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
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Other: A HIV POCT program adapted for & provided by community pharmacists||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||123 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|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.
- 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.
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
|Canada, Newfoundland and Labrador|
|School of Pharmacy, Memorial University|
|St. John's, Newfoundland and Labrador, Canada, A1A 0L1|