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Completed

NCT Number: NCT00218335

A Network & Dyad HIV Prevention Intervention for IDU's - 1

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.

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Key information

Conditions

HIV Digestive System Diseases Hepatitis Liver Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Lighthouse

Baltimore, Maryland, 21231, United States

About this study

HIV seroincidence among injection drug users remains high, with unprotected sexual contact substantially contributing to new HIV infections among injection drug users (IDUs). Interventions that are culturally competent and target drug users' main sex and drug partners may be especially effective for HIV/STI and HCV control and prevention.

The intervention to be tested in this study draws upon theoretical and empirical evidence suggesting that peer educator programs can have significant effects on the risk-related behaviors of both the educators and the peers whom they educate. Specifically, through group and individual focused sessions, participants learn and practice skills designed to reduce drug and sex related risk behaviors. Furthermore, individuals and their main risk partners attend a training session that focuses on risk reduction within their relationship.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(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

Exclusion criteria

  • Not concurrently enrolled in another HIV prevention intervention

Treatment and study plan

Intervention Condition

Behavioral

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.

Other names: STEP into action

Control condition

Behavioral

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.

Primary outcomes

  1. Any Sex Risk

    Time frame: 6 months

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

    Time frame: 6 months

  3. Showed a Needleless Syringe to Drug Buddies

    Time frame: 6 months

  4. Talked About Responding to Overdose to Drug Buddies

    Time frame: 6 months

  5. Any Injection Risk (Monthly Versus Never)

    Time frame: 12 months

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

    Time frame: 12 months

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

    Time frame: 12 months

  8. Showed a Needleless Syringe to Drug Buddies

    Time frame: 12 months

  9. Any Injection Risk (Monthly Versus Never)

    Time frame: 18 months

  10. Shared Cooker When Preparing Drugs

    Time frame: 18 months

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

    Time frame: 18 months

  12. Injecting Drugs

    Time frame: 18 months

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

    Time frame: 18 months

  14. Showed a Needleless Syringe to Drug Buddies

    Time frame: 18 months

  15. Talked About Hepatitis to Drug Buddies

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • Johns Hopkins University
  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

A Network & Dyad HIV Prevention Intervention for IDU's

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Sep 22, 2005
Registry last updated
Apr 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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