- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01380613
Neighborhoods, Networks, Depression, and HIV Risk (Workshop)
September 4, 2013 updated by: Carl Latkin, Johns Hopkins Bloomberg School of Public Health
The Impact of Neighborhoods, Networks, and Depression on Drug Users' HIV Risk
The goal of this study is to examine how social networks, neighborhood, and depression are related to HIV risk.
The intervention is designed to train individuals to cope with feelings of depression or stress as a way to reduce their risk for HIV.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study included implementation and evaluation of a small group, randomized controlled, phase II intervention to reduce depressive symptoms and HIV risk behaviors among inner city drug users.
The intervention included elements of cognitive behavioral therapy (CBT) for depression among impoverished individuals, emphasizing depressive cognitions and behaviors theorized to be associated with depression and with HIV risk behaviors among mildly to moderately depressed drug users.
In addition, the study examined active drug users' social and environmental pathways to depression and subsequent HIV risk behaviors.
Specifically, we will hypothesized mediating/moderating effects of neighborhood characteristics, social network factors, and individual level factors on depressive symptoms and HIV risk behaviors.
Study Type
Interventional
Enrollment (Actual)
965
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Maryland
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Baltimore, Maryland, United States, 21205
- Lighthouse Studies @ Peer Points- JHSPH
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18-55 years old
- HIV Risk Behavior:
3a. Injected drugs more than 3 times in the past week OR
3b. Snorted/sniffed heroin or cocaine or smoked crack in the past 6 months AND had 1 of the following sex risks in the past 6 months: i) 2 or more sex partners ii) Had a sex partner who injected drugs iii)Had a sex partner who smoked crack iv) Had a sex partner who was HIV+
4. Willingness to attend group sessions
Exclusion Criteria:
- Enrolled in another HIV behavioral intervention or depression study in past the 3 years
- Enrolled in another Lighthouse study in past the 5 years
- Enrolled in the formative research (Phase 1) or pilot (Phase 2) of the current project.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Workshop Control
Participants receive HIV/STDs risk reduction information.
|
1 session intervention on standard HIV/STD information
|
Experimental: Intervention Workshop
Participants learn skills to cope with depressive symptoms and stress as well as safer sex and injection skills.
|
10 session intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from Baseline in Depressive Symptoms Measured by the CESD Scale at 6 months
Time Frame: 6 months
|
6 months
|
Change from Baseline in Depressive Symptoms Measured by the CESD Scale at 12 months
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from Baseline in Sex Risk Behavior Based on Number of Sex Partners and Condom Use at 6 months
Time Frame: 6 months
|
6 months
|
Change from Baseline in Injection Risk Behavior Based on Sharing Needles, Cookers, and Cotton For Injection and Drug Splitting at 6 months
Time Frame: 6 months
|
6 months
|
Change from Baseline in Sex Risk Behavior Based on Number of Sex Partners and Condom Use at 12 months
Time Frame: 12 months
|
12 months
|
Change from Baseline in Injection Risk Behavior Based on Sharing Needles, Cookers, and Cotton For Injection and Drug Splitting at 12 months
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Actual)
July 1, 2013
Study Completion (Actual)
July 1, 2013
Study Registration Dates
First Submitted
March 7, 2011
First Submitted That Met QC Criteria
June 22, 2011
First Posted (Estimate)
June 27, 2011
Study Record Updates
Last Update Posted (Estimate)
September 5, 2013
Last Update Submitted That Met QC Criteria
September 4, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DESPR-DA022961-03
- R01DA022961 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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