- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00705705
Effectiveness of an HIV Prevention Program That Targets the Inner Workings of High-risk Social Networks
Targeted Social Network HIV Prevention Intervention
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Over the past decade, the number of new HIV infections in the United States has remained on a steady level, with approximately 40,000 Americans contracting the disease each year. Risk of contracting HIV is not evenly distributed throughout the population, with groups such as intravenous drug users, men who have sex with men (MSM), and impoverished people in inner cities being disproportionately affected. Many members of these groups have already made risk-reduction behavior changes, but there are certain clusters or networks of people within these populations who remain at a greater risk of HIV infection and who account for the majority of new infections. Therefore, more effective HIV prevention approaches directed toward high-risk social networks are needed. Training social leaders within the high-risk networks to communicate HIV prevention messages directly to their members may be an effective means of reaching these vulnerable population segments. This study will evaluate the effectiveness of an HIV prevention program that targets the inner workings of high-risk social networks (particularly young MSM and young high-risk heterosexual adult men and women) in reducing frequency of risky sexual behaviors among network members.
Participation in this study will last up to 2 years and will include the leaders and general members of multiple social networks. First, the eligibility of a given social network will be determined through a period of in-depth formative ethnographic research that will include a 20-minute interview with members of the social networks. During the eligibility interview, participants will be asked to provide personal information about themselves and their close friends, called a friendship group in this study. After the interview, participants will be asked to distribute a flyer about participating in the study to their friendship group. If enough members of the friendship group agree to complete the initial interview and the group meets the eligibility criteria, then members of the group will be asked to participate in the assessment interviews.
The first 1-hour assessment interview will be conducted at baseline and will include two parts. During the first part of the interview, participants will complete a survey about the friendship group, including questions about their most and least trusted members and communication among group members. The second part of the interview will include taking a computer survey with questions about sexual behavior, substance abuse, STD treatment history, condom use, and beliefs about HIV/AIDS. After completing the interview, participants will undergo a brief HIV/AIDS prevention counseling session. Participants will repeat this assessment interview 12 and 24 months later.
When at least half of the friendship group has completed the first assessment interview, the group will be assigned randomly to one of two conditions:
- For groups assigned to Condition 1, participants will receive a phone call when it is time for their repeat assessment interviews. In addition, a computer program will identify one person as the leader of the friendship group, and this person will be asked to attend nine 3-hour meetings over 17 weeks. These meetings will train and encourage leaders to provide positive HIV/AIDS prevention advice to the members of their friendship group.
- For groups assigned to Condition 2, participants will receive a phone call when it is time for their repeat assessment interviews. If the leadership program in Condition 1 appears to be effective, participants may be offered the same program at a later time.
Study participation will be complete after the 24-month assessment interview.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
-
-
Wisconsin
-
Milwaukee, Wisconsin, Vereinigte Staaten, 53202
- Medical College of Wisconsin
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Identified by the network leader as a member of the social group (e.g., men who have sex with men, young heterosexual men and women)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: 1
Participating social networks will receive standard HIV risk-reduction counseling and network leadership training on HIV prevention.
|
Network leaders will receive a nine-session training segment designed to enable them to motivate their peer networks to reduce sexual risk.
The sessions will teach the identified leader of each network how to communicate HIV prevention messages to other members of his or her personal social network.
Leaders will be asked to share these messages with other members of their groups.
Participants will undergo interviews about their friendship groups, sexual behavior, substance abuse, STD treatment history, condom use, and beliefs about HIV/AIDS.
Participants will undergo a brief session about HIV/AIDS prevention methods after the first interview.
|
Aktiver Komparator: 2
Participating social networks will receive standard HIV risk-reduction counseling.
|
Participants will undergo interviews about their friendship groups, sexual behavior, substance abuse, STD treatment history, condom use, and beliefs about HIV/AIDS.
Participants will undergo a brief session about HIV/AIDS prevention methods after the first interview.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Frequency of high-risk sexual practices
Zeitfenster: Measured at baseline and Months 12 and 24
|
Measured at baseline and Months 12 and 24
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Effectiveness and usefulness of HIV prevention intervention as a public health approach for reaching population segments that remain vulnerable to HIV and other STDs
Zeitfenster: Measured at baseline and Months 12 and 24
|
Measured at baseline and Months 12 and 24
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Studienleiter: David W. Seal, PhD, Medical College of Wisconsin
- Studienleiter: Jeffrey A. Kelly, PhD, Medical College of Wisconsin
- Studienleiter: Carol L. Galletly, JD, PhD, Medical College of Wisconsin
- Studienleiter: Laura R. Glasman, PhD, Medical College of Wisconsin
- Studienleiter: Timothy L. McAuliffe, PhD, Medical College of Wisconsin
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
- RNA-Virusinfektionen
- Viruserkrankungen
- Infektionen
- Durch Blut übertragene Infektionen
- Übertragbare Krankheiten
- Sexuell übertragbare Krankheiten, viral
- Sexuell übertragbare Krankheiten
- Lentivirus-Infektionen
- Retroviridae-Infektionen
- Immunologische Mangelsyndrome
- Erkrankungen des Immunsystems
- HIV-Infektionen
Andere Studien-ID-Nummern
- R01MH070316 (US NIH Stipendium/Vertrag)
- DAHBR 9A-ASPQ (NIMH)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur HIV-Infektionen
-
Duke UniversityAbgeschlossenCentral Line-associated Bloodstream Infection (CLABSI)Vereinigte Staaten
-
Catholic University of the Sacred HeartAbgeschlossenCentral Line-associated Bloodstream Infection (CLABSI)
-
Abbott Medical DevicesThoratec CorporationAbgeschlossenDriveline Heart-assisted Device Related InfectionVereinigte Staaten
-
University of MalayaTeleflexRekrutierungCLABSI – Central Line Associated Bloodstream InfectionMalaysia
-
Princess Maxima Center for Pediatric OncologyUMC Utrecht; Dutch Cancer SocietyRekrutierungCentral Line-associated Bloodstream Infection (CLABSI)Niederlande
-
Johns Hopkins UniversityAbgeschlossenCLABSI – Central Line Associated Bloodstream InfectionVereinigte Staaten
-
National Taiwan University Hospital Hsin-Chu BranchAbgeschlossenCentral Line-associated Bloodstream Infection (CLABSI)
-
National Taiwan University HospitalAbgeschlossenCentral Line-associated Bloodstream Infection (CLABSI)Taiwan
-
Princess Anna Mazowiecka Hospital, Warsaw, PolandNutricia FoundationAktiv, nicht rekrutierendWachstumsfehler | CLABSI – Central Line Associated Bloodstream InfectionPolen
-
Port Said UniversityRekrutierungCentral Line-associated Bloodstream Infection (CLABSI)Ägypten
Klinische Studien zur Network leader training
-
Jordi Gol i Gurina FoundationDepartment of Health, Generalitat de CatalunyaAbgeschlossen
-
Penn State UniversityAbgeschlossen
-
University of British ColumbiaBrainTrust Canada; ABI Wellness; The Kelowna Women's Shelter; Nanaimo Brain Injury...RekrutierungLeichte traumatische HirnverletzungKanada
-
Medtronic Cardiac Rhythm and Heart FailureAbgeschlossenHerzfehlerVereinigte Staaten, Frankreich, Saudi-Arabien, Kanada, Italien, Dänemark, Australien, Österreich
-
Magellan DiagnosticsUnbekanntBleivergiftungVereinigte Staaten
-
Medtronic Cardiac Rhythm and Heart FailureAbgeschlossen
-
Medtronic Cardiac Rhythm and Heart FailureAbgeschlossenHerzfehlerVereinigte Staaten, Kanada, Italien
-
Kenneth M Peters, MDWilliam Beaumont HospitalsBeendet
-
Medtronic Cardiac Rhythm and Heart FailureAbgeschlossenHerzfehler | Indikationen für die ElektrodenentfernungVereinigte Staaten, Kanada
-
University of ManitobaButterfly NetworkRekrutierungErkrankungen des Kiefergelenks | Magnetresonanzbild | HandultraschallKanada