Leadership and Operations Center (LOC): Microbicide Trials Network

NIH RePORTER · NIH · UM1 · $3,164,556 · view on reporter.nih.gov ↗

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
MAGEE-WOMEN'S RES INST AND FOUNDATION
Principal Investigator
Sharon L. Hillier
Activity code
UM1
Funding institute
NIH
Fiscal year
2021
Award amount
$3,164,556
Award type
4C
Project period
2006-06-29 → 2021-11-30