Enhanced Health Promotion and Screening (EHPS) Program Implementation at Clinical Settings and Corrections in Pennsylvania

Transcription

1 Enhanced Health Promotion and Screening (EHPS) Program Implementation at Clinical Settings and Corrections in Pennsylvania PENNSYLVANIA DEPARTMENT OF HEALTH Bureau of Communicable Diseases, Division of HIV/AIDS In Conjunction with Pennsylvania Expanded HIV Testing Initiative (PEHTI) and the Minority Aids Initiative (MAI)

2 Objectives To routinize opt-out screenings for conditions of public health importance (including HIV) in correctional healthcare settings and also ensure linkage of individuals offered screenings with relevant care/prevention and with primary care providers.

3 Backgrounds CDC released revised guidelines for HIV testing in health care settings in 2006 calling for opt out routine incorporation of HIV screening into clinical settings and correctional facilities. PA DOH has designated PSCOM to administer PEHTI and to provide technical support for the EHPS program implementation. In accordance with CDC guidelines, PEHTI has targeted community health centers to expand HIV testing as part of the EHPS program; universal HIV testing will be implemented in an opt-out format.

4 Why Do We Test?

5 A Few Facts about Pennsylvania Early findings suggest that 1/3 of persons testing positive for HIV develop AIDS within one year On average an HIV positive patient unaware of their status, will visit a clinical setting 4.5 x before diagnosis From 2007 to 2009, only 33% of Pennsylvanians were tested for HIV

6 And on a national level. 1.2 million people in the United States are living with HIV infection and 21 percent of them are unaware of their condition. MSM individuals are most severely affected. African Americans are disproportionately burdened.

7 Testing Modalities Lab-based Analyzer ELISA Rapid Kitbased But which to choose

8 Lab-Based Rapid Testing using a Chemoluminescence Analyzer

9 Lab-Based Analyzer Testing Suitable for high volume settings Use endogenous staff No specialized training or additional storage Cost-effective Easy to assimilate into the flow of patient care Tests have high specificity/sensitivity Same blood sample used for confirmatory tests Drawbacks..only suitable for clinical settings with machinery.

10 Lab-Based Analyzer Assays HIV Chemilumine sence Assays Manufacturer /Lab Antibody Detection Specimen Type Specificity Sensitivity Machine Compatibility Abbott PRISM HIV O Test Kit Abbott HIV-1 Group M and O envelope HIV 2 envelope Human serum and plasma % % All HIV 1/O/2 Enhance d (EHIV) ADVIA Centaur HIV 1 Group O HIV 2 Human serum and plasma % % All

11 Rapid Kit-Based Testing

12 In brief Lab-based analyzer testing is an easy method to integrate into the flow of patient care. It minimizes the need to access risk. Minimal disruption to the flow of patient care. The test is a normal blood test, ordered with other labs. Rapid kit-based testing is an historically successful testing method in the right clinical setting. Offers flexibility in terms of the specimen needed and location of test.

13 Where are we now? Current progress that has been made within the PEHTI Project

14 Average Number of Monthly Tests= The purpose of these slides is to review the number of tests performed and the estimated monthly patient visits to each site This indicates great potential for expanded testing under the opt-out approach permitted by Act 59 and the PA-DOH

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16 This example is from a PEHTI correctional site (we are not at liberty to name), but the estimated cumulative number of intakes is is ~500/month and the number of tests performed is ~25/month, approximately 5% tested. This indicates great potential for increasing testing under the new opt-out approach permitted by Act 59

17 This example is from a PEHTI correctional site (we are not at liberty to name), but the estimated cumulative number of intakes is ~350/month and the number of tests performed is ~280/month, approximately 80% tested through use of general consent with opt-out testing. This indicates great achievement and potential for sustaining increased under the new opt-out approach permitted by Act 59

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20 Components of EHPS program Examples of components of EHPS which can be initiated at medical examinations: Immunizations TB screening and treatment; STD, HIV and Viral Hepatitis screening; Linkage to prevention/care (case management, PCPs, community clinics, medications, & more) Health education regarding age- and gender-appropriate recommended screenings; Some cancer screenings;

