The Evidence Base for Initial Intervention Strategies for Ending the HIV Epidemic in the U.S.

June 2021 marked 40 years since the first reported cases of AIDS.1Centers for Disease Control (CDC)Pneumocystis pneumonia–Los Angeles.MMWR Morb Mortal Wkly Rep. 1981; 30: 250-252PubMed Google Scholar In the 30 years that followed its detection, there have been several critical successes2Centers for Disease Control and PreventionEnding the HIV Epidemic. Notice of funding opportunity (NOFO) PS19–1906: strategic partnerships and planning to support Ending the HIV Epidemic in the United States component B: accelerating state and local HIV planning to end the HIV epidemic. Published 2020; https://www.cdc.gov/hiv/pdf/funding/announcements/ps19-1906/cdc-hiv-ps19-1906-component-b-program-guidance.pdfDate accessed: January 26, 2021Google Scholar (Figure 1): identifying HIV as the causative agent3Barré-Sinoussi F Chermann JC Rey F et al.Isolation of a T-lymphotropic retrovirus from a patient at risk for acquired immune deficiency syndrome (AIDS).Science. 1983; 220: 868-871https://doi.org/10.1126/science.6189183Crossref PubMed Scopus (4764) Google Scholar; defining the sexual and injection drug use behaviors that lead to a high risk for HIV transmission or acquisition4Whitmore SK Zaidi IF Dean HD. The integrated epidemiologic profile: using multiple data sources in developing profiles to inform HIV prevention and care planning.AIDS Educ Prev. 2005; 17: 3-16https://doi.org/10.1521/aeap.2005.17.Supplement B.3Crossref Google Scholar; developing HIV antibody tests of increasing sensitivity and ease of use5Petricciani JC. Licensed tests for antibody to human T-lymphotropic virus type III. Sensitivity and specificity.Ann Intern Med. 1985; 103: 726-729https://doi.org/10.7326/0003-4819-103-5-726Crossref Scopus (55) Google Scholar,6Alexander TS. Human immunodeficiency virus diagnostic testing: 30 years of evolution.Clin Vaccine Immunol. 2016; 23: 249-253https://doi.org/10.1128/CVI.00053-16Crossref PubMed Scopus (78) Google Scholar that allowed accurate monitoring of epidemic trends, provision of blood product transfusion safety, and identification of people in need of treatment; identifying a broad array of medications used in combinations to effectively treat HIV infection and prevent perinatal transmission7FDA-approved HIV medicines. HIV.gov, NIH.gov. https://hivinfo.nih.gov/understanding-hiv/fact-sheets/fda-approved-hiv-medicines. Updated February 8, 2021. Accessed January 2, 2021.Google Scholar; and developing HIV nucleic acid tests that allow monitoring of treatment effectiveness.8Holodniy M Katzenstein DA Sengupta S et al.Detection and quantification of human immunodeficiency virus RNA in patient serum by use of the polymerase chain reaction.J Infect Dis. 1991; 163: 862-866https://doi.org/10.1093/infdis/163.4.862Crossref PubMed Scopus (130) Google Scholar,9Hughes MD Johnson VA Hirsch MS et al.Monitoring plasma HIV-1 RNA levels in addition to CD4+ lymphocyte count improves assessment of antiretroviral therapeutic response. ACTG 241 Protocol Virology Substudy Team.Ann Intern Med. 1997; 126: 929-938https://doi.org/10.7326/0003-4819-126-12-199706150-00001Crossref PubMed Scopus (250) Google Scholar These accomplishments, along with behavioral counseling interventions10Compendium of evidence-based interventions and best practices for HIV prevention. Centers for Disease Control and Prevention. https://www.cdc.gov/hiv/research/interventionresearch/compendium/index.html. Updated June 28, 2021. Accessed January 2, 2021.Google Scholar to increase condom use; reduce injection equipment sharing; engage people in prevention, care, and treatment; and support medication adherence, were implemented by state and local public health partners and led to a marked reduction in the estimated number of new HIV infections from a high of 130,000 in 1984 to 50,000 in 2006,11Hall HI Song R Rhodes P et al.Estimation of HIV incidence in the United States.JAMA. 2008; 300: 520-529https://doi.org/10.1001/jama.300.5.520Crossref PubMed Scopus (1135) Google Scholar which stabilized at 47,500 from 2008 to 2010.12Centers for Disease Control and PreventionEstimated HIV incidence in the United States, 2007–2010. Centers for Disease Control and Prevention, Atlanta, GAPublished December 2012https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-supplemental-report-vol-17-4.pdfDate accessed: January 2, 2021Google Scholar In the most recent 10 years, estimated HIV incidence has fallen slowly to 36,400 in 2018.13Centers for Disease Control and PreventionEstimated HIV incidence and prevalence