HIV InfectionsPROACTNCT03067948

Improving Identification of Mental Health/Substance Use Disorders in HIV Primary Care: Pilot Clinical Response

A study testing Patient Designated Positive Screen Shared with Provider in people with HIV Infections, run by Johns Hopkins University at 1 site in United States.

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

Who is it for?: Ages 18 to 99 years
Conditions the study is for: HIV Infections
What is being tested?: Patient Designated Positive Screen Shared with Provider
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteUnited States
Study dates: 9 Feb 2017to 31 Jul 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 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

must be enrolled in the Johns Hopkins Clinical Cohort at the Johns Hopkins Moore Clinic
must be living with HIV

Who cannot join

Trial locations and contacts

1 site in 1 country.

United States1 site

Moore Clinic for HIV Care
Baltimore, Maryland, 21287

Other trials in United States

About this study

This research is a feasibility pilot of an intervention to respond to positive screening tests for mental health(MH) and substance use (SU) captured through the Patient Reported Outcomes questionnaires (PROs). The PROs are currently performed in the clinic, however, the results are neither reviewed with patients nor transmitted to providers. This pilot assesses the feasibility of moving the PROs into the clinical realm by having patients review the PRO results, identifying an issue to discuss at the patient's next HIV primary care visit, and determining whether this process increases discussion of MH and SU disorders in the subsequent clinical visit and/or increases referrals to MH and/or SU treatment.

Conditions: HIV Infections
Being tested: Patient Designated Positive Screen Shared with Provider
Medical subject headings: HIV Infections

What participants receive

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

Patient Designated Positive Screen Shared with ProviderBehavioural
Patient Designated Positive Screen Shared with Provider -- In the intervention, participants will be given the opportunity to determine which positive screen, if any, that the participant would like to discuss with the participant's provider at the next HIV primary care appointment. The participant will be notified that all positive screens will be shared with the provider prior to their next HIV primary care visit, and that any positive screen the patient has chosen to discuss with the provider will be specified. The provider will receive the PROs result (score, interpretation, and recommendation) prior to their next HIV primary care visit

Study groups in NCT03067948
Study group	Role	What they receive
Intervention - Positive Screen Shared	Experimental	In the intervention, participants will be given the opportunity to determine which positive screen, if any, that the participant would like to discuss with the participant's provider at the next HIV primary care appointment. The participant will be notified that all positive screens will be shared with the provider prior to the participant's next HIV primary care visit, and that any positive screen the patient has chosen to discuss with the provider will be specified. The provider will receive the PROs result (score, interpretation, and recommendation) prior to the next HIV primary care visit. Receives: Behavioral: Patient Designated Positive Screen Shared with Provider

What is being measured

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

Mental Health or Substance Use Issue Raised in Visit
Number of participants for whom review and coding of audio recording captured a mental health or substance use issue during their visit
Measured: Visit following intervention which will occur on the same day or up to 1 week after the intervention
Audio Recording Data - Mental Health/Substance Use Action Taken
Number of participants for whom review of transcript of clinic visit characterized discussion of mental health issues and referral for services
Measured: Visit following intervention which will occur on the same day or up to 1 week after the intervention

Timeline

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

9 Feb 201731 Jul 2017

First posted1 Mar 2017
Study start9 Feb 2017
Primary completion30 Jun 2017
Study completion31 Jul 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.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
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: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03067948
Sponsor's protocol ID: IRB00115401
Other IDs: 5K23MH105284
Acronym: PROACT
Status last verified: Nov 2018
First submitted: 6 Dec 2016
Last updated: 19 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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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All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Improving Identification of Mental Health/Substance Use Disorders in HIV Primary Care: Pilot Clinical Response
ClinicalTrials.gov ID: NCT03067948
Acronym / sponsor ID: PROACT / IRB00115401
Conditions: HIV Infections
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Johns Hopkins UniversityUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 9 Feb 2017 (actual)
Primary completion: 30 Jun 2017 (actual)
Study completion: 31 Jul 2017 (actual)
First posted: 1 Mar 2017 (actual)
Results: Posted 19 Nov 2018

Clinical summary

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

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Intervention - Positive Screen Shared	Experimental	Behavioral: Patient Designated Positive Screen Shared with ProviderIn the intervention, participants will be given the opportunity to determine which positive screen, if any, that the participant would like to discuss with the participant's provider at the next HIV primary care appointment. The participant will be notified that all positive screens will be shared with the provider prior to the participant's next HIV primary care visit, and that any positive screen the patient has chosen to discuss with the provider will be specified. The provider will receive the PROs result (score, interpretation, and recommendation) prior to the next HIV primary care visit.

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

must be enrolled in the Johns Hopkins Clinical Cohort at the Johns Hopkins Moore Clinic
must be living with HIV

Key exclusion criteria (1 listed)

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
Patient Designated Positive Screen Shared with ProviderPatient Designated Positive Screen Shared with Provider -- In the intervention, participants will be given the opportunity to determine which positive screen, if any, that the participant would like to discuss with the participant's provider at the next HIV primary care appointment. The participant will be notified that all positive screens will be shared with the provider prior to their next HIV primary care visit, and that any positive screen the patient has chosen to discuss with the provider will be specified. The provider will receive the PROs result (score, interpretation, and recommendation) prior to their next HIV primary care visit	Behavioural	Intervention - Positive Screen Shared

Primary outcome

Mental Health or Substance Use Issue Raised in Visit
Time frame: Visit following intervention which will occur on the same day or up to 1 week after the intervention
Number of participants for whom review and coding of audio recording captured a mental health or substance use issue during their visit
Audio Recording Data - Mental Health/Substance Use Action Taken
Time frame: Visit following intervention which will occur on the same day or up to 1 week after the intervention
Number of participants for whom review of transcript of clinic visit characterized discussion of mental health issues and referral for services

Results and safety

Results posted to the registry on 19 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention - Positive Screen Shared	32	32

Primary outcome: Mental Health or Substance Use Issue Raised in Visit

Time frame: Visit following intervention which will occur on the same day or up to 1 week after the intervention. Count of participants. Unit: Participants

Measure	Intervention - Positive Screen Shared n = 32
Value	32

Primary outcome: Audio Recording Data - Mental Health/Substance Use Action Taken

Time frame: Visit following intervention which will occur on the same day or up to 1 week after the intervention. Count of participants. Unit: Participants

Measure	Intervention - Positive Screen Shared n = 32
Value	32

Adverse events

Time frame: intervention consisted of 1 study visit; no subsequent monitoring of participants was undertaken. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention - Positive Screen Shared	0 of 32 (0%)	0 of 32 (0%)	0 of 32

Limitations and caveats (from the sponsor): The sample size was small and recruited patients from one urban outpatient infectious diseases clinic, and may not be generalizable to other patient populations living with HIV.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Not yet recruiting
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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.

Anne Monroe, MD, MSPH principal investigator

Johns Hopkins University

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

Questions about this trial

What is this clinical trial studying?

A study testing Patient Designated Positive Screen Shared with Provider in people with HIV Infections, run by Johns Hopkins University at 1 site in United States.

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 2 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 Nov 2018. 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 United States. 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 Nov 2018). 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?

Mental Health or Substance Use Issue Raised in Visit (time frame: Visit following intervention which will occur on the same day or up to 1 week after the intervention). The study lists 2 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 NCT03067948.

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 Nov 2018.