NCT01380613

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
965

participants targeted

Target at P75+ for phase_2 hiv

Timeline
Completed

Started Sep 2007

Longer than P75 for phase_2 hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 27, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

September 5, 2013

Status Verified

September 1, 2013

Enrollment Period

5.8 years

First QC Date

March 7, 2011

Last Update Submit

September 4, 2013

Conditions

HIVDepressionDrug Use

Keywords

HIVdepressiondrug use,risk reduction

Outcome Measures

Primary Outcomes (2)

  • Change from Baseline in Depressive Symptoms Measured by the CESD Scale at 6 months

    6 months

  • Change from Baseline in Depressive Symptoms Measured by the CESD Scale at 12 months

    12 months

Secondary Outcomes (4)

  • Change from Baseline in Sex Risk Behavior Based on Number of Sex Partners and Condom Use at 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

    6 months

  • Change from Baseline in Sex Risk Behavior Based on Number of Sex Partners and Condom Use at 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

    12 months

Study Arms (2)

Workshop Control

ACTIVE COMPARATOR

Participants receive HIV/STDs risk reduction information.

Behavioral: Workshop control

Intervention Workshop

EXPERIMENTAL

Participants learn skills to cope with depressive symptoms and stress as well as safer sex and injection skills.

Behavioral: Workshop

Interventions

WorkshopBEHAVIORAL

10 session intervention

Intervention Workshop
Workshop controlBEHAVIORAL

1 session intervention on standard HIV/STD information

Workshop Control

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years old
  • HIV Risk Behavior:
  • a. Injected drugs more than 3 times in the past week OR
  • b. 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+
  • \. Willingness to attend group sessions

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lighthouse Studies @ Peer Points- JHSPH

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

  • 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.

    PMID: 29240757DERIVED

MeSH Terms

Conditions

DepressionRisk Reduction Behavior

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Carl A Latkin, PhD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 7, 2011

First Posted

June 27, 2011

Study Start

September 1, 2007

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

September 5, 2013

Record last verified: 2013-09

Locations

US(1)