Hazardous Alcohol UseNCT05097430

PrEP and Alcohol - Enhancing HIV Pre-Exposure Prophylaxis (PrEP)

A study testing Alcohol-focused brief intervention in people with Hazardous Alcohol Use, run by Centre for Addiction and Mental Health at 3 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The present investigation entails a pilot randomized controlled trial to explore whether a stand-alone, alcohol-reduction, brief intervention (with a module on substance use and depression) would be feasible, acceptable, and potentially efficacious within the context of HIV pre-exposure prophylaxis (PrEP) treatment. Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Hazardous Alcohol Use
What is being tested?: Alcohol-focused brief intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 122 participants
Where: 3 sitesCanada
Study dates: 28 Sep 2021to 31 Aug 2024
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
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

aged 18 years or older,
be a patient of Toronto General Hospital (TGH) or Maple Leaf Medical Clinic (MLMC),
be a man who identifies as gay, bisexual, and/or a man who has sex with other men,
have been prescribed PrEP for at least 3 months, and
meet the criteria for hazardous drinking, (i.e., based on a score of ≥4 on the Alcohol Use Disorders Identification Test-Consumption measures (AUDIT-C)).

Who cannot join

Participants will be excluded if they do not meet all of the above-mentioned inclusion criteria.

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

Maple Leaf Medical Clinic
Toronto, Ontario, M5G 1K2
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Centre for Addiction and Mental Health
Toronto, Ontario, M5S 2S1

Other trials in Canada

About this study

Official title: Enhancing HIV Pre-Exposure Prophylaxis (PrEP) by Targeting Hazardous Alcohol Use and Concurrent Conditions

Read the detailed description

Although HIV pre-exposure prophylaxis (PrEP) is an effective tool that can help prevent the acquisition of HIV, its degree of effectiveness has been shown to be linked to a number of key behaviors, including treatment adherence, attendance in follow-up care, and the concurrent use of condoms. Hazardous alcohol consumption has the potential to contribute to suboptimal PrEP adherence, poor retention in PrEP care, and condomless sex/sexually transmitted infections (STIs); and its impact on these PrEP-related behaviors may also become exacerbated in the presence of concurrent issues such as substance use and depression, thus reflecting a potential syndemic effect. The present investigation entails a pilot randomized controlled trial in which 120 hazardous drinking, PrEP-prescribed men who have sex with men (MSM) will be randomly assigned to receive either a tablet-based, alcohol-reduction brief intervention or treatment-as-usual. Participants assigned to the former condition for whom substance use- and/or depression-related concerns are identified will additionally be provided with links to relevant supportive resources. Feasibility and acceptability of the intervention will be examined. Furthermore, biomarker testing and self-report electronic surveys at baseline, 3-months, and 6-months will be employed to assess the preliminary impact of the intervention on alcohol use, PrEP adherence, retention in PrEP care, and the engagement in condomless sex/STI acquisition.

Conditions: Hazardous Alcohol Use
Being tested: Alcohol-focused brief intervention
Keywords: PrEP, Alcohol, Substance use, Depression
Medical subject headings: Substance-Related Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Alcohol-focused brief interventionBehavioural
The primary intervention component is the Check Your Drinking (CYD) intervention - an electronically-delivered brief intervention designed to assess and provide personalized feedback regarding the quantity, frequency, and severity of one's alcohol consumption. Additionally, intervention condition participants who are identified as having a concurrent substance use concern or who may be experiencing depression will receive information about local resources that can assist with such concerns.

