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Federal Business Opportunities (FBO) SOURCES SOUGHT NOTICE Solicitation Number: NIH-NIMH-22001773SS Title: Taxonomical Meta-Analysis Required to Identify Strategies to Support HIV Treatment Adherence ... Federal Business Opportunities (FBO) SOURCES SOUGHT NOTICE Solicitation Number: NIH-NIMH-22001773SS Title: Taxonomical Meta-Analysis Required to Identify Strategies to Support HIV Treatment Adherence and Retention Classification Code: R499 – SUPPORT – PROFESSIONAL: OTHER NAICS Code: 541990 -- All Other Professional, Scientific, and Technical Service Description: This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. Background: Medication adherence and retention in clinical care form the cornerstones of HIV treatment success. Although contemporary antiretroviral therapy regimens are more potent and forgiving of imperfect adherence than prior regimens, medication adherence remains strongly predictive of viral suppression and clinical outcomes. It is therefore concerning that large proportions of people with HIV in the United States lack consistent ART adherence and sustained viral suppression, often due to psychosocial challenges such as mental health and substance use that operate in concert with social and structural barriers of stigma, discrimination, and poverty. These same challenges impede HIV care engagement as well as adherence, resulting in under half of people with HIV in the U.S. engaging in regular HIV medical care. Further efforts to strengthen adherence and retention are needed to improve the individual and public health benefits of ART. A recent modeling study from the Centers for Disease Control and Prevention found that improved investments in the HIV care continuum–and especially those that support adherence to achieve sustained viral suppression–provide the best approach for reducing HIV incidence in the US. This is a very timely moment to learn more from research literature on oral ART adherence and HIV care retention interventions. Recent years have seen a growing number of adherence interventions demonstrate impact on viral suppression, which may reflect improvements in intervention design and research rigor in global adherence research. A sea-change in HIV treatment regimens is also underway, with Food and Drug Administration approval of the first long-acting injectable HIV treatment regimen in January 2021. New insights from the burgeoning literature on HIV care retention interventions would benefit future implementation and use of long-acting ART regimens, which are administered at strict monthly or bimonthly intervals. Purpose: The Division of AIDS Research seeks a Contractor to conduct a state-of-the-science taxonomic meta-analysis to discover new patterns in the scientific literature promoting HIV treatment adherence and retention. Uncovering patterns across interventions with diverse elements or strategies, recipients, and implementation settings requires the development of a common language or framework (taxonomy) for describing the active ingredients of the intervention. The taxonomy-based database can then be used to identify effective HIV treatment adherence and retention interventions. A taxonomic meta-analysis extends the traditional meta-analytic approach which often narrowly focus on efficacy to model variation of the effect as a function of outcomes, components of the interventions, characteristics of the intended recipients, contexts, and methodological characteristics of the study. The taxonomy-based database can also be extended to identify other features such as the observed mechanisms of change that are associated with the taxonomical elements all of which allows for the design of more powerful, efficient, and targeted intervention approaches. Therefore, a taxonomic meta-analysis can begin to unpack the “black box” of HIV care retention interventions to more precisely identify the internal workings of the interventions to facilitate more rapid translation of evidence to practice. The aims of this project are to: Use grounded theory to develop taxonomies of outcomes (e.g., objective measures of adherence), intervention components (e.g., provided tools for scheduling reminders), mechanisms of change (e.g., skills building), recipient characteristics (e.g., mental health, substance use, comorbidities), contexts and implementation strategies (e.g., clinical setting), and methodological characteristics (e.g., controlled trials) of the study used to promote ART adherence and HIV care retention interventions. Determine the optimal intervention content to achieve viral suppression among people with HIV by using meta-regression models to identify the intervention component or combination of components that produce the strongest effect on adherence and retention. Identify the mechanisms of change, recipient characteristics, contexts and implementation strategies, and methodological characteristics that explain the conditions under which intervention efficacy is improved. The U.S. Department of Health and Human Services set forth a bold plan for ending the HIV epidemic by 2030 that proposed critical scientific advances to treat people with HIV rapidly and effectively to reach sustained viral suppression. Achieving this target will require the discovery of effective approaches to accelerate efforts to promote ART adherence and HIV care retention. Findings and recommendations from the proposed taxonomic meta-analysis will be disseminated by the Division of AIDS to agencies throughout the U.S. Department of Health and Human Services, scientific community, specialty HIV care clinics, and other key stakeholders in collaboration with the Office of Communications and Public Liaison and will provide critical information that can accelerate the pace at which knowledge is translated into practice to effectively support sustained viral suppression in people with HIV. Specific Requirements: This project involves conducting a state-of-the-science taxonomic meta-analysis to discover new patterns in the scientific literature promoting HIV treatment adherence and retention. This requires using systematic review and meta-analytic methods consistent with meta-analytic procedures outlined in the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) 2020 statement and using grounded theory to create and apply taxonomies to describe the key elements of HIV treatment adherence and retention interventions, including the active ingredients, mechanisms of change, and desired outcomes. As a meta-analytic expert, the Contractor will: Document all procedures carried out throughout the course of the project in a manual detailing the taxonomy development, study and coding procedures, including refinements and alternations with dates of changes, and decisions throughout the project. Determine the scope