Neighborhoods, Networks, Depression, and HIV Risk

Depression Clinical Trial

— Workshop  

Official title:

The Impact of Neighborhoods, Networks, and Depression on Drug Users' HIV Risk

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

• Depression
• Depressive Disorder
• Drug Use
• HIV

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