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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23DA039769-01 | U.S. NIH Grant/Contract | View source | |
| KL2TR001429 | U.S. NIH Grant/Contract | View source | |
| OCR25582 | Other Identifier | UF OnCore |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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Substance misuse is a common problem among HIV+ individuals. Research suggests that a Screening, Brief Intervention, and Treatment (SBIRT) model can be effective in reducing substance misuse in the general older adult population; however these findings have not been verified in the more vulnerable HIV+ older adult population. The present study seeks to address the problem of substance misuse in older HIV+ adults by piloting a SBIRT model for older HIV+ adults in a in a primary care setting. Individual reductions in alcohol and drug use can have significant effects on public health and safety when observed over a large population at risk for substance use problems. With wider dissemination statewide, a relatively low-cost intervention such as SBIRT could offer demonstrated benefits in this population.
The current project will pilot SBIRT with a peer navigator (SBIRT-PN) versus treatment at usual (TAU) to increase substance use treatment engagement among HIV-positive adults aged 50 years and older. The investigators will recruit patients from the Southern HIV and Alcohol Research Consortium (SHARC) HIV primary care clinic network.
In order to develop effective substance use intervention models for HIV care settings the specific aims of the current project are:
Aim1: Examine the feasibility of the SBIRT-PN model at the UF Health Infectious Disease-Medical Specialties Clinic. The investigators hypothesize that the SBIRT-PN model will demonstrate high feasibility within the UF Health Infectious Disease - Medical Specialties Clinic.
Aim2a: Assess the acceptability of SBIRT-PN. The investigators hypothesize that SBIRT-PN will demonstrate high acceptability among patients enrolled in this condition.
Aim2b: Assess the acceptability of SBIRT-PN among HIV-positive individuals by age cohort (younger vs older). The investigators hypothesize that SBIRT-PN will demonstrate higher acceptability among older HIV-positive patients enrolled in this condition.
Aim3: Assess influence of SBIRT-PN model on treatment engagement and substance use compared to enhanced treatment as usual (TAU).The investigators hypothesize that those in the SBIRT-PN condition will evidence greater treatment engagement and a reduction in substance use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBIRT Intervention | Experimental | The interventionist will discuss substance use and misuse, HIV, and the interaction of aging and substance use; will give the patient feedback on their NM-ASSIST score and assess the patient's readiness to change based on Prochaska's stages of change; motivational interviewing techniques to identify the patients' most salient reasons for addressing substance use issues. Identifying and prioritizing need; problem-solving techniques to help patients identify which services may best help them work towards their goals; will use a referral resource guide to provide the contact information of agency representatives and help the patient formulate a plan for follow-up. |
|
| Treatment as Usual | No Intervention | Participants in the enhanced care treatment as usual group will receive the same illustrated handout depicting their substance use screening score and the same referral resource guide provided to those in the control group. These will be provided with only a quick introduction by the research assistant to minimize intervention elements in the control condition and to resemble the notification and referral strategy that would be standard care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psycho-educational content (5 Minutes) | Behavioral | The interventionist will discuss substance use and misuse and the influence of substance use on self care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Ranking Intervention as Acceptable | To examine ratings of acceptability, the investigators will use the overall acceptability score and percentage of acceptability. Overall acceptability will be assessed by summing ratings from the 10-item questionnaire to provide a total intervention acceptability score for the intervention, such that acceptability scores for the intervention could range from 10 (low acceptability) to 50 (high acceptability). The intervention will be considered to have acceptability if 80% of the participants rank the intervention as acceptable (i.e., 4 or higher) on 80% or more of the scale items. The investigators will then examine each question of the Acceptability Questionnaire separately to determine strengths and weaknesses of the intervention. | 30 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Obtained Formal Substance Use Treatment | Participants will self-report if they obtained formal substance use treatment (i.e., any services sought to address substance use from individual therapy to 12 step fellowships). The investigators will request treatment facility information and permission to verify treatment. Once treatment has been verified, treatment engagement will be coded as 0= no formal treatment 1= formal treatment engagement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicole Ennis, PHD | Florida State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32611 | United States | ||
