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Neighborhoods, Networks, Depression, and HIV Risk (Workshop)

Primary Purpose

HIV, Depression, Drug Use

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Workshop

Workshop control

About this trial

This is an interventional prevention trial for HIV focused on measuring HIV, depression, drug use,, risk reduction

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Lighthouse Studies @ Peer Points- JHSPH

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Workshop Control

Intervention Workshop

Arm Description

Participants receive HIV/STDs risk reduction information.

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

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Change from Baseline in Sex Risk Behavior Based on Number of Sex Partners and Condom Use at 6 months

Change from Baseline in Injection Risk Behavior Based on Sharing Needles, Cookers, and Cotton For Injection and Drug Splitting at 6 months

Change from Baseline in Sex Risk Behavior Based on Number of Sex Partners and Condom Use at 12 months

Change from Baseline in Injection Risk Behavior Based on Sharing Needles, Cookers, and Cotton For Injection and Drug Splitting at 12 months

Full Information

NCT ID

NCT01380613

First Posted

March 7, 2011

Last Updated

September 4, 2013

Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT01380613

Brief Title

Neighborhoods, Networks, Depression, and HIV Risk

Acronym

Workshop

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV, Depression, Drug Use

Keywords

HIV, depression, drug use,, risk reduction

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

965 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Workshop Control

Arm Type

Active Comparator

Arm Description

Participants receive HIV/STDs risk reduction information.

Arm Title

Intervention Workshop

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Workshop

Intervention Description

10 session intervention

Intervention Type

Behavioral

Intervention Name(s)

Workshop control

Intervention Description

1 session intervention on standard HIV/STD information

Primary Outcome Measure Information:

Title

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

Time Frame

6 months

Title

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

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Change from Baseline in Sex Risk Behavior Based on Number of Sex Partners and Condom Use at 6 months

Time Frame

6 months

Title

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

Title

Change from Baseline in Sex Risk Behavior Based on Number of Sex Partners and Condom Use at 12 months

Time Frame

12 months

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carl A Latkin, PhD

Organizational Affiliation

Johns Hopkins Bloomberg School of Public Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Lighthouse Studies @ Peer Points- JHSPH

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21205

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

29240757

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.

Results Reference

derived

Learn more about this trial

Neighborhoods, Networks, Depression, and HIV Risk

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