HIV incidence, defined as the rate of new HIV infections ...
Establishing HIV-1 Recent Infection Surveillance Using a Rapid Test for Recent Infection among Persons Newly Diagnosed with HIV Infection in [Country]Project OverviewInvestigators Countries will add investigators. NOTE: The investigators should discuss CDC’s level of engagement. Countries should decide what level of information CDC investigators will have access to and an explicit statement should be included in the protocol. There are multiple options 1) CDC will have non-engaged roles “CDC staff will not have access to personal identifying information (PII). 2) CDC will be engaged and have access to PII.1.2 Collaborating InstitutionsCountries will add Collaborating Institutions.1.3 AcronymsAIDS Acquired Immunodeficiency SyndromeANCAntenatal clinicART Antiretroviral TherapyCDC US Centers for Disease Control and PreventionCGHCenter for Global HealthDBSDried blood spotDGHTDivision of Global HIV and TBEDTAEthylene-diamine-tetra-acetic acidEIAEnzyme immunoassayFRRFalse recent rateFSWFemale sex workersHIV Human Immunodeficiency VirusHQHeadquartersHTC HIV testing and counselingHTSHIV testing servicesIDIdentification numberILBInternational Laboratory BranchIPImplementing partnerIPVIntimate Partner ViolenceKP Key PopulationLAgLimiting AntigenLDMSLaboratory Data Management SystemsLIMS Laboratory Information Management SystemsMOH Ministry of HealthMSMMen who have sex with menPEPFAR President’s Emergency Plan for AIDS ReliefPOCPoint-of-carePWIDPersons who inject drugsR/LTRecent or long termRITARecent infection testing algorithmRNARibonucleic acidRTRIRapid test for recent infectionSOPs Standard Operating ProceduresSTI Sexually Transmitted InfectionTRITests for Recent InfectionUNAIDSThe Joint United Nations Programme on HIV and AIDSVCT Voluntary Counselling and TestingVL Viral LoadWHOWorld Health Organization 1.4 Funding Source(s)Countries will add funding source(s).2.0 Background HIV EpidemicIn 2016, an estimated 36.7 million people were living with HIV, of whom an estimated 1.8 million people (including 160,000 children) acquired their infection within the year, and 1 million people had died from AIDS-related illnesses ADDIN EN.CITE <EndNote><Cite><Author>UNAIDS</Author><Year>2017</Year><RecNum>10</RecNum><DisplayText>[1]</DisplayText><record><rec-number>10</rec-number><foreign-keys><key app="EN" db-id="rte0srzd5r95dce90v45pss3rev5etez2xzt" timestamp="1529420164">10</key></foreign-keys><ref-type name="Report">27</ref-type><contributors><authors><author>UNAIDS, </author></authors></contributors><titles><title>UNAIDS Data 2017.</title></titles><dates><year>2017</year></dates><pub-location>Geneva, Switzerland.</pub-location><urls><related-urls><url>;[1]. There has been significant progress over the past decade in the global health response to HIV/AIDS. Between 2010 and 2016, the annual number of new HIV infections declined by 16% ADDIN EN.CITE <EndNote><Cite><Author>UNAIDS</Author><Year>2017</Year><RecNum>10</RecNum><DisplayText>[1]</DisplayText><record><rec-number>10</rec-number><foreign-keys><key app="EN" db-id="rte0srzd5r95dce90v45pss3rev5etez2xzt" timestamp="1529420164">10</key></foreign-keys><ref-type name="Report">27</ref-type><contributors><authors><author>UNAIDS, </author></authors></contributors><titles><title>UNAIDS Data 2017.</title></titles><dates><year>2017</year></dates><pub-location>Geneva, Switzerland.</pub-location><urls><related-urls><url>;[1].In June 2017, 20.9 million people were receiving antiretroviral therapy (ART), an increase from 17.1 million people in 2015 and 7.7 million in 2010 ADDIN EN.CITE <EndNote><Cite><Author>UNAIDS</Author><Year>2017</Year><RecNum>11</RecNum><DisplayText>[2]</DisplayText><record><rec-number>11</rec-number><foreign-keys><key app="EN" db-id="rte0srzd5r95dce90v45pss3rev5etez2xzt" timestamp="1529420167">11</key></foreign-keys><ref-type name="Report">27</ref-type><contributors><authors><author>UNAIDS</author></authors></contributors><titles><title>Right to Health</title></titles><dates><year>2017</year><pub-dates><date>2017</date></pub-dates></dates><pub-location>Geneva</pub-location><publisher>UNAIDS</publisher><urls></urls></record></Cite></EndNote>[2]. In 2016, ART coverage was approximately 53% for all people living with HIV (54% for adults and 43% for children) ADDIN EN.CITE <EndNote><Cite><Author>UNAIDS</Author><Year>2017</Year><RecNum>11</RecNum><DisplayText>[2]</DisplayText><record><rec-number>11</rec-number><foreign-keys><key app="EN" db-id="rte0srzd5r95dce90v45pss3rev5etez2xzt" timestamp="1529420167">11</key></foreign-keys><ref-type name="Report">27</ref-type><contributors><authors><author>UNAIDS</author></authors></contributors><titles><title>Right to Health</title></titles><dates><year>2017</year><pub-dates><date>2017</date></pub-dates></dates><pub-location>Geneva</pub-location><publisher>UNAIDS</publisher><urls></urls></record></Cite></EndNote>[2]. Since the advent of widespread availability of ART, treatment of HIV infection has helped to change survival trends. AIDS-related deaths have fallen by 45% from 1.9 million people in 2005 to 1 million in 2016 ADDIN EN.CITE <EndNote><Cite><Author>UNAIDS</Author><Year>2017</Year><RecNum>11</RecNum><DisplayText>[2]</DisplayText><record><rec-number>11</rec-number><foreign-keys><key app="EN" db-id="rte0srzd5r95dce90v45pss3rev5etez2xzt" timestamp="1529420167">11</key></foreign-keys><ref-type name="Report">27</ref-type><contributors><authors><author>UNAIDS</author></authors></contributors><titles><title>Right to Health</title></titles><dates><year>2017</year><pub-dates><date>2017</date></pub-dates></dates><pub-location>Geneva</pub-location><publisher>UNAIDS</publisher><urls></urls></record></Cite></EndNote>[2]. In addition, through prevention of mother-to-child transmission programs, the world has seen enormous progress in reductions of new infections among children, where the number has fallen by 47% from 300,000 in 2010 to 160,000 in 2016 ADDIN EN.CITE <EndNote><Cite><Author>UNAIDS</Author><Year>2017</Year><RecNum>11</RecNum><DisplayText>[2]</DisplayText><record><rec-number>11</rec-number><foreign-keys><key app="EN" db-id="rte0srzd5r95dce90v45pss3rev5etez2xzt" timestamp="1529420167">11</key></foreign-keys><ref-type name="Report">27</ref-type><contributors><authors><author>UNAIDS</author></authors></contributors><titles><title>Right to Health</title></titles><dates><year>2017</year><pub-dates><date>2017</date></pub-dates></dates><pub-location>Geneva</pub-location><publisher>UNAIDS</publisher><urls></urls></record></Cite></EndNote>[2]. To accelerate the impact of the public health response to the HIV epidemic, in 2014, the Joint United Nations Programme on HIV/AIDS (UNAIDS) issued ambitious fast-track treatment targets in an effort to eliminate HIV disease by 2030 ADDIN EN.CITE <EndNote><Cite><Author>UNAIDS</Author><Year>2016</Year><RecNum>12</RecNum><DisplayText>[3]</DisplayText><record><rec-number>12</rec-number><foreign-keys><key app="EN" db-id="rte0srzd5r95dce90v45pss3rev5etez2xzt" timestamp="1529420169">12</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>UNAIDS</author></authors></contributors><titles><title>Ending the AIDS epidemic 2030 - Global Statistics 2016</title><secondary-title>UNAIDS Fact Sheet 2016</secondary-title></titles><periodical><full-title>UNAIDS Fact Sheet 2016</full-title></periodical><dates><year>2016</year></dates><urls><related-urls><url>;[3]. The targets called for 90% of HIV-positive persons to be diagnosed, 90% of these to be on treatment, and 90% of these to have viral suppression by 2020 (’90-90-90’). Since then, countries have demonstrated strong political will towards meeting these targets by integrating UNAIDS’ 90-90-90 targets into their strategic plans through expanded testing strategies and adoption of “Test and Start” initiatives. As countries move closer towards reaching “90-90-90,” the real-time monitoring of the epidemiology of recent HIV infections will allow countries to adjust the public health response to sub-populations and locations where high levels of transmission may be occurring. Laboratory Tests for HIV-1 Recent Infection Antibody-based tests for recent infection (TRI) that can help distinguish recent from long-term HIV infection have been used since the mid-1990s to estimate population-level HIV incidence and to evaluate the impact of large-scale HIV interventions in preventing HIV infection PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Ccm9va21leWVyPC9BdXRob3I+PFllYXI+MTk5NTwvWWVh
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ADDIN EN.CITE.DATA [4, 5]. Interpretation of these assays is challenged, however, by a number of factors that can cause ‘false-recent’ results on the assay, including variable immune responses at the individual-level, variable performance of the assay across diverse HIV-1 subtypes and across populations with naturally low viral loads, current ART use, and advanced HIV disease. Considerable efforts have been made in the last few years to improve the accuracy of the interpretation of these assays through recent infection testing algorithms (RITAs) that incorporate the TRI result with other markers of chronic infection (e.g., low viral load, evidence of treatment) PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LYXNzYW5qZWU8L0F1dGhvcj48WWVhcj4yMDE2PC9ZZWFy
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ADDIN EN.CITE.DATA [6]. Testing for recent infection among all newly diagnosed HIV-positive persons has been integrated into routine HIV surveillance in the United Kingdom and other European countries PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5BZ2hhaXp1PC9BdXRob3I+PFllYXI+MjAxNDwvWWVhcj48
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ADDIN EN.CITE.DATA [7]. In these settings, the assay has been applied to samples of blood collected from persons with new HIV diagnosis. Because the tests are conducted centrally, test for recent infection results are returned to the referring clinics at a later time. Given the potential of this test to aid in the identification of persons most likely to transmit the virus, alternative methods that can expedite the results of recent infection testing through point-of-care (POC) testing are needed. Rapid Test for HIV-1 Recent InfectionModified rapid test developed specifically to detect HIV-1 recent infection has been described previously in the literature PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5HcmFuYWRlPC9BdXRob3I+PFllYXI+MjAxMzwvWWVhcj48
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ADDIN EN.CITE.DATA [8-10]. Similar to other tests for recent HIV infection, the rapid test for recent infection (RTRI) has important application on a population-level where it can be used to describe shifting dynamics in the HIV epidemic, such as the proportion of recent infections and for tracing active HIV transmission networks PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5OaWtvbG9wb3Vsb3M8L0F1dGhvcj48WWVhcj4yMDE2PC9Z
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ADDIN EN.CITE.DATA [11] to inform targeted prevention strategies. While results from laboratory-based recent infection tests may take weeks to months to be ready due to sample transport, laboratory processing, and turnaround time from the testing laboratory to the referring clinic, the results of the rapid test for recent infection can be available within minutes, facilitating a more efficient and targeted responses for maximum public health impact. A rapid assay using a single test device that can simultaneously diagnose HIV infection and differentiate between recent and long-term HIV-1 infection has been developed and described previously ADDIN EN.CITE <EndNote><Cite><Author>Granade</Author><Year>2013</Year><RecNum>5</RecNum><DisplayText>[8]</DisplayText><record><rec-number>5</rec-number><foreign-keys><key app="EN" db-id="rte0srzd5r95dce90v45pss3rev5etez2xzt" timestamp="1529418670">5</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Granade, T. C.</author><author>Nguyen, S.</author><author>Kuehl, D. S.</author><author>Parekh, B. S.</author></authors></contributors><auth-address>Division of HIV/AIDS, National Center for HIV, Hepatitis, STD and TB Prevention, Centers for Disease Control and Prevention, Atlanta, GA 30329, USA. tgranade@</auth-address><titles><title>Development of a novel rapid HIV test for simultaneous detection of recent or long-term HIV type 1 infection using a single testing device</title><secondary-title>AIDS Res Hum Retroviruses</secondary-title></titles><periodical><full-title>AIDS Res Hum Retroviruses</full-title></periodical><pages>61-7</pages><volume>29</volume><number>1</number><keywords><keyword>AIDS Serodiagnosis/*methods</keyword><keyword>HIV Antibodies/blood/immunology</keyword><keyword>HIV Envelope Protein gp41/blood/immunology</keyword><keyword>HIV Infections/*diagnosis/epidemiology/immunology</keyword><keyword>HIV Seropositivity/diagnosis/immunology</keyword><keyword>HIV-1/*immunology</keyword><keyword>Humans</keyword><keyword>Immunoenzyme Techniques</keyword><keyword>Incidence</keyword><keyword>Prevalence</keyword><keyword>Sensitivity and Specificity</keyword></keywords><dates><year>2013</year><pub-dates><date>Jan</date></pub-dates></dates><isbn>1931-8405 (Electronic)
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ADDIN EN.CITE.DATA [12]. This CDC in-house evaluation of the rapid test for recent infection has provided preliminary data which showed a percent agreement of 93.2% and a Spearman’s Rho of 0.83 when compared to results from the LAg Avidity EIA [13]. The mean duration of recent infection detected by the RTRI was approximately 6 months (161 days; 95% CI 148-174) ADDIN EN.CITE <EndNote><Cite><Author>Parekh</Author><Year>2017</Year><RecNum>13</RecNum><DisplayText>[13]</DisplayText><record><rec-number>13</rec-number><foreign-keys><key app="EN" db-id="rte0srzd5r95dce90v45pss3rev5etez2xzt" timestamp="1529420170">13</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Parekh, B. </author></authors></contributors><titles><title>Performance evaluation of Asante? Rapid Recency Assay for HIV diagnosis and detection of recent infection: potential for surveillance and prevention</title><secondary-title>IAS 2017 abstract number A-854-0164-05286</secondary-title></titles><periodical><full-title>IAS 2017 abstract number A-854-0164-05286</full-title></periodical><dates><year>2017</year></dates><urls></urls></record></Cite></EndNote>[12]. However, due to variability of immune response among people, the recent result for an individual is interpreted as having acquired within the last one year. Preliminary data from ongoing field validations of the RTRI in Vietnam and Malawi have shown similar results with a Spearman’s Rho of 0.75 in Vietnam and 0.74 in Malawi when compared to the LAg Avidity EIA [14]. Based on similar tests for recent infection (e.g., LAg-Avidity EIA), we expect that, on average, there is a one in ten chance that someone who tests recent on the rapid test for recent infection may have been infected over a year ago. Misclassification can vary depending on multiple contextual factors, including ART coverage, duration of ART, and proportion of elite controllers.Rapid tests for recent infection have paved the way for establishment of a HIV recent infection surveillance system that can be integrated into routine HIV testing services (HTS). Surveillance data from this system can be used to rapidly detect and characterize recent HIV infection among newly diagnosed PLHIV to inform a timely and targeted public health response. 3.0 Project JustificationThe aim of this project is to establish a HIV-1 recent infection surveillance system among persons newly diagnosed with HIV infection by integrating RTRI into routine HTS. Data from this project will provide information on the proportion of newly diagnosed HIV-positive individuals who test recent and characterize these individuals to inform HIV prevention interventions. These data can also provide sentinel event data for HIV cases on the point of HIV infection in a HIV case-based surveillance system, if such a system exists in a country. This project is a collaboration between [PEPFAR implementing agency: e.g., US Agency for International Development (USAID), US Peace Corps, US Department of Defense, and/or US Centers for Disease Control and Prevention], country Ministry of Health offices, and [PEPFAR implementing partner(s)]. 