NCT00218335

Brief Summary

The purpose of this study is to evaluate a peer-based HIV prevention intervention that targets active injection drug users and their drug and sex partners.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,024

participants targeted

Target at P75+ for phase_2 hiv

Timeline
Completed

Started Jun 2003

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
5 years until next milestone

Results Posted

Study results publicly available

April 18, 2013

Completed
Last Updated

April 18, 2013

Status Verified

March 1, 2013

Enrollment Period

4.9 years

First QC Date

September 16, 2005

Results QC Date

January 25, 2013

Last Update Submit

March 7, 2013

Conditions

HIVHepatitis

Keywords

HIV prevention Intervention, injection drug user,peer-oriented, randomized controlled trial, social network

Outcome Measures

Primary Outcomes (15)

  • Any Sex Risk

    6 months

  • Talked About HIV-related Topics With Drug Buddies (in the Past Month)

    6 months

  • Showed a Needleless Syringe to Drug Buddies

    6 months

  • Talked About Responding to Overdose to Drug Buddies

    6 months

  • Any Injection Risk (Monthly Versus Never)

    12 months

  • Number of Needle or Cooker Sharers (2 or More Versus None)

    12 months

  • Talked About HIV-related Topics With Drug Buddies (in the Past Month)

    12 months

  • Showed a Needleless Syringe to Drug Buddies

    12 months

  • Any Injection Risk (Monthly Versus Never)

    18 months

  • Shared Cooker When Preparing Drugs

    18 months

  • Number of Needle or Cooker Sharers (2 or More Versus None)

    18 months

  • Injecting Drugs

    18 months

  • Talked About HIV-related Topics With Drug Buddies (in Past Month)

    18 months

  • Showed a Needleless Syringe to Drug Buddies

    18 months

  • Talked About Hepatitis to Drug Buddies

    18 months

Study Arms (2)

Intervention Condition

EXPERIMENTAL

Participants were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.

Behavioral: Intervention Condition

Control Condition

ACTIVE COMPARATOR

The control condition focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.

Behavioral: Control Condition

Interventions

Intervention ConditionBEHAVIORAL

In the intervention Condition participants were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.

Also known as: STEP into action
Intervention Condition
Control ConditionBEHAVIORAL

The control condition focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.

Control Condition

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (i)Self reported injection drug use within the prior 6 months; (ii)Willingness to invite a risk network member into the study and to talk about HIV prevention; (iii)Age 18 or older

You may not qualify if:

  • Not concurrently enrolled in another HIV prevention intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Lighthouse

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

Hepatitis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Results Point of Contact

Title
Carl Latkin, PhD
Organization
Johns Hopkins Bloomberg School of Public Health
clatkin@jhsph.edu

Study Officials

  • Carl Latkin, Ph.D.

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 22, 2005

Study Start

June 1, 2003

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

April 18, 2013

Results First Posted

April 18, 2013

Record last verified: 2013-03

Locations

US(1)