Trial Outcomes & Findings for Improving HIV and Alcohol-Related Outcomes Among HIV+ Persons in Clinic Settings (NCT NCT02390908)

Last Updated: 2021-04-12

Results Overview

Standard of care HIV-1 viral load results were run using local laboratories and results were abstracted from EMR data, indicating the participant's most recent viral load result. Each viral load result indicates the number of HIV copies in a milliliter (copies/mL), and raw values were log-transformed to deal with non-normal distribution. Minimum and maximum log-viral load values in the current sample were 1.28 and 6.07, respectively.

Recruitment status

COMPLETED

Study phase

Target enrollment

174 participants

Primary outcome timeframe

most recent result within past 90 days

Results posted on

2021-04-12

Participant Flow

174 participants were enrolled in the experimental arms of PLUS. An additional 120 comparison patients, in regular care at sites but not enrolled in the study, had their electronic medical records (EMR) accessed. They were not considered enrolled in the study, as they did not sign informed consent, and did not receive intervention. Data for this "No-Treatment EMR Control" group included viral load, CD4 and demographics but not study measures (alcohol and drug use severity, medication adherence).

Participant milestones

Participant milestones
Measure	Site 1 Immediate PLUS Intervention Immediate delivery of the PLUS intervention (Six sessions of Motivational Interviewing and Cognitive Behavioral Skills Training) Immediate PLUS intervention: The Positive Living through Understanding and Support (PLUS) intervention consists of six sessions that utilizes motivational interviewing and cognitive behavioral skills training to reduce alcohol use and improve medication adherence.	Site 2 Immediate PLUS Intervention Immediate delivery of the PLUS intervention (Six sessions of Motivational Interviewing and Cognitive Behavioral Skills Training) Immediate PLUS intervention: The Positive Living through Understanding and Support (PLUS) intervention consists of six sessions that utilizes motivational interviewing and cognitive behavioral skills training to reduce alcohol use and improve medication adherence.	Site 3 Immediate PLUS Intervention Immediate delivery of the PLUS intervention (Six sessions of Motivational Interviewing and Cognitive Behavioral Skills Training) Immediate PLUS intervention: The Positive Living through Understanding and Support (PLUS) intervention consists of six sessions that utilizes motivational interviewing and cognitive behavioral skills training to reduce alcohol use and improve medication adherence.	Wait-list PLUS Condition Received the PLUS intervention at 12 months post-baseline PLUS intervention: The Positive Living through Understanding and Support (PLUS) intervention consists of six sessions that utilizes motivational interviewing and cognitive behavioral skills training to reduce alcohol use and improve medication adherence. Wait-list PLUS intervention: In addition to treatment as usual, participants will receive handouts with printed information about HIV, the importance of ART adherence, and problematic alcohol use and HIV disease progression. Following their assessment 12 months after their baseline visit, participants will receive the PLUS intervention.	No-Treatment EMR Control Group The EMRs of randomly selected patients who belonged to the TAU site and were not enrolled in the PLUS trial were matched on key patient characteristics for comparisons with EMRs of patients in the PLUS intervention and Waitlist control conditions. This matched cohort of patients received care at a fourth clinic that did not receive any intervention (i.e., PLUS or eTAU) and was considered as a natural history comparison group. This group were only included in analyses comparing VL and CD4.
Overall Study STARTED	40	22	22	90	120
Overall Study COMPLETED	40	22	22	90	120
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Drug Use data is only available for the 174 participants who received the intervention. The 120 patients whose EMR records were extracted for viral load and CD4 results did not have data for this variable and were thus not included in analyses.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Site 1 Immediate PLUS Intervention n=40 Participants Immediate delivery of the PLUS intervention (Six sessions of Motivational Interviewing and Cognitive Behavioral Skills Training) Immediate PLUS intervention: The Positive Living through Understanding and Support (PLUS) intervention consists of six sessions that utilizes motivational interviewing and cognitive behavioral skills training to reduce alcohol use and improve medication adherence.	Site 2 Immediate PLUS Intervention n=22 Participants Immediate delivery of the PLUS intervention (Six sessions of Motivational Interviewing and Cognitive Behavioral Skills Training) Immediate PLUS intervention: The Positive Living through Understanding and Support (PLUS) intervention consists of six sessions that utilizes motivational interviewing and cognitive behavioral skills training to reduce alcohol use and improve medication adherence.	Site 3 Immediate PLUS Intervention n=22 Participants Immediate delivery of the PLUS intervention (Six sessions of Motivational Interviewing and Cognitive Behavioral Skills Training) Immediate PLUS intervention: The Positive Living through Understanding and Support (PLUS) intervention consists of six sessions that utilizes motivational interviewing and cognitive behavioral skills training to reduce alcohol use and improve medication adherence.	