1. Routine Opt-Out HIV Testing Texas STD Clinics 1996-2005 James H. Lee, Senior Public Health Advisor HIV/STD Program Texas Department of State Health Services

2. Targeted Opt-In Testing Prior to 1996 Clients with high risk behaviors (e.g. MSM, IDU, genital ulcer disease) Clients with high risk behaviors (e.g. MSM, IDU, genital ulcer disease) Clients requesting an HIV test Clients requesting an HIV test Separate consent form required Separate consent form required

3. Routine Opt-Out Testing Phased Implementation 1996- 1997 All clients tested Unless: All clients tested Unless: Client was known to be HIV-positive Client was known to be HIV-positive Had been recently tested (last 30 - 90 days) Had been recently tested (last 30 - 90 days) Client declined test Client declined test General consent for all STD services

4. Background - Reasons Seroprevalence studies: ~50% of HIV-positive clients were not tested in some STD clinics Seroprevalence studies: ~50% of HIV-positive clients were not tested in some STD clinics Only 50% of clients accepted opt-in HIV testing Only 50% of clients accepted opt-in HIV testing Routine opt-out testing is effective and has been the norm for other STD screening historically Routine opt-out testing is effective and has been the norm for other STD screening historically Early detection of HIV can help communities, STD clinicians and especially clients (Early Intervention) Early detection of HIV can help communities, STD clinicians and especially clients (Early Intervention)

5. Background: Focus Groups Pre-test counseling identified as a deterrent to HIV testing Pre-test counseling identified as a deterrent to HIV testing Many clients thought they were tested routinely and assumed they were HIV negative after their STD clinic visit Many clients thought they were tested routinely and assumed they were HIV negative after their STD clinic visit Focus group participants strongly recommended making routine HIV testing part of STD screening Focus group participants strongly recommended making routine HIV testing part of STD screening

6. Texas Informed Consent Law Sec. 81.105. Informed Consent. Sec. 81.105. Informed Consent. (a) Except as otherwise provided by law, a person may not perform a test designed to identify HIV antibody without first obtaining the informed consent of the person to be tested. (a) Except as otherwise provided by law, a person may not perform a test designed to identify HIV antibody without first obtaining the informed consent of the person to be tested.

7. Texas General Consent Law Sec. 81.106. General Consent. Sec. 81.106. General Consent. (a) A person who has signed a general consent form for the performance of medical tests is not required to also sign a specific consent form relating to medical tests to determine HIV infection that will be performed on the person during the time in which the general consent form is in effect.

8. Evaluation Objective Evaluate major changes in the implementation of routine, opt-out HIV testing in STD clinics: Change in eligibility, from “targeted” to “routine” Change in eligibility, from “targeted” to “routine” Change in consent, from Change in consent, from –“opt-in” (separate consent solicited) to –“opt-out” (HIV test included as one of regular screening tests, unless it is refused.)

9. Other Changes in Procedures Bilingual Signs and videotapes developed to inform clients Bilingual Signs and videotapes developed to inform clients High risk individuals and those opting-out referred to a Disease Intervention Specialist (DIS) High risk individuals and those opting-out referred to a Disease Intervention Specialist (DIS) During clinic visit, prevention counseling offered to all clients During clinic visit, prevention counseling offered to all clients

10. Evaluation Outcomes Change in the number and percentage of positive clients identified Change in the number and percentage of positive clients identified Change in demographics of positive clients Change in demographics of positive clients Change in the risk profile of positive clients Change in the risk profile of positive clients Compare partner services outcomes Compare partner services outcomes

11. Methods 6-month evaluation periods before and after implementing opt-out at 6 STD programs: 6-month evaluation periods before and after implementing opt-out at 6 STD programs: Amarillo, Austin, Dallas, Fort Worth, Houston, Lubbock Amarillo, Austin, Dallas, Fort Worth, Houston, Lubbock Each site recorded data on: Each site recorded data on: –Utilization of HIV testing, prevention counseling –Number of new HIV infections identified –Partner elicitation, counseling, and HIV testing

13. I hereby voluntarily consent to medical and/or dental examinations, treatments and procedures including laboratory tests and x-rays which are deemed necessary in the opinion of my physician and health care providers selected by my physician. I understand that no guarantees or warranties have been made to me concerning the results of the examinations, treatments or procedures. My signature acknowledges that I have been given the opportunity to ask questions about this consent form. HOUSTON DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL CONSENT FORM