Study groups in NCT05097430
Study group	Role	What they receive
Alcohol-focused brief intervention	Experimental	Intervention arm participants will be provided with an electronically-delivered, personalized drinking feedback report that compares their drinking with other Canadian males of the same age. This report also includes other relevant feedback, including an assessment of severity of alcohol use, and it provides recommendations for safe levels of alcohol consumption. Receives: Behavioral: Alcohol-focused brief intervention
Treatment as usual	No intervention	Treatment as usual (TAU) participants will not receive the intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

Intervention Feasibility: Intervention Uptake
Intervention uptake will be employed as an indicator of intervention feasibility. Intervention uptake will entail the proportion of eligible, hazardous drinking, PrEP-prescribed MSM who express a willingness to take part in the intervention trial.
Measured: At study baseline
Intervention Feasibility: Intervention Completion
Intervention completion will be employed as an indicator of intervention feasibility. This outcome will entail the proportion of participants assigned to the intervention condition who complete the intervention module.
Measured: At study baseline
Intervention Acceptability
Intervention acceptability will be assessed using a 13-item self-report measure that is comprised of two published scales (references shown below) and three items created by the investigators.
Bauermeister JA, Pingel ES, Jadwin-Cakmak L, et al. Acceptability and preliminary efficacy of a tailored online HIV/STI testing intervention for young men who have sex with men: the Get Connected! program. AIDS Behav 2015 Oct;19(10):1860-74.
NDA-NIH. NIMH Data Archive (NDA). 2020. Acceptability of Intervention, Intervention Appropriateness, and Feasibility of Intervention Measure. https://nda.nih.gov/data_structure.html?short_name=aimiamfim01
Measured: At 6-months post-baseline
Alcohol Consumption: Alcohol Use Disorders Identification Test (AUDIT)
Self-report-based Alcohol Use Disorders Identification Test (AUDIT) scores will be compared across baseline, 3-months post-baseline, and 6-months post-baseline sessions. Babor TF, Higgins-Biddle JC, Saunders JB, Monteiro MG, World Health Organization. Dept. of Mental Health and Substance Dependence. The Alcohol Use Disorders Identification Test. Guidelines for Use in Primary Care. 2nd ed. Geneva: World Health Organization; 2001. A cut-off based on AUDIT-C (i.e., AUDIT-consumption) criteria categorizes the presence (i.e., AUDIT-C scores ≥4) or absence (i.e., AUDIT-C scores <4) of hazardous drinking. Minimum and maximum scores of the AUDIT-C are 0 and 12, respectively.
Measured: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
Alcohol Consumption: Drinks Consumed in a Typical Week
A single self-report question will ask "How many drinks containing alcohol do you have on a typical week when you are drinking?" Responses will be compared across baseline, 3-months post-baseline, and 6-months post-baseline sessions.
Measured: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
Alcohol Consumption: Maximum Drinks on One Day in the Last 3 Months
A single self-report question will ask "What is the greatest number of drinks you've had on one day in the last 3 months?" Responses will be compared across baseline, 3-months post-baseline, and 6-months post-baseline sessions.
Measured: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
Alcohol Consumption: Phosphatidylethanol (PEth)
PEth levels will be measured from dried blood spot (DBS) samples using liquid chromatography-tandem mass spectrometry to identify hazardous drinking. PEth will be compared across baseline, 3-months post-baseline, and 6-months post-baseline sessions.
Measured: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)

Secondary outcomes (6)

