Trial Outcomes & Findings for A New APPROACH to HIV Testing: Adaptation of POCT for Pharmacies to Reduce Risk and Optimize Access to Care in HIV (NCT NCT03210701)

NCT ID: NCT03210701

Last Updated: 2020-05-19

Results Overview

Number of patients who presented to a community pharmacy test site and requested a rapid HIV test.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 123 participants
• Primary outcome timeframe: Collected at the end of the study period (6-8 months)
• Results posted on: 2020-05-19

Participant Flow

Participant milestones

Measure	Study Participants Patients requesting a rapid HIV test at a community pharmacy study site.
Overall Study STARTED	123
Overall Study COMPLETED	123
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Study Participants n=123 Participants Patients requesting a rapid HIV test at a community pharmacy study site.
Age, Continuous	34.8 years n=5 Participants
Sex/Gender, Customized Male	93 participants n=5 Participants
Sex/Gender, Customized Female	28 participants n=5 Participants
Sex/Gender, Customized Trans person	0 participants n=5 Participants
Sex/Gender, Customized Other	2 participants n=5 Participants
Race/Ethnicity, Customized Caucasian	98 Participants n=5 Participants
Race/Ethnicity, Customized African, Caribbean or Black	8 Participants n=5 Participants
Race/Ethnicity, Customized Indigenous	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian	12 Participants n=5 Participants
Race/Ethnicity, Customized Other	3 Participants n=5 Participants
Region of Enrollment Canada · Urban	112 Participants n=5 Participants
Region of Enrollment Canada · Rural	11 Participants n=5 Participants
Relationship status Single	42 Participants n=5 Participants
Relationship status Casually Dating	39 Participants n=5 Participants
Relationship status Married, Common-Law or Committed	34 Participants n=5 Participants
Relationship status Separted, divorced, widowed (SDW)	6 Participants n=5 Participants
Relationship status SDW and Casually Dating	2 Participants n=5 Participants
Employment Status Full time	76 Participants n=5 Participants
Employment Status Part time	4 Participants n=5 Participants
Employment Status Student	17 Participants n=5 Participants
Employment Status Retired or on Disability	9 Participants n=5 Participants
Employment Status Not Employed	12 Participants n=5 Participants
Employment Status working and student	4 Participants n=5 Participants
Employment Status Other	1 Participants n=5 Participants
Highest level of education Some high school	2 Participants n=5 Participants
Highest level of education High school diploma or equivalent	25 Participants n=5 Participants
Highest level of education Some university or college	21 Participants n=5 Participants
Highest level of education Trade or technical school diploma	30 Participants n=5 Participants
Highest level of education University degree	45 Participants n=5 Participants
Annual Income <$20K	32 Participants n=5 Participants
Annual Income $20 - $39,999	25 Participants n=5 Participants
Annual Income $40 - $59,999	26 Participants n=5 Participants
Annual Income $60 - $79,999	11 Participants n=5 Participants
Annual Income $80 - $99,999	14 Participants n=5 Participants
Annual Income >$100K	15 Participants n=5 Participants
Tested for HIV previously Tested previously	86 Participants n=5 Participants
Tested for HIV previously Not tested previously	33 Participants n=5 Participants
Tested for HIV previously Unsure	2 Participants n=5 Participants
Tested for HIV previously Other	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Study Participants n=123 Participants Patients requesting a rapid HIV test at a community pharmacy study site.
Patients Requesting a Rapid HIV Test at a Community Pharmacy Study Site	123 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Study Participants n=123 Participants Patients requesting a rapid HIV test at a community pharmacy study site.
Number of Reactive Test Results	1 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Study Participants n=123 Participants Patients requesting a rapid HIV test at a community pharmacy study site.
Total Time Required for the HIV Testing Process	30.4 Minutes Standard Deviation 6.95

PRIMARY outcome

Timeframe: Completed immediately after each individual participants testing process was completed, approximately 10 minutes on average

Population: Percentage continuous response scale (0-100)

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.

Outcome measures

Measure	Study Participants n=123 Participants Patients requesting a rapid HIV test at a community pharmacy study site.
Participant Satisfaction With Testing Experience Importance of finger prick blood sample	80.35 score on a scale Interval 0.0 to 100.0
Participant Satisfaction With Testing Experience Comfort with testing at pharmacy	88.66 score on a scale Interval 0.0 to 100.0
Participant Satisfaction With Testing Experience Confidence PhC did a good job administering test	96.93 score on a scale Interval 0.0 to 100.0
Participant Satisfaction With Testing Experience Likelihood to get tested for other STBBI	83.14 score on a scale Interval 0.0 to 100.0
Participant Satisfaction With Testing Experience Importance of privacy at pharmacy site	89.42 score on a scale Interval 0.0 to 100.0
Participant Satisfaction With Testing Experience Importance of immediate test results	94.87 score on a scale Interval 0.0 to 100.0
Participant Satisfaction With Testing Experience Importance of private room for testing and consult	94.87 score on a scale Interval 0.0 to 100.0
Participant Satisfaction With Testing Experience Importance of free testing	88.78 score on a scale Interval 0.0 to 100.0
Participant Satisfaction With Testing Experience Imporatance of not needing an appointment	91.22 score on a scale Interval 0.0 to 100.0
Participant Satisfaction With Testing Experience Willingness to pay for testing	78.69 score on a scale Interval 0.0 to 100.0
Participant Satisfaction With Testing Experience Should HIV testing be offered at pharmacies	99.2 score on a scale Interval 0.0 to 100.0

PRIMARY outcome

Timeframe: Immediately prior to testing process, participant completed the survey, approximately 5 - 10 minutes on average

Population: Not all patients answered all questions; numbers of respondents for each question is provided.

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.

Outcome measures

Measure	Study Participants n=123 Participants Patients requesting a rapid HIV test at a community pharmacy study site.
Participants Self-identified HIV Risk Behaviours Previously exchanged sex for money or drugs	8 Participants
Participants Self-identified HIV Risk Behaviours Prior blood transfusion	2 Participants
Participants Self-identified HIV Risk Behaviours Men who have sex with men	56 Participants
Participants Self-identified HIV Risk Behaviours History of IV drug use	6 Participants
Participants Self-identified HIV Risk Behaviours Denver HIV risk score >/= 30	89 Participants

Adverse Events

Study Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Debbie Kelly

School of Pharmacy, Memorial University

Phone: 709 864 7805

Email: dvkelly@mun.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place