NCT00038688

Brief Summary

Injection drug use is the major mode of HIV transmission in many countries. Injection drug users (IDUs) transmit HIV not only through shared drug injection equipment but also through heterosexual and homosexual transmission and mother-to-child transmission. Studies have shown that peer education programs can reduce HIV risk behavior in IDUs. However, it is not known if reduced HIV risk behavior leads to fewer HIV infections. The purpose of this study is to find out if a peer education program can reduce the number of new HIV infections by changing the behavior of IDUs and their HIV risk contacts.

Trial Health

85
On Track

Trial Health Score

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

Enrollment
2,610

participants targeted

Target at P75+ for phase_3 hiv-infections

Geographic Reach
2 countries

3 active sites

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

First Submitted

Initial submission to the registry

June 4, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 5, 2002

Completed
Last Updated

October 30, 2009

Status Verified

March 1, 2006

First QC Date

June 4, 2002

Last Update Submit

October 29, 2009

Conditions

Keywords

Health EducationSubstance Abuse, IntravenousProgram EvaluationPeer GroupRisk-TakingHIV SeronegativitySubstance-related Disorders

Interventions

Eligibility Criteria

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

You may qualify if:

  • HIV uninfected within 60 days of study entry
  • Injected drugs at least 12 times in the last 3 months
  • Out of methadone maintenance treatment for at least 3 months and have relapsed
  • Willing to identify and attempt to recruit at least two HIV risk network members who are eligible for study
  • Able to recruit at least one HIV risk network member eligible for study participation
  • Recruited by an eligible index participant for the study
  • Have injected drugs with and/or had sex with the relevant index participant within 3 months prior to screening

You may not qualify if:

  • For index participants: prior or concurrent enrollment in another HIV behavioral or biomedical prevention study (e.g., vaccine or microbicide research, or any other behavioral or clinical research to test an intervention aimed at preventing or reducing the risk of HIV infection)
  • Already enrolled in another network of HPTN 037 as a network member or index participant
  • Mental, learning, or any other problems that would interfere with the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Univ of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

RAP Office

Philadelphia, Pennsylvania, 19123, United States

Location

Research Institute for Health Sciences

Chiang Mai, 50202, Thailand

Location

Related Publications (8)

  • Needle RH, Coyle SL, Normand J, Lambert E, Cesari H. HIV prevention with drug-using populations--current status and future prospects: introduction and overview. Public Health Rep. 1998 Jun;113 Suppl 1(Suppl 1):4-18. No abstract available.

    PMID: 9722806BACKGROUND
  • Rietmeijer CA, Kane MS, Simons PZ, Corby NH, Wolitski RJ, Higgins DL, Judson FN, Cohn DL. Increasing the use of bleach and condoms among injecting drug users in Denver: outcomes of a targeted, community-level HIV prevention program. AIDS. 1996 Mar;10(3):291-8.

    PMID: 8882669BACKGROUND
  • Latkin CA, Mandell W, Vlahov D, Oziemkowska M, Celentano DD. The long-term outcome of a personal network-oriented HIV prevention intervention for injection drug users: the SAFE Study. Am J Community Psychol. 1996 Jun;24(3):341-64. doi: 10.1007/BF02512026.

    PMID: 8864208BACKGROUND
  • Kamb ML, Fishbein M, Douglas JM Jr, Rhodes F, Rogers J, Bolan G, Zenilman J, Hoxworth T, Malotte CK, Iatesta M, Kent C, Lentz A, Graziano S, Byers RH, Peterman TA. Efficacy of risk-reduction counseling to prevent human immunodeficiency virus and sexually transmitted diseases: a randomized controlled trial. Project RESPECT Study Group. JAMA. 1998 Oct 7;280(13):1161-7. doi: 10.1001/jama.280.13.1161.

    PMID: 9777816BACKGROUND
  • Latkin CA, Sherman S, Knowlton A. HIV prevention among drug users: outcome of a network-oriented peer outreach intervention. Health Psychol. 2003 Jul;22(4):332-9. doi: 10.1037/0278-6133.22.4.332.

    PMID: 12940388BACKGROUND
  • Latkin CA, Forman V, Knowlton A, Sherman S. Norms, social networks, and HIV-related risk behaviors among urban disadvantaged drug users. Soc Sci Med. 2003 Feb;56(3):465-76. doi: 10.1016/s0277-9536(02)00047-3.

    PMID: 12570967BACKGROUND
  • Hernandez-Ramirez RU, Spiegelman D, Lok JJ, Forastiere L, Friedman SR, Latkin CA, Vermund SH, Buchanan AL. Overall, Direct, Spillover, and Composite Effects of Components of a Peer-Driven Intervention Package on Injection Risk Behavior Among People Who Inject Drugs in the HPTN 037 Study. AIDS Behav. 2024 Jan;28(1):225-237. doi: 10.1007/s10461-023-04213-x. Epub 2023 Nov 7.

  • Latkin C, Donnell D, Liu TY, Davey-Rothwell M, Celentano D, Metzger D. The dynamic relationship between social norms and behaviors: the results of an HIV prevention network intervention for injection drug users. Addiction. 2013 May;108(5):934-43. doi: 10.1111/add.12095. Epub 2013 Jan 30.

MeSH Terms

Conditions

HIV InfectionsHealth EducationSubstance Abuse, IntravenousRisk-TakingSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorChemically-Induced DisordersMental Disorders

Study Officials

  • Carl Latkin, PhD

    Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
NIH

Study Record Dates

First Submitted

June 4, 2002

First Posted

June 5, 2002

Last Updated

October 30, 2009

Record last verified: 2006-03

Locations