HIV InfectionsAPPROACHNCT03210701
A New APPROACH to HIV Testing: Adaptation of POCT for Pharmacies to Reduce Risk and Optimize Access to Care in HIV
A study testing A HIV POCT program adapted for & provided by community pharmacists in people with HIV Infections, run by Memorial University of Newfoundland at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- A HIV POCT program adapted for & provided by community pharmacists
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteCanada
- Study dates
- 14 Feb 2017to 1 Sep 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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+.
Who cannot join
- Anyone unwilling to sign the consent form will be unable to participate in the study or receive HIV POCT.
Trial locations and contacts
1 site in 1 country.
Canada1 site
School of Pharmacy, Memorial University
St. John's, Newfoundland and Labrador, A1A 0L1
About this study
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
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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- A HIV POCT program adapted for & provided by community pharmacists
- Keywords
- pharmacy, pharmacist, POCT, Implementation science
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A HIV POCT program adapted for & provided by community pharmacistsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients requesting a HIV screening test | Other | Not described Receives: Other: A HIV POCT program adapted for & provided by community pharmacists |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients Requesting a Rapid HIV Test at a Community Pharmacy Study Site
Number of patients who presented to a community pharmacy test site and requested a rapid HIV test.
Measured: Collected at the end of the study period (6-8 months)
Number of Reactive Test Results
Number of patients who requested a rapid HIV test at a community pharmacy and received a reactive test result
Measured: Collected at the end of the study period (6-8 months)
Total Time Required for the HIV Testing Process
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.
Measured: 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
Participant Satisfaction With Testing Experience
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.
Measured: Completed immediately after each individual participants testing process was completed, approximately 10 minutes on average
Participants Self-identified HIV Risk Behaviours
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.
Measured: Immediately prior to testing process, participant completed the survey, approximately 5 - 10 minutes on average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start14 Feb 2017
- Primary completion1 Sep 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial University of Newfoundland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah Kelly, Memorial University of Newfoundland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03210701
- Sponsor's protocol ID
- HREB-2016.178
- Acronym
- APPROACH
- Status last verified
- May 2020
- First submitted
- 29 Jun 2017
- Last updated
- 19 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32380978Kielly 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.
PubMed 30788134
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03210701
- Acronym / sponsor ID
- APPROACH / HREB-2016.178
- Conditions
- HIV Infections
- Keywords
- pharmacy, pharmacist, POCT, Implementation science
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Memorial University of NewfoundlandUniversity, hospital or other
- Study start
- 14 Feb 2017 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 7 Jul 2017 (actual)
- Results
- Posted 19 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients requesting a HIV screening test | Other | Other: A HIV POCT program adapted for & provided by community pharmacists |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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+.
Key exclusion criteria (1 listed)
- Anyone unwilling to sign the consent form will be unable to participate in the study or receive HIV POCT.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A HIV POCT program adapted for & provided by community pharmacistsUsing 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. | Other | Patients requesting a HIV screening test |
Primary outcome
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.
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
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32380978Kelly 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.
- Derived from this study: PubMed 30788134Kielly 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A HIV POCT program adapted for & provided by community pharmacists in people with HIV Infections, run by Memorial University of Newfoundland at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03210701, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2020.