3.1 Project GoalThe goal of this project is to use an RTRI to provide continuous epidemiological data on person, place, and time of newly diagnosed individuals to inform HIV prevention and control strategies.3.2 Project Objectives Primary Objectives:To determine the proportion of individuals with recent HIV infection, as evaluated by RTRI, among newly diagnosed HIV-positive persons in participating health facilities To determine the proportion of individuals with recent HIV infection, as evaluated by Recent Infection Testing Algorithm (RITA), among clients newly diagnosed as HIV-infected in participating health facilities iTo monitor trends in the proportion testing recent on the RTRI and/or RITA: Among newly diagnosed PLHIV by select demographic and HIV risk variables Among proxy population at risk of HIV infection, calculated as the number of clients testing recent (RTRI or RITA) divided by the number of clients testing HIV negative plus clients testing recentTo identify geographic locations associated with testing recent on the RTRI and/or RITA to inform geographic prioritization of HIV prevention interventions and in addition, to determine demographic characteristics and factors associated with recent HIV-infection among individuals seen in participating health facilitiesSecondary Objectives:To assess the demographic and behavioural and clinical profile of HIV positives clients by their recent status To determine the number and proportion of misclassified recent cases (tested recent with< 1000 cp/ml) by select demographic characteristics4.0 Methods 4.1 General DesignAn RTRI will be applied to blood samples from persons who are diagnosed as a new HIV-positive case (i.e., previously undiagnosed HIV infection) and consent to having the rapid recent infection assay performed in routine HTS. Persons who test recent on the rapid test for recent infection may be requested to provide an additional sample of blood for viral load testing as part of a recent infection testing algorithm. Results will be linked to information on demographics, behavior, and access to services.NOTE: Viral load testing in concert with tests for recent infection can provide useful additional information as false recent results, including those which may be seen by patients with long term HIV infection who are on antiretroviral therapy (ART). Preliminary data from field validations of the rapid test for recent infection have found that 20% of persons who had new HIV diagnosis and tested recent were virally suppressed (HIV-1 RNA <1,000 copies/mL). The majority of the 20% were individuals who were diagnosed previously (e.g., those on ART) but did not report a prior diagnosis. Using a recent infection test on truly new positives who never had exposure to ART, the false-recent rate should be closer to 1-2%. To minimize these false-recent cases, viral load testing may be incorporated into a recent infection testing algorithm (RITA) at sites with ready access to viral load testing or sample referral networks but is not required at sites that do not have this infrastructure in place. If viral load testing is included as part of a recent infection testing algorithm, persons who test recent and have a viral load ≥1,000 copies/mL will be considered a RITA recent case.If viral load testing is not included, results of the rapid test for recent infection will be considered the final surveillance result. Where feasible, efforts should be made to identify potential false-recent cases through existing client-level data (e.g., previous HIV diagnosis or ART use) to minimize false-recent results. If viral load testing is included in the recent infection testing algorithm:Specify whether (and when) viral load results will be returned to the clientSpecify whether viral load results will be added to the client’s medical recordProvide explanation of these procedures during informed consent and on the information sheetConsiderations for future research activities (if of interest to the country team): If an additional blood specimen is collected for viral load testing, consider consenting participant to store specimen for future unspecified testing. 4.2 Study Population The study population will be persons ≥15 years of age who are diagnosed as a new HIV-positive case in HTS programs (i.e., previously undiagnosed HIV case) who provide informed consent for their blood to be tested for recent HIV infection. This can include newly diagnosed individuals encountered in routine antenatal HIV testing, voluntary counselling and testing (VCT), provider-initiated testing and counselling (PITC), and index testing programs.4.3 Sampling and Inclusion CriteriaPersons with a new diagnosis of HIV will be offered the rapid test for recent infection during HTS. Informed consent will be obtained after discussing information about the test, including accuracy of results, and the implications of the results. Patients will be informed that clinical management will be identical whether they consent to the rapid recency test or not. See further details on informed consent in text box below. After informed consent is provided, a blood sample (finger prick or venous blood) will be collected. Counselling messages that explain recent HIV infection and reinforce HIV prevention messages and partner testing for all HIV infected persons will be incorporated into the counselling session. To utilize the rapid test for recent infection to meet our objectives, we will consecutively recruit persons with a new diagnosis of HIV in HTS.Inclusion criteriaNewly diagnosed HIV cases at HTS visitGiving voluntary informed consent for supplementary testing using test for recent infectionAged ≥15 yearsExclusion criteriaClients who opt out or do not consent to RTRI testClients with documented history of testing HIV positive Clients reporting ARV use for HIV management at any point during the HTS visit [IF POSSIBLE] Persons with advanced HIV disease, including diagnosis of AIDS or low CD4+ T cell counts (below 200 cells per ?L)NOTE: Tests for recent infection should be performed only on persons aged 15 years and older.??Most HIV-positive cases <15 years of age are likely to have been acquired perinatally and not likely to be newly infected. Some countries have aligned the age with the age for consent for HIV testing in country (e.g., Malawi age 13+ years are eligible for RTRI). 4.4 Data and Specimen Collection ProceduresPersons with a new diagnosis of HIV identified through routine HIV testing according to national HIV testing algorithm will be asked for their consent to provide a fingerprick sample of blood (or 5mL of venous blood in the event that a fingerprick sample is not feasible) for rapid testing for recent infection (Appendix A. Written Informed Consent- if applicable). This sample will be applied directly to the rapid test for recent infection by a trained HTS provider. The results of the rapid test for recent infection are available by examining the testing strip, which has a control line, a positive verification line, and a long-term infection line. HTS providers will use the Test for Recent Infection Results Form (Appendix B) to record the qualitative values (e.g. a check mark for each line that was present) by clinic and client unique ID. NOTE: There may be several options for informed consent. In alignment with national scientific regulations, a waiver of documentation of consent (i.e., not obtaining client’s signature on a consent form) may be requested, and an information sheet or oral script to be read to the potential subject provided as an appendix. An IRB may waive the requirement for a signed consent form for some or all of the prospective participants in a study if one of the following applies: 1) Consent is the only link - The only record linking the participant to the research would be the consent document, and the principal risk would be potential harm resulting from a breach of confidentiality. Prospective participants must decide if they want documentation linking them with the research and their wish is to govern; or2) Minimal risk and common non-consent procedure are involved – The research presents no more than minimal risk or harm to participants and involves no procedures for which written consent is normally required outside of the research context.The information or script should: State that the study involves researchExplain the purposes of the research and the expected duration of the subject's participationDescribe any foreseeable risk or discomforts to the subjectDescribe any benefits to subjects or to others that may reasonably be expected from the researchDisclose alternatives Additional considerations for implementation within routine HTS and HIV program services: Blood collection to test for recent infection may be introduced during group information sessions, as is done for HIV testing in some settings. Clients should be provided necessary information about the test for recent infection and be given time to think about participation or opting out of the activity.If RTRI and/or RITA results are returned, clients will be provided counselling messages based on the rapid test for recent infection results along with routine counselling for HIV diagnosis (Appendix C) and information on recent and long-term infection (Appendix D). Individuals who test recent on the rapid test for recent infection will be noted as a probable recent case and may be asked to provide an additional blood sample [venous or dried blood spot (DBS)] to improve accuracy of test for recent infection status through viral load testing at a laboratory. If a country decides to incorporate viral load testing, NOTE: If it is possible, blood collected for routine HIV testing procedures (e.g., verification testing or other routine blood work for clinical care) may be used for testing for recent infection. This can avoid collection of an additional blood sample or additional fingerprick.The Information Sheet (Appendix D) may be a handout offered to clients and/or presented as an informational poster in the lobby of a clinic to explain the new testing. Indicate if participants will receive a copy of the consent form and/or a copy of the information sheet (e.g., participants will not be provided a copy of the consent form, but will not be provided an information sheet (Appendix D)).4.5 Testing MethodsRapid test for recent infection: Using a fingerprick or venous blood sample, preliminary HIV recent infection will be assessed using a rapid test for recent infection (e.g., Asante rapid recency assay) that helps to distinguish recent infection (occurring, on average, in the past 6 months and ranges up to 12 months) from long-term infection (occurring over 12 months ago). The rapid recency assay is formatted as a lateral flow device with three lines, representing a control line (C), a positive verification line (V) and a long term line (LT) to distinguish recent from long-term infection in 20 minutes (Figure 1). Limiting antigen applied to the third line (LT) forms the basis for separation of recent (low-avidity antibodies) from long-term (high-avidity antibodies) infection. The test can be interpreted qualitatively by visual assessment of the presence or absence of the three lines. Presence of only the control line (C) indicates the client’s recency status is unknown, while presence of C and V lines indicates HIV-positive diagnosis with probable recent infection. The presence of all three lines indicates HIV-positive diagnosis with long-term infection. Figure 1: Rapid Test for Recent Infection Illustration019685Long-term infection C V LTRecent infection Recency status unknown 00Long-term infection C V LTRecent infection Recency status unknown Viral load testing: If viral load testing data are not available for persons who test recent on the rapid test for recent infection, an additional DBS or 5 ml of venous blood sample may be requested for viral load testing in a laboratory to identify persons who are virally suppressed and may be misclassified recent by the RTRI. If viral load testing is conducted, HIV-1 RNA will be measured using a viral load testing platform that has been validated for plasma and DBS, such as the Abbott m2000 platform or Roche COBAS? AmpliPrep/COBAS? TaqMan? HIV-1 Test kit or a similar system, according to manufacturer’s instructions. Handling, storage, and transportation will be conducted according to the national algorithm and standard operating procedures (SOPs). RITA: Specimens that test recent on the rapid test for recent infection may be tested for HIV-1 RNA concentration in settings where viral load testing infrastructure is in place to improve accuracy of recent infection test result. Specimens that test recent on RTRI with a viral load result ≥ 1,000 copies/mL will be noted as a RITA recent infection result PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5BZ2hhaXp1PC9BdXRob3I+PFllYXI+MjAxNDwvWWVhcj48
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ADDIN EN.CITE.DATA [6, 7] (Figure 2). Figure 2: Interpretation of a Recent Infection Testing Algorithm (RITA) Using a Rapid Test for Recent Infection and Viral Load Testing*3568021124460000*This figure can be modified based on the country-specific recent infection testing algorithm applied which may or may not include viral load testing.NOTE: TO BE ADDED… ILB language on possible actions for RTRI Recency Unknown. Additional HIV testing?4.6 Return of ResultsEligible clients will be informed that the rapid test for recent infection will be conducted to test for recent infection. Please note that the HIV rapid test for recent infection is currently under evaluation, it is not pre-qualified by the World Health Organization, results of this test does not affect clients’ HIV diagnosis and clinical care. Results of this test will be used for surveillance purposes only. Therefore, we are not routinely returning the results of recency testing. Return of VL test resultsEligible clients will be informed that the rapid test for recent infection will be supplemented with a viral load test as part of a recent infection testing algorithm.Recognizing that an individual has a right to know test results about themselves, we typically return individual test results of approved HIV-related tests. We are not routinely returning the VL result from the algorithm for the following reasons: XXXXX.For ## (months/years), the viral load result from the recent infection testing algorithm will remain linked to the individual. Should an individual request to receive his/her viral load result, he/she will be instructed to contact his/her clinician for more information, and the clinician will access the result via a standard operating procedure to be developed by the study team.NOTE: There may be settings where viral load testing is conducted as part of a recent infection testing algorithm, but the viral load result will not be routinely returned to the client or clinic. In these cases, explain reasons why viral load results will not be returned. Clients should be informed that the viral load result is not clinically actionable but will remain linked to their record for a defined period of time. If they would like to receive these results, they may do so by contacting their clinician who will follow a standard operating procedure for accessing the results. Suggested language during informed consent and on the information sheet is provided below: As part of the recent infection testing algorithm a viral load test will be done. The result of a viral load test done as part of the recent infection testing algorithm is not considered clinically actionable under Ministry of Health HIV treatment guidelines at this time. However if you are interested in receiving the result, please contact your clinician within in a period of # months.NOTE: If test for recent infection results are not returned to clients, it is still necessary to obtain informed consent to test for recent infection, explain why results will not be returned, explain the broader benefit that will be gained from their results to understand population-level information on recent HIV infection, and consider returning alternative population-level information (e.g., aggregated surveillance results describing proportion testing recent from that HTS site or geographic area). An explanation for not returning results may note that test for recent infection results will not be included in the client’s medical record, will not alter standard of care for clients that accept the test for recent infection, and that the research test results cannot currently be meaningfully interpreted at the individual client-level. 4.7 Data ManagementAll results from rapid tests for recent infection for newly diagnosed HIV-positive clients (Appendix B) and additional information collected from the case including demographics and risk behavior, will be entered electronically into an electronic data capture application that implements comprehensive managed authentication and authorization functions, and includes essential provisions for data quality assurance, data integrity, and information security, by HTS staff assigned to the project. Automated data quality checks will be programmed into the electronic database to improve the validity of data entered, including checks in the completeness of responses, restrictions in the range of numerical data and responses for categorical data. Specimens that are sent for viral load testing at a central laboratory (i.e., those that test recent on the rapid test for recent infection) will be labelled with a client’s unique ID and HTS facility code. Once the specimens are received at the testing laboratory, they will receive a laboratory-generated specimen identification number and tested for viral load using routine procedures for testing and documentation of results. Once available, a print-out of viral load results labelled with the client’s unique ID, will be transmitted back to the HTS facility, viral load results will be entered into the electronic database, and test results will be updated. All paper-based forms will be stored in a locked cabinet at the HTS facility with access limited to key study staff according to the data security and storage procedures in place at the HTS site. Comprehensive data security measures will be implemented, including human, physical and electronic procedures and protections at every stage of the activity: data collection, transfer and storage. All electronic devices, if used, will be physically secured when not in use. All electronic devices and databases will be encrypted, password protected and accessible only by appropriate staff. The database will be backed up monthly on a secure, external system. All staff with access to data will receive training in data security and confidentiality and must individually affirm that they will abide by data security and confidentiality principles and procedures (Appendix E).The protocol authors will prepare a separate data management plan as an appendix to the protocol that provides sufficient detail on data security measures. Data GovernanceAll data collected through this protocol are the property of the country Ministry of Health and will be monitored by the investigators of this project. All investigators will have unimpeded access to the data. Data ArchivalAt the end of the project after the final report has been disseminated, the project data manager will transmit a copy of all data to a designee within the Ministry of Health and the investigators of this project.NOTE: The electronic data capture application will either 1) meet CDC’s minimum requirements for health information systems and data management for surveillance purposes (per Division of Global HIV and Tuberculosis (DGHT) data management checklist) or 2) is described in sufficient detail to allow an independent technical review by a data management subject matter expert. Protocol authors are advised to consult with health information systems and data management subject matter experts to ensure that the selected application will meet minimum requirements as per the DGHT data management checklist or equivalent. According to country context, provide additional information in the data management section to address the following:* Type of electronic data capture system and whether it is part of an existing health information systems; if not a part of existing health information system, consider interoperability with EMRs (e.g., OpenMRS)* How automated data checks will be performed to ensure data integrity, coherency, and consistency in the data collection and aggregation process* Whether any personally identifiable information will be collected* Sources of any additional data linked to test results (e.g., HTS register or module for demographics, behavior, and access to services)* Process to establish role-based access, permissions and privileges for database and/or health information system* Description of how electronic devices will be physically secured (i.e., locked file cabinet)* Process for securely storing information/data collected from the activity* Plans for archiving data* Special considerations if surveillance data is to be abstracted from a laboratory information system portal.Data Management Standard Operating Procedures will provide additional detail.4.8 Data AnalysisObjective 1. Monitor trends in the proportion testing recent on the RITA (if applicable) among newly diagnosed PLHIV by select demographic and HIV risk indicators to inform targeted interventions. The number of HTS clients with recent HIV infection will be divided by the total number of HTS clients that are new HIV diagnosed cases to calculate the proportion testing recent on the RITA among newly diagnosed PLHIV. This calculation will be conducted by select demographic and behavioral characteristics, including age, sex, risk behavior, and access to health services (Appendix F).The number and proportion of eligible persons who choose not to participate in or decline testing for recent infection will be calculated. Where possible, comparisons of demographic and behavioral characteristics of persons who did not receive testing for recent infection to those who were tested will be made. Objective 2. Identify geographic locations associated with testing recent on the RITA to inform geographic prioritization of interventions. Using GIS software packages (e.g., ArcGIS, QGIS), maps (e.g., dot maps, shaded maps, heat maps, bubble maps) will be created to visualize the location of recent and long-term HIV infections by health facility GIS location or client residence (e.g., client village).Further, more advanced statistical analyses may be conducted to identify demographic, behavioral, and health service-related factors associated with testing recent versus long-term on the RITA. Demographic and behavioral characteristics of persons with recent infection and long-term infection can be compared using a 2-sided Pearson chi-square or fisher exact test to assess for statistical significance. Continuous variables can be compared using the Wilcoxon rank sum test. Regression analysis can be conducted to identify independent factors associated with recent infection. Where appropriate, analyses will account for site clustering and/or include examination of differences across sites. NOTE: If client residence (e.g., village) is collected and used to map recent HIV infections, consider the lowest level geographic unit to protect client privacy and reduce the risk of re-identification of clients. If residence will be collected, describe how it will be collected.4.9 Training, Monitoring and Quality ControlTraining, monitoring and quality control measures will be applied to ensure that the implementation of this project is done according to protocol with a high degree of quality, accuracy, completeness and representativeness. Training, supervision and quality control will include multiple components and actors. Sensitization meetings may be held with all stakeholders prior to implementation.TrainingTraining will be conducted starting with TOT to develop a cadre of trained personnel who can then provide training to site-level personnel as well as help monitor quality of testing. Training for site-level personnel involved in this project will occur prior to its implementation in sites pre-selected by and could include nurses, midwives, doctors, and laboratory technicians. Training will cover the following areas with both didactic and hands-on practice where appropriate:Human subjects protectionThe objectives of project Eligibility criteriaThe completion of the project data collection formsInformed consent process and completion of the consent form The RTRI procedures with hands-on testing (3 QC specimens + 10 specimens of training panels) The preparation, packaging and storage of blood specimens for viral load, including DBS, if not routinely doneThe secure and timely transport of specimensHuman and physical procedures and protections to ensure the security and confidentiality of data[IF APPLICABLE:] The return of results, including appropriate training on:Accurate and clear counseling messages on what ‘recent infection’ means and implications for disclosure of status to partnersAssessment of risk for intimate partner and gender-based violence Assessment of client’s psychological well-being pre- and post- recency testingReferral systems for individuals to receive psychosocial support as neededTraining for health facility implementersTraining for laboratoryTraining for data management and analysisTraining for data security, privacy and confidentialityThe training data will be logged in a standardized spreadsheet to document both competency in hands-on practice and knowledge using a set of questions. Only those meeting minimum passing criteria will be certified as competent testers. MonitoringMonitoring teams will provide regular oversight to HTS sites to verify procedures are being followed at the site level, including:Persons who do not consent to rapid testing for recent infection are not tested;The HTS site has an appropriate supply of laboratory consumables;Data forms are being completed appropriately;Specimens going to the laboratory are appropriately labeled with the client unique identification number, stored, and transmitted, within the timeframe prescribed by the protocol;The completion, handing and storage of data and biological specimens is in accordance with procedures and protections to ensure the security and confidentiality of data as described in the protocol; andAdverse events, including social harm.Project investigators with Ministry of Health (MoH) staff will hold monitoring and evaluation visits at least on a quarterly basis. A supervision checklist, such as SPI-RT/RTRI, will be used to assist supervisors in conducting supervision visits and documenting results of such visits. Sites where supervision visits document problems will be prioritized for follow-up supervision visits. Quality Assurance / Quality controlAll tests will be performed according to manufacturer’s instructions including the use of appropriate QC specimens, and all tests will be interpreted according to manufacturer’s instructions, unless stated otherwise. Quality assurance of activities will take place primarily at health facilities where rapid testing for recent infection will be conducted. Rapid test for recent infection kit verification will be carried out using quality control (QC) panels at regular intervals, for example at the beginning of each month or upon receiving a new lot and a new consignment at the hub laboratory.All testers using the rapid test for recent infection will undergo hands-on training before testing client specimens, competency testing during their training, and proficiency testing thereafter annually. Intermittent supervision of the sites conducting recent infection testing will be carried out by trained staff and the investigators to ensure quality testing standards are maintained. The project data manager will review all paper data forms and the electronic database for incomplete or invalid data on a continual basis, with monthly summaries made available to investigators; Similarly, the hub and/or central laboratory will review all arriving specimens to ensure:Sample requisition forms are complete and correspond to associated specimensSpecimens arrive in a timely fashion Specimens are appropriately packagedSpecimens are in good conditionStandard sample rejection procedures/documentation in place in country will be used for this surveillance activity. Sites submitting problematic specimens or forms will be prioritized for supportive supervision. All HTS clinics will have accessible SOPs for the following procedures: Blood specimens collection by venipuncture using universal precautions and universal blood collection procedures (according to each HTS site SOP)Handling, storage, and transportation (according to the national algorithm and SOPs) HIV diagnosis using antibody detection assays (according to the national algorithm and SOPs) Rapid test for recent infection assay proceduresData flow [AS APPLICABLE] Returning of test result, including RTRI, RITA, and viral load test 5.0 Ethics The probability and magnitude of harm or discomfort anticipated with the integration of recent infection testing are currently not anticipated to be that much greater than those encountered during the receipt of routine HTS. In addition to routinely recorded clinical data and blood specimens, this activity will also collect an additional blood sample for rapid recent infection testing. Participants will be consented for the additional blood draw. All participants who give consent to receive rapid recent infection results, will be given the results with counseling. Clients will not benefit directly from participation, though the data collected by this project will be used to improve HIV prevention interventions and treatment service for the communities in which they live. The main risk of participating in this study is the breach of confidentiality, namely the disclosure of personal medical information collected as part of this activity, such as HIV status. However, project staff will implement human, physical and electronic procedures and protections to ensure the confidentiality and security of personal information. No names or personal identifiers will be used in reports, presentations, or publications from this project. To prevent inadvertent identification of study participants due to fine stratification (e.g., small cell size related to residence), any stratification units resulting in less than 25 participants will not be released. An additional risk is the breach of confidentiality and disclosure of personal medical information collected as part of this activity, such as HIV status. However, study staff will implement human, physical and electronic procedures and protections at every stage of the study to ensure the confidentiality and security of personal information.NOTE: Include the following text if opt to return RTRI resultsReturn of routine HTS test results will occur according to the standard clinic practice, however, given that recent infection testing is new to this setting, there may be some risk in informing participants whether they were recently infected with HIV. Recognizing the gravity of HIV diagnosis, a newly diagnosed patient with an understanding that that infection was contracted in the past year, may convey added psychological and emotional distress. This may include stresses related to determining the source of their infection, as well as that which impacts social and family structures. Additionally, it is not known whether there may be increased intimate partner violence (IPV) or other unanticipated adverse events associated with a client’s knowledge of recent infection and perceived source of infection based on the timing (i.e., a sex partner within the past year if test recent). Protection of participants <18 years of age Every measure possible will be taken by staff to minimize potential risks to the participants, including minors. In [country], minors who are at least 16 years of age can consent for HIV testing. Extra steps will be taken to ensure that persons below 18 years old receive the support needed to understand the activity, procedures for participation, and risks and benefits of participation. Protection of other vulnerable populationsThe volunteer that is likely to be vulnerable to coercion or undue influence might include individuals such as minors, pregnant women, soldiers, the physically handicapped, or mentally incompetent persons. Other vulnerable volunteers could include persons living on streets and very sick persons who are incapable of giving consent or providing continuing consent.Special considerations apply to participants under 18 years of age who state being or having been: 1-engaged in sex work, 2-trafficked, or 3-subjected to violence per the CDC DGHT guidance for the Development of Surveillance, Research or Program Protocols that Include Children who are Sex Workers, Trafficked or Victims of Violence. Such participants will be referred for support services (intimate partner violence/ gender-based violence if available) in line with standard procedures at the testing site. Reporting of Adverse Events or Protocol ViolationsAdverse incidents, to include unexpected protocol violations, security incidents harming participants or surveillance staff, breaches of confidentiality, or adverse physical or mental reactions to surveillance procedures will be reported to all relevant ethical review committees. Health facility staff or surveillance staff will report the incident in writing or email to the project coordinator (for their facility or next in command) within 24 hours of discovering the event. The study coordinator will determine through team consultation whether an event took place, and if so, report to the study Principal Investigators within 24 hours and to ethical review committees within 5 to 10 days. The project coordinator will complete follow-up reporting of any additional information required.NOTE: If RTRI or RITA results will be returned to the client, we recommend including a description of how incidents and adverse events related