- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00705705
Effectiveness of an HIV Prevention Program That Targets the Inner Workings of High-risk Social Networks
Targeted Social Network HIV Prevention Intervention
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Wisconsin
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Milwaukee, Wisconsin, Stati Uniti, 53202
- Medical College of Wisconsin
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 1
Participating social networks will receive standard HIV risk-reduction counseling and network leadership training on HIV prevention.
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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.
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Comparatore attivo: 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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Frequency of high-risk sexual practices
Lasso di tempo: Measured at baseline and Months 12 and 24
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Measured at baseline and Months 12 and 24
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
Effectiveness and usefulness of HIV prevention intervention as a public health approach for reaching population segments that remain vulnerable to HIV and other STDs
Lasso di tempo: Measured at baseline and Months 12 and 24
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Measured at baseline and Months 12 and 24
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Direttore dello studio: David W. Seal, PhD, Medical College of Wisconsin
- Direttore dello studio: Jeffrey A. Kelly, PhD, Medical College of Wisconsin
- Direttore dello studio: Carol L. Galletly, JD, PhD, Medical College of Wisconsin
- Direttore dello studio: Laura R. Glasman, PhD, Medical College of Wisconsin
- Direttore dello studio: Timothy L. McAuliffe, PhD, Medical College of Wisconsin
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Infezioni da virus a RNA
- Malattie virali
- Infezioni
- Infezioni a trasmissione ematica
- Malattie trasmissibili
- Malattie sessualmente trasmissibili, virali
- Malattie trasmesse sessualmente
- Infezioni da lentivirus
- Infezioni da retroviridae
- Sindromi da deficit immunologico
- Malattie del sistema immunitario
- Infezioni da HIV
Altri numeri di identificazione dello studio
- R01MH070316 (Sovvenzione/contratto NIH degli Stati Uniti)
- DAHBR 9A-ASPQ (NIMH)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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