PrEP Adherence: 7-day ACTG-based Measure
Self-reported adherence to PrEP will be assessed using a 7-day, PrEP-focused, ACTG-based adherence measure (the reference for the original, antiretroviral therapy (ART)-focused ACTG measure is shown below). 7-day adherence will be compared across baseline, 3-months post-baseline, and 6-months post-baseline sessions.
Chesney MA. Ickovics JR. Chambers DB, et al. Self-reported adherence to antiretroviral medications among participants in HIV clinical trials: Tthe AACTG adherence instruments. Patient Care Committee \& Adherence Working Group of the Outcomes Committe of the Adult AIDS Clinical Trials Group (AACTG) AIDS Care. 2000;12:255-266.
Measured: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
PrEP Adherence: Past Month Visual Analog Scale (VAS)
A self-report-based, PrEP-focused visual analog scale (VAS) will be used to assess PrEP adherence over the past month (the reference for the original, antiretroviral therapy (ART)-focused VAS is shown below). Past month adherence will be compared across baseline, 3-months post-baseline, and 6-months post-baseline sessions.
Amico KR. Fisher WA. Cornman DH, et al. Visual analog scale of ART adherence: Association with 3-day self-report and adherence barriers. J Acquir Immune Defic Syndr. 2006;42:455-459.
Measured: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
PrEP Adherence: Tenofovir-diphosphate (TFV-DP) and Emtricitabine-triphosphate Concentrations
Dried blood spots will be assessed for Tenofovir-diphosphate (TFV-DP) and emtricitabine-triphosphate concentrations using validated liquid chromatography tandem mass spectrometry. Concentrations will be compared across baseline, 3-months post-baseline, and 6-months post-baseline sessions.
Measured: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
Retention in PrEP Care: PrEP Appointment Attendance
Missed PrEP appointments across the six-month follow-up period will be identified through clinic chart extraction.
Measured: Six-month follow-up period
Condomless Sex
The engagement in condomless anal sex will be assessed using a self-report measure based on an MSM-focused sexual behavior assessment that has been employed in previous trials (see reference below). Condomless sex will be compared across baseline, 3-months post-baseline, and 6-months post-baseline sessions.
The Explore Team. Effects of a behavioural intervention to reduce acquisition of HIV infection among men who have sex with men: the EXPLORE randomised controlled study. Lancet 2004;364:41-50.
Measured: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
Sexually Transmitted Infection (STI) Incidence
Incident sexually transmitted infections (STIs) during the 6-month follow-up period will be identified through clinic chart extraction.
Measured: Six-month follow-up period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Sep 202131 Aug 2024

First posted28 Oct 2021
Study start28 Sep 2021
Primary completion31 Aug 2024
Study completion31 Aug 2024

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.
Other trials for Hazardous Alcohol UseStudies 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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants will be randomly assigned to either the intervention condition or treatment as usual (TAU) based on a 2:1 intervention:TAU ratio.
Masking: Single blind
Who is masked: Investigator
Enrolment: 122 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05097430
Sponsor's protocol ID: 4UH3AA026212-03
Status last verified: Feb 2025
First submitted: 30 Sep 2021
Last updated: 10 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Due to the sensitive nature of the data, there is no plan to make IPD available to other researchers. Data will only be accessible to designated research personnel.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Improving Help-seeking Propensity Through a Micro-intervention Targeting Common Concerns Among Individuals With Alcohol Problems: A Randomized Controlled Experiment
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Integrated Digital Health Approach to Reduce Hazardous Alcohol Use and Chronic Pain Among Rural Populations
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All Hazardous Alcohol Use trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Enhancing HIV Pre-Exposure Prophylaxis (PrEP) by Targeting Hazardous Alcohol Use and Concurrent Conditions
ClinicalTrials.gov ID: NCT05097430
Acronym / sponsor ID: 4UH3AA026212-03
Conditions: Hazardous Alcohol Use
Keywords: PrEP, Alcohol, Substance use, Depression
Study type: Interventional
Recruitment status: Completed
Enrolment: 122 participants (actual)
Lead sponsor: Centre for Addiction and Mental HealthUniversity, hospital or other
Collaborators: University Health Network, Toronto, Maple Leaf Research
Study start: 28 Sep 2021 (actual)
Primary completion: 31 Aug 2024 (actual)
Study completion: 31 Aug 2024 (actual)
First posted: 28 Oct 2021 (actual)
Results: Posted 10 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2
Model description: Participants will be randomly assigned to either the intervention condition or treatment as usual (TAU) based on a 2:1 intervention:TAU ratio.

Arm	Type	Receives
Alcohol-focused brief intervention	Experimental	Behavioral: Alcohol-focused brief interventionIntervention arm participants will be provided with an electronically-delivered, personalized drinking feedback report that compares their drinking with other Canadian males of the same age. This report also includes other relevant feedback, including an assessment of severity of alcohol use, and it provides recommendations for safe levels of alcohol consumption.
Treatment as usual	No intervention	–Treatment as usual (TAU) participants will not receive the intervention.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

aged 18 years or older,
be a patient of Toronto General Hospital (TGH) or Maple Leaf Medical Clinic (MLMC),
be a man who identifies as gay, bisexual, and/or a man who has sex with other men,
have been prescribed PrEP for at least 3 months, and
meet the criteria for hazardous drinking, (i.e., based on a score of ≥4 on the Alcohol Use Disorders Identification Test-Consumption measures (AUDIT-C)).

