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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23MH105284 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Designated Positive Screen Shared with Provider | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Visit following intervention which will occur on the same day or up to 1 week after the intervention |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Anne Monroe, MD, MSPH | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moore Clinic for HIV Care | Baltimore | Maryland | 21287 | United States |
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We only enrolled an intervention group (and utilized a historic control). Thus, all patient participants were assigned to the intervention group.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention - Positive Screen Shared | Participants were given the opportunity to determine which positive screen, if any, that the participant wanted to discuss with the participant's provider at the next HIV primary care appointment. The participant was notified that all positive screens would be shared with the provider prior to the participant's next HIV primary care visit, and that any positive screen the patient chose to discuss with the provider would be specified. The received the Patient Reported Outcomes (PROs) result (score, interpretation, and recommendation) prior to the next HIV primary care visit. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | Visit following intervention which will occur on the same day or up to 1 week after the intervention |
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intervention consisted of 1 study visit; no subsequent monitoring of participants was undertaken
The intervention only lasted the duration of the study visit; no subsequent monitoring was performed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention - Positive Screen Shared | Participants were given the opportunity to determine which positive screen, if any, that the participant wanted to discuss with the participant's provider at the next HIV primary care appointment. The participant was notified that all positive screens would be shared with the provider prior to the participant's next HIV primary care visit, and that any positive screen the patient chose to discuss with the provider would be specified. The received the PROs result (score, interpretation, and recommendation) prior to the next HIV primary care visit. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne Monroe MD | Johns Hopkins University SOM (Adjunct) | 202-994-0251 | amonroe@gwu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 20, 2016 | Sep 17, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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|
| years |
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| Sex/Gender, Customized | Number | participants |
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| Race/Ethnicity, Customized | Number | participants |
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|
|
| 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 | Posted | Count of Participants | Participants | Visit following intervention which will occur on the same day or up to 1 week after the intervention |
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|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |