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A New APPROACH to HIV Testing: Adaptation of POCT for Pharmacies to Reduce Risk and Optimize Access to Care in HIV (APPROACH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03210701
Recruitment Status : Completed
First Posted : July 7, 2017
Results First Posted : May 19, 2020
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
Deborah Kelly, Memorial University of Newfoundland

Brief Summary:
An estimated 21% of Canadians with HIV are unaware of their infection. There is a need to improve access to HIV testing to detect infections earlier so individuals can access care early and take steps to prevent transmission to others. Barriers to HIV testing include limited access or reluctance to go to traditional testing sites (doctor's offices and sexually transmitted infection clinics), and the lengthy wait time to receive test results from standard laboratory-based HIV testing (usually 1-2 weeks). These deterrents are particularly significant for those at highest risk of infection, who may be socially marginalized or stigmatized. In rural areas, HIV testing may only be available through doctor's offices and hospitals, yet many Canadians do not have access to a family physician. Pharmacists are among the most trusted and accessible healthcare providers, and are well positioned to improve access to HIV testing. Point of care tests for HIV are easy to administer and results are available within minutes, making them ideal for use in the community pharmacy setting. Point of care testing (POCT) by pharmacists can ensure individuals receive their test results, and facilitate timely linkages to care and treatment. This adaptation grant will look at factors influencing the acceptability and feasibility of pharmacist-provided rapid POCT for HIV in two Canadian provinces, including pharmacies in both urban and rural areas. The effectiveness of pharmacist-delivered POCT will be considered from a variety of perspectives including people living with or at risk of HIV, as well as pharmacists as the service providers.

Condition or disease Intervention/treatment Phase
HIV Infections Other: A HIV POCT program adapted for & provided by community pharmacists Not Applicable

Detailed Description:
Background: There is a need to improve access to HIV testing to detect infections earlier so individuals can access care and prevent transmission. Barriers to testing include limited access or reluctance to go to traditional testing sites, and the lengthy wait time to receive results. Pharmacists are trusted, accessible health providers and are well positioned to offer HIV testing. Point of care tests (POCT) for HIV are easy to administer and results available within minutes, making them ideal for use in the pharmacy setting. HIV POCT may overcome barriers to standard testing for those at high risk and in healthcare resource-limited settings. Preliminary data suggest pharmacist-administered POCT can reach those who have never had an HIV test. Implementation and effectiveness of pharmacist-delivered POCT is the focus of this study. Study goals: To determine whether a multi-faceted HIV POCT program adapted for community pharmacies in two Canadian provinces is acceptable, feasible and effective in reaching those at high risk and those who have never been tested. Implementation and effectiveness of an integrated, contextualized model of HIV POCT in urban and rural pharmacies in Newfoundland (NL) and Alberta (AB) will be assessed. Participant characteristics, responses to satisfaction measures on the participant questionnaire, and pharmacist time to offer HIV POCT were analyzed using descriptive statistics. Pre-testing questionnaire data was used to calculate a Denver HIV Risk Score for each participant, as a means to predict their probability of having an undiagnosed HIV infection. ANOVA was used to assess differences in participants' Denver HIV Risk Scores between provinces, and urban versus rural testing sites, and multivariate analysis of variance (MANOVA) was used to assess differences in participant satisfaction with the testing experience based on province, urban/rural testing site, sex, and history of prior HIV testing. Fisher's Exact tests were used to assess whether history of prior HIV testing depended on province or urban/rural centre for testing. Qualitative data were analysed using a thematic analysis approach. Interview transcripts and extensive field notes were included for analysis from the participant interviews and pharmacist focus groups. Transcripts from participant interviews were coded using an open or emergent scheme where codes were developed and modified throughout the coding process. Descriptive codes were assigned to identify recurring concepts, and sub-themes were then identified and. Themes from the pharmacist focus groups were considered according to the Capability, Opportunity, Motivation, Behaviour (COM-B) model to understand behaviour change, which considers opportunities and challenges in the context of professional capability, opportunity, and motivation to offer the HIV POCT program. Impact: This study will inform further modifications to the pharmacy HIV POCT model to optimize effectiveness and increase scalability prior to full adoption and implementation. This will form the basis for a subsequent grant application. Knowledge gained can be used to scale up effective testing programs to increase the number of high risk individuals getting tested. The pharmacy is a novel venue to offer HIV testing, and if successful could be a widely accessible option applicable to other provinces and other countries. This study will provide proof of concept for pharmacy based POCT for other sexually transmitted and blood-borne infections (STBBI) (once tests become available) and successful implementation may also lead to pharmacist-delivered pre-exposure prophylaxis (PrEP) programs, to further reduce HIV infection rates.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: 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
Actual Study Start Date : February 14, 2017
Actual Primary Completion Date : September 1, 2017
Actual Study Completion Date : September 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Patients requesting a HIV screening test Other: A HIV POCT program adapted for & provided by community pharmacists
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.




Primary Outcome Measures :
  1. 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) ]
    Number of patients who presented to a community pharmacy test site and requested a rapid HIV test.

  2. Number of Reactive Test Results [ Time Frame: Collected at the end of the study period (6-8 months) ]
    Number of patients who requested a rapid HIV test at a community pharmacy and received a reactive test result

  3. 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 ]
    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.

  4. Participant Satisfaction With Testing Experience [ Time Frame: Completed immediately after each individual participants testing process was completed, approximately 10 minutes on average ]

    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.


  5. Participants Self-identified HIV Risk Behaviours [ Time Frame: Immediately prior to testing process, participant completed the survey, approximately 5 - 10 minutes on average ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03210701


Locations
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Canada, Newfoundland and Labrador
School of Pharmacy, Memorial University
St. John's, Newfoundland and Labrador, Canada, A1A 0L1
Sponsors and Collaborators
Memorial University of Newfoundland
  Study Documents (Full-Text)

Documents provided by Deborah Kelly, Memorial University of Newfoundland:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Deborah Kelly, Associate Professor and Special Advisor of Innovation, Memorial University of Newfoundland
ClinicalTrials.gov Identifier: NCT03210701    
Other Study ID Numbers: HREB-2016.178
First Posted: July 7, 2017    Key Record Dates
Results First Posted: May 19, 2020
Last Update Posted: May 19, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Deborah Kelly, Memorial University of Newfoundland:
pharmacy
pharmacist
POCT
Implementation science
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases