HIV/AIDSPrEPDSANCT03637244
Decision Support Intervention Adapted for HIV Pre-Exposure Prophylaxis for Adoption and Adherence for Black Canadians
A study testing Decision Support Aid and PrEP for Black Canadians in people with HIV/AIDS, run by Unity Health Toronto at 1 site in Canada.
Trial summary
Aim 1: Adapt Ottawa Decision Support Framework for the HIV PrEP decisional needs of African, Caribbean and Black (ACB) Canadian patients Aim 2. Pilot Test The Adapted Decision-Support Intervention Using a Two-Arm Randomized Controlled Design Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Decision Support Aid and PrEP for Black Canadians
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- 9 Apr 2019to 15 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Self identify as Black African, Caribbean and or Canadian
- HIV sero-negative
- Not in a monogamous sexual partnership with a recently tested HIV negative man
- Self report unprotected anal sex with a man in the past six months
- Diagnosed with gonorrhea, chlamydia or syphilis in the past six months
- Are in an ongoing sexual relationship with an HIV positive partner
- Currently live in the Greater Toronto metropolitan area
- Can speak and understand either English or French
Who cannot join
- Non Black African Caribbean and or Canadian person
- Diagnosed with HIV and or AIDS
- Unable to consent to provide documentation of negative HIV status
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Michael's Hospital Academic Family Health Team
Toronto, Ontario, M5B 1T8
Rebecca Brown, 416-864-6060 ext. 77492, BrownRe@smh.ca
Cheryl Pedersen, 416-864-6060 ext. 77374, PedersenC@smh.ca
About this study
Official title: Pilot Randomized Controlled Trial of a Decision Support Intervention Adapted for HIV Pre-Exposure Prophylaxis Adoption and Adherence Among African, Caribbean and Black Canadian Patients
Aim 1: Adapt Ottawa Decision Support Framework for the HIV PrEP decisional needs of African, Caribbean and Black (ACB) Canadian patients Aim 2. Pilot Test The Adapted Decision-Support Intervention Using a Two-Arm Randomized Controlled Design
Read the detailed description
Aim 1: Adapt Ottawa Decision Support Framework for the HIV PrEP decisional needs of ACB Canadian patients. Investigators propose a cross-sectional qualitative descriptive study using data collected from key informant interviews with PrEP eligible patients and surveys with health professionals involved in HIV PrEP management. Under this aim two research questions will be investigated.
Q1) What factors do ACB Canadian patients consider when deciding whether to adopt HIV PrEP? Q2. How do SDT constructs of autonomy, competence and relatedness influence ACB Canadian's decision-making experiences regarding PrEP adoption?
AIM 2. Pilot Test The Adapted Decision-Support Intervention Using a Two-Arm Randomized Controlled Design.Hypothesis testing will be de-emphasized in favor of generating effect size estimates. Under this aim three research questions will be investigated. Preliminary hypotheses include:
H1: PrEP decision support increases decision quality in both LDQ and HDQ groups, H2: HDQ + decision-support group more likely to initiate PrEP than HDQ control, H3: HDQ PrEP initiators are more likely than LDQ initiators to have serum levels consistent with adherence at 60-days.
Data on decision quality survey and PrEP initiation data will generated by the subject from self-administered assessments via the decision-support app on the study-issued smartphone. Investigators will also collect biological specimens to measure adherence to HIV PrEP at 60-days post enrollment.
The study will take place in the Toronto metropolitan area (pop. 2.5 million). Over half (59%) of Canada's ACB population is settled in the province of Ontario. Moreover, the majority (70%) of ACB people in Ontario live in metro Toronto, making it the ideal location for this study. The trial procedures will be conducted at sites within the St. Michael's Hospital (SMH) system, including the SMH Li Ka Shing Knowledge Institute.
