Trial Outcomes & Findings for Brief Therapy Intervention for Heavy/Hazardous Drinking in HIV-Positive Women (NCT NCT00127231)
NCT ID: NCT00127231
Last Updated: 2017-12-06
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
148 participants
Primary outcome timeframe
Baseline through 1 year follow-up
Results posted on
2017-12-06
Participant Flow
Participant milestones
| Measure |
1 Brief Intervention
The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content.
Brief alcohol intervention based on Project Treat: The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content.
|
2 Standard Care Arm
Standard care: Hazardous/binge female drinkers will be identified in the Johns Hopkins Hospital HIV clinic and will be randomized to brief intervention or standard care. Outcome measures will include: alcohol/drug use, engagement in an on-site alcohol support group and other substance abuse treatment services, HIV-risk behaviors, HIV disease markers and treatment compliance, and psychiatric symptoms.
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
74
|
|
Overall Study
COMPLETED
|
68
|
68
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Brief Therapy Intervention for Heavy/Hazardous Drinking in HIV-Positive Women
Baseline characteristics by cohort
| Measure |
1 Brief Intervention
n=74 Participants
The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content.
Brief alcohol intervention based on Project Treat: The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content.
|
2 Standard Care Arm
n=74 Participants
Standard care: Hazardous/binge female drinkers will be identified in the Johns Hopkins Hospital HIV clinic and will be randomized to brief intervention or standard care. Outcome measures will include: alcohol/drug use, engagement in an on-site alcohol support group and other substance abuse treatment services, HIV-risk behaviors, HIV disease markers and treatment compliance, and psychiatric symptoms.
|
Total
n=148 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.27 years
STANDARD_DEVIATION 7.07 • n=5 Participants
|
44.86 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
45.56 years
STANDARD_DEVIATION 8.08 • n=5 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
67 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
74 participants
n=5 Participants
|
74 participants
n=7 Participants
|
148 participants
n=5 Participants
|
|
Employment %
Working part-time or full-time
|
21 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Employment %
Unemployed
|
53 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Income, Continuous
|
8497.38 dollars
STANDARD_DEVIATION 7166.03 • n=5 Participants
|
8189.19 dollars
STANDARD_DEVIATION 7239.17 • n=7 Participants
|
8343.28 dollars
STANDARD_DEVIATION 7202.60 • n=5 Participants
|
|
Undetectable HIV-1 RNA %
Undetectable HIV-1 RNA (<50 copies)
|
29 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Undetectable HIV-1 RNA %
Detectable HIV-1 RNA
|
45 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
CD4 count, Continuous
|
398.11 cells/mm3
STANDARD_DEVIATION 269.02 • n=5 Participants
|
393.24 cells/mm3
STANDARD_DEVIATION 236.78 • n=7 Participants
|
395.68 cells/mm3
STANDARD_DEVIATION 252.9 • n=5 Participants
|
|
AUDIT score, continuous
|
11.9 units on a scale
STANDARD_DEVIATION 8.7 • n=5 Participants
|
12.3 units on a scale
STANDARD_DEVIATION 8.9 • n=7 Participants
|
12.1 units on a scale
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Total number of drinking days out of the past 90 days
|
34.03 days
STANDARD_DEVIATION 29.47 • n=5 Participants
|
30.45 days
STANDARD_DEVIATION 27.57 • n=7 Participants
|
32.24 days
STANDARD_DEVIATION 28.52 • n=5 Participants
|
|
Number of standard drinks per episode, continuous
|
9.69 standard drinks
STANDARD_DEVIATION 9.13 • n=5 Participants
|
9.55 standard drinks
STANDARD_DEVIATION 6.42 • n=7 Participants
|
9.62 standard drinks
STANDARD_DEVIATION 7.78 • n=5 Participants
|
|
Number of participants with illicit drug use in past 6 months
|
50 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through 1 year follow-upPopulation: All randomized participants were included in analyses although 6 participants from each arm did not complete the study due to loss to follow up
Outcome measures
| Measure |
1 Brief Intervention
n=74 Participants
The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content.
Brief alcohol intervention based on Project Treat: The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content.
|
2 Standard Care Arm
n=74 Participants
Standard care: Hazardous/binge female drinkers will be identified in the Johns Hopkins Hospital HIV clinic and will be randomized to brief intervention or standard care. Outcome measures will include: alcohol/drug use, engagement in an on-site alcohol support group and other substance abuse treatment services, HIV-risk behaviors, HIV disease markers and treatment compliance, and psychiatric symptoms.
|
|---|---|---|
|
Number of Drinking Days Out of the Past 90 Days
Baseline
|
34.03 days
Standard Deviation 29.47
|
30.45 days
Standard Deviation 27.57
|
|
Number of Drinking Days Out of the Past 90 Days
3-month follow-up
|
13.58 days
Standard Deviation 19.89
|
20.22 days
Standard Deviation 25.27
|
|
Number of Drinking Days Out of the Past 90 Days
6-month follow-up
|
14.42 days
Standard Deviation 22.20
|
24.48 days
Standard Deviation 26.78
|
|
Number of Drinking Days Out of the Past 90 Days
12-month follow-up
|
15.96 days
Standard Deviation 24.07
|
20.83 days
Standard Deviation 27.53
|
PRIMARY outcome
Timeframe: Baseline through 12 month follow-upPopulation: Not all subjects participated in every follow-up interview.
Number of days during the past 90 days on which women drank more than 3 standard drinks
Outcome measures
| Measure |
1 Brief Intervention
n=74 Participants
The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content.
Brief alcohol intervention based on Project Treat: The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content.
|
2 Standard Care Arm
n=74 Participants
Standard care: Hazardous/binge female drinkers will be identified in the Johns Hopkins Hospital HIV clinic and will be randomized to brief intervention or standard care. Outcome measures will include: alcohol/drug use, engagement in an on-site alcohol support group and other substance abuse treatment services, HIV-risk behaviors, HIV disease markers and treatment compliance, and psychiatric symptoms.
|
|---|---|---|
|
Number of Binge Drinking Days Out of the Past 90 Days
Baseline
|
24.91 days out of past 90 days
Standard Deviation 26.99
|
26.71 days out of past 90 days
Standard Deviation 28.55
|
|
Number of Binge Drinking Days Out of the Past 90 Days
3-month follow-up
|
7.68 days out of past 90 days
Standard Deviation 13.75
|
13.95 days out of past 90 days
Standard Deviation 22.11
|
|
Number of Binge Drinking Days Out of the Past 90 Days
6-month follow-up
|
12.07 days out of past 90 days
Standard Deviation 21.61
|
16.14 days out of past 90 days
Standard Deviation 23.63
|
|
Number of Binge Drinking Days Out of the Past 90 Days
12 month follow-up
|
12.76 days out of past 90 days
Standard Deviation 23.42
|
13.23 days out of past 90 days
Standard Deviation 20.40
|
SECONDARY outcome
Timeframe: baseline through 1 year follow-upthe % of kept appointments out of scheduled appointments was determined for each participant, and then averaged for the set of participants at each time point
Outcome measures
| Measure |
1 Brief Intervention
n=74 Participants
The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content.
Brief alcohol intervention based on Project Treat: The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content.
|
2 Standard Care Arm
n=74 Participants
Standard care: Hazardous/binge female drinkers will be identified in the Johns Hopkins Hospital HIV clinic and will be randomized to brief intervention or standard care. Outcome measures will include: alcohol/drug use, engagement in an on-site alcohol support group and other substance abuse treatment services, HIV-risk behaviors, HIV disease markers and treatment compliance, and psychiatric symptoms.