Key exclusion criteria (1 listed)

Participants will be excluded if they do not meet all of the above-mentioned inclusion criteria.

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
Alcohol-focused brief interventionThe primary intervention component is the Check Your Drinking (CYD) intervention - an electronically-delivered brief intervention designed to assess and provide personalized feedback regarding the quantity, frequency, and severity of one's alcohol consumption. Additionally, intervention condition participants who are identified as having a concurrent substance use concern or who may be experiencing depression will receive information about local resources that can assist with such concerns.	Behavioural	Alcohol-focused brief intervention

Primary outcome

Intervention Feasibility: Intervention Uptake
Time frame: At study baseline
Intervention uptake will be employed as an indicator of intervention feasibility. Intervention uptake will entail the proportion of eligible, hazardous drinking, PrEP-prescribed MSM who express a willingness to take part in the intervention trial.
Intervention Feasibility: Intervention Completion
Time frame: At study baseline
Intervention completion will be employed as an indicator of intervention feasibility. This outcome will entail the proportion of participants assigned to the intervention condition who complete the intervention module.
Intervention Acceptability
Time frame: At 6-months post-baseline
Intervention acceptability will be assessed using a 13-item self-report measure that is comprised of two published scales (references shown below) and three items created by the investigators. Bauermeister JA, Pingel ES, Jadwin-Cakmak L, et al. Acceptability and preliminary efficacy of a tailored online HIV/STI testing intervention for young men who have sex with men: the Get Connected! program. AIDS Behav 2015 Oct;19(10):1860-74. NDA-NIH. NIMH Data Archive (NDA). 2020. Acceptability of Intervention, Intervention Appropriateness, and Feasibility of Intervention Measure. https://nda.nih.gov/data_structure.html?short_name=aimiamfim01
Alcohol Consumption: Alcohol Use Disorders Identification Test (AUDIT)
Time frame: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
Self-report-based Alcohol Use Disorders Identification Test (AUDIT) scores will be compared across baseline, 3-months post-baseline, and 6-months post-baseline sessions. Babor TF, Higgins-Biddle JC, Saunders JB, Monteiro MG, World Health Organization. Dept. of Mental Health and Substance Dependence. The Alcohol Use Disorders Identification Test. Guidelines for Use in Primary Care. 2nd ed. Geneva: World Health Organization; 2001. A cut-off based on AUDIT-C (i.e., AUDIT-consumption) criteria categorizes the presence (i.e., AUDIT-C scores ≥4) or absence (i.e., AUDIT-C scores <4) of hazardous drinking. Minimum and maximum scores of the AUDIT-C are 0 and 12, respectively.
Alcohol Consumption: Drinks Consumed in a Typical Week
Time frame: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
A single self-report question will ask "How many drinks containing alcohol do you have on a typical week when you are drinking?" Responses will be compared across baseline, 3-months post-baseline, and 6-months post-baseline sessions.
Alcohol Consumption: Maximum Drinks on One Day in the Last 3 Months
Time frame: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
A single self-report question will ask "What is the greatest number of drinks you've had on one day in the last 3 months?" Responses will be compared across baseline, 3-months post-baseline, and 6-months post-baseline sessions.
Alcohol Consumption: Phosphatidylethanol (PEth)
Time frame: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
PEth levels will be measured from dried blood spot (DBS) samples using liquid chromatography-tandem mass spectrometry to identify hazardous drinking. PEth will be compared across baseline, 3-months post-baseline, and 6-months post-baseline sessions.

