- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01825252
Prevention of HIV Infection in High-Risk Social Networks of African American Men Who Have Sex With Men (MSM) (C3)
Prevention of HIV Infection in High-Risk Social Networks of African American MSM
During the formative research phase, investigators will undertake formative studies to locate, understand, and characterize high-risk social networks of African American MSM in the community; gain community participation, involvement, and input; and undertake interviews with key informants and community members to gain information needed to pilot test study recruitment procedures, measures, and intervention content.
During a 4-year main outcome trial phase, the investigators will enroll 24 separate sociocentric ("bounded") social networks composed predominantly of Black MSM. Each sociocentric network will consist of the ring of friends surrounding an initial high-risk index as well as all friends surrounding persons in this second ring and then friends surrounding a successive third snowball ring of enrollees. Each 3-ring sociocentric network is expected to consist of approximately 40 unique members (n=24 networks, each with 40 members = approximately 960 individual participants).
All participants will be assessed at baseline to measure sexual practices, substance use, and other risk characteristics over the past 3 months; asked to provide biological specimens to be tested for HIV and other sexually transmitted diseases (STDs); and counseled in HIV/STD risk reduction. STDs will be treated and those with HIV will be referred for treatment.
The investigators will identify the individuals in intervention condition networks with the greatest number of reciprocal interconnections and the most favorable sociometric standing in the network. These individuals--expected to constitute approximately 20% of the sociocentric network and designated as network leaders--will be recruited to attend a 9-session program that provides training and guidance in how to deliver on-going, theoretically-based, and culturally tailored risk reduction advice and counseling to other members within the same network.
Six and 18 months following the intervention, all participants will be reassessed on risk behavior and STD/HIV laboratory measures as well as measures of intervention exposure, with positive STD and HIV cases respectively treated or referred to care at each assessment point. Outcome analyses will test whether there is greater reduction in high-risk sexual practices, substance use associated with risky sex, and HIV/STD incidence within social networks in the intervention condition. The primary trial endpoints are reductions in prevalence and frequency of unprotected anal intercourse with nonexclusive partners, increased condom use, and lower incidence on a composite biological measure of new HIV/STD disease during the followup period.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Ohio
-
Cleveland, Ohio, Stati Uniti, 44113
- AIDS TaskForce of Greater Cleveland
-
-
Wisconsin
-
Milwaukee, Wisconsin, Stati Uniti, 53202
- Medical College of Wisconsin
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- are age 18 or older;
- except for the initial index, were named as part of a friendship circle of an already-enrolled participant;
- provide written informed consent and do not exhibit intoxication, drug use,or psychiatric impairment that leads the research staff member to question capacity to provide informed consent;
- can complete study measures and participate in study activities in English;
- reside in or near the study city and do not have definite plans to leave the area in the next 12 months.
Exclusion Criteria:
- are age 17 or younger;
- exhibit intoxication, drug use, or psychiatric impairment such that they are unable to provide written informed consent;
- cannot complete study measures or adequately comprehend study activities conducted in English; or
- live in a location distant from the study city.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Social Network Intervention
Approximately 20% of people in this condition will be trained to have discussions endorsing less risky behaviors with their social network members.
|
Approximately 20% of people are trained to have discussions endorsing less risky behaviors with members of their social network.
|
|
Comparatore attivo: Counsel, Test, and Treat
People in this arm will only receