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Proposing a Network Behavioral Study MTN
This page is for current and future network behavioral and social science researchers as they propose new studies, request data sets for additional analyses, apply for scholar programs, and liaise with colleagues.
 
Below, please find information on the steps required to propose a NIH HIV/AIDS Clinical Trials Network study. Included are links to web pages offering details on proposing a study to the various NIH networks and committees addressing behavioral and social science questions.
 
Click on the name of the Network to view the information below.
 
 

 Networks

 

ACTG                                                   IMPAACT       ​

HPTN                                                    MTN

HVTN                                                    Affiliated Research Groups              

MTN Network Background & Scientific Priorities:

MTN was established in 2006, with co-funding from the NIH’s National Institute of Mental Health and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The MTN brings together international investigators and community and industry partners devoted to reducing the sexual transmission of HIV through the development and evaluation of products used orally or applied topically. MTN-affiliated researchers and partners work within a unique infrastructure specifically designed to facilitate the research required to support licensure of these products for widespread use.  MTN was designed to identify promising candidate microbicides and provide the necessary safety and efficacy testing in an efficient and cost effective manner to support the progression of safe, effective products to licensure. With the belief that the best clinical research program involves an open submission process for study concepts and a timeline-driven protocol development and implementation process, the MTN accepts concepts for new protocols from all interested parties.
 
Because the network focuses on development of new drug entities for prevention, the types of studies which are within the scope of the MTN are those that fill gaps in the development product pathway toward licensure (classic Phase 1 safety and acceptability studies, Phase 2 expanded safety studies and Phase 2B/3 effectiveness studies), bridging studies to other populations (adolescents, pregnant or lactating women, post-menopausal women), and ancillary studies which provide data on adherence, biomarkers of efficacy, or evaluation of alternative formulations. Concepts arise from a variety of sources and MTN reviews all study concepts that are submitted for consideration. Importantly, many study concepts are submitted by researchers or organizations outside of the network, most frequently by product Investigational New Drug (IND) holders based upon FDA request for safety or efficacy data. Other protocol concepts are submitted from members of the Biomedical Science Working Group (BSWG), Behavioral Research Working Group (BRWG) or Community Working Group (CWG), from site investigators, or by members of the Network Laboratory. Provided that the proposed study fits into the mission of MTN, the concept is routed to the Executive Committee (EC) for review, and approval is based on a tally of written ballots.
Opportunities & Proposal Process:
Relevant Committees:
  • Behavioral Research Working Group: will develop and implement the MTN behavioral science agenda through participation of BRWG members on each MTN protocol for which there is a behavioral component and to set priorities for behavioral research on microbicides within the MTN. 
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