- Conditions
- HIV/AIDS
- Being tested
- Decision Support Aid and PrEP for Black Canadians
- Keywords
- HIV PrEP Decision support African Caribbean Black Canadians
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision Support Aid and PrEP for Black CanadiansBehavioural
Ottawa Decision Support Framework Adaptation.Investigators will use the inputs from the qualitative findings, CDC public health guidance and the tenofovir + emtricitabine product monograph to tailor the ODSF for use in the C5TM PrEP decision support web-app.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Condition | Experimental | Patients assigned to the experimental condition (LDQ + DS and HDQ + DS) will be asked to use the bookmarked link to the decision-aid within the first 7-14 days (and thereafter as needed) during the study period. The routine care group will be asked to use a bookmarked link to frequently asked questions on tenofovir + emtricitabine for PrEP. All groups will be compared on decision-quality at 14-days, self-reported PrEP initiation at 30-days, and PrEP adherence at 60-days post enrollment. Receives: Behavioral: Decision Support Aid and PrEP for Black Canadians |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baseline (initiation of PrEP) to adherence of PrEP for ACB Canadians
PrEP Initiation (does the person fill a prescription for PrEP) PrEP Adherence (analysis of intracellular tenofovir+emtricitabine concentration in dried blood spot)
Measured: Self-reported PrEP initiation at 30-days and PrEP adherence at 60-days post enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start9 Apr 2019
- Primary completion15 Oct 2019 (estimated)
- Study completion15 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- H1: PrEP decision support increases decision quality in both LDQ and HDQ groups, H2: HDQ + decision-support group more likely to initiate PrEP than HDQ control, H3: HDQ PrEP initiators are more likely than LDQ initiators to have serum levels consistent with adherence at 60-days. Investigators supply one smartphone/ participant,each registered to St. Mike's Hospital to protect participant privacy. The decision support aid will be a pre-programmed bookmark, an RA will give participants a brief tutorial on its use. Patients assigned to the experimental condition (LDQ + DS and HDQ + DS) will use the bookmarked link to the decision-aid within the first 7-14 days (and thereafter as needed) during the study period. The routine care group will be asked to use a bookmarked link to frequently asked questions on tenofovir + emtricitabine for PrEP. All groups will be compared on decision-quality at 14-days, self-reported PrEP initiation at 30-days, and PrEP adherence at 60-days post enrollment.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LaRon E Nelson, PhD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03637244
- Sponsor's protocol ID
- StMichaelnelsonla
- Acronym
- PrEPDSA
- Status last verified
- Apr 2019
- First submitted
- 22 Jan 2018
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study findings (no identifiable data is included) will be shared via study participant focused community meeting first. Then findings will be published in peer reviewed journals and other relevant publications
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Controlled Trial of a Decision Support Intervention Adapted for HIV Pre-Exposure Prophylaxis Adoption and Adherence Among African, Caribbean and Black Canadian Patients
- ClinicalTrials.gov ID
- NCT03637244
- Acronym / sponsor ID
- PrEPDSA / StMichaelnelsonla
- Conditions
- HIV/AIDS
- Keywords
- HIV PrEP Decision support African Caribbean Black Canadians
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 9 Apr 2019 (actual)
- Primary completion
- 15 Oct 2019 (estimated)
- Study completion
- 15 Jan 2020 (estimated)
- First posted
- 17 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim 1: Adapt Ottawa Decision Support Framework for the HIV PrEP decisional needs of African, Caribbean and Black (ACB) Canadian patients Aim 2. Pilot Test The Adapted Decision-Support Intervention Using a Two-Arm Randomized Controlled Design
Detailed description
Aim 1: Adapt Ottawa Decision Support Framework for the HIV PrEP decisional needs of ACB Canadian patients. Investigators propose a cross-sectional qualitative descriptive study using data collected from key informant interviews with PrEP eligible patients and surveys with health professionals involved in HIV PrEP management. Under this aim two research questions will be investigated.
Q1) What factors do ACB Canadian patients consider when deciding whether to adopt HIV PrEP? Q2. How do SDT constructs of autonomy, competence and relatedness influence ACB Canadian's decision-making experiences regarding PrEP adoption?
AIM 2. Pilot Test The Adapted Decision-Support Intervention Using a Two-Arm Randomized Controlled Design.Hypothesis testing will be de-emphasized in favor of generating effect size estimates. Under this aim three research questions will be investigated. Preliminary hypotheses include:
H1: PrEP decision support increases decision quality in both LDQ and HDQ groups, H2: HDQ + decision-support group more likely to initiate PrEP than HDQ control, H3: HDQ PrEP initiators are more likely than LDQ initiators to have serum levels consistent with adherence at 60-days.
Data on decision quality survey and PrEP initiation data will generated by the subject from self-administered assessments via the decision-support app on the study-issued smartphone. Investigators will also collect biological specimens to measure adherence to HIV PrEP at 60-days post enrollment.
The study will take place in the Toronto metropolitan area (pop. 2.5 million). Over half (59%) of Canada's ACB population is settled in the province of Ontario. Moreover, the majority (70%) of ACB people in Ontario live in metro Toronto, making it the ideal location for this study. The trial procedures will be conducted at sites within the St. Michael's Hospital (SMH) system, including the SMH Li Ka Shing Knowledge Institute.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- H1: PrEP decision support increases decision quality in both LDQ and HDQ groups, H2: HDQ + decision-support group more likely to initiate PrEP than HDQ control, H3: HDQ PrEP initiators are more likely than LDQ initiators to have serum levels consistent with adherence at 60-days. Investigators supply one smartphone/ participant,each registered to St. Mike's Hospital to protect participant privacy. The decision support aid will be a pre-programmed bookmark, an RA will give participants a brief tutorial on its use. Patients assigned to the experimental condition (LDQ + DS and HDQ + DS) will use the bookmarked link to the decision-aid within the first 7-14 days (and thereafter as needed) during the study period. The routine care group will be asked to use a bookmarked link to frequently asked questions on tenofovir + emtricitabine for PrEP. All groups will be compared on decision-quality at 14-days, self-reported PrEP initiation at 30-days, and PrEP adherence at 60-days post enrollment.
| Arm | Type | Receives |
|---|---|---|
| Experimental Condition | Experimental | Behavioral: Decision Support Aid and PrEP for Black CanadiansPatients assigned to the experimental condition (LDQ + DS and HDQ + DS) will be asked to use the bookmarked link to the decision-aid within the first 7-14 days (and thereafter as needed) during the study period. The routine care group will be asked to use a bookmarked link to frequently asked questions on tenofovir + emtricitabine for PrEP. All groups will be compared on decision-quality at 14-days, self-reported PrEP initiation at 30-days, and PrEP adherence at 60-days post enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Self identify as Black African, Caribbean and or Canadian
- HIV sero-negative
- Not in a monogamous sexual partnership with a recently tested HIV negative man
- Self report unprotected anal sex with a man in the past six months
- Diagnosed with gonorrhea, chlamydia or syphilis in the past six months
Key exclusion criteria (3 listed)
- Non Black African Caribbean and or Canadian person
- Diagnosed with HIV and or AIDS
- Unable to consent to provide documentation of negative HIV status
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 |
|---|---|---|
| Decision Support Aid and PrEP for Black CanadiansOttawa Decision Support Framework Adaptation.Investigators will use the inputs from the qualitative findings, CDC public health guidance and the tenofovir + emtricitabine product monograph to tailor the ODSF for use in the C5TM PrEP decision support web-app. | Behavioural | Experimental Condition |
Primary outcome
Change in baseline (initiation of PrEP) to adherence of PrEP for ACB Canadians
Time frame: Self-reported PrEP initiation at 30-days and PrEP adherence at 60-days post enrollment.
PrEP Initiation (does the person fill a prescription for PrEP) PrEP Adherence (analysis of intracellular tenofovir+emtricitabine concentration in dried blood spot)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2019.
- Individual participant dataSharing planned: No. Study findings (no identifiable data is included) will be shared via study participant focused community meeting first. Then findings will be published in peer reviewed journals and other relevant publications
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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.
LaRon E Nelson, PhD principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision Support Aid and PrEP for Black Canadians in people with HIV/AIDS, run by Unity Health Toronto 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 8 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 12 Apr 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact LaRon E Nelson, PhD (416-864-6060 ext. 77340, nelsonla@smh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in baseline (initiation of PrEP) to adherence of PrEP for ACB Canadians (time frame: Self-reported PrEP initiation at 30-days and PrEP adherence at 60-days post enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2019.