A Study of Peer Education to Prevent HIV Transmission Among Injection Drug Users and Their HIV Risk Contacts
NCT ID: NCT00038688
Last Updated: 2009-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
2610 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Individuals at the study clinics will undergo a screening survey and HIV counseling and testing; they will return to the clinic to receive their HIV test results, post-test counseling, and further screening. Those who are HIV uninfected, meet preliminary eligibility requirements, and are willing to participate will be enrolled as index participants. Each index participant will be asked to identify and attempt to recruit at least two other people (potential network members) whom he/she has had sex with or taken drugs with in the 3 months prior to screening. Infected and uninfected network members will be eligible for enrollment. Index participants will be randomly assigned with their network members to either the intervention group or a control group. All participants will receive HIV counseling and regular HIV testing. Index participants assigned to the intervention group attend six, two-hour peer educator-training sessions over a period of 4 weeks. The training sessions focus on skills building and promotion of risk-reducing behaviors. A one-hour booster training session is held for index participants after their 6- and 12-month follow-up assessments.
The study will last approximately 48 months, with enrollment expected to take about 30 months. Participants will be followed for a minimum of 18 months and a maximum of 30 months. Both index participants and network members have follow-up visits every 6 months, at which they will complete surveys designed to assess HIV risk behavior, network characteristics, the intensity of the intervention delivery, and social harms that may be associated with study participation. Average network HIV incidence rates will be compared for the two study groups.
NOTE: as of January 31, 2006, the HPTN 037 trial was terminated. Participants enrolled in the study will continue to be followed at a reduced number of study visits.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
NONE
Interventions
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Peer HIV Education Program
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute of Mental Health (NIMH)
NIH
National Institute on Drug Abuse (NIDA)
NIH
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Principal Investigators
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Carl Latkin, PhD
Role: STUDY_CHAIR
Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University
Locations
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Univ of Pennsylvania
Philadelphia, Pennsylvania, United States
RAP Office
Philadelphia, Pennsylvania, United States
Research Institute for Health Sciences
Chiang Mai, , Thailand
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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HPTN 037
Identifier Type: -
Identifier Source: org_study_id