| CAN Community Health |
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase I: SBIRT Intervention (Pre-COVID-19) | Interventionist will discuss substance use/misuse, HIV, interaction of aging & substance use; give feedback on ASSIST scores; assess patients' readiness to change based on Prochaska's stages of change; motivational interviewing techniques to identify patients' most salient reasons for addressing substance use; Identify/prioritize need; problem-solving techniques to help patients identify which services may best help them work toward their goals; use referral guide to provide contact information of agency representatives & help patients formulate follow-up plan. Psycho-educational content: Interventionist will discuss substance use/misuse & influence of substance use on self care. Readiness Assessment: Interventionist will give feedback on ASSIST score & assess patients' readiness to change based on Prochaska's stages of change. Goal-Setting: Interventionist will use MI techniques to identify patients' most salient reasons for addressing substance use. Identifying/prioritizing needs: Interventionist will use problem-solving techniques to help patients identify which services may best help them work toward their goals (e.g., as crisis services, substance use counseling, local self-help groups (AA, NA, etc), legal aid, faith-based counseling, mental health counseling, or inpatient SUD treatment). Explanation of PN/Session wrap: Interventionist will use referral guide to provide contact information of agency representatives & help patients formulate follow-up plan. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 26, 2019 | Jun 12, 2023 |
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A repeated measures randomized control trial design to compare patient outcomes at baseline as well as 3 and 6 months post-intervention
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| Readiness Assessment (10 minutes) | Behavioral | The interventionist will give the patient feedback on their ASSIST score and assess the patient's readiness to change based on Prochaska's stages of change. |
|
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| Goal-Setting (5 minutes) | Behavioral | The interventionist will use motivational interviewing techniques to identify the patients' most salient reasons for addressing substance use issues. |
|
| Identifying and prioritizing needs (5 minutes) | Behavioral | The interventionist will use problem-solving techniques to help patients identify which services may best help them work towards their goals. Services will include (but are not limited to) emergency crisis services, counseling to deal with substance use, referral to local self-help groups (Alcoholics Anonymous, Narcotics Anonymous, etc.), legal assistance, faith-based counseling, mental health counseling or inpatient substance use treatment. |
|
| Explanation of Peer Navigator and Session wrap (5 minutes) | Behavioral | The interventionist will use a referral resource guide to provide the contact information of agency representatives and help the patient formulate a plan for follow-up. |
|
| 6 Months |
| Number of Participants Who Used Different Types of Substances (Self-Reported) | A standard measure from the NIDA STTR Vulnerable Populations Data Harmonization tool kit will be used. | 6 Months |
| Number of Participants Who Used Different Types of Substances (Biologically Confirmed Via Urinalysis) | A CLIA 12-Panel Instant Drug Test Cup (CLIAwaivedTM, San Diego, CA), which tests for the presence of 12 common substances in the urine will be used. | 6 Months |
| Jacksonville |
| Florida |
| 32207 |
| United States |
| Department of Health in Columbia County", | Lake City | Florida | 32055 | United States |
| FG001 | Phase I: Treatment as Usual (Pre-COVID-19) | Participants in the enhanced care treatment as usual group will receive the same illustrated handout depicting their substance use screening score and the same referral resource guide provided to those in the control group. These will be provided with only a quick introduction by the research assistant to minimize intervention elements in the control condition and to resemble the notification and referral strategy that would be standard care. |
| FG002 | Phase II: CAN Pandemic Telesurvey (Post-COVID-19) | Given the need for social support among people living with HIV during the COVID-19 pandemic, we made the decision to initiate a pandemic telehealth assessment that used screening, brief intervention, and referral to treatment to address behavioral and emotional distress in a among people living with at CAN Community Health, which is in the only EHE designated county in North Florida (Duval County, FL). Participants were asked to complete an online survey via Qualtrics at T1, T2, and T3 with the help of a research assistant affiliated with the clinic. Each survey included the Patient Health Questionnaire (PHQ-9) and Pandemic Stress Index (PSI). Participants were also asked demographic questions (e.g., about their employment), about their alcohol, tobacco, and substance use prior to and during the COVID-19 pandemic, and questions about access to (and availability of) healthcare resources. |