14. Results Opt-in Opt-out N (%) N (%) % Change STD Visits31,558 34,533 +9 STD Visits31,558 34,533 +9 Eligible Clients19,184 (61) 23,686 (69) +23 Eligible Clients19,184 (61) 23,686 (69) +23 Pre-test Counsel15,038 (78) 11,466 (48) -24 Pre-test Counsel15,038 (78) 11,466 (48) -24 Tested14,927 (78) 23,020 (97) +54 Tested14,927 (78) 23,020 (97) +54 Post-test Counsel 6,014 (40) 4,406 (19) -27 Post-test Counsel 6,014 (40) 4,406 (19) -27 HIV-positive 168 (1.1) 268 (1.2) +59 HIV-positive 168 (1.1) 268 (1.2) +59

15. Partner Services Opt-in Opt-out HIV+ Index Patients145 251 HIV+ Index Patients145 251 Partners Elicited139 (.96) 206 (.82) Partners Elicited139 (.96) 206 (.82) Known HIV+ 19 (14%) 26 (13%) Known HIV+ 19 (14%) 26 (13%) Unknown HIV Status120 (86%) 180 (87%) Unknown HIV Status120 (86%) 180 (87%) Partners Located 96 (80%) 131 (73%) Partners Located 96 (80%) 131 (73%) Partners Tested 85 (89%) 111 (85%) Partners Tested 85 (89%) 111 (85%) Partners HIV+ 10 (12%) 30 (27%) Partners HIV+ 10 (12%) 30 (27%)

16. Evaluation Summary HIV testing increased 54% (attendance increased 9%) HIV testing increased 54% (attendance increased 9%) HIV-positive clients identified increased 60% HIV-positive clients identified increased 60% Number of HIV-positive clients successfully referred to early intervention programs increased 89% Number of HIV-positive clients successfully referred to early intervention programs increased 89% Number of new HIV-positive partners increased 200% Number of new HIV-positive partners increased 200% Demographics did not change Demographics did not change Risk profile did not change Risk profile did not change Uninfected STD clients receiving prevention counseling decreased Uninfected STD clients receiving prevention counseling decreased

17. Evaluation Conclusions Opt-out HIV testing in STD Clinics is an effective strategy for identifying HIV- positive individuals and linking them into early intervention services Opt-out HIV testing in STD Clinics is an effective strategy for identifying HIV- positive individuals and linking them into early intervention services Partner notification is an effective strategy for identifying HIV-positive individuals Partner notification is an effective strategy for identifying HIV-positive individuals

18. STD Clients Eligible for HIV Test STD clients are eligible for HIV test unless: Client is known to be HIV-positive Client is known to be HIV-positive Has been recently tested (last 30 - 90 days) based on the clinic’s syphilis testing procedure Has been recently tested (last 30 - 90 days) based on the clinic’s syphilis testing procedure

19. Eligible STD Clients Percent Tested for HIV

20. Eligible STD Clients Percent Positive

21. Eligible STD Clients Percent Prevention Counseled

22. Conclusions: 1997-2005  HIV testing rates remain high (average, 92%)  The proportion of clients who test HIV-positive remains stable (average, 0.8%)  Approximately half of persons tested with opt-out consent (average, 48%) accept prevention counseling  This compares favorably to the percentage of STD clients who accepted participation in the Project RESPECT study of prevention counseling (43%)

23. Acknowledgements Bernard Branson, CDC Bernard Branson, CDC Don Hutcheson, Dallas County HIV/STD Program Don Hutcheson, Dallas County HIV/STD Program Barry Mitchell, DSHS Barry Mitchell, DSHS Beverly Nolt, DSHS (now CDC) Beverly Nolt, DSHS (now CDC) John Paffel, Houston HIV/STD Program John Paffel, Houston HIV/STD Program Ann Robbins, DSHS Ann Robbins, DSHS Michelle C. Thomas, DSHS Michelle C. Thomas, DSHS

24. Contact Information Jim Lee 512-533-3109 Jim.Lee@dshs.state.tx.us Program Operations Procedures and Standards (POPS) Chapter 4 HIV Testing in STD Clinics http://www.tdh.state.tx.us/hivstd/guidelines/default. htm