- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03210701
A New APPROACH to HIV Testing: Adaptation of POCT for Pharmacies to Reduce Risk and Optimize Access to Care in HIV (APPROACH)
A New APPROACH to HIV Testing: Adaptation of POCT for Pharmacies to Reduce Risk and Optimize Access to Care in HIV - A Type II Hybrid Implementation-Effectiveness Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada, A1A 0L1
- School of Pharmacy, Memorial University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Consistent with current testing guidelines and the National HIV POCT Action Plan HIV testing will be offered to anyone age 18+ who requests a test and is not known to be HIV+.
Exclusion Criteria:
- Anyone unwilling to sign the consent form will be unable to participate in the study or receive HIV POCT.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SCREENING
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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OTHER: Patients requesting a HIV screening test
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Using a Type II hybrid Implementation-Effectiveness study design investigators will assess the implementation and effectiveness of a multi-faceted, integrated, contextualized model of HIV POCT in pharmacies in urban and rural settings in NL and AB, Canada.
This design will be flexible, responsive and capable of capturing changing elements at multiple points in time.
A mixed methods approach will be used to assess Implementation and Effectiveness aims.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patients Requesting a Rapid HIV Test at a Community Pharmacy Study Site
Time Frame: Collected at the end of the study period (6-8 months)
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Number of patients who presented to a community pharmacy test site and requested a rapid HIV test.
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Collected at the end of the study period (6-8 months)
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Number of Reactive Test Results
Time Frame: Collected at the end of the study period (6-8 months)
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Number of patients who requested a rapid HIV test at a community pharmacy and received a reactive test result
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Collected at the end of the study period (6-8 months)
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Total Time Required for the HIV Testing Process
Time Frame: From time of participant consenting through to providing pre-test counseling, administering the test & explaining the result, post-test counseling, & referring the participant for additional STBBI testing as indicated, 30-40 minutes on average
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This was the time of the total patient pharmacist interaction, which began with the pharmacist explaining the study and ended with referring the patient for additional sexually transmitted blood borne infections (STBBI) counselling.
The entire testing process included time spent explaining the study and consenting the participant, providing pre-test counselling, administering the test and explaining the result, post-test counselling, and referring the participant for additional STBBI testing as indicated.
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From time of participant consenting through to providing pre-test counseling, administering the test & explaining the result, post-test counseling, & referring the participant for additional STBBI testing as indicated, 30-40 minutes on average
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Participant Satisfaction With Testing Experience
Time Frame: Completed immediately after each individual participants testing process was completed, approximately 10 minutes on average
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Once the testing was completed (see Outcome 3) prior to leaving, participants were asked to complete a de-identified, blinded questionnaire which assessed perception of the testing experience including factors that influenced their decision to be tested at the pharmacy & whether they would have sought HIV testing elsewhere if not at the pharmacy. Information was captured using a percentage continuous response scale from 0 to 100%. Participants were instructed to answer the questions by marking an "x" on the line at the point which represented their experience. For example, in response to the question "How likely are you to buy a lottery ticket today?", the participant was instructed that if they were 50% certain, they would mark an "x" at the 50% notch on the line. Questions were positively worded, with higher scores indicating higher agreement. Not all patients answered all questions; reported data is based on the number of respondents for each question. |
Completed immediately after each individual participants testing process was completed, approximately 10 minutes on average
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Participants Self-identified HIV Risk Behaviours
Time Frame: Immediately prior to testing process, participant completed the survey, approximately 5 - 10 minutes on average
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Prior to initiating the testing process participants were asked to complete a de-identified, blinded questionnaire that included demographic data (age, gender, ethnicity, relationship status, highest education attained, and income level) as well as information about HIV risk factors and previous HIV testing history. Pre-testing questionnaire data on HIV risk factors was used to calculate a Denver HIV Risk Score (www.denverptc.org/resource.php?id=33) for each participant, as a means to predict their probability of having an undiagnosed HIV infection. Patients who score 30 points or greater on the Denver HIV Risk Score are considered at increased risk of undiagnosed HIV infection and should be offered routine screening. Not all patients answered all questions; numbers of respondents for each question is provided. |
Immediately prior to testing process, participant completed the survey, approximately 5 - 10 minutes on average
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Collaborators and Investigators
Publications and helpful links
General Publications
- Kelly DV, Kielly J, Hughes C, Gahagan J, Asghari S, Hancock S, Burt K, Smyczek P, Charlton C, Nguyen H. Expanding access to HIV testing through Canadian community pharmacies: findings from the APPROACH study. BMC Public Health. 2020 May 7;20(1):639. doi: 10.1186/s12889-020-08719-0.
- Kielly J, Kelly DV, Hughes C, Day K, Hancock S, Asghari S, Gahagan J, Marra C, Nguyen H. Adaptation of POCT for pharmacies to reduce risk and optimize access to care in HIV, the APPROACH study protocol: examining acceptability and feasibility. Pilot Feasibility Stud. 2018 Feb 27;4:59. doi: 10.1186/s40814-018-0252-1. eCollection 2018.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HREB-2016.178
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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