| Completed T1 |
|
| Completed T2 |
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| Completed T3 |
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| COMPLETED | Completed all 3 assessments |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase I: SBIRT Intervention (Pre-COVID-19) | Interventionist will discuss substance use/misuse, HIV, the interaction of aging & substance use; give patient feedback on ASSIST score, assess patients' readiness to change based on Prochaska's stages of change; motivational interviewing techniques to identify patients' most salient reasons for addressing substance use. Identifying/prioritizing need; problem-solving techniques to help patients identify which services may best help them work toward their goals; use referral guide to provide contact information of agency representatives & help patient formulate follow-up plan Psychoeducational content: Interventionist will discuss substance use/misuse & the influence of substance use on self care Readiness Assessment: Interventionist will give patient feedback on ASSIST score & assess their readiness to change based on Prochaska's stages of change Goal-Setting: Interventionist will use MI techniques to identify patients' most salient reasons for addressing substance use Identifying/prioritizing needs: Interventionist will use problem-solving techniques to help patients identify which services may best help them work toward their goals (e.g. crisis services, counseling, local self-help groups (AA, NA, etc.), legal aid, faith-based counseling, mental health counseling or inpatient SUD tx) Explanation of PN/Session wrap: Interventionist will use referral guide to provide contact information of agency representatives & help the patient formulate follow-up plan |
| BG001 | Phase I: Treatment as Usual (Pre-COVID-19) | Participants in the enhanced care treatment as usual group will receive the same illustrated handout depicting their substance use screening score and the same referral resource guide provided to those in the control group. These will be provided with only a quick introduction by the research assistant to minimize intervention elements in the control condition and to resemble the notification and referral strategy that would be standard care. |
| BG002 | Phase II: CAN Pandemic Telesurvey (Post-COVID-19) | Given the need for social support among people living with HIV during the COVID-19 pandemic, we made the decision to initiate a pandemic telehealth assessment that used screening, brief intervention, and referral to treatment to address behavioral and emotional distress in a among people living with at CAN Community Health, which is in the only EHE designated county in North Florida (Duval County, FL). Participants were asked to complete an online survey via Qualtrics at T1, T2, and T3 with the help of a research assistant affiliated with the clinic. Each survey included the Patient Health Questionnaire (PHQ-9) and Pandemic Stress Index (PSI). Participants were also asked demographic questions (e.g., about their employment), about their alcohol, tobacco, and substance use prior to and during the COVID-19 pandemic, and questions about access to (and availability of) healthcare resources. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | Number of Participants Ranking Intervention as Acceptable | To examine ratings of acceptability, the investigators will use the overall acceptability score and percentage of acceptability. Overall acceptability will be assessed by summing ratings from the 10-item questionnaire to provide a total intervention acceptability score for the intervention, such that acceptability scores for the intervention could range from 10 (low acceptability) to 50 (high acceptability). The intervention will be considered to have acceptability if 80% of the participants rank the intervention as acceptable (i.e., 4 or higher) on 80% or more of the scale items. The investigators will then examine each question of the Acceptability Questionnaire separately to determine strengths and weaknesses of the intervention. | CAN Pandemic Telesurvey arm of this study did not include an intervention or a peer navigation element, and therefore did not have include the acceptability measures as in Phase I. | Posted | Count of Participants | Participants | No | 30 Days |
|
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| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Obtained Formal Substance Use Treatment | Participants will self-report if they obtained formal substance use treatment (i.e., any services sought to address substance use from individual therapy to 12 step fellowships). The investigators will request treatment facility information and permission to verify treatment. Once treatment has been verified, treatment engagement will be coded as 0= no formal treatment 1= formal treatment engagement | CAN Pandemic Telesurvey arm of this study did not include an intervention or a peer navigation element, and therefore did not have include the treatment engagement measures as in Phase I. | Posted | Count of Participants | Participants | No | 6 Months |