to the return of results, including social harm or intimate partner violence, will be monitored and any protective measures to reduce the risk to clients or partners of clients. For example, social harm monitoring may involve: longitudinal follow up assessment of index clients and contacts, oral or written reporting by health facility staff and/or community-based health workers or volunteers, a telephone hotline, etc. Additionally, if transmission modes are being elucidated it will be important to discuss how priority/key populations will be protected.Any unanticipated problems involving new or increased risk to participants or others will be promptly reported to the investigators, MoH and IRB(s).6.0 TimelineCountries will provide specific timelines based on their local objectives with respect to integration of the rapid test for recent infection into HTS.7.0 Data Use and DisseminationAggregate surveillance data describing where and among whom recent infections are occurring among newly diagnosed PLHIV will be shared widely with in-country stakeholders on an ongoing basis, for example through the national data repository dashboards, to inform the national HIV response to guide public health response as well as prevention and control measures. Stakeholders will include government (Ministry of Health), civil society, health facilities, non-governmental organizations, donors, international technical experts. Periodic, formal dissemination of results will take several forms, including national epidemiologic reports or surveillance reports for distribution and peer-reviewed publications.NOTE: If RTRI or RITA results will be used at the site-level or individual-level (e.g., if used for index testing triage), it is necessary to describe this use and provide relevant information during informed consent process.For example: All index cases will be offered index testing/partner notification services as part of routine HTS. If there are more index cases than can be traced with existing personnel/resources, these results (RTRI result; RITA result; VL result) may be one of several criteria used to prioritize which index case contacts are traced first. 8.0 References ADDIN EN.REFLIST 1.UNAIDS, UNAIDS Data 2017. 2017: Geneva, Switzerland.2.UNAIDS, Right to Health. 2017, UNAIDS: Geneva.3.UNAIDS, Ending the AIDS epidemic 2030 - Global Statistics 2016. UNAIDS Fact Sheet 2016, 2016.4.Brookmeyer, R. and T.C. Quinn, Estimation of current human immunodeficiency virus incidence rates from a cross-sectional survey using early diagnostic tests. Am J Epidemiol, 1995. 141(2): p. 166-72.5.Janssen, R.S., et al., New testing strategy to detect early HIV-1 infection for use in incidence estimates and for clinical and prevention purposes. JAMA, 1998. 280(1): p. 42-8.6.Kassanjee, R., et al., Viral load criteria and threshold optimization to improve HIV incidence assay characteristics. AIDS, 2016. 30(15): p. 2361-71.7.Aghaizu, A., et al., Recent infection testing algorithm (RITA) applied to new HIV diagnoses in England, Wales and Northern Ireland, 2009 to 2011. Euro Surveill, 2014. 19(2).8.Granade, T.C., et al., Development of a novel rapid HIV test for simultaneous detection of recent or long-term HIV type 1 infection using a single testing device. AIDS Res Hum Retroviruses, 2013. 29(1): p. 61-7.9.Girardi, S.B., et al., Evaluation of rapid tests for human immunodeficiency virus as a tool to detect recent seroconversion. Braz J Infect Dis, 2012. 16(5): p. 452-6.10.Soroka, S.D., et al., Modification of rapid human immunodeficiency virus (HIV) antibody assay protocols for detecting recent HIV seroconversion. Clin Diagn Lab Immunol, 2005. 12(8): p. 918-21.11.Nikolopoulos, G.K., et al., A network intervention that locates and intervenes with recently HIV-infected persons: The Transmission Reduction Intervention Project (TRIP). Sci Rep, 2016. 6: p. 38100.12.Duong, Y.T., et al., Recalibration of the limiting antigen avidity EIA to determine mean duration of recent infection in divergent HIV-1 subtypes. PLoS One, 2015. 10(2): p. e0114947.13.Parekh, B., et al. Performance evaluation of Asante? Rapid Recency Assay for HIV diagnosis and detection of recent infection: potential for surveillance and prevention. IAS 2017 abstract number A-854-0164-05286, 2017.14.Ageymang E., et al. Performance of a novel point-of-care HIV recency test among newly diagnosed pregnant adolescent girls and young women — Malawi, 2017. International AIDS Conference 2018 abstract number THPEC 200, 2018.Appendix A. WRITTEN CONSENT Form FOR rapid TESTING for recent infection IN HTSFlesh-Kincaid Grade Level = 5.7This informed consent form is for persons who have a new HIV diagnosis. The informed consent form has two parts:Information Sheet (to share information about the program with you)Certificate of Consent (for signatures if you agree to take part)You may have a copy of the form.Part I. Information sheetPurpose of the Public Health Program activityMinistry of Health is doing a surveillance activity to know how many new HIV infections have happened in the past one year. We will use a new test called a “Recent Infection Test,” during the usual HIV tests. Participation in this activity is voluntary. Your choice to participate will not change your care. Individuals will be asked to participate if they are:At least 15 years old, Never diagnosed with HIV before,Never have taken HIV medication (ART) before, and HIV positive based on tests today. ProceduresIf you agree to take part, we will collect a few small drops of blood. We will use the blood to do the “HIV rapid test for recent infection.” I may ask you to take an additional blood sample (approximately 2 tablespoons). This blood will be used to measure the amount of virus in the blood (viral load). I will put a number on the container with the blood. Your name will not be on the container with your blood. This will keep your information private. Because the Recent Infection Test is currently under evaluation and not yet approved by the World Health Organization, the test result will not be available. Your HIV diagnosis and access to normal care will not change.. Risks and Benefits:We do not think the recent infection test (or viral load test) will add to your risks. We may need to prick your finger again if we are unable to get enough blood with the finger pricks for HIV testing. You may feel some pain and soreness from the finger prick. This is similar to routine testing. There is always a risk your personal information may accidentally be shared to unauthorized persons. Every effort will be made to keep your information private. There is no direct benefit from participating. The results will help inform HIV services in your country. If you have questions about this activity or if you feel that you have been harmed by taking part, you may contact [INSERT CONTACT HERE]If you have any questions on what your rights are as a participant in this project, you can contact the Secretariat for the Ethical Review Committee [INSERT CONTACT HERE]PART II: Certificate of Consent/AssentI have read the previous information, or it has been read to me. I was able to ask questions about the program. My questions have been answered to my satisfaction. ? I consent/assent voluntarily to have my blood tested for recent infection. I understand this will not change my medical care.? I do not consent/assent voluntarily to have my blood tested for recent infection. I understand this will not change my medical care.Print Name of Participant_____________________________________________________Signature of Participant ______________________________________________________Signature Date ______________________________________________________________Print Name of person taking the consent/assent ____________________________________Signature _______________________________________________________________Signature Date ___________________________________________________________UPI created_____________________________________________________ If needed, due to language barrier, this consent/assent was witnessed by:Print Name of person witnessing the consent/assent ____________________________________Signature _______________________________________________________________Signature Date ________________________________________________________Appendix B. Example Rapid Test for Recent Infection Results Documentation FormHIV Testing ServicesRapid Test for Recent Infection?Sample Type (Circle): Finger Prick Venous Blood Plasma SerumTest Name: Kit Lot #Kit Expiration Date (DD/MM/YYYY)Site/Facility NameTester Name????NoFirst initialLast nameHTS IDARV IDDate of Diagnosis(DD/MM/YYYY)Site/Facility NameSample IDVisual Results(Mark "√" if Line is present)Recency Interpretation(All 3 lines =LT; C&V Lines= Recent; Only C Line= Negative)(Please circle one)Control LineVerification LineLong Term LineQc-Long term???LTRecentNegInvalidQC - Recent???LTRecentNegInvalidQC-Negative???LTRecentNegInvalid1?????LTRecentNegInvalid2?????LTRecentNegInvalid3?????LTRecentNegInvalid4?????LTRecentNegInvalid5?????LTRecentNegInvalid6?????LTRecentNegInvalid7?????LTRecentNegInvalid8?????LTRecentNegInvalid9?????LTRecentNegInvalid10?????LTRecentNegInvalid11?????LTRecentNegInvalid12?????LTRecentNegInvalid13?????LTRecentNegInvalid14?????LTRecentNegInvalid15?????LTRecentNegInvalidResults Reviewed on:Results Reviewed By:Appendix C. Counseling Procedures and Messages for Return of Test Results (If applicable)StepMessage1Ask client whether he/she has any questions about his/her care, specifically the new HIV diagnosis and treatment. Ask whether he/she has any questions regarding test for recent infection and if ready to receive test for recent infection results.2Provide test for recent infection result and allow time to process. The nurse/counsellor should anticipate the emotional reaction from a client who has been told they were recently infected and its implications. A client may express anger, shock, confusion, distrust, etc. Use counselling skills: listen to client and support accordingly.2.1If tested long-term on the rapid test for recent infection state the following:We tested your blood sample and the test indicates you may have long-term infection. You were most likely infected with HIV more than 12 months ago and possibly several years ago. The test cannot tell exactly when you were infected or who infected you. There is a small chance that the result is not correct and that you have been infected within the past 12 months.Take your time we have plenty of time to talk about your results.How do you understand this result?How are you feeling about this result??How can I help support you?2.2If RITA recent (test for recent infection + viral load test) state the following: We tested your blood sample and the tests indicate you may have recent infection. You were likely infected with HIV within the past 12 months. The test cannot tell exactly when you were infected or who infected you. There is a small (one in ten) chance that the result is not correct and that you have been infected for more than 12 months and possibly for several years. Take your time we have plenty of time to talk about your results.How do you understand this result?How are you feeling about this result??How can I help support you?3Answer any questions the client may have about test for recent infection test result.4Discuss and reinforce HIV prevention messages and partner testing for all HIV infected persons:Your result does not reflect your partner(s) HIV status. You need to ask your partner(s) to get tested whether you tested as having a recent infection or a long-term infection. We have many options on how to do so and we can discuss further. You do not need to tell your partners the results from your test for recent infection, the important thing is to share your HIV status and that you are on treatment.You can pass HIV on to your loved one(s) by having unprotected sex. Disclosing your HIV status to your loved ones may help you discuss ways that you can use to protect them from HIV.A good practice to prevent transmission to unborn or newborn children and partner(s) is to be on treatment, and with partner(s) using a condom during sex The best way to keep yourself healthy and to keep your partner(s) healthy is to start taking ART. Once you start HIV treatment, it is critical that you continue taking it every day as prescribed by your nurse or doctor. ?Appendix D. Information Sheet on Understanding Recent and Long-term HIV Infection (if applicable – returning results)Flesh-Kincaid grade level: 6.1What does recent HIV infection mean? Recent HIV infection means a person likely got HIV within the past one year. People with recent HIV infection have high amounts of HIV in their blood. Having more virus means that it is easier to pass on infection to others. HIV medications (antiretrovirals or ARVs) lower the amount of HIV in your body. ARVs help you to stay healthy. ARVs make it less likely for you to pass the infection to others, including unborn and breastfeeding infants and sex partners. ARVs need to be taken every day or as prescribed by a doctor for your health. This will also lower the risk of passing HIV. Now, the test for recent infection is a research tool. There is a small (one in ten) chance that someone who got HIV more than one year ago will test as if they have a recent infection. The test cannot tell exactly when you got HIV. The test cannot tell you who passed the infection to you.What does long-term HIV infection mean? A long-term HIV infection means a person likely got HIV more than one year ago. A person with long-term HIV infection can still pass HIV to other people. People with any HIV infection should start and stay on HIV medications (ARVs) as prescribed by your doctor for your health. ARVs lower the risk of passing HIV to others. At this time, the test for recent infection is a research tool. There is a chance that someone who got HIV within the past one year will test as if they have a long-term infection. The test cannot tell exactly when you got HIV. The test cannot tell you who passed the infection to you.How can I reduce the risk of transmitting HIV to others?If you have a recent or long-term HIV infection, you have HIV in your blood. Start HIV medication (ARVs) as soon as possible. Take the pills everyday as prescribed by your healthcare provider. If you forget to take your HIV medicine, take it as soon as you remember. If HIV medications make you feel sick, talk to your healthcare provider.You can pass HIV to sex partners [and to your unborn or breastfeeding baby or persons you share needles with]. Not having sex is the best way to not pass HIV to your sex partner. If you do have sex, you and your partner need to use a condom the right way every time you have sex. Limit the number of people you have any kind of sex with. If you have HIV and are pregnant or breastfeeding, it is important to start and stay on HIV medications. It is important for your baby to take HIV medicines for 6-12 weeks after birth. This will lower the chance of passing infection on to your baby. If you inject drugs outside of the clinic or hospital, only use sterile needles or syringes. Do not share the needle or syringe with anyone else.Appendix E. Statement of Intent to Maintain Confidentiality I, …………………………………………, will at all times maintain the confidentiality of the patients whose patient data are reviewed as part of this project. At no time will I disclose the names of patients whose patient data are reviewed, or any information within their patient charts. All patient data will be reviewed in a private location. If there are questions related to the patient data, these will be discussed with the study team in a private location. Once the project is complete, individual-level patient data, including names and information, will not be discussed with anyone outside of the study team.Signed by:………………………………………………….Study Role:………………………………………………….Place:………………………………………………………Date:………………………………………………………Appendix F. Example analysis table shell to describe the percentage recent infection among persons with new HIV diagnosis by select variables Total new HIV diagnosisRecent infection among new HIV diagnosisLong-term infection among new HIV diagnosisPersons who declined testing for recent infection*Select variablesN n n/N (%)nn/N (%)nn/N (%)Municipality12345SexMaleFemaleTransgenderAge category (years) 15-2425-3435-4445-5455-64>65Marital statusSingle (Never married)Married/Co-habitingSeparated/DivorcedWidowedRisk factors(if applicable)HeterosexualHomosexualInjection drug use (last 12 months)Blood transfusion (last 12 months)Work accidentGender-based violenceUnknown *Note: Where possible, conduct separate analysis for persons who did not receive testing for recent infection and persons who declined testing for recent infection. ................
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