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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03067948
Acronym
PROACT
Enrollment
32
Registered
2017-03-01
Start date
2017-02-09
Completion date
2017-07-31
Last updated
2018-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Brief summary

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.

Interventions

BEHAVIORALPatient Designated Positive Screen Shared with Provider

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

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Mental Health or Substance Use Issue Raised in VisitVisit following intervention which will occur on the same day or up to 1 week after the interventionNumber 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 TakenVisit following intervention which will occur on the same day or up to 1 week after the interventionNumber of participants for whom review of transcript of clinic visit characterized discussion of mental health issues and referral for services

Countries

United States

Participant flow

Pre-assignment details

We only enrolled an intervention group (and utilized a historic control). Thus, all patient participants were assigned to the intervention group.

Participants by arm

ArmCount
Intervention - Positive Screen Shared
In the intervention, participants were 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 was 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 had chosen to discuss with the provider will be specified. The provider received the PROs result (score, interpretation, and recommendation) prior to the next HIV primary care visit.
32
Total32

Baseline characteristics

CharacteristicIntervention - Positive Screen Shared
Age, Continuous51.6 years
STANDARD_DEVIATION 8.9
Race/Ethnicity, Customized
Black
29 participants
Race/Ethnicity, Customized
Other
1 participants
Race/Ethnicity, Customized
White
2 participants
Sex/Gender, Customized
Female
11 participants
Sex/Gender, Customized
Male
21 participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 32
other
Total, other adverse events
0 / 32
serious
Total, serious adverse events
0 / 32

Outcome results

Primary

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

Time frame: Visit following intervention which will occur on the same day or up to 1 week after the intervention

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Intervention - Positive Screen SharedAudio Recording Data - Mental Health/Substance Use Action Taken32 Participants
Primary

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

Time frame: Visit following intervention which will occur on the same day or up to 1 week after the intervention

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Intervention - Positive Screen SharedMental Health or Substance Use Issue Raised in Visit32 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026