21 CDC s revised recommendations for HIV testing of adults, adolescents, and pregnant women in health care settings, including correctional facilities (Sept, 2006) Objectives: To increase HIV screenings to earlier detect HIV infection, to identify and counsel persons with unknown HIV infection and link them to care and to reduce perinatal transmission of HIV in the U.S. General Population: Opt-out approach: Patients are notified that the HIV testing will be performed unless they decline. Persons at high risk for HIV infection should be screened for HIV at least annually. Separate written consent form should not be required and can be replaced with general consent form for medical care. Prevention counseling should not be required with HIV diagnostic testing or as part of HIV screening programs in health-care settings.

22 ACT 59

23 Summary of ACT 59

24 Key Components Requirements 2006 CDC s recommendation Consent Documentation Was/ Is patient consent required for HIV testing? Should written consent form be separate or combined with general medical consent forms? Were/Are you required to document HIV consent? What information shall be provided to patients to obtain their consent for testing? Yes. Separate written consent for HIV testing should not be required. General consent for medical care should be considered sufficient. Specific signed consent for HIV testing should not be required. General informed consent for medical care should be considered sufficient. ACT 148 (1990) ACT 59 (2011) Steps to implement Enhanced Health Promotion & Screening (EHPS) program, including HIV testing Yes/No Yes/No Yes (written) Either separate or combined Yes (verbal/written in general consent form for medical care) Not applicable: written consent not required. Yes. 1 st option: Use EHPS opt-out sticker system to document a) verbal consent, with b) patient initials on the sticker to signify patient acknowledgment of receipt of pre-test info & consent; 2 nd option is to replace separate dedicated HIV consent with EHPS opt-out general consent form for care (referencing EHPS incl. HIV screening); DISCONTINUE separate dedicated HIV consent form). Not applicable: written consent not required. However, site may elect 1 or the 2 options above to document (verbal) consent Yes Yes Yes Yes. EHPS opt-out sticker system includes a feature for documentation of verbal consent. Prevention counseling should not be required. Oral or written information should include an explanation of HIV infection and the meanings of positive and negative test results. Explanation of test: purpose of testing, potential uses, limitation and the meaning of results Use the EHPS brochure which includes all the information required by Act 59 (2011).

25 Provision of Pre-test information Was/ Is pre-test information required? Was/ Is face-to-face pre-test counseling required? Could/ Can pre-test information offering be verbal, or by written or video materials? What information shall be included in the pretest information? Is documentation of provision of pretest information required? Yes Yes (Act 148 references pretest counseling) Yes Yes. Use the EHPS brochure which includes all the information required No No No No. Provision of EHPS brochure will suffice, followed by provider establishing if patient wishes to opt out of any of the optional screenings/ehps services including HIV. (Documentation of acknowledgment of receipt of pre-test info is addressed in EHPS optout sticker system or (EHPS opt-out general consent approach which includes references to HIV ). Yes Yes Yes Yes. Use the EHPS brochure which includes all the information required. Explanation of HIV infection and the meanings of positive and negative test results Modes of exposure and transmission of HIV & disease prevention Explanations of tests: purpose, potential uses, limitation & meaning of results Use the EHPS brochure which includes all the information required. No No Yes Yes. EHPS sticker system includes a feature whereby patient initials signify acknowledgement of receipt of pre-test information and (verbal) consent (the same is addressed by EHPS opt-out general consent approach referenced above)

26 Provision of Post-test Counseling Was/Is the post-test counseling required for negative results? Was/Is the post-test counseling required for positive results? Was/ Is a face-to-face post-test counseling session for positive results required? What information shall be included in the posttest counseling for positive results? No (except persons with high risk) Yes No No Yes Yes Yes Yes. The EHPS program ensures that patients with positive results will be linked to appropriate prevention/care. Yes ( HIV positive test Yes Yes Yes results should be communicated confidentially through personal contact by a clinician, nurse, midlevel practitioner, counselor, or other skilled staff) Providers should inform patients who receive a new diagnosis of HIV infection that they might be contacted by health department staff for a voluntary interview to discuss notification of their partners. - Significance of the test results. - Info on disease transmission and prevention. - Linkage to appropriate care (treatment, mental health, social and support services). - Benefits of notifying/counseling partners. Post-test counselor will ensure provision of the following: - Significance of the test results. - Info on disease transmission and prevention. - Linkage to appropriate care (treatment, mental health, social and support services). - Benefits of notifying/counseli ng partners.

