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A Study of Peer Education to Prevent HIV Transmission Among Injection Drug Users and Their HIV Risk Contacts

A Phase III Randomized Study to Evaluate the Efficacy of a Network-Oriented Peer Education Intervention for the Prevention of HIV Transmission Among Injection Drug Users and Their Network Members

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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

More than 20 years of research in implementing interventions for IDUs indicate that HIV transmission among these users can be prevented, slowed, and stopped with the appropriate intervention. Intervening early with multiple strategies can prevent epidemic spread and its consequences. Even after prevalence has increased substantially, prevention interventions can reduce the further spread of HIV in drug-using populations and transmission into other populations. Although research results have been promising, it is unknown if self-reported behavior change is correlated with reducing rates of HIV transmission. This study will determine the efficacy of a peer-educator, network-oriented intervention to prevent HIV transmission among substance users and their risk network members. IDUs will be recruited using street and community outreach methods in Chiang Mai and Chiang Rai, Thailand and in Philadelphia, Pennsylvania, USA.

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.

Undersøgelsestype

Interventionel

Tilmelding

2610

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Univ of Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19123
        • RAP Office
      • Chiang Mai, Thailand, 50202
        • Research Institute for Health Sciences

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Inclusion Criteria for Index Participants

  • 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

Inclusion Criteria for Network Members

  • 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

  • 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Faktoriel opgave
  • Maskning: Ingen (Åben etiket)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Datoer for studieregistrering

Først indsendt

4. juni 2002

Først indsendt, der opfyldte QC-kriterier

4. juni 2002

Først opslået (Skøn)

5. juni 2002

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

30. oktober 2009

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. oktober 2009

Sidst verificeret

1. marts 2006

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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