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Used Different Types of Substances (Self-Reported) | A standard measure from the NIDA STTR Vulnerable Populations Data Harmonization tool kit will be used. | CAN Pandemic Telesurvey arm of this study did not include an intervention or a peer navigation element, and therefore did not have include the NIDA STTR Drug and Alcohol Use Measure as in Phase I. | Posted | Count of Participants | Participants | No | 6 Months |
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Used Different Types of Substances (Biologically Confirmed Via Urinalysis) | A CLIA 12-Panel Instant Drug Test Cup (CLIAwaivedTM, San Diego, CA), which tests for the presence of 12 common substances in the urine will be used. | CAN Pandemic Telesurvey arm of this study did not include an intervention or a peer navigation element, and therefore did not have include the urinalysis measure as in Phase I. | Posted | Count of Participants | Participants | No | 6 Months |
|
Adverse event data were collected throughout the entire study data collection process (6 months for each participant)
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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 | Phase I: SBIRT Intervention (Pre-COVID-19) | Interventionist will discuss substance use/misuse, HIV, interaction of aging & substance use; give feedback on ASSIST scores; assess patients' readiness to change based on Prochaska's stages of change; motivational interviewing techniques to identify patients' most salient reasons for addressing substance use; Identify/prioritize need; problem-solving techniques to help patients identify which services may best help them work toward their goals; use referral guide to provide contact information of agency representatives & help patients formulate follow-up plan. Psycho-educational content: Interventionist will discuss substance use/misuse & influence of substance use on self care. Readiness Assessment: Interventionist will give feedback on ASSIST score & assess patients' readiness to change based on Prochaska's stages of change. Goal-Setting: Interventionist will use MI techniques to identify patients' most salient reasons for addressing substance use. Identifying/prioritizing needs: Interventionist will use problem-solving techniques to help patients identify which services may best help them work toward their goals (e.g., as crisis services, substance use counseling, local self-help groups (AA, NA, etc), legal aid, faith-based counseling, mental health counseling, or inpatient SUD treatment). Explanation of PN/Session wrap: Interventionist will use referral guide to provide contact information of agency representatives & help patients formulate follow-up plan. | 1 | 17 | 0 | 17 | 0 | 17 |
| EG001 | Phase I: Treatment as Usual (Pre-COVID-19) | Participants in the enhanced care treatment as usual group will receive the same illustrated handout depicting their substance use screening score and the same referral resource guide provided to those in the control group. These will be provided with only a quick introduction by the research assistant to minimize intervention elements in the control condition and to resemble the notification and referral strategy that would be standard care. | 0 | 17 | 0 | 17 | 0 | 17 |
| EG002 | Phase II: CAN Pandemic Telesurvey (Post-COVID-19) | Given the need for social support among people living with HIV during the COVID-19 pandemic, we made the decision to initiate a pandemic telehealth assessment that used screening, brief intervention, and referral to treatment to address behavioral and emotional distress in a among people living with at CAN Community Health, which is in the only EHE designated county in North Florida (Duval County, FL). Participants were asked to complete an online survey via Qualtrics at T1, T2, and T3 with the help of a research assistant affiliated with the clinic. Each survey included the Patient Health Questionnaire (PHQ-9) and Pandemic Stress Index (PSI). Participants were also asked demographic questions (e.g., about their employment), about their alcohol, tobacco, and substance use prior to and during the COVID-19 pandemic, and questions about access to (and availability of) healthcare resources. | 0 | 52 | 0 | 52 | 0 | 52 |
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In March 2020, the COVID-19 pandemic made in-person assessments as described in Phase I (SBIRT-PN & TAU), particularly involving vulnerable populations such as PLWH and older adults, impossible. Recommendations for social distancing/self-isolation remained in place for extended periods of time. Data was needed regarding the impact of the pandemic, both physically and emotionally, on PLWH. We gathered this data within a specialized HIV care setting in order to optimize health outcomes (Phase II).
