N/A
N=148
Brief Therapy Intervention for Heavy/Hazardous Drinking in HIV-Positive Women
HIV Infections · Alcoholism
Bottom Line
View on ClinicalTrials.gov: NCT00127231 ↗Enrolled (actual)
148
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Number of Drinking Days Out of the Past 90 Days — 34.03; 30.45; 13.58; 20.22 days — p=<0.005
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Brief alcohol intervention based on Project Treat (Behavioral); Standard care (Behavioral)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- Johns Hopkins University
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Drinking Days Out of the Past 90 Days |
34.03; 30.45; 13.58; 20.22; 14.42; 24.48 | <0.005 sig |
| PRIMARY Number of Binge Drinking Days Out of the Past 90 Days |
24.91; 26.71; 7.68; 13.95; 12.07; 16.14 | — |
| SECONDARY HIV Clinic Appointment Adherence (Kept/Scheduled Appointments) |
63.40; 58.59; 70.11; 60.57; 67.87; 62.22 | — |
| SECONDARY % of Patients Currently on Antiretroviral Therapy |
72.97; 67.57; 78.18; 68.42; 75.81; 70.97 | — |
| SECONDARY Number of Days in Past 90 Days on Which Participants Reported Having Unprotected Vaginal Sex |
2.68; 3.31; 2.56; 3.06; 2.31; 1.35 | — |
Summary
The purpose of this study is to determine whether two brief counseling sessions reduce drinking and improve health outcomes in HIV-positive women who drink at heavy/hazardous levels. Also, the study seeks to compare hazardous drinking versus nonhazardous drinking women on a variety of alcohol, HIV and life quality outcome measures.
Eligibility Criteria
Inclusion Criteria
- Heavy/hazardous drinking levels (i.e., consuming 8 or more drinks per week, or have reported at least two heavy drinking occasions [4 or more drinks/drinking episode] in the last six months, or score positively on the CAGE or T-ACE).
- HIV-positive
- Receiving HIV care in Johns Hopkins Hospital (JHH) Moore Clinic
Exclusion Criteria
- Actively psychotic and other severe mental health symptoms
- Current enrollment in alcohol or drug treatment
- Current enrollment in Hopkins psychiatric services
- Pregnancy (because of the ethical concern of randomization to standard care)
Data sourced from ClinicalTrials.gov (NCT00127231). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.