Hiv Clinical Trial
Official title:
A Randomized Controlled Trial to Evaluate Feasibility of Bundled HCV/HIV Rapid Screening
This randomized controlled trial was implemented to evaluate the effect of integrating rapid Hepatitis C (HCV) testing into a pre-existing screening program for Human Immunodeficiency Virus (HIV) on HIV test acceptance and diagnosis of both HCV and HIV. A sample of 478 adults in a New York City Emergency Department participated in the study. Participants were randomized to receive either an offer of bundled HIV/HCV testing or HIV testing alone. Public Health Advocates approached eligible patients in the Emergency Department, performed HIV and HCV raid testing, and delivered test results to participants with post-test counseling. The primary outcome, HIV test acceptance, was compared between the two groups to evaluate whether the addition of an HCV test adversely impacted participants' consent to test for HIV. Questionnaires were also distributed to participants to assess HCV knowledge.
The high prevalence of HIV and HCV co-infection, similarity in testing strategies, and
interrelated risk factors suggest a practical overlap in integrating screening services. This
integration could effectively utilize existing resources and infrastructure to address both
epidemics and facilitate the linkage of HCV-infected individuals to care.
The objective of this study was to integrate rapid HCV testing into a well-established HIV
testing and counseling program to evaluate the effect of rapid bundled screening on HIV test
acceptance rate. Secondary outcomes include HCV test acceptance, identification of newly
diagnosed HCV- and HIV-positive patients, HCV knowledge, risk assessment, and refusal
reasons.
The two-armed, randomized controlled trial was conducted at Jacobi Medical Center, a Level 1
trauma and tertiary care center located in the Bronx, New York. Upon recruitment, all
participants completed questionnaires that included demographic information, HCV risk
assessment, and HCV knowledge questions. Participants were randomized either to the control
arm or the intervention arm. The control arm was offered HIV testing only and the
intervention arm was offered HIV testing concurrently with HCV testing (bundled HIV/HCV
screening).
Sample size was determined using the following parameters: 1) 80% power; 2) significance
level of 0.05; 3) two-sided significant test; and 4) 10% difference between groups on the
acceptance of HIV testing. Using these parameters, a sample of 227 in each group was needed
to test the primary outcome: acceptance of an integrated screening program for HIV and HCV
infection. Groups of at least 333 were used to allow for drop-outs and protocol violations.
Patients were recruited from the adult Emergency Department (ED) at Jacobi Medical Center.
Recruitment took place during a six-month period from December 2012 to May 2013, and 478
patients were enrolled in the study.
Research Assistants were trained as Public Health Advocates to perform HIV and HCV testing
and counseling. The Public Health Advocates approached eligible patients in the ED and
followed a script to ask patients if they were interested in participating in a study through
which they would be offered free screenings recommended for their general health. Patients
who refused the offer of the HIV and/or HCV tests completed a test-refusal questionnaire. All
enrolled participants completed a questionnaire including demographic information, HCV risk
assessment, and HCV knowledge.
After providing verbal consent, participants were randomized to either an HIV test only group
(control) or a bundled HIV/HCV test group (intervention). Randomization was performed by an
independent statistician who used a computer generated allocation schedule. Randomization
assignments were placed in sealed opaque envelopes that were opened sequentially after verbal
consent was obtained for the study.
Those randomized to the control group were offered only an HIV test, and those randomized to
the intervention group were offered both HCV and HIV tests. The OraQuick® HCV Rapid Antibody
Test was employed as a rapid blood fingerstick test for HCV antibodies. The OraQuick Rapid
Antibody Test Advance® HIV-1/2 Antibody test was used to test for HIV-1 and HIV-2 antibodies
in oral fluid. Both point-of-care tests provide results in 20 minutes.
A Public Health Advocate delivered the test(s) results to the patient and conducted post-test
counseling. In the case of a preliminary positive result on either test, the Public Health
Advocate informed the patient and the patient's provider and scheduled a follow up
appointment for the patient.
Data was recorded in an electronic database using Microsoft Excel (Microsoft Corp., Redmond,
WA). Data obtained from subjects were entered using unique subject numbers, without specific
identifiers. Acceptance rates for HIV testing in experimental and intervention arms was
compared using chi square with fisher's exact derived confidence intervals. Stata statistical
software was used to tabulate participant demographics and testing frequencies for HIV, HCV,
or both.
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