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A Peer-Oriented HIV Prevention Outreach Program for Individuals at High Risk for HIV and Other STIs

24. juni 2013 opdateret af: Johns Hopkins Bloomberg School of Public Health

Network HIV Prevention Intervention for Drug Users

This study will determine the effectiveness of a peer outreach intervention in preventing HIV infection in adults at high risk for contracting HIV and other sexually transmitted diseases (STDs).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The persistence of HIV and STD epidemics indicates that more effective, sustainable preventive interventions are needed, particularly for low-income, inner-city populations. This study will determine the effectiveness of a theoretically based peer outreach program in preventing HIV and STD transmission among adults in the Baltimore, Maryland area.

Participants will be randomly assigned to receive either a network-oriented peer program emphasizing one's social identity and the goals of protecting one's family and community or group cognitive behavioral therapy (CBT). The peer program will also train participants to provide HIV/STD education to their peers. Participants will be assessed at study entry and during several subsequent follow-up visits. At these study visits, participants will complete questionnaires about their sexual health knowledge and sexual behaviors. Participants and members of their peer network will have follow-up visits at Months 6, 12, and 18.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

746

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21231
        • The Lighthouse

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 til 74 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria for CBT or Peer Intervention Participants:

  1. Female
  2. Age 18-55
  3. Did not inject drugs in the past 6 months
  4. Self-reported sex with at least 1 male partner in the past 6 months

  5. Had at least 1 of the following sexual risk factors:

    1. More than 2 sex partners in the past 6 months
    2. STI diagnosis in the past 6 months
    3. Had a high risk sex partner in the past 90 days (i.e. a sex partner that injected drugs, smoked crack, was HIV+, or MSM)

Inclusion Criteria for Peer Network Participants:

  1. 18 years old or older

  2. One of the following:

    1. Injected drugs
    2. Sex partner of index
    3. Social network member that the index felt comfortable talking to about HIV/STIs

Exclusion Criteria for All Participants:

  • Currently enrolled in another HIV prevention intervention

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: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention Condition: CHAT
Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
Adfærdsmæssigt: Peer-oriented intervention
The peer-oriented intervention program emphasized social identity and the goals of protecting family and community. The peer program also trained participants to provide HIV/STD education to their peers.
Aktiv komparator: Comparison Condition: Standard of Care
The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
Adfærdsmæssigt: Group cognitive behavioral therapy (CBT)
Group CBT will focus on teaching ways to modify thoughts and behaviors associated with risky sexual behaviors.
Ingen indgriben: Network Participants
Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
Ingen indgriben: Non-randomized Baseline index participants
This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sex Risk Behaviors: Number of Sex Partners (>=2 Sex Partners)
Tidsramme: 6 months
Number of participants that had 2 or more sex partners in the past 90 days.
6 months
Sex Risk Behaviors: Unprotected Sex With Non-main Partner (Past 90 Days)
Tidsramme: 12 months
12 months
Sex Risk Behaviors: Unprotected Anal Sex (Past 90 Days)
Tidsramme: 18 month
18 month
Sex Risk Behaviors: Unprotected Vaginal Sex (Past 90 Days)
Tidsramme: 18 months
18 months
Sex Risk Behaviors: Unprotected Sex With Main Partner (Past 90 Days)
Tidsramme: 18 months
18 months
Sex Risk Behaviors: Unprotected Sex With a Non-main Partner (Past 90 Days)
Tidsramme: 18 months
18 months
Sex Risk Behaviors: Any High Risk Sexual Behavior (Past 90 Days)
Tidsramme: 18 months
18 months

Sekundære resultatmål

Resultatmål
Tidsramme
HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)
Tidsramme: 6 months
6 months
HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)
Tidsramme: 12 months
12 months
HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)
Tidsramme: 18 months
18 months

Samarbejdspartnere og efterforskere

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

Sponsor

Johns Hopkins Bloomberg School of Public Health

Samarbejdspartnere

National Institute of Mental Health (NIMH)

Efterforskere

  • Ledende efterforsker: Carl A. Latkin, PhD, Johns Hopkins Bloomberg School of Public Health

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.

Studer store datoer

Studiestart

1. september 2005

Primær færdiggørelse (Faktiske)

1. juli 2007

Studieafslutning (Faktiske)

1. december 2009

Datoer for studieregistrering

Først indsendt

13. september 2005

Først indsendt, der opfyldte QC-kriterier

13. september 2005

Først opslået (Skøn)

16. september 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

28. juni 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. juni 2013

Sidst verificeret

1. juni 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • R01MH066810 (U.S. NIH-bevilling/kontrakt)
  • DAHBR 9A-ASI

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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