Wait-list PLUS Condition n=90 Participants Received the PLUS intervention at 12 months post baseline PLUS intervention: The Positive Living through Understanding and Support (PLUS) intervention consists of six sessions that utilizes motivational interviewing and cognitive behavioral skills training to reduce alcohol use and improve medication adherence. Wait-list PLUS intervention: In addition to treatment as usual, participants will receive handouts with printed information about HIV, the importance of ART adherence, and problematic alcohol use and HIV disease progression. Following their assessment 12 months after their baseline visit, participants will receive the PLUS intervention.	No-Treatment EMR Control Group n=120 Participants Patients whose electronic medical records (EMRs) were extracted for viral load and CD4 outcomes over the study period, but who were not enrolled in PLUS and did not receive the intervention.	Total n=294 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=40 Participants	0 Participants n=22 Participants	0 Participants n=22 Participants	0 Participants n=90 Participants	0 Participants n=120 Participants	0 Participants n=294 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=40 Participants	21 Participants n=22 Participants	22 Participants n=22 Participants	87 Participants n=90 Participants	119 Participants n=120 Participants	288 Participants n=294 Participants
Age, Categorical >=65 years	1 Participants n=40 Participants	1 Participants n=22 Participants	0 Participants n=22 Participants	3 Participants n=90 Participants	1 Participants n=120 Participants	6 Participants n=294 Participants
Age, Continuous	45.2 years STANDARD_DEVIATION 11.5 • n=40 Participants	41.2 years STANDARD_DEVIATION 11.3 • n=22 Participants	44.0 years STANDARD_DEVIATION 10.2 • n=22 Participants	45.5 years STANDARD_DEVIATION 11.9 • n=90 Participants	45.2 years STANDARD_DEVIATION 10.7 • n=120 Participants	44.9 years STANDARD_DEVIATION 11.2 • n=294 Participants
Sex: Female, Male Female	2 Participants n=40 Participants	3 Participants n=22 Participants	8 Participants n=22 Participants	20 Participants n=90 Participants	21 Participants n=120 Participants	54 Participants n=294 Participants
Sex: Female, Male Male	38 Participants n=40 Participants	19 Participants n=22 Participants	14 Participants n=22 Participants	70 Participants n=90 Participants	99 Participants n=120 Participants	240 Participants n=294 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black	18 Participants n=40 Participants	10 Participants n=22 Participants	15 Participants n=22 Participants	51 Participants n=90 Participants	62 Participants n=120 Participants	156 Participants n=294 Participants
Race/Ethnicity, Customized Race/Ethnicity · Latino	8 Participants n=40 Participants	8 Participants n=22 Participants	3 Participants n=22 Participants	22 Participants n=90 Participants	21 Participants n=120 Participants	62 Participants n=294 Participants
Race/Ethnicity, Customized Race/Ethnicity · Other	7 Participants n=40 Participants	4 Participants n=22 Participants	1 Participants n=22 Participants	9 Participants n=90 Participants	21 Participants n=120 Participants	42 Participants n=294 Participants
Race/Ethnicity, Customized Race/Ethnicity · White	7 Participants n=40 Participants	0 Participants n=22 Participants	3 Participants n=22 Participants	8 Participants n=90 Participants	16 Participants n=120 Participants	34 Participants n=294 Participants
Region of Enrollment United States	40 participants n=40 Participants	22 participants n=22 Participants	22 participants n=22 Participants	90 participants n=90 Participants	120 participants n=120 Participants	174 participants n=294 Participants
Drug Use DAST Score	4.1 units on a scale STANDARD_DEVIATION 2.7 • n=40 Participants • Drug Use data is only available for the 174 participants who received the intervention. The 120 patients whose EMR records were extracted for viral load and CD4 results did not have data for this variable and were thus not included in analyses.	4.0 units on a scale STANDARD_DEVIATION 2.5 • n=22 Participants • Drug Use data is only available for the 174 participants who received the intervention. The 120 patients whose EMR records were extracted for viral load and CD4 results did not have data for this variable and were thus not included in analyses.	2.8 units on a scale STANDARD_DEVIATION 2.3 • n=22 Participants • Drug Use data is only available for the 174 participants who received the intervention. The 120 patients whose EMR records were extracted for viral load and CD4 results did not have data for this variable and were thus not included in analyses.	3.74 units on a scale STANDARD_DEVIATION 2.7 • n=90 Participants • Drug Use data is only available for the 174 participants who received the intervention. The 120 patients whose EMR records were extracted for viral load and CD4 results did not have data for this variable and were thus not included in analyses.	—	3.74 units on a scale STANDARD_DEVIATION 2.7 • n=174 Participants • Drug Use data is only available for the 174 participants who received the intervention. The 120 patients whose EMR records were extracted for viral load and CD4 results did not have data for this variable and were thus not included in analyses.

