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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01380613
Other study ID # DESPR-DA022961-03
Secondary ID R01DA022961
Status Completed
Phase Phase 2
First received March 7, 2011
Last updated September 4, 2013
Start date September 2007
Est. completion date July 2013

Study information

Verified date September 2013
Source Johns Hopkins Bloomberg School of Public Health
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 965
Est. completion date July 2013
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

1. 18-55 years old

2. 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:

1. Enrolled in another HIV behavioral intervention or depression study in past the 3 years

2. Enrolled in another Lighthouse study in past the 5 years

3. Enrolled in the formative research (Phase 1) or pilot (Phase 2) of the current project.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Workshop
10 session intervention
Workshop control
1 session intervention on standard HIV/STD information

Locations

Country Name City State
United States Lighthouse Studies @ Peer Points- JHSPH Baltimore Maryland

Sponsors (2)

Lead Sponsor Collaborator
Johns Hopkins Bloomberg School of Public Health National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline in Depressive Symptoms Measured by the CESD Scale at 6 months 6 months No
Primary Change from Baseline in Depressive Symptoms Measured by the CESD Scale at 12 months 12 months No
Secondary Change from Baseline in Sex Risk Behavior Based on Number of Sex Partners and Condom Use at 6 months 6 months No
Secondary Change from Baseline in Injection Risk Behavior Based on Sharing Needles, Cookers, and Cotton For Injection and Drug Splitting at 6 months 6 months No
Secondary Change from Baseline in Sex Risk Behavior Based on Number of Sex Partners and Condom Use at 12 months 12 months No
Secondary Change from Baseline in Injection Risk Behavior Based on Sharing Needles, Cookers, and Cotton For Injection and Drug Splitting at 12 months 12 months No
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