Notice of Clarification on Research Objectives in RFA-AI-15-021 "NIH-PEPFAR Collaboration on Implementation Science for HIV: Towards an AIDS-free Generation (R21)"

Notice Number: NOT-AI-15-036

Key Dates
Release Date:   May 27, 2015

Related Announcements
RFA-AI-15-021    

Issued by
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institute of Nursing Research (NINR)

Purpose

The purpose of this Notice is to clarify the (a) responsive applications and (b) non-responsive applications in the Funding Opportunity Description section, as well as the (c) Research Plan in the Application and Submission Information section of the RFA-AI-15-021 "NIH-PEPFAR Collaboration on Implementation Science for HIV: Towards an AIDS-free Generation (R21)".

Part 2. Section I. Funding Opportunity Description

 

Research Objectives

Responsive Applications:
Current Language:

Neglected and Hard to Reach Populations:
Specific issues related to adolescent girls and young women as neglected and hard to reach populations include:

  • What are the most successful approaches for implementing and monitoring complex, multi-component interventions for females age 15-24? Can inputs that address more distal outcomes like social capital, personal agency and norms be tied to concrete health outcomes?
  • How can different combinations of interventions for females age 15-24 be evaluated for effectiveness in a way that is rigorous, fast and cost-efficient?
  • HIV prevalence tends to rise most sharply in females age 20-24, yet the most effective known interventions are for females age 15-19. What are the most effective packages for young women age 20-24?
  • Under the DREAMS initiative, PEPFAR will support limited demonstration projects of pre-exposure prophylaxis (PrEP) for sub-populations of females age 18-24 at very high risk. What are the most effective ways to identify appropriate sub-populations for PrEP? What are the most effective and appropriate delivery models?
  • Male sexual partners of girls and young women are often reluctant to be tested for HIV, and then to seek appropriate services, e.g. VMMC for those test negative and ART for those who test positive. What are the most effective approaches for identifying these male partners, and increasing uptake of HTC, VMMC and ART in this population?
  • What are the most effective approaches for increasing access to, and uptake of, appropriate clinical services among females age 15-24? Is there a model that is both effective and sustainable to make services “youth friendly”?
  • In some countries, young females in the higher wealth quintiles have higher rates of HIV, yet most prevention programs target those in lower income quintiles. What are effective HIV prevention strategies for reaching those higher wealth young females?
  • What are the most effective approaches for reaching vulnerable subsets of females age 15-24 such as young, married girls and women, young sex workers and those living in urban areas?
  • Girls who stay in school have a reduced risk of HIV acquisition. What are the key factors in parents’ decisions to enroll female children in school and support continued attendance? What are the most effective approaches for increasing parental support for school attendance in this population?

Revised Language:

Neglected and Hard to Reach Populations:
Specific issues related to adolescent girls and young women as neglected and hard to reach populations include:

  • What are the most successful approaches for implementing and monitoring complex, multi-component interventions for females age 15-24? Can inputs that address more distal outcomes like social capital, personal agency and norms be tied to concrete health outcomes?
  • How can different combinations of interventions for females age 15-24 be evaluated for effectiveness in a way that is rigorous, fast and cost-efficient?
  • HIV prevalence tends to rise most sharply in females age 20-24, yet the most effective known interventions are for females age 15-19. What are the most effective packages for young women age 20-24?
  • Under the DREAMS initiative, PEPFAR will support limited demonstration projects of pre-exposure prophylaxis (PrEP) for sub-populations of females age 18-24 at very high risk. What are the most effective ways to identify appropriate sub-populations for PrEP? What are the most effective and appropriate delivery models? NIH Implementation Science research is limited to evidence based interventions, and all interventions to be implemented must have appropriate regulatory approval and be indicated for the study population. Therefore, the following special requirements must be met by applicants wishing to address questions on PrEP in young women:
    • Research addressing PrEP is limited to study populations of young women between the ages of 18 and 24 years.  Adolescent girls less than 18 years of age may not be included
    • The research is restricted to countries where PrEP has been approved for use in HIV prevention by the MOH and/or national drug regulatory board
    • If special approval is being provided for PrEP demonstration projects, the PD/PI must submit a letter from the PEPFAR Coordinator in the country where the research will be done, verifying that government approval is anticipated prior to the date of these grant awards (Winter/Spring 2016).  This letter must be submitted with the grant application.  Applicants seeking information on the current PEPFAR Coordinator may contact the Scientific/Research Contact for this FOA (Melanie Bacon: mbacon@niaid.nih.gov
    • Applications including the required letter (indicating anticipated approval by local authorities) will be reviewed, but awards will not be made for any PrEP research which does not have written approval from the local government by December 31, 2015, regardless of how meritorious it is rated by reviewers.  Applications for research in countries where PrEP is not approved, or applications from countries involved in the PEPFAR DREAMS initiative that do not have a letter from the PEPFAR Coordinator, will be considered incomplete and will not proceed to review.
  • Male sexual partners of girls and young women are often reluctant to be tested for HIV, and then to seek appropriate services, e.g. VMMC for those test negative and ART for those who test positive. What are the most effective approaches for identifying these male partners, and increasing uptake of HTC, VMMC and ART in this population?
  • What are the most effective approaches for increasing access to, and uptake of, appropriate clinical services among females age 15-24? Is there a model that is both effective and sustainable to make services “youth friendly”?
  • In some countries, young females in the higher wealth quintiles have higher rates of HIV, yet most prevention programs target those in lower income quintiles. What are effective HIV prevention strategies for reaching those higher wealth young females?
  • What are the most effective approaches for reaching vulnerable subsets of females age 15-24 such as young, married girls and women, young sex workers and those living in urban areas?
  • Girls who stay in school have a reduced risk of HIV acquisition. What are the key factors in parents’ decisions to enroll female children in school and support continued attendance? What are the most effective approaches for increasing parental support for school attendance in this population?

Part 2. Section I. Funding Opportunity Description

Research Objectives

Current Language:
Non Responsive Applications:
Applications proposing basic laboratory based research or clinical trials testing unlicensed drugs/products or unproven interventions will be considered not responsive and will not be reviewed.

Revised Language:
Non Responsive Applications:
Applications proposing basic laboratory based research or clinical trials testing unlicensed drugs/products or unproven interventions will be considered not responsive and will not be reviewed.

Applications proposing PrEP research in countries where PrEP is not approved, or applications from countries involved in the PEPFAR DREAMS initiative that do not have a letter from the PEPFAR Coordinator, will be considered incomplete and will not proceed to review.

PHS 398 Research Plan

The following instructions for the Letters of Support attachment are being added to this FOA

Letters of Support:  If special approval is being provided for PrEP demonstration projects, the PD/PI must submit a letter from the PEPFAR Coordinator in the country where the research will be done, verifying that government approval is anticipated prior to the date of these grant awards (Winter/Spring 2016).  This letter must be submitted with the grant application.  Applicants seeking information on the current PEPFAR Coordinator may contact the Scientific/Research Contact for this FOA (Melanie Bacon: mbacon@niaid.nih.gov)

All other aspects of this FOA remain the same.

Inquiries

Please direct all inquiries to:

Kendall Bryant, PhD
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-402-0332
Email: kbryant@mail.nih.gov

Melanie C. Bacon, R.N., M.P.H. 
National Institute of Allergy and Infectious Diseases (NIAID) 
Telephone: 240-627-3215 
Email: mbacon@niaid.nih.gov

George Siberry, MD, MPH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 
Telephone: 301-496-7350
Email: siberryg@mail.nih.gov

Shoshana Y. Kahana, Ph.D. 
National Institute on Drug Abuse (NIDA) 
Telephone: 301-443-2261
Email: kahanas@nida.nih.gov 

Christopher Gordon, Ph.D. 
National Institute of Mental Health (NIMH) 
Telephone: 240-627-3867
Email: cgordon1@mail.nih.gov

Lyn Hardy, Ph.D., R.N. 
National Institute of Nursing Research (NINR) 
Telephone: 301-594-5976
Email: hardylr@mail.nih.gov