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katie Kloss | Florida State University | 9045716395 | katie.kloss@med.fsu.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 15, 2022 | Aug 14, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 6, 2019 | Feb 26, 2023 | ICF_002.pdf |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D000163 | Acquired Immunodeficiency Syndrome |
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| < 50 years old |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 | Phase I: Treatment as Usual (Pre-COVID-19) | Participants in the enhanced care treatment as usual group will receive the same illustrated handout depicting their substance use screening score and the same referral resource guide provided to those in the control group. These will be provided with only a quick introduction by the research assistant to minimize intervention elements in the control condition and to resemble the notification and referral strategy that would be standard care. |
| OG002 | Phase II: CAN Pandemic Telesurvey (Post-COVID-19) | Given the need for social support among people living with HIV during the COVID-19 pandemic, we made the decision to initiate a pandemic telehealth assessment that used screening, brief intervention, and referral to treatment to address behavioral and emotional distress in a among people living with at CAN Community Health, which is in the only EHE designated county in North Florida (Duval County, FL). Participants were asked to complete an online survey via Qualtrics at T1, T2, and T3 with the help of a research assistant affiliated with the clinic. Each survey included the Patient Health Questionnaire (PHQ-9) and Pandemic Stress Index (PSI). Participants were also asked demographic questions (e.g., about their employment), about their alcohol, tobacco, and substance use prior to and during the COVID-19 pandemic, and questions about access to (and availability of) healthcare resources. |
|
|
| OG001 | Phase I: Treatment as Usual (Pre-COVID-19) | Participants in the enhanced care treatment as usual group will receive the same illustrated handout depicting their substance use screening score and the same referral resource guide provided to those in the control group. These will be provided with only a quick introduction by the research assistant to minimize intervention elements in the control condition and to resemble the notification and referral strategy that would be standard care. |
| OG002 | Phase II: CAN Pandemic Telesurvey (Post-COVID-19) | Given the need for social support among people living with HIV during the COVID-19 pandemic, we made the decision to initiate a pandemic telehealth assessment that used screening, brief intervention, and referral to treatment to address behavioral and emotional distress in a among people living with at CAN Community Health, which is in the only EHE designated county in North Florida (Duval County, FL). Participants were asked to complete an online survey via Qualtrics at T1, T2, and T3 with the help of a research assistant affiliated with the clinic. Each survey included the Patient Health Questionnaire (PHQ-9) and Pandemic Stress Index (PSI). Participants were also asked demographic questions (e.g., about their employment), about their alcohol, tobacco, and substance use prior to and during the COVID-19 pandemic, and questions about access to (and availability of) healthcare resources. |
|
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| OG001 | Phase I: Treatment as Usual (Pre-COVID-19) | Participants in the enhanced care treatment as usual group will receive the same illustrated handout depicting their substance use screening score and the same referral resource guide provided to those in the control group. These will be provided with only a quick introduction by the research assistant to minimize intervention elements in the control condition and to resemble the notification and referral strategy that would be standard care. |
| OG002 | Phase II: CAN Pandemic Telesurvey (Post-COVID-19) | Given the need for social support among people living with HIV during the COVID-19 pandemic, we made the decision to initiate a pandemic telehealth assessment that used screening, brief intervention, and referral to treatment to address behavioral and emotional distress in a among people living with at CAN Community Health, which is in the only EHE designated county in North Florida (Duval County, FL). Participants were asked to complete an online survey via Qualtrics at T1, T2, and T3 with the help of a research assistant affiliated with the clinic. Each survey included the Patient Health Questionnaire (PHQ-9) and Pandemic Stress Index (PSI). Participants were also asked demographic questions (e.g., about their employment), about their alcohol, tobacco, and substance use prior to and during the COVID-19 pandemic, and questions about access to (and availability of) healthcare resources. |
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