A Peer-Oriented HIV Prevention Outreach Program for Individuals at High Risk for HIV and Other STIs
Network HIV Prevention Intervention for Drug Users
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
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Maryland
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Baltimore, Maryland, Vereinigte Staaten, 21231
- The Lighthouse
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria for CBT or Peer Intervention Participants:
- Female
- Age 18-55
- Did not inject drugs in the past 6 months
- Self-reported sex with at least 1 male partner in the past 6 months
Had at least 1 of the following sexual risk factors:
- More than 2 sex partners in the past 6 months
- STI diagnosis in the past 6 months
- 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:
- 18 years old or older
One of the following:
- Injected drugs
- Sex partner of index
- 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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: 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.
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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.
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Aktiver 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.
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Group CBT will focus on teaching ways to modify thoughts and behaviors associated with risky sexual behaviors.
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Kein Eingriff: 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.
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Kein Eingriff: 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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Sex Risk Behaviors: Number of Sex Partners (>=2 Sex Partners)
Zeitfenster: 6 months
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Number of participants that had 2 or more sex partners in the past 90 days.
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6 months
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Sex Risk Behaviors: Unprotected Sex With Non-main Partner (Past 90 Days)
Zeitfenster: 12 months
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12 months
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Sex Risk Behaviors: Unprotected Anal Sex (Past 90 Days)
Zeitfenster: 18 month
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18 month
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Sex Risk Behaviors: Unprotected Vaginal Sex (Past 90 Days)
Zeitfenster: 18 months
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18 months
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Sex Risk Behaviors: Unprotected Sex With Main Partner (Past 90 Days)
Zeitfenster: 18 months
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18 months
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Sex Risk Behaviors: Unprotected Sex With a Non-main Partner (Past 90 Days)
Zeitfenster: 18 months
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18 months
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Sex Risk Behaviors: Any High Risk Sexual Behavior (Past 90 Days)
Zeitfenster: 18 months
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18 months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)
Zeitfenster: 6 months
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6 months
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HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)
Zeitfenster: 12 months
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12 months
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HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)
Zeitfenster: 18 months
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18 months
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Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Carl A. Latkin, PhD, Johns Hopkins Bloomberg School of Public Health
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- R01MH066810 (US NIH Stipendium/Vertrag)
- DAHBR 9A-ASI
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