Does the Addition of HCV Testing to a Rapid HIV Testing Program Impact HIV Test Acceptance? A Randomized Controlled Trial.

Transcription

1 Does the Addition of HCV Testing to a Rapid HIV Testing Program Impact HIV Test Acceptance? A Randomized Controlled Trial. Yvette Calderon, MD MS 1,2, Ethan Cowan, MD MS 1,2, Rajesh Verma, MD 1, Mark Iscoe BA 1, Sara Rahman BA 1, John Rhee BS 1, Lisa N Glass MS BS 2, Mathew Barbery BA BS 2, Jason Leider, MD PhD 2,3 Department of 1 Emergency Medicine, Jacobi Medical Center, Bronx, NY, USA; 2 Albert Einstein College of Medicine, Bronx, NY, USA; Department of 3 Internal Medicine, Jacobi Medical Center, Bronx, NY, USA

2 Background: 3.2 million chronic HCV infections 16,500 persons newly infected each year Majority of cases remain undiagnosed High HCV prevalence in urban populations New therapies able to cure more HCV-infected individuals in less time Rapid, point-of-care HCV test Existing infrastructure of rapid HIV testing programs

3 Study: Primary Objective: Determine how offering a rapid HCV test along with an HIV test in an urban emergency department (ED) would impact HIV-testing acceptance rate Design: 2-armed randomized controlled trial on a convenience sample of patients aged 18 and above in a Bronx, NY ED Randomized to either an offer of: A) an HIV test or B) both HIV and HCV tests

4 Study: Secondary Objectives: Hepatitis C knowledge (adapted from Balfour) Risk factor information collected

5 Study Participants Approached 733 Enrolled 500 Refused 233 Eligible Participants 478 Ineligible Participants 22 True Refusals 188 Ineligible Refusals 45 Experimental Arm: Offered HCV & HIV 234 Control Arm: Offered HIV only 244 Accepted both tests 184 Only HCV Test 3 Only HIV Test 28 Declined both 19 Accepted HIV Test 224 Declined HIV test 20

6 Study Participants Approached 733 Enrolled 500 Refused 233 Eligible Participants 478 Ineligible Participants 22 True Refusals 188 Ineligible Refusals 45 Experimental Arm: Offered HCV & HIV 234 Control Arm: Offered HIV only 244 Accepted both tests 184 Only HCV Test 3 Only HIV Test 28 Declined both 19 Accepted HIV Test 224 Declined HIV test 20

7 Participant Demographics (n=478) Demographics Control Arm: HIV Only (n=244) Experimental Arm: HIV & HCV (n=234) Age 35.8± ±13.0 Gender Male: 43.4% Female: 55.7% Transgender: 0.8% Male: 45.3% Female: 53.8% Transgender: 0.4% Ethnicity Hispanic: 52.9 % Non-Hispanic: 45.9% Race Black: 39.3% White: 12.7% Other: 34.5% Education 0-8 th grade: 7.0% Some high school: 20.5% High school degree: 58.7% College degree: 7.8% Graduate degree: 0.8% Insurance Medicaid: 32.0% Medicare: 4.5% Private: 23.4% Not insured: 35.7% Hispanic: 53.8 % Non-Hispanic: 44.9% Black: 36.3% White: 13.7% Other: 36.7% 0-8 th grade: 8.1% Some high school: 20.1% High school degree: 58.6% College degree: 7.3% Graduate degree: 1.7% Medicaid: 37.6% Medicare: 2.6% Private: 20.1% Not insured: 35.0% Previously tested for HIV* 89.0% 89.7% Previously tested for HCV* 37.7% 38.0% * self-reported

8 Control Arm: HIV test Only Tests Accepted (n=244) HIV test: 224; 92% Refused HIV test: 20; 8% Reason for HIV test refusal (n=20; multiple responses permitted) I don t feel that I am at risk of having HIV. I am afraid to find out my results. I don t care whether I have HIV or not. 11 No Reason Given 7 1 1

9 Experimental Arm: HIV and HCV Tests Accepted (n=234) HCV Only: 3; 1% Total Tests Conducted Both HIV & HCV: 184; 79% HIV Only: 28; 12% HIV HCV 90.6% (212/234) 80.0% (187/234) Declined Both: 19; 8%

10 Experimental Arm: Test Refusals Reason for HIV test refusal (n=22; multiple responses permitted) I don t feel that I am at risk of having HIV. I don t have time to test. 6 I am worried that the test will slow my care. I am with family or friends. 1 No Reason Given Reason for HCV test refusal (n=47; multiple responses permitted) I do not want to have my finger stuck. I don t feel that I am at risk of having hepatitis C. I don t have time to test. 6 I don t care whether I have hepatitis C or not. I am worried that the test will slow my care No Reason Given 7 3 1

11 Results No participants tested HIV positive 1 (0.5%) participant tested HCV antibody positive There was no significant difference in HIV test acceptance between the control arm and the experimental arm HIV arm: 91.8% (224/244) accepted an HIV test HIV & HCV arm: 90.6% (212/234) accepted an HIV test p=0.642

12 Hepatitis C Knowledge 7-Question True/False Knowledge Measure* (n=478) % responding correctly Hepatitis C can be given to someone during sexual intercourse. (T) 66.9% There are no treatments for hepatitis C. (F) 55.9% People can live with hepatitis C for many years without knowing that they have been infected with the virus. (T) 74.3% People living with hepatitis C can damage their liver if they drink alcohol. (T) 70.7% There exists a hepatitis C vaccine that can be used to prevent people from getting infected with the hepatitis C virus. (F) 43.9% There is no cure for hepatitis C. (F) 45.8% Hepatitis C infections are more common in people born between 1945 and (T) 47.3% *Adapted from Balfour et al. (2009)

13 HCV Risk Factors Risk Factors (n=478) Percentage (%) Risk Factors (n=478) Percent age (%) 1. Tattoo Sex with MSM Piercing other than the ear Sex with someone who is HCV positive 3. Birth Cohort ( ) Ever used injection drugs Sex with someone who exchanged sex for money or drugs (prostitute) Currently using inject drugs Accidental needle stick at work Long term dialysis Lived with someone who is HCV positive Ever used methamphetamine (crystal meth) 7. Sex with an IDU Received blood clotting factor before Blood transfusion or organ transplant before

14 Limitations This study was conducted at a single public hospital that serves low-to-moderate income population and may not be generalizable to other populations or settings Acceptability of non-free hepatitis testing cannot be determined

15 Conclusions Offering HCV along with HIV did not impact HIV test acceptance Hepatitis C knowledge was poor among this population Hepatitis C risk was high, with only about a third of participants having been previously tested for hepatitis C Integration with existing HIV testing programs may expand hepatitis testing efforts. The success of such programs will depend on cooperation of providers, patients, and social institutions

16 Contact Sara Rahman Senior Research Analyst, Project BRIEF Jacobi Medical Center, Bronx, NY Yvette Calderon, MD, MS Professor of Clinical Emergency Medicine Albert Einstein College of Medicine; Adult Urgent Care Director Jacobi Medical Center, Bronx, NY