|
|---|---|---|
|
HIV Clinic Appointment Adherence (Kept/Scheduled Appointments)
Baseline
|
63.40 percentage of kept/scheduled appointment
Standard Deviation 23.47
|
58.59 percentage of kept/scheduled appointment
Standard Deviation 23.66
|
|
HIV Clinic Appointment Adherence (Kept/Scheduled Appointments)
3-month follow-up
|
70.11 percentage of kept/scheduled appointment
Standard Deviation 25.15
|
60.57 percentage of kept/scheduled appointment
Standard Deviation 33.69
|
|
HIV Clinic Appointment Adherence (Kept/Scheduled Appointments)
6-month follow-up
|
67.87 percentage of kept/scheduled appointment
Standard Deviation 28.57
|
62.22 percentage of kept/scheduled appointment
Standard Deviation 33.98
|
|
HIV Clinic Appointment Adherence (Kept/Scheduled Appointments)
12-month follow-up
|
63.33 percentage of kept/scheduled appointment
Standard Deviation 23.82
|
56.63 percentage of kept/scheduled appointment
Standard Deviation 27.91
|
SECONDARY outcome
Timeframe: baseline through 1 year follow-upnumber of participants who are currently receiving antiretroviral therapy/total number of participants
Outcome measures
| Measure |
1 Brief Intervention
n=74 Participants
The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content.
Brief alcohol intervention based on Project Treat: The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content.
|
2 Standard Care Arm
n=74 Participants
Standard care: Hazardous/binge female drinkers will be identified in the Johns Hopkins Hospital HIV clinic and will be randomized to brief intervention or standard care. Outcome measures will include: alcohol/drug use, engagement in an on-site alcohol support group and other substance abuse treatment services, HIV-risk behaviors, HIV disease markers and treatment compliance, and psychiatric symptoms.
|
|---|---|---|
|
% of Patients Currently on Antiretroviral Therapy
Baseline
|
72.97 percentage of participants
|
67.57 percentage of participants
|
|
% of Patients Currently on Antiretroviral Therapy
3-month follow-up
|
78.18 percentage of participants
|
68.42 percentage of participants
|
|
% of Patients Currently on Antiretroviral Therapy
6-month follow-up
|
75.81 percentage of participants
|
70.97 percentage of participants
|
|
% of Patients Currently on Antiretroviral Therapy
12-month follow-up
|
84.38 percentage of participants
|
76.56 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to 12 month follow-upPopulation: Not all subjects participated in every follow-up interview.
Number of days in the past 90 days on which participants reported having unprotected vaginal sex
Outcome measures
| Measure |
1 Brief Intervention
n=74 Participants
The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content.
Brief alcohol intervention based on Project Treat: The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content.
|
2 Standard Care Arm
n=74 Participants
Standard care: Hazardous/binge female drinkers will be identified in the Johns Hopkins Hospital HIV clinic and will be randomized to brief intervention or standard care. Outcome measures will include: alcohol/drug use, engagement in an on-site alcohol support group and other substance abuse treatment services, HIV-risk behaviors, HIV disease markers and treatment compliance, and psychiatric symptoms.
|
|---|---|---|
|
Number of Days in Past 90 Days on Which Participants Reported Having Unprotected Vaginal Sex
Baseline
|
2.68 days
Standard Deviation 8.61
|
3.31 days
Standard Deviation 9.21
|
|
Number of Days in Past 90 Days on Which Participants Reported Having Unprotected Vaginal Sex
3-month follow-up
|
2.56 days
Standard Deviation 12.15
|
3.06 days
Standard Deviation 10.31
|
|
Number of Days in Past 90 Days on Which Participants Reported Having Unprotected Vaginal Sex
6-month follow-up
|
2.31 days
Standard Deviation 7.83
|
1.35 days
Standard Deviation 4.54
|
|
Number of Days in Past 90 Days on Which Participants Reported Having Unprotected Vaginal Sex
12-month follow-up
|
1.59 days
Standard Deviation 5.11
|
4.74 days
Standard Deviation 13.78
|
Adverse Events
1 Brief Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2 Standard Care Arm
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
Mary E McCaul
Johns Hopkins University School of Medicine
Phone: 410-955-9526
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place