PRIMARY outcome

Timeframe: most recent result within past 90 days

Outcome measures

Outcome measures
Measure	Site 1 Immediate PLUS Intervention n=40 Participants Site 1 Immediate delivery of the PLUS intervention (Six sessions of Motivational Interviewing and Cognitive Behavioral Skills Training) Immediate PLUS intervention: The Positive Living through Understanding and Support (PLUS) intervention consists of six sessions that utilizes motivational interviewing and cognitive behavioral skills training to reduce alcohol use and improve medication adherence.	Site 2 Immediate PLUS Intervention n=22 Participants Site 2 Immediate delivery of the PLUS intervention (Six sessions of Motivational Interviewing and Cognitive Behavioral Skills Training) Immediate PLUS intervention: The Positive Living through Understanding and Support (PLUS) intervention consists of six sessions that utilizes motivational interviewing and cognitive behavioral skills training to reduce alcohol use and improve medication adherence.	Site 3 Immediate PLUS Intervention n=22 Participants Site 3 Immediate delivery of the PLUS intervention (Six sessions of Motivational Interviewing and Cognitive Behavioral Skills Training) Immediate PLUS intervention: The Positive Living through Understanding and Support (PLUS) intervention consists of six sessions that utilizes motivational interviewing and cognitive behavioral skills training to reduce alcohol use and improve medication adherence.	Wait-list PLUS Condition n=90 Participants Received the PLUS intervention at 12 months post baseline Wait-list PLUS intervention: In addition to treatment as usual, participants will receive handouts with printed information about HIV, the importance of ART adherence, and problematic alcohol use and HIV disease progression. Following their assessment 12 months after their baseline visit, participants will receive the PLUS intervention.	No-Treatment Control EMR Group n=120 Participants 120 matched patients in the No-Treatment Control Group whose Viral Load results were obtained through Electronic Medical Records (EMR)
Viral Load	3.1 Log-transformed copies per. milimeter Standard Deviation 1.7	1.8 Log-transformed copies per. milimeter Standard Deviation 1.0	1.8 Log-transformed copies per. milimeter Standard Deviation 0.6	2.6 Log-transformed copies per. milimeter Standard Deviation 1.4	2.5 Log-transformed copies per. milimeter Standard Deviation 1.4

PRIMARY outcome

Timeframe: most recent result within past 90 days

CD4 results were accessed through clinic EMR data, and represent cells per cubic millimeter.

