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Medical Monitoring Project 2010 protocol : 2021-2023
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February 2021
[PDF-703.26 KB]
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Description:Version: 1.0
Version Date: February 2021
The U.S. Centers for Disease Control and Prevention (CDC) National HIV Surveillance System (NHSS) collects a core set of data on the characteristics of persons diagnosed with HIV infection in all 50 states and dependent areas. Domestic HIV surveillance projects, such as the Medical Monitoring Project (MMP), provide complementary information about clinical outcomes of HIV infection, care seeking and care utilization of persons living with HIV, and ongoing transmission risk behaviors. From 2005 to 2014, MMP’s study design relied on a probability sample of HIV- diagnosed persons sampled from HIV facilities to generate nationally representative estimates of clinical outcomes and HIV-related behaviors [1-3]. MMP has provided high-priority national HIV prevention indicators, such as the number of HIV-positive persons receiving care for HIV infection and the proportion of HIV-positive persons receiving care who have achieved viral suppression. In 2015, MMP implemented new methods to include all HIV-diagnosed persons both receiving and not receiving HIV care.
When MMP was first proposed in 2004, the importance of antiretroviral therapy (ART) for HIV treatment was clear—ART had already been shown to dramatically reduce the probability of AIDS or death[4, 5]—but the role of ART in HIV prevention had yet to be firmly established. Since that time, strong evidence has emerged that ART can reduce the amount of HIV in the blood to undetectable levels[6-10]. As a result, people living with HIV who take HIV medicine as prescribed and get and keep an undetectable viral load have effectively no risk of transmitting HIV to their HIV-negative sexual partners. Mathematical models show the potential for halting the HIV epidemic through an aggressive program of universal testing and immediate ART initiation, a strategy dubbed “test and treat”[11-13]. In its National HIV/AIDS Strategy for the United States: Updated to 2020 (NHAS), the White House identified two key areas for critical focus: “broad support for people living with HIV to remain engaged in comprehensive care, including support for treatment adherence” and “universal viral suppression among people living with HIV”[14].
cdc-hiv-mmp-protocol-2021-2023.pdf
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Content Notes:1. Introduction – 2. Methods -- 3. Data Management and Analysis – 4. Security and Confidentiality of MMP Data -- 5. Human Subjects Considerations – 6. Data Dissemination -- 7. References -- Appendix A. First Stage Project Area Sampling -- Appendix B . Second Stage Person Sample by Project Area -- Appendix C.1. Model Recruitment Letter -- Appendix C.2. Model Recruitment Script-Project Staff -- Appendix C.3. Model Recruitment Script-Facility -- Appendix C.4. Model Recruitment Text and E-mail Scripts -- Appendix D. Agreement for Cross-Jurisdictional Data Collection -- Appendix E.1. 2021-2023 Interview Questionnaire (English) -- Appendix E.2. 2021-2023 Interview Questionnaire (Spanish) -- Appendix F. MRA Data Structure -- Appendix G. Sampling Frame Data Elements -- Appendix H. NCHHSTP Non-research Determination -- Appendix I.1. Adverse Event Protocol Breach Guidance -- Appendix I.2. Model Adverse Events Protocol Breach Report Form -- Appendix J.1. Statement of Informed Consent (English) -- Appendix J.2. Statement of Informed Consent (Spanish).
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Pages in Document:32 numbered pages
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