Clinical trial NCT01380613: Neighborhoods, Networks, Depression, and HIV Risk
Official title: The Impact of Neighborhoods, Networks, and Depression on Drug Users' HIV Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV
Depression
Drug Use
Keywords: HIV
depression
drug use,
risk reduction
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2011-06-27
Enrollment: 965
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in Depressive Symptoms Measured by the CESD Scale at 6 months
timeFrame: 6 months
measure: Change from Baseline in Depressive Symptoms Measured by the CESD Scale at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Change from Baseline in Sex Risk Behavior Based on Number of Sex Partners and Condom Use at 6 months
timeFrame: 6 months
measure: Change from Baseline in Injection Risk Behavior Based on Sharing Needles, Cookers, and Cotton For Injection and Drug Splitting at 6 months
timeFrame: 6 months
measure: Change from Baseline in Sex Risk Behavior Based on Number of Sex Partners and Condom Use at 12 months
timeFrame: 12 months
measure: Change from Baseline in Injection Risk Behavior Based on Sharing Needles, Cookers, and Cotton For Injection and Drug Splitting at 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Lighthouse Studies @ Peer Points- JHSPH
state: Maryland
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Carl A Latkin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tobin K, Davey-Rothwell MA, Nonyane BAS, Knowlton A, Wissow L, Latkin CA. RCT of an integrated CBT-HIV intervention on depressive symptoms and HIV risk. PLoS One. 2017 Dec 14;12(12):e0187180. doi: 10.1371/journal.pone.0187180. eCollection 2017.