Outcome measures

Outcome measures
Measure	Site 1 Immediate PLUS Intervention n=40 Participants Site 1 Immediate delivery of the PLUS intervention (Six sessions of Motivational Interviewing and Cognitive Behavioral Skills Training) Immediate PLUS intervention: The Positive Living through Understanding and Support (PLUS) intervention consists of six sessions that utilizes motivational interviewing and cognitive behavioral skills training to reduce alcohol use and improve medication adherence.	Site 2 Immediate PLUS Intervention n=22 Participants Site 2 Immediate delivery of the PLUS intervention (Six sessions of Motivational Interviewing and Cognitive Behavioral Skills Training) Immediate PLUS intervention: The Positive Living through Understanding and Support (PLUS) intervention consists of six sessions that utilizes motivational interviewing and cognitive behavioral skills training to reduce alcohol use and improve medication adherence.	Site 3 Immediate PLUS Intervention n=22 Participants Site 3 Immediate delivery of the PLUS intervention (Six sessions of Motivational Interviewing and Cognitive Behavioral Skills Training) Immediate PLUS intervention: The Positive Living through Understanding and Support (PLUS) intervention consists of six sessions that utilizes motivational interviewing and cognitive behavioral skills training to reduce alcohol use and improve medication adherence.	Wait-list PLUS Condition n=90 Participants Received the PLUS intervention at 12 months post baseline Wait-list PLUS intervention: In addition to treatment as usual, participants will receive handouts with printed information about HIV, the importance of ART adherence, and problematic alcohol use and HIV disease progression. Following their assessment 12 months after their baseline visit, participants will receive the PLUS intervention.	No-Treatment Control EMR Group n=120 Participants 120 matched patients in the No-Treatment Control Group whose Viral Load results were obtained through Electronic Medical Records (EMR)
CD4 Count	632.4 number of cells per cubic milimeter Standard Deviation 355.1	696.2 number of cells per cubic milimeter Standard Deviation 356.2	390.5 number of cells per cubic milimeter Standard Deviation 462.9	398.2 number of cells per cubic milimeter Standard Deviation 252.2	409.1 number of cells per cubic milimeter Standard Deviation 254.7

PRIMARY outcome

Timeframe: past 30 days

Percentage of antiretroviral medication (ART) doses that were taken as prescribed, within the past 30 days. Minimum and maximum values were 0% and 100%, respectively.

Outcome measures

Outcome measures
Measure	Site 1 Immediate PLUS Intervention n=40 Participants Site 1 Immediate delivery of the PLUS intervention (Six sessions of Motivational Interviewing and Cognitive Behavioral Skills Training) Immediate PLUS intervention: The Positive Living through Understanding and Support (PLUS) intervention consists of six sessions that utilizes motivational interviewing and cognitive behavioral skills training to reduce alcohol use and improve medication adherence.	Site 2 Immediate PLUS Intervention n=22 Participants Site 2 Immediate delivery of the PLUS intervention (Six sessions of Motivational Interviewing and Cognitive Behavioral Skills Training) Immediate PLUS intervention: The Positive Living through Understanding and Support (PLUS) intervention consists of six sessions that utilizes motivational interviewing and cognitive behavioral skills training to reduce alcohol use and improve medication adherence.	Site 3 Immediate PLUS Intervention n=22 Participants Site 3 Immediate delivery of the PLUS intervention (Six sessions of Motivational Interviewing and Cognitive Behavioral Skills Training) Immediate PLUS intervention: The Positive Living through Understanding and Support (PLUS) intervention consists of six sessions that utilizes motivational interviewing and cognitive behavioral skills training to reduce alcohol use and improve medication adherence.	Wait-list PLUS Condition n=90 Participants Received the PLUS intervention at 12 months post baseline Wait-list PLUS intervention: In addition to treatment as usual, participants will receive handouts with printed information about HIV, the importance of ART adherence, and problematic alcohol use and HIV disease progression. Following their assessment 12 months after their baseline visit, participants will receive the PLUS intervention.	No-Treatment Control EMR Group 120 matched patients in the No-Treatment Control Group whose Viral Load results were obtained through Electronic Medical Records (EMR)
ART Medication Adherence	85.5 percentage of adherent days Standard Deviation 31.1	86.6 percentage of adherent days Standard Deviation 15.8	83.4 percentage of adherent days Standard Deviation 18.5	77.6 percentage of adherent days Standard Deviation 34.0	—

PRIMARY outcome

Timeframe: past 90 days

Severity of alcohol consumption as measured by the Alcohol Use Disorders Identification Test (AUDIT). The AUDIT is a 10-item, widely-used screening questionnaire consisting of three questions related to drinking frequency, three questions on dependence, and four questions on problems caused by alcohol over the past three months. Scores range from 0 to 40, with higher scores indicating greater alcohol use.