27 How can you implement the EHPS program at your facilities? the EHPS model in testing flow chart (intake/discharge) Dissemination/ Scale-up project Staff training Program monitoring and evaluation in consultation with PEHTI/DOH team Tracking and reporting system

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30 Implementation Methods During medical examinations, each patient will receive the EHPS brochure and document patient consent with patient initials on a sticker (per example in brochure) OR signed patient consent form for general care. Each patient will have an opportunity to opt-out of any of the optional/voluntary screenings and health education services, including the HIV test, as outlined in the brochure;

31 Implementation Methods (Cont.) A healthcare provider MUST: a) review that the patient has read and understood the brochure and verbally summarize the offered EHPS services including HIV screening, and explicitly ask the patient if they have concerns or wish to opt-out of any of the offered services(a script on a laminated card can be used); b) ascertain that there is documentation that patient is not opting out/is opting out (using the sticker with predetermined language or opt-out general consent for EHPS including HIV screening);

32 Implementation Methods (Cont.) For patients who do not opt-out of HIV screening aspects of the initiation of EHPS as documented in the patient record, an HIV test will be included in the normal test orders. Staff members will receive communications of how the EHPS program is implemented and evaluated which include number of tests, number of HIV positive patients identified and the number of patients successfully linked to care. In addition, the staff member who is responsible for the most tests will be recognized.

33 Monitoring and Evaluation I(M&E) Performance sites will be expected to report services rendered to the PA DOH by generating data from electronic medical record systems on patients offered screening and tests performed consistent with HIPAA, and preferred provider agreements (PPA) which will be signed with participating performance sites. The simplest approach to do this is as follows: All sites testing for HIV, including correctional facilities, must submit specimens for HIV testing to laboratories supporting them along with all the information required in accordance with HIV regulations; Upon completion of the test, the laboratory should be asked to return to the correctional facility the HL7 file that the laboratory already generates for electronic laboratory reporting of HIV to the state/pa-nedss; the HL7 file must includes both positives and negatives; The HL7 file can be processed into an XML file using software to be provided by PEHTI; PEHTI may work out arrangements with individual sites for M&E

34 Monitoring and Evaluation II Reactive/positive test results and case reports will still need to be reported to PA DOH in accordance with reporting regulations for HIV and related conditions. To measure the success of the HIV testing protocol, we will identify and analyze the percentage of patients test acceptance, HIV serostatus/ positive test results including new diagnoses, and the number of patients successfully linked to care. The PA DOH will perform secondary analyses as needed to address program planning and resource allocation needs.

35 Human Subjects Protection EHPS/PEHTI interventions will be offered as part of the routine/standard of care at all performance/intervention sites and surveillance/program implementation monitoring and outcome assessment data collection aspects of the project is permitted by HIPAA (PA DOH is an exempt public health authority), covered by PPAs/contracts, and existing surveillance and public health regulations, hence the proposed activities are determined to be nonresearch public health intervention activities by CDC All supplemental secondary analyses which may generate generalizeable knowledge/findings applicable beyond the population in which the project is to be conducted (i.e. meeting the relevant federal regulations definition of research ) must be submitted to the PA DOH IRB for review before implementation of such supplemental aspects of the project.

36 Anticipated Use of Findings The implementation and analyses of outcomes from the project will be used to: determine appropriate procedure for EHPS program implementation at other correctional institutions. Reports detailing project outcomes are expected to be presented to PA Department of Health, site medical directors, project staff, scientific conferences, and journals for quality assurance and continuing education through peer review, and to facilitate dissemination of findings.

37 Thank you!