Frequently Asked Questions (FAQ)

What is the STAR Sexually Transmitted Infections Clinical Trials Group (STI CTG)?

The STAR STI CTG is a National Institutes of Health (NIH)-sponsored clinical trials group that supports large, randomized clinical trials in the field of prevention, diagnosis, and treatment of STIs. (https://starstictg.s-3.net/about)

Who is the leadership for the STAR STI CTG?

The STAR STI CTG is led by Jeffrey Klausner, M.D., Professor of Medicine and Public Health at the University of California, Los Angeles (UCLA), and Dr. Sheldon Morris, Associate Professor at University of California, San Diego in the Division of Infectious Diseases, Department of Medicine and Division of Family Medicine, Department of Family Medicine and Public Health.

How is the STAR STI CTG funded?

The STAR STI CTG is funded through an indefinite delivery indefinite quantity (IDIQ) contract awarded annually by the NIH, National Institute of Allergy and Infectious Diseases (NIAID), Division of Microbiology and Infectious Diseases (DMID). (http://www.niaid.nih.gov/about/organization/dmid/Pages/default.aspx)

What is an IDIQ? How does the IDIQ process work?

An IDIQ is a U.S. Federal Government contracting acronym meaning indefinite delivery/indefinite quantity. This type of contract provides for an indefinite quantity of supplies or services during a fixed period of time. An IDIQ is used when the U.S. General Services Administration (GSA) cannot determine, above a specified minimum, the precise quantities of supplies or services that the Government will require during the contract period.

IDIQ contracts have no associated work; rather, work/funding is issued using task orders (TOs). Every TO has a prescribed scope of work, and only original IDIQ awardees can compete for TOs. Future TOs may be issued for either protocol development or protocol implementation.

Who can submit concept proposals (CPs) to the STAR STI CTG?

Anyone can submit a CP to the STAR STI CTG.

How can I submit a CP to the STAR STI CTG?

Please submit CPs via the CP submission portal (https://proposals.starstictg.s-3.net).

What types of CPs are appropriate for submission to the STAR STI CTG?

The STAR STI CTG supports large, randomized clinical trials in the field of prevention, diagnosis, and treatment of STIs. Included below is a list of priority areas of research provided by DMID/NIH. CP submissions are not restricted to these priority areas of research.

  • Antibiotic Resistance in STIs
  • Prevention of Preterm Birth and Stillbirth
  • Diagnostics of STIs
  • Neglected and Reemerging Sexually Transmitted Diseases
  • Adolescent Sexual Health and STD Vaccines
  • Syphilis in Men Who Have Sex With Men
  • Drug-Resistant Gonorrhea (GC)
  • Pelvic Inflammatory Disease (PID)
  • Bacterial Vaginosis (BV)
  • Herpes and Chlamydia Vaccines

Are proposals for observational studies considered or just clinical trials?

The STAR STI CTG was created to fund large, randomized clinical trials in the field of prevention, diagnosis, and treatment of STIs. CPs for observational studies will be considered, but continued development or funding is not guaranteed.

Is the budget required at the time of submitting the CP?

Once a CP is submitted via https://proposals.starstictg.s-3.net, the STAR STI CTG CP Coordinator will forward the budget template to the proposing investigator for completion.

Is there a budget limit per concept proposal?

There is no budget limit per concept proposal. The STAR STI CTG requests that all submitted budgets be reasonable and accurately capture the costs for the proposed CP.

Will funding be provided for clinical research site (CRS) core personnel?

Funding will be provided to sites on an ad hoc basis dependent upon the protocol into which a site is enrolling.

Will salary support be provided for protocol team leadership?

Salary support for a protocol PI or protocol team leadership may be included in the CP budget. Please note that DMID will review and approve all budgets prior to protocol development and/or implementation. As such, the funding of all costs included in the original CP budget is not guaranteed.