HIV InfectionsNCT00127231
Brief Therapy Intervention for Heavy/Hazardous Drinking in HIV-Positive Women
A study testing Brief alcohol intervention based on Project Treat in people with HIV Infections and Alcoholism, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- HIV Infections, Alcoholism
- What is being tested?
- Brief alcohol intervention based on Project Treat
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Nov 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brief Alcohol Intervention in HIV+ Women
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.
Read the detailed description
Heavy alcohol use negatively impacts HIV/AIDS in several important ways. It increases HIV-risk behaviors, impairs the immune system and accelerates HIV disease progression. Heavy alcohol use also interferes with HIV care compliance, including appointment attendance and medication adherence.
Women are particularly important targets for alcohol use interventions. The threshold for harmful alcohol effects is strikingly low in women, with two drinks per day placing women at risk for negative health consequences. Heavy/hazardous alcohol use is less likely to be detected in women receiving health services. Women may be less likely to seek and or engage in alcohol treatment services, making nontraditional care settings particularly important for reaching this population.
This proposal tests the utility of a brief alcohol intervention for HIV+ women delivered in a medical setting. Hazardous/binge female drinkers will be identified in the Johns Hopkins Hospital HIV clinic and will be randomized to brief intervention or standard care. 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. In addition, a comparison group of nonhazardous drinking, HIV+ women will be recruited. 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.
The investigators hypothesize that women who receive the brief intervention will report lower mean weekly alcohol consumption and fewer heavy drinking episodes than women in standard care. The investigators also predict that women who receive brief intervention will adhere to their HIV medications and keep their health care appointments more consistently, and have improved HIV-related health outcomes. Finally, the investigators hypothesize that nonhazardous drinkers will have fewer psychiatric symptoms and better quality of life than hazardous drinking women.
Comparison(s): Standard HIV care
- Conditions
- HIV Infections, Alcoholism
- Being tested
- Brief alcohol intervention based on Project Treat, Standard care
- Keywords
- Controlled Clinical Trials, Randomized, Alcohol Consumption, Behavioral Research, HIV, Alcohol Abuse
- Medical subject headings
- HIV Infections, Alcoholism, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief alcohol intervention based on Project TreatBehavioural
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.
Standard careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 Brief Intervention | Experimental | 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. Receives: Behavioral: Brief alcohol intervention based on Project Treat |
| 2 Standard Care Arm | Active comparator | Not described Receives: Behavioral: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Drinking Days Out of the Past 90 Days
Measured: Baseline through 1 year follow-up
Number of Binge Drinking Days Out of the Past 90 Days
Number of days during the past 90 days on which women drank more than 3 standard drinks
Measured: Baseline through 12 month follow-up
Secondary outcomes (3)
HIV Clinic Appointment Adherence (Kept/Scheduled Appointments)
the % of kept appointments out of scheduled appointments was determined for each participant, and then averaged for the set of participants at each time point
Measured: baseline through 1 year follow-up
% of Patients Currently on Antiretroviral Therapy
number of participants who are currently receiving antiretroviral therapy/total number of participants
Measured: baseline through 1 year follow-up
Number of Days in Past 90 Days on Which Participants Reported Having Unprotected Vaginal Sex
Number of days in the past 90 days on which participants reported having unprotected vaginal sex
Measured: Baseline to 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2005 (estimated)
- Study startSep 2007
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Mary E. McCaul, Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00127231
- Sponsor's protocol ID
- NIAAAMCC014500
- Other IDs
- R01AA014500, K23AA015313
- Status last verified
- Nov 2017
- First submitted
- 3 Aug 2005
- Last updated
- 6 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Alcohol Intervention in HIV+ Women
- ClinicalTrials.gov ID
- NCT00127231
- Acronym / sponsor ID
- NIAAAMCC014500
- Conditions
- HIV Infections, Alcoholism
- Keywords
- Controlled Clinical Trials, Randomized, Alcohol Consumption, Behavioral Research, HIV, Alcohol Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Sep 2007
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 5 Aug 2005 (estimated)
- Results
- Posted 6 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Heavy alcohol use negatively impacts HIV/AIDS in several important ways. It increases HIV-risk behaviors, impairs the immune system and accelerates HIV disease progression. Heavy alcohol use also interferes with HIV care compliance, including appointment attendance and medication adherence.
Women are particularly important targets for alcohol use interventions. The threshold for harmful alcohol effects is strikingly low in women, with two drinks per day placing women at risk for negative health consequences. Heavy/hazardous alcohol use is less likely to be detected in women receiving health services. Women may be less likely to seek and or engage in alcohol treatment services, making nontraditional care settings particularly important for reaching this population.
This proposal tests the utility of a brief alcohol intervention for HIV+ women delivered in a medical setting. Hazardous/binge female drinkers will be identified in the Johns Hopkins Hospital HIV clinic and will be randomized to brief intervention or standard care. 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. In addition, a comparison group of nonhazardous drinking, HIV+ women will be recruited. 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.
The investigators hypothesize that women who receive the brief intervention will report lower mean weekly alcohol consumption and fewer heavy drinking episodes than women in standard care. The investigators also predict that women who receive brief intervention will adhere to their HIV medications and keep their health care appointments more consistently, and have improved HIV-related health outcomes. Finally, the investigators hypothesize that nonhazardous drinkers will have fewer psychiatric symptoms and better quality of life than hazardous drinking women.
Comparison(s): Standard HIV care
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Brief Intervention | Experimental | Behavioral: Brief alcohol intervention based on Project TreatThe 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 | Active comparator | Behavioral: Standard care |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief alcohol intervention based on Project TreatThe brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content. | Behavioural | 1 Brief Intervention |
| Standard careHazardous/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. | Behavioural | 2 Standard Care Arm |
Primary outcome
Number of Drinking Days Out of the Past 90 Days
Time frame: Baseline through 1 year follow-up
Number of Binge Drinking Days Out of the Past 90 Days
Time frame: Baseline through 12 month follow-up
Number of days during the past 90 days on which women drank more than 3 standard drinks
3 secondary outcomes
HIV Clinic Appointment Adherence (Kept/Scheduled Appointments)
Time frame: baseline through 1 year follow-up
% of Patients Currently on Antiretroviral Therapy
Time frame: baseline through 1 year follow-up
Number of Days in Past 90 Days on Which Participants Reported Having Unprotected Vaginal Sex
Time frame: Baseline to 12 month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary E. McCaul, Ph.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief alcohol intervention based on Project Treat in people with HIV Infections and Alcoholism, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Drinking Days Out of the Past 90 Days (time frame: Baseline through 1 year follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2017.