in the United States, 2014-2018. Centers for Disease Control and Prevention, Atlanta, GAPublished May 2020https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-supplemental-report-vol-25-1.pdfDate accessed: January 2, 2021Google Scholar Over this same time period, clinician-delivered interventions were proven effective, including treatment as prevention (undetectable=untransmittable)14Evidence of HIV treatment and viral suppression in preventing the sexual transmission of HIV. Centers for Disease Control and Prevention, Updated December 14, 2020https://www.cdc.gov/hiv/risk/art/evidence-of-hiv-treatment.htmlDate accessed: January 2, 2021Google Scholar that reduces sexual HIV transmission for partners of people living with HIV to negligible levels and antiretroviral pre-exposure prophylaxis that can reduce both sexual and injection drug use–related HIV acquisition among people without HIV if exposed to the virus.15Chou R Evans C Hoverman A et al.Preexposure prophylaxis for the prevention of HIV infection: evidence report and systematic review for the U.S. Preventive Services Task Force.JAMA. 2019; 321: 2214-2230https://doi.org/10.1001/jama.2019.2591Crossref Scopus (100) Google Scholar However, dissemination and implementation of these clinician-delivered interventions for demographic and geographic groups at the highest risk of transmitting or acquiring HIV have been slow. An intensified approach is clearly needed now to significantly reduce the number of Americans acquiring HIV infection. In response to this need, a new initiative, Ending the HIV Epidemic (EHE) in the U.S., was announced during the 2019 State of the Union Address to Congress.16Fauci AS Redfield RR Sigounas G Weahkee MD Giroir BP. Ending the HIV Epidemic: a plan for the United States.JAMA. 2019; 321: 844-845https://doi.org/10.1001/jama.2019.1343Crossref PubMed Scopus (648) Google Scholar Building on the efforts made through the existing funding provided to health departments (HDs), selected large cities, and community-based organizations and on the HIV National Strategic Plan recently updated through 2025,17HHSHIV National Strategic Plan: a road map to end the epidemic for the United States. HHS, Washington, DCPublished 2021: 2021-2025https://files.hiv.gov/s3fs-public/HIV-National-Strategic-Plan-2021-2025.pdfDate accessed: January 20, 2021Google Scholar new funds are being provided through the EHE initiative, and multiple federal agencies are engaged in an all of government approach. Over the 10-year EHE initiative, the goal is to reduce new HIV infections by 75% by 2025 and by 90% by 2030.18Ending the HIV Epidemic: plan for America: overview. HIV.gov, Office of Infectious Disease and HIV/AIDS Policy, HHS. https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview. Updated June 2. Accessed December 22, 2020.Google Scholar The initiative will leverage prevention science to scale up effective interventions in the 4 key program areas: diagnosing all HIV infections early (Diagnose pillar), treating HIV infections rapidly to achieve and sustain viral suppression (Treat pillar), protect people at risk of acquiring HIV using interventions proven highly effective (Protect pillar), and rapidly detect and respond to growing HIV clusters with prevention and care resources (Respond pillar). In the first phase, EHE funding is directed to 48 counties; the District of Columbia; San Juan, Puerto Rico; and 7 states with significant rural epidemics. Together, these jurisdictions accounted for >50% of new HIV diagnoses in 2016–2017. Lessons learned in Phase 1 will guide a later extension of EHE to all U.S. jurisdictions. This new focus on county HDs and those responsible for rural areas recognize the critical nature of supporting and real-time monitoring of local service delivery if high levels of HIV prevention impact are to be achieved. Although local HDs (LHDs) continue to have serious financial constraints, reduced staffing, and limited engagement with clinical services in many jurisdictions,19National Association of City and County Health Officials. Annual report 2019. Washington, DC: National Association of City and County Health Officials. https://www.naccho.org/uploads/downloadable-resources/2019-NACCHO-Annual-Report.pdf#. Published May 2020. Accessed December 22, 2020.Google Scholar the demands are not going away for responding to other urgent community health issues (coronavirus disease 2019 [COVID-19], rising syphilis rates, maternal mortality) and for addressing HIV. Therefore, it is important both to increase the resources available to LHDs through the EHE