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

Sponsor:	Johns Hopkins Bloomberg School of Public Health
Collaborators:	National Institute on Drug Abuse (NIDA) Johns Hopkins University
Information provided by:	Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:	NCT00218335

Purpose

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.

Condition	Intervention	Phase
HIV Hepatitis	Behavioral: STEP into Action	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention
Official Title:	A Network & Dyad HIV Prevention Intervention for IDU's

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Hepatitis Hepatitis A

U.S. FDA Resources

Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:

HIV Risk and Outreach Behaviors [ Time Frame: Assessed at 0, 6, 12, and 18 months ] [ Designated as safety issue: No ]
(i) Injection risk based on sharing needles, cookers, and cotton for injection and drug splitting; (ii) Sex risk based on number of sex partners, condom use, and exchanging sex; (iii) Index HIV outreach behavior

Enrollment:	1024
Study Start Date:	June 2003
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	Behavioral: STEP into Action 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. 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.
Active Comparator: Control Condition 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: STEP into Action 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. 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.

Arms

Assigned Interventions

Experimental: 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.

Behavioral: STEP into Action

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.

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.

Active Comparator: Control Condition

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: STEP into Action

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.

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.

Detailed Description:

HIV seroincidence among injection drug users remains high, with unprotected sexual contact substantially contributing to new HIV infections among 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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00218335

Locations

United States, Maryland
The Lighthouse
Baltimore, Maryland, United States, 21231

Sponsors and Collaborators

Johns Hopkins Bloomberg School of Public Health

National Institute on Drug Abuse (NIDA)

Johns Hopkins University

Investigators

Principal Investigator:

Carl Latkin, Ph.D.

Johns Hopkins University

More Information

No publications provided

Responsible Party:	Carl Latkin, JHU
ClinicalTrials.gov Identifier:	NCT00218335 History of Changes
Obsolete Identifiers:	NCT00597155
Other Study ID Numbers:	DESPR DA016555-1, 5R01DA016555-05, 5R01DA016555-04, 5R01DA016555-03, 3R01DA016555-03S1, 3R01DA016555-02S1, 5R01DA016555-02, 3R01DA016555-01S1, 1R01DA016555-01, R01-16555-1, NIDA-16555-1
Study First Received:	September 16, 2005
Last Updated:	June 21, 2011
Health Authority:	United States: Federal Government

Keywords provided by Johns Hopkins Bloomberg School of Public Health:

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

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human

Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on February 09, 2012