Trial Outcomes & Findings for Feasibility of SBIRT-PN (NCT NCT03057119)
NCT ID: NCT03057119
Last Updated: 2023-09-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
86 participants
Primary outcome timeframe
30 Days
Results posted on
2023-09-11
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
52
|
|
Overall Study
Completed T1
|
17
|
17
|
45
|
|
Overall Study
Completed T2
|
9
|
5
|
30
|
|
Overall Study
Completed T3
|
4
|
3
|
35
|
|
Overall Study
COMPLETED
|
4
|
3
|
13
|
|
Overall Study
NOT COMPLETED
|
13
|
14
|
39
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Feasibility of SBIRT-PN
Baseline characteristics by cohort
| Measure |
Phase I: SBIRT Intervention (Pre-COVID-19)
n=17 Participants
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
|
Phase I: Treatment as Usual (Pre-COVID-19)
n=17 Participants
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.
|
Phase II: CAN Pandemic Telesurvey (Post-COVID-19)
n=52 Participants
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.
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
≥ 50 years old
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
37 participants
n=5 Participants
|
46 participants
n=4 Participants
|
|
Age, Customized
< 50 years old
|
12 participants
n=5 Participants
|
13 participants
n=7 Participants
|
15 participants
n=5 Participants
|
40 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 30 DaysPopulation: 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.
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.
Outcome measures
| Measure |
Phase I: SBIRT Intervention (Pre-COVID-19)
n=9 Participants
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.
|
Phase I: Treatment as Usual (Pre-COVID-19)
n=5 Participants
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.
|
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.
|
|---|---|---|---|
|
Number of Participants Ranking Intervention as Acceptable
|
9 Participants
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: 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.
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
Outcome measures
| Measure |
Phase I: SBIRT Intervention (Pre-COVID-19)
n=17 Participants
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.
|
Phase I: Treatment as Usual (Pre-COVID-19)
n=17 Participants
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.
|
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.
|
|---|---|---|---|
|
Number of Participants Who Obtained Formal Substance Use Treatment
|
1 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: 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.
A standard measure from the NIDA STTR Vulnerable Populations Data Harmonization tool kit will be used.
Outcome measures
| Measure |
Phase I: SBIRT Intervention (Pre-COVID-19)
n=17 Participants
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.
|
Phase I: Treatment as Usual (Pre-COVID-19)
n=17 Participants
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.
|
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.
|
|---|---|---|---|
|
Number of Participants Who Used Different Types of Substances (Self-Reported)
Marijuana
|
16 Participants
|
17 Participants
|
—
|
|
Number of Participants Who Used Different Types of Substances (Self-Reported)
Opiates/Opioids
|
5 Participants
|
4 Participants
|
—
|
|
Number of Participants Who Used Different Types of Substances (Self-Reported)
Cocaine
|
1 Participants
|
2 Participants
|
—
|
|
Number of Participants Who Used Different Types of Substances (Self-Reported)
Amphetamines
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants Who Used Different Types of Substances (Self-Reported)
Methamphetamine
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants Who Used Different Types of Substances (Self-Reported)
MDMA
|
0 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: 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.
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.
Outcome measures
| Measure |
Phase I: SBIRT Intervention (Pre-COVID-19)
n=17 Participants
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.
|
Phase I: Treatment as Usual (Pre-COVID-19)
n=17 Participants
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.
|
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.
|
|---|---|---|---|
|
Number of Participants Who Used Different Types of Substances (Biologically Confirmed Via Urinalysis)
Benzodiazepines
|
4 Participants
|
2 Participants
|
—
|
|
Number of Participants Who Used Different Types of Substances (Biologically Confirmed Via Urinalysis)
Marijuana
|
16 Participants
|
17 Participants
|
—
|
|
Number of Participants Who Used Different Types of Substances (Biologically Confirmed Via Urinalysis)
Buprenorphine
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants Who Used Different Types of Substances (Biologically Confirmed Via Urinalysis)
Methadone
|
3 Participants
|
1 Participants
|
—
|
|
Number of Participants Who Used Different Types of Substances (Biologically Confirmed Via Urinalysis)
Tricyclic Antidepressants
|
4 Participants
|
7 Participants
|
—
|
|
Number of Participants Who Used Different Types of Substances (Biologically Confirmed Via Urinalysis)
Barbiturates
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Who Used Different Types of Substances (Biologically Confirmed Via Urinalysis)
Oxycodone
|
2 Participants
|
2 Participants
|
—
|
|
Number of Participants Who Used Different Types of Substances (Biologically Confirmed Via Urinalysis)
Amphetamines
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants Who Used Different Types of Substances (Biologically Confirmed Via Urinalysis)
Methamphetamine
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants Who Used Different Types of Substances (Biologically Confirmed Via Urinalysis)
Cocaine
|
1 Participants
|
2 Participants
|
—
|
|
Number of Participants Who Used Different Types of Substances (Biologically Confirmed Via Urinalysis)
MDMA
|
0 Participants
|
2 Participants
|
—
|
|
Number of Participants Who Used Different Types of Substances (Biologically Confirmed Via Urinalysis)
PCP
|
0 Participants
|
0 Participants
|
—
|
Adverse Events
Phase I: SBIRT Intervention (Pre-COVID-19)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Phase I: Treatment as Usual (Pre-COVID-19)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase II: CAN Pandemic Telesurvey (Post-COVID-19)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place