initiative and to facilitate the selection of evidence-based strategies that have the -greatest chance of being both effective and resource efficient as well as feasible and sustainable for HD implementation. Several federal agencies have key responsibilities in supporting the all of government approach to achieving EHE initiative goals. The Office of Infectious Diseases and HIV/AIDS Policy in the Office of the Assistant Secretary of Health provides coordination and management of the EHE initiative. The Office of Infectious Diseases and HIV/AIDS Policy has Prevention through Active Community Engagement Officers in 3 HHS Regions: Region 4 (Atlanta), Region 6 (Dallas), and Region 9 (Los Angeles). The Centers for Disease Control and Prevention's Division of HIV Prevention (DHP) has a critical role in implementing the EHE initiative. DHP has supported state and LHDs since the 1980s to implement HIV prevention programs and conduct HIV surveillance, which serves as the lynchpin to monitoring national progress toward the goals of EHE. The Centers for Disease Control and Prevention funds 32 HDs that comprise the 57 Phase 1 EHE jurisdictions to support the development and implementation of programs tailored to EHE in America.20Funding opportunity announcement PS20-2010: integrated HIV programs for Health Departments to support Ending the HIV Epidemic in the United States. Centers for Disease Control and Prevention, Updated April 20, 2020https://www.cdc.gov/hiv/funding/announcements/ps20-2010/index.htmlDate accessed: January 29, 2021Google Scholar The Health Resources and Services Administration (HRSA) also plays a critical role in implementing the EHE initiative. The HIV/AIDS Bureau (HAB) Ryan White HIV/AIDS Program has provided a comprehensive system of HIV primary medical care,21About the Ryan White HIV/AIDS program. Health Resources and Services Administration.Updated December 2020https://hab.hrsa.gov/about-ryan-white-hivaids-program/about-ryan-white-hivaids-programDate accessed: January 29, 2021Google Scholar essential support services, and medications for low-income people with HIV since its authorization by Congress in 1990. It provides services to more than half of the people with diagnosed HIV in the U.S. and has demonstrated improvement in HIV-related disparities in clinical outcomes.22Mandsager P Marier A Cohen S Fanning M Hauck H Cheever LW. Reducing HIV-related health disparities in the health resources and services administration's Ryan White HIV/AIDS Program.Am J Public Health. 2018; 108: S246-S250https://doi.org/10.2105/AJPH.2018.304689Crossref Scopus (40) Google Scholar HRSA HAB provided additional funds to 60 Ryan White HIV/AIDS Program recipients in EHE Phase 1 jurisdictions to complement the existing funding to achieve EHE objectives.23FY2020 Ending the HIV Epidemic awards. Health Resources and Services Administration. https://hab.hrsa.gov/about-ryan-white-hivaids-program/fy2020-ending-hiv-epidemic-awards. Updated February 2020. Accessed January 29, 2021.Google Scholar Since 2015, DHP and HAB have supported locally developed integrated HIV prevention and care plans, an experience that was critical to developing EHE plans for the Phase 1 jurisdictions. In addition, both DHP and the Ryan White HIV/AIDS Program provide technical assistance for HIV prevention care. DHP provides a capacity-building assistance program for HDs and funded community-based organizations. It supports behavioral, biomedical, and structural interventions; public health strategies; and social marketing campaigns from the Compendium of Evidence-Based Interventions and Best Practices for HIV Prevention.10Compendium of evidence-based interventions and best practices for HIV prevention. Centers for Disease Control and Prevention. https://www.cdc.gov/hiv/research/interventionresearch/compendium/index.html. Updated June 28, 2021. Accessed January 2, 2021.Google Scholar DHP also funds a Provider Network to implement national training, regional technical assistance, continuous quality improvement, and sustainability for community-based organizations as well as marketing and administrative support.24Notice of funding opportunity (NOFO) PS19-1904: capacity building assistance (CBA) for high impact HIV prevention program integration. Centers for Disease Control and Prevention, Updated April 2, 2019https://www.cdc.gov/hiv/funding/announcements/ps19-1904/index.htmlDate accessed: January 29, 2021Google Scholar The HRSA HAB supports the AIDS Education and Training Center, which provides tailored education, clinical consultation, and technical assistance to healthcare professionals and organizations.25About the AIDS Education and Training Center program. AIDS Education & Training Center Program, Updated December 30, 2020https://aidsetc.org/aboutDate accessed: January 29, 2021Google Scholar In addition, HAB's Special Projects of National Significance Program has developed, evaluated, and replicated innovative strategies and interventions for HIV care, treatment, and support for people with HIV.22Mandsager P Marier A Cohen S Fanning M Hauck H Cheever LW. Reducing HIV-related health disparities in the health resources and services administration's Ryan White HIV/AIDS Program.Am J Public Health. 