and focus of the scientific literature to be included in the meta-analysis with input from the External Scientific Panel (EP) and the Division of AIDS Research Scientific Officer. Use the Population, Interventions, Comparators, Outcomes, and Study Designs (PICOS) framework to establish the study inclusion criteria. Define key terms and outcomes. Obtain recommendations of representative manuscripts from the EP. Use grounded theory to develop taxonomies of outcomes, intervention components, mechanisms of change, recipient characteristics, contexts and implementation strategies, and methodological characteristics of the study used to promote ART adherence and HIV care retention interventions; taxonomies should align with relevant behavior change theory. Establish taxonomy development process and opportunities for EP feedback. Create initial taxonomies using the representative manuscripts generated by the EP (see 2.c); review, refine, and finalize the taxonomies with the EP. Conduct a comprehensive search to identify, locate, and retrieve the relevant scientific literature. Develop, test, and revise the search string using Boolean operators as needed with attention to controlled vocabulary used by electronic bibliographic databases to reach the relevant scientific literature. Search multiple electronic bibliographic databases (e.g., PubMed, Embase, PsycInfo, CINAHL), electronic databases of funded research (NIH RePORTER), and registered clinical trials (www.ClinicalTrials.gov) for the relevant scientific literature. Review relevant published reviews and meta-analyses and reference lists of manuscripts retrieved from the database searches. Screen and retrieve records based on the established study inclusion criteria; generate the PRISMA flow diagram. Organize electronic bibliographic, grant, and trial database records, obtain and include PDFs of the relevant scientific literature, and document reasons for exclusion using a reference management system. Use taxonomies and other assessment measures or tools to code important features of the studies, samples, interventions, and methodological characteristics. All data must be coded or extracted from each study by two research assistants and inter-rater reliability must be assessed across all characteristics coded or extracted. Use the taxonomies to qualitatively code outcomes, intervention components, mechanisms of change, recipient characteristics, contexts and implementation strategies and methodological characteristics of each study and intervention. Generate and use a well-defined coding scheme to allow for the collection of descriptive study (e.g., publication year), sample (e.g., mean age), and intervention (e.g., number and minutes of intervention sessions) characteristics. Use an established tool to assess the quality of the individual studies. Use an established tool to assess the risk of bias in the individual studies. Organize all qualitative and quantitative data collected or extracted using an electronic database with all variables and response choices well-described in an accompanying key for data sharing purposes. Extract relevant data to calculate between group effect sizes representing the difference between interventions targeting adherence and/or retention and a control condition. Operationally define the primary study outcomes—adherence and retention—for this meta-analysis with input from the EP (see 2.b.). Represent effect sizes as the mean difference between the treatment(s) and control or comparison group while controlling for baseline. Calculate effect sizes for all assessments following completion of the behavioral, social, or biomedical intervention (i.e., immediate post-intervention, 3-months post-intervention). Organize all effect size data collected, extracted, and calculated using an electronic database with all outcomes or calculation fields well-described in an accompanying key for data sharing purposes. Analyze the database and interpret the findings. Determine the overall efficacy of adherence and retention interventions using separate meta-analytic models. Determine the optimal intervention content to achieve viral suppression among people with HIV by using meta-regression models to identify the intervention component or combination of components that produce the strongest effect on adherence and retention. Identify the mechanisms of change, recipient characteristics, contexts and implementation strategies, and methodological characteristics that explain the conditions under which intervention efficacy is improved. Present the preliminary findings to the EP and Division of AIDS Research Scientific/Contracting Officers. Prepare a manuscript for publication with the EP and Division of AIDS Research Scientific/Contracting Officers. Use the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) to assess the quality of the evidence and provide recommendations to promote ART adherence and HIV care retention. These recommendations will be provided to the Division of AIDS Research in the Final Research Report that summarizes the development of the taxonomies, outcomes of the meta-analysis, identifies current gaps in the scientific literature, and provides recommendations to promote ART adherence and HIV care retention. The Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform. Anticipated Period of Performance: 12 months Capability statement/information sought: Contractors that believe they possess the ability to provide the required service, should submit documentation on their ability to meet each of the project requirements to the Contract Specialist. The Contractor should directly and specifically state in the capabilities statement how they are able to fulfill the project requirements independently and not as an agent of the Government. The Contractor must also provide their DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HubZone, GSA number (If available) etc., pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements. The information submitted must be in an outline format that addresses each of the elements of the project requirement and in the capability statement/information sought paragraphs stated herein. A cover page and an executive summary may be included but is not required. The response is limited to a two (2) page limit. The 2-page limit does not include the cover page or executive summary. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. All responses to this notice must be submitted electronically to the Contract Specialist. Facsimile responses are NOT accepted. The response must be submitted to Tiffany Stone, Contract Specialist, at Tiffany.Stone@nih.gov. The response must be received on or before February 17, 2022 at 3pm, Eastern Time. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a presolicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).