Notice Number: NOT-AI-19-066

Key Dates
Release Date: August 16, 2019

Issued by
National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

The purpose of this Notice is to announce a change to the following section of RFA-AI-19-045 “HIV/AIDS Clinical Trials Units (UM1 Clinical Trial Required)” to include the addition of an optional Attachment.

Part 2. Full Text of Announcement
Section IV. Application and Submission Information
2. Content and Form of Application Submission

Current language:

Other Attachments: Applicants must provide the following additional material specified below. Each attachment should be uploaded as a separate PDF using the indicated filenames (which will serve as application bookmarks).

Attachment 1. Proposed Clinical Trials Network Affiliation per CRS (use filename "Overall CRS-Network")

Each CRS must propose to affiliate with at least one HIV/AIDS clinical trials network. Provide the following information in a table format for each CRS (if desired, applicants may use the suggested Overall CRS-Network Table format described at the following website): CRS Name, current NIAID CRMS site ID (if applicable), CRS Leader, Network Affiliation (HIV Vaccines Clinical Trials Network, HIV Prevention Clinical Trials Network, HIV/AIDS Adult Therapeutics Clinical Trials Network, and/or HIV/AIDS Maternal, Adolescent and Pediatric Therapeutics Clinical Trials Network)

Attachment 2. CRS Site Characteristics (use filename "CRS Site Characteristics")

For each proposed CRS, provide the following information in a table format to describe the participant cohort(s) that the CRS has demonstrated experience recruiting into clinical trials. For each CRS provide the following categories and population characteristics (if desired, applicants may use the suggested Site Characteristic table format described at the following website) labeled by site name and site number (if applicable). Include the following categories and population characteristics:

• Sex: Female, Male, and/or Transgender
• Age: Infant, Children, Adolescent (13-17 years), Young Adult (18-24 years), and/or Adult
• Race: American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, White, and/or Other Race
• Ethnicity: Hispanic or Latino and/or, Not Hispanic or Latino
• Risk Factor: Mother-to-Child Transmission (MTCT), Men Who Have Sex with Men (MSM), Bisexual, Heterosexual, Sex Work, Transactional Sex, People Who Inject Drugs, Sero-Discordant Couple, Breastfeeding/Lactating, and/or Substance Abuse
• Disease/Condition: HIV Uninfected, HIV Exposed Infants, HIV Infected, HIV Clade A, HIV Clade B, HIV Clade C, HIV Clade D, HIV Clade E, Acute HIV Infection, Chronic HIV Infection, Treatment Na ve, HIV Related Malignancies, HIV/TB Co-infection, TB, MDR TB, XDR TB, HIV/HBV Co-Infection, HBV, HIV/HCV Co-infection, HCV, Infectious Comorbidities, Non-Infectious Comorbidities, Pregnancy, and/or Post-Menopausal

Revised language:

Other Attachments: Applicants must provide the following additional material specified below for Attachments 1 and 2. Attachment 3 is optional. Each attachment should be uploaded as a separate PDF using the indicated filenames (which will serve as application bookmarks).

Attachment 1. Proposed Clinical Trials Network Affiliation per CRS (use filename "Overall CRS-Network")

Each CRS must propose to affiliate with at least one HIV/AIDS clinical trials network. Provide the following information in a table format for each CRS (if desired, applicants may use the suggested Overall CRS-Network Table format described at the following website): CRS Name, current NIAID CRMS site ID (if applicable), CRS Leader, Network Affiliation (HIV Vaccines Clinical Trials Network, HIV Prevention Clinical Trials Network, HIV/AIDS Adult Therapeutics Clinical Trials Network, and/or HIV/AIDS Maternal, Adolescent and Pediatric Therapeutics Clinical Trials Network)

Attachment 2. CRS Site Characteristics (use filename "CRS Site Characteristics")

For each proposed CRS, provide the following information in a table format to describe the participant cohort(s) that the CRS has demonstrated experience recruiting into clinical trials. For each CRS provide the following categories and population characteristics (if desired, applicants may use the suggested Site Characteristic table format described at the following website) labeled by site name and site number (if applicable). Include the following categories and population characteristics:

• Sex: Female, Male, and/or Transgender
• Age: Infant, Children, Adolescent (13-17 years), Young Adult (18-24 years), and/or Adult
• Race: American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, White, and/or Other Race
• Ethnicity: Hispanic or Latino and/or, Not Hispanic or Latino
• Risk Factor: Mother-to-Child Transmission (MTCT), Men Who Have Sex with Men (MSM), Bisexual, Heterosexual, Sex Work, Transactional Sex, People Who Inject Drugs, Sero-Discordant Couple, Breastfeeding/Lactating, and/or Substance Abuse
• Disease/Condition: HIV Uninfected, HIV Exposed Infants, HIV Infected, HIV Clade A, HIV Clade B, HIV Clade C, HIV Clade D, HIV Clade E, Acute HIV Infection, Chronic HIV Infection, Treatment Na ve, HIV Related Malignancies, HIV/TB Co-infection, TB, MDR TB, XDR TB, HIV/HBV Co-Infection, HBV, HIV/HCV Co-infection, HCV, Infectious Comorbidities, Non-Infectious Comorbidities, Pregnancy, and/or Post-Menopausal

Attachment 3. Ending the HIV Epidemic: A Plan for America (use filename "Ending the HIV Epidemic”)

This attachment is optional and separate from the NIH HIV/AIDS Clinical Trials Networks research priority areas referenced above and listed here. The role of the NIH, as a research platform in the Ending the HIV Epidemic: A Plan for America (EHE) initiative, is to support implementation science research by addressing the four key pillars (Diagnose, Treat, Prevent, and Respond). NIH/NIAID is seeking domestic (U.S.) institutions/sites with demonstrated linkages to partners in specific jurisdictions: local, county and state health departments and community-based organizations (CBOs) funded by the Centers for Diseases Control and Prevention (CDC), the Health Resources and Services Administration (HRSA), the Substance Abuse and Mental Health Services Administration (SAMSHA), the Indian Health Service (IHS), or other non-NIAID funding, to conduct implementation science research aligned with the goals of this initiative. Eligible CTU applicants will have one or more linkages to the highest burden areas of the nation (48 highest burden U.S. counties, DC, San Juan or in 7 states with a substantial rural HIV burden). Applicants may work with jurisdictions outside of their institution’s location.

Interested and eligible applicants should describe linkages with domestic institutions/sites that have the capacity and capability to conduct research as outlined above. Label and number each partner institution/site in the specific jurisdictions described above, using the following outline as guidance:

(i) Identify the partner name and geographic location of the partner site.
(ii) Describe the linkage/relationship with partner site.
(iii) Describe the capacity and capability of the partner site to perform implementation science research.

The “Ending the HIV Epidemic” attachment is limited to 12 pages.

All other aspects of the FOA remain unchanged.

Inquiries

Please direct all inquiries to:

Bola Adedeji, R.Ph., M.S.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3055
Email: BAdedeji@niaid.nih.gov