2018; 108: S246-S250https://doi.org/10.2105/AJPH.2018.304689Crossref Scopus (40) Google Scholar The HRSA Bureau of Primary Health Care (BPHC)’s Health Center Program provides a model of health care that integrates primary care services, which include HIV prevention, with behavioral health and other support services. It funds a national network of federally qualified health centers that include community and migrant health centers, health care for the homeless, and health centers for public housing residents.26About the Health Center Program. Health Resources and Services Administration. https://bphc.hrsa.gov/about/index.html. Updated February 2020. Accessed January 29, 2021.Google Scholar This BPHC clinic network serves 1 in 11 U.S. residents regardless of their ability to pay. The Health Center Program will support EHE by leveraging their existing patient-centric care and case management to expand HIV testing and provision of HIV care for those who test HIV positive.27FY2020 Ending the HIV Epidemic-primary care HIV prevention (PCHP) awards. Health Resources and Services Administration, Updated February 2020https://bphc.hrsa.gov/program-opportunities/primary-care-hiv-prevention/fy2020-awardsDate accessed: January 29, 2021Google Scholar In addition, the BPHC network is expanding the provision of HIV prevention services for those who test HIV negative, including prescribing pre-exposure prophylaxis or nonoccupational postexposure prophylaxis when indicated. In 2019, HRSA BPHC provided awards to 195 health centers in Phase 1 EHE jurisdictions. The Indian Health Service National HIV/AIDS Program coordinates and promotes a comprehensive approach to HIV/AIDS prevention and treatment activities specific to Native Americans, including the identification of new approaches to implement effective prevention interventions.28HIV/AIDS. Indian Health Service. https://www.ihs.gov/hivaids/. Updated September 28, 2020. Accessed January 29, 2021.Google Scholar The HIV Center of Excellence for American Indians/Alaska Natives is a clinically based center for HIV prevention, care, medical treatment, and research with a mission to increase services, disease management, and care through a culturally competent and comprehensive HIV healthcare delivery system. The NIH Centers for AIDS Research, first established in 1988, supports multidisciplinary and translational research aimed at reducing the burden of HIV. This network of researchers now is undertaking research in collaboration with Phase 1 EHE jurisdictions to enhance the knowledge base needed to identify the most effective strategies for implementation of sustainable interventions.29CFAR/ARC Ending the HIV Epidemic supplement awards. NIH, National Institute of Allergy and Infectious Diseases, Updated September 28, 2020https://www.niaid.nih.gov/research/cfar-arc-ending-hiv-epidemic-supplement-awards#:∼:text=ending%20the%20hiv%20epidemic%202020%20supplements:%20two-year%20awards,prep%20implement%20...%20%208%20more%20rowsDate accessed: January 29, 2021Google Scholar The Substance Abuse and Mental Health Services Administration supports EHE at the intersection of HIV and substance use disorders to help ensure that behavioral health interventions are implemented.30HHS Agencies involved in Ending the HIV Epidemic. HIV.gov. https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/agencies. Updated May 29, 2020. Accessed January 29, 2021.Google Scholar The Substance Abuse and Mental Health Services Administration also supports access to syringe services programs to reduce the spread of infectious diseases, including HIV, through testing and referral for care. The federal agencies funding the EHE initiative recognize the invaluable experience of state and LHDs in delivering HIV prevention and care. Familiarity with community-focused HIV public health efforts and existing partnerships position HDs to be critical partners for achieving EHE goals. The following 2 specific examples