NOT-AA-19-006: Notice of Special Interest on Methodological Advances to Improve Alcohol Measurement and its Consequences for People Living with HIV who have Comorbidities, Coinfections, and Complications

Notice of Special Interest on Methodological Advances to Improve Alcohol Measurement and its Consequences for People Living with HIV who have Comorbidities, Coinfections, and Complications

Notice Number: NOT-AA-19-006

Key Dates
Release Date:January 28, 2019

Related Announcements

PA-18-345

PA-18-484

Issued by
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Purpose

The primary goal of this notice is to more accurately assess, through improved measurement and analysis, the impact of HIV infection and alcohol use on health outcomes related to associated comorbidities, coinfections, and complications (CCC).

Background:

NIAAA seeks to implement novel analytic technologies for advancing high-priority HIV/AIDS research that is informed by patterns of both acute and chronic alcohol use. Advanced data-generating and data-analytic technologies should take advantage of existing datasets by either performing secondary analysis of existing data and biorepositories and/or augmenting these high-value datasets with informative measures that can be derived from multiple behavioral (e.g. ecological momentary assessment) and/or biological domains (biomarkers, biosensors, etc.) and /or informative combinations of multiple data sources. It is expected that this activity should significantly advance the use of big data and advanced analytic procedures that may in the future be able to address issues related to targeting interventions and expediting the use of individualized medicine. Proposals to support joint research projects between methodological experts and HIV care providers should lead to fundamental and multidisciplinary biomedical research, addressing prevention and treatment of HIV/AIDS and HIV-associated co-morbidities, coinfections, and complications.

Methodological advances include (but are not limited to) broadly improving measurement accuracy, reliability, and validity of alcohol exposure and its consequences in multiple cohorts of people living with HIV/AIDS supported by NIH through the Office of AIDS Research (OAR). In addition, this research may advance the use of predictive analytic techniques in both observational and intervention research for people living with HIV/AIDS who consume alcohol in collaboration with multiple institutes and utilization of novel technologies to improve self-report data, biomarkers, and biosensors. Advanced analytic techniques can be used to evaluate both direct and indirect effects of alcohol use and burden of disease on rates of new infections, diseases progression, and morbidity and mortality and to promote use of advanced decision-making tools/algorithms for implementation of preventive and treatment interventions.

Research Objectives:

NIAAA proposes to support evaluation for all HIV/AIDS applications with cohorts that utilize alcohol measures across institutes and identify where improvement in measurement and analytic approaches can be implemented within these cohorts. These models for attenuated effects of the accuracy for alcohol measurement can be extrapolated to treatment cascade and the effectiveness of development of interventions and combinations of interventions. Multiple levels of assessment can be tailored to these activities for (but are not limited to):

Improving assessment of marginalized or under sampled populations (e.g. pregnant women, sexual and racial/ethnic minorities, migrants) who drink;
Improving approaches in adaptive intervention models and multilevel models using decision algorithms for individuals with alcohol and related substance and/or mental health problems;
Applying advanced analytic approaches (e.g. deep learning or machine learning approaches) for alcohol and HIV outcomes;
Identifying effective pharmacological agents to reduce alcohol use and potential toxic interactions with HIV medications using "big data";
Modeling HIV and alcohol outcomes to assess overall impact at local, state, and country levels particularly in relationship to available resources and in low and middle-income countries (LMIC);
Advancing biomarker discovery and predictive value through utilization of available biorepositories (blood spots, organ and tissue samples, etc.) related to organ and tissue damage (cardiovascular, neurological, hepatic, etc.)

In addition, the following high-priority areas for alcohol and HIV/AIDS research described in the FY2019 Plan, Office of AIDS Research, National Institutes of Health, may be addressed to further understand the role of alcohol in:

HIV and alcohol treatment research, including the utility of biomarkers to assess use, adherence to treatment, and other health mediators and outcomes;
Development of effective multipurpose prevention technologies, including microbicides, vaccines, and the assessment of their acceptability, use, and adherence among individuals with alcohol use disorders;
HIV prevention in high-risk women and children and reproductive health and pregnancy in women living with HIV/AIDS who drink during pregnancy;
Mapping and geocoding of alcohol and HIV hotspots and social-structural and ecological impact overtime on health outcomes related to comorbidity, coinfection, and complications (CCC);
Multidisciplinary biomedical and behavioral research to enhance HIV testing, entry and retention in care, and treatment adherence, with a focus on viral suppression in vulnerable and high-risk alcohol using populations ( care cascade/continuum );
Research toward a cure for HIV/AIDS, including studies on: HIV reservoirs, latency, and persistence; screening and testing of novel compounds; developing and testing novel approaches combining virologic-, immunologic-, and cell-based therapies, as well as strategies to activate latent virus among chronic and acute alcohol users;
Research on metabolic and inflammatory processes related to HIV infection and clinical syndromes associated with dysfunction associated with chronic and acute alcohol exposure in these processes;
Immunology studies on HIV disease and HIV-related co-morbidities, including microbiome studies and impact of alcohol use on immunological and metabolic function and resulting organ and tissue injury;
Studies to identify or characterize genomic factors and genetic variability of HIV and the alcohol-using host that are associated with protection from or risk of acquiring HIV infection and associated comorbidities;

Prior to preparing an application, prospective applicants are encouraged to read the OAR and the NIAAA Strategic Plans, and to reach out to the scientific contact listed in this FOA..

Applications that include animal studies are not responsive.

Application and Submission Information:

Applications for this Notice must submit an application through NIH Parent Announcement PA-18-345: NIH Research Project Grant (Parent R01 Clinical Trial Required) or PA-18-484: NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed).

All instructions for the Parent Announcement must be followed.

Submissions should indicate that they are in response to NOT-AA-19-006 in Field 4.b on the SF 424 form.

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