6 secondary outcomes

PrEP Adherence: 7-day ACTG-based Measure
Time frame: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
PrEP Adherence: Past Month Visual Analog Scale (VAS)
Time frame: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
PrEP Adherence: Tenofovir-diphosphate (TFV-DP) and Emtricitabine-triphosphate Concentrations
Time frame: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
Retention in PrEP Care: PrEP Appointment Attendance
Time frame: Six-month follow-up period
Condomless Sex
Time frame: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
Sexually Transmitted Infection (STI) Incidence
Time frame: Six-month follow-up period

Results and safety

Results posted to the registry on 10 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Alcohol-focused Brief Intervention	81	80
Treatment as Usual	41	39

Primary outcome: Intervention Feasibility: Intervention Uptake

Time frame: At study baseline. Count of participants. Unit: Participants

Measure	Alcohol-focused Brief Intervention n = 128
Value	122

Population analysed: 128 were eligible; 122 took part in the study.

Primary outcome: Intervention Feasibility: Intervention Completion

Time frame: At study baseline. Count of participants. Unit: Participants

Measure	Alcohol-focused Brief Intervention n = 81
Value	81

Population analysed: All 81 participants assigned to the intervention condition completed the intervention module.

Primary outcome: Intervention Acceptability

Time frame: At 6-months post-baseline. Mean (Standard Deviation). Unit: units on a scale

Measure	Alcohol-focused Brief Intervention n = 78
1. Overall, I was very satisfied with the Personalized Drinking Feedback Report.	5.72 (1.02)
2. Using the personalized Drinking Feedback Report was very frustrating.	2.58 (1.50)
3. I would recommend the Personalized Drinking Feedback Report to my friends.	5.27 (1.22)
4. The Personalized Drinking Feedback Report was easy to use.	5.76 (0.98)
5. The Personalized Drinking Feedback Report provided me accurate information.	5.60 (0.92)
6. How likely to continue using the Personalized Drinking Feedback Report if it were available?	4.78 (1.54)
7. The Personalized Drinking Feedback Report was appealing to me.	3.47 (0.89)
8. I liked the Personalized Drinking Feedback Report.	3.69 (0.74)

Population analysed: Scales on Items 1-6: 1=Strongly Disagree, 2=Disagree, 3=Somewhat Disagree, 4=Neither Agree or Disagree, 5=Somewhat Agree, 6=Agree, 7=Completely Agree. Scales on Items 7-10: 1=Completely Disagree, 2=Disagree, 3=Neither Agree or Disagree, 4=Agree, 5=Completely Agree. Scales on Items 11-13: 1=Completely Disagree, 2=Disagree, 3=Neither Agree or Disagree, 4=Agree, 5=Completely Agree.

Primary outcome: Alcohol Consumption: Alcohol Use Disorders Identification Test (AUDIT)

Time frame: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline). Count of participants. Unit: Participants

Measure	Alcohol-focused Brief Intervention n = 81	Treatment as Usual n = 41
Baseline	81	41
3-months	63	38
6-months	68	35

Population analysed: Overall changes in alcohol consumption were evaluated using AUDIT-C hazardous drinking criteria (i.e., AUDIT-C score ≥ 4). Missing values were imputed by controlled multiple imputations.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Data for each participant was collected over 6 month study period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Alcohol-focused Brief Intervention	0 of 81 (0%)	0 of 81 (0%)	0 of 81
Treatment as Usual	0 of 41 (0%)	0 of 41 (0%)	0 of 41

Limitations and caveats (from the sponsor): This was a pilot trial and was therefore not statistically powered to test the effect of the intervention.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Due to the sensitive nature of the data, there is no plan to make IPD available to other researchers. Data will only be accessible to designated research personnel.

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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.

Paul A. Shuper, PhD principal investigator

Senior Scientist and Section Head

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Alcohol-focused brief intervention in people with Hazardous Alcohol Use, run by Centre for Addiction and Mental Health at 3 sites 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 5 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 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 10 Feb 2025). 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?

Intervention Feasibility: Intervention Uptake (time frame: At study baseline). The study lists 7 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 NCT05097430.

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 10 Feb 2025.