of EHE preimplementation activities reflect the critical importance of HD leadership in expanding services on the basis of their long experience and evaluation to identify both local urgent needs and best practices. Early in the initiative, 3 HDs (jump starts) were provided 12 months of funding to demonstrate and evaluate the implementation of key foundational programs that could provide insights to help accelerate progress for other EHE Phase 1 jurisdictions toward achieving the EHE goals.31Centers for Disease Control and PreventionCDC's progress in Ending the HIV Epidemic initiative. Centers for Disease Control and Prevention, Atlanta, GAPublished December 2020https://www.cdc.gov/endhiv/docs/CDC-Progress-Fact-Sheet-508.pdfDate accessed: January 26, 2021Google Scholar Baltimore City, Maryland; DeKalb County, Georgia; and East Baton Rouge Parish, Louisiana each developed and implemented scalable, feasible, and potentially impactful activities that addressed ≥1 of the EHE key strategies. An activity under the Diagnose pillar established opt-out HIV and viral hepatitis screening in an emergency department (East Baton Rouge Parish, Louisiana). For the Treat pillar, a program provided same-day linkage to care and treatment for those diagnosed with HIV during targeted outreach testing (DeKalb County, Georgia). For the Prevent pillar, a program incorporated HIV and sexually transmitted disease testing into a mobile syringe services program (Baltimore City, Maryland).31Centers for Disease Control and PreventionCDC's progress in Ending the HIV Epidemic initiative. Centers for Disease Control and Prevention, Atlanta, GAPublished December 2020https://www.cdc.gov/endhiv/docs/CDC-Progress-Fact-Sheet-508.pdfDate accessed: January 26, 2021Google Scholar The evaluation of these jump-start activities promises to highlight the value of timely information sharing that is led by LHDs. An EHE jurisdictional planning process was implemented to the critical role of HDs in identifying and activities that local needs to achieve EHE The EHE plans include an epidemiologic a that of and needs HIV surveillance, program prevention, and care and identification of with HIV incidence in their for these plans HDs to the development of innovative activities in learned and for Disease Control and PreventionEnding the HIV Epidemic. Notice of funding opportunity (NOFO) PS19–1906: strategic partnerships and planning to support Ending the HIV Epidemic in the United States component B: accelerating state and local HIV planning to end the HIV epidemic. Published 2020; https://www.cdc.gov/hiv/pdf/funding/announcements/ps19-1906/cdc-hiv-ps19-1906-component-b-program-guidance.pdfDate accessed: January 26, 2021Google Scholar that will expand their capacity to support integrated HIV strategic and additional partnerships to local HIV prevention goals. EHE plans include for key local and community HDs their approach for both partners and new to or expand community and several Phase 1 in their These EHE plans provide for the plans of local Phase 1 and for Disease Control and PreventionEnding the HIV Epidemic. Notice of funding opportunity (NOFO) PS19–1906: strategic partnerships and planning to support Ending the HIV Epidemic in the United States component B: accelerating state and local HIV planning to end the HIV epidemic. Published 2020; https://www.cdc.gov/hiv/pdf/funding/announcements/ps19-1906/cdc-hiv-ps19-1906-component-b-program-guidance.pdfDate accessed: January 26, 2021Google Scholar HDs are to an plan for the of their EHE jurisdictional plan that both and needs their jurisdictions. The EHE initiative a community in public health to HIV. and state HDs as the primary for implementing critical HIV prevention and care and their efforts will be the of the local impact of the EHE initiative. achieve the goals of it is critical to the evidence base for and interventions and strategies proven to be effective and It is important to identify efforts that are proven or not effective that can be and with more effective strategies. This state of the science and best the strategies by LHDs the EHE initiative for which an evaluation supports the dissemination of the approach. The of this supplement is to the sharing of learned as HDs and program efforts on the basis of an evidence base to achieve EHE goals. financial were reported by the of this This is of a supplement The for for Ending the HIV Epidemic in the U.S., which is by the U.S. Centers for Disease Control and Prevention U.S. of Health and Human Services The and in this are those of the and not the position of or HHS.