies.
the MTN has been scientifically productive with completion of clinical trials in Asia, South America, Africa
and the US including approximately 15,000 participants. The MTN has supported the successful
completion of a broad range of studies which will support the licensure of the 25 mg dapivirine ring. The
MTN was on a trajectory toward completion of its activities by the end of the grant period. Activation,
enrollment and/or follow-up has been significantly interrupted by the COVID-19 pandemic for three
protocols which will provide essential safety data regarding the dapivirine vaginal ring in African
adolescents, as well as pregnant and breastfeeding African women. Clinical trial activities were suspended
indefinitely as of March 2020, to protect the safety of the clinical staff and study participants. Additionally,
study sample analysis on completed and ongoing was halted in accordance with stay at home orders. We
are requesting a one-year extension for UM1AI 068633 MTN Leadership and Operations Center for
successful completion of clinical trials and analyses of completed trials which have been interrupted due to
the COVID-19 pandemic. Completion of clinical trial activities and sample analysis fulfills our obligation to
protect scientific quality and data integrity as well as ensuring that obligations to study participants and
communities who have participated in these trials will be met.

## Key facts

- **NIH application ID:** 10174309
- **Project number:** 4UM1AI068633-15
- **Recipient organization:** MAGEE-WOMEN'S RES INST AND FOUNDATION
- **Principal Investigator:** Sharon L. Hillier
- **Activity code:** UM1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $3,164,556
- **Award type:** 4C
- **Project period:** 2006-06-29 → 2021-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10174309

## Citation

> US National Institutes of Health, RePORTER application 10174309, Leadership and Operations Center (LOC): Microbicide Trials Network (4UM1AI068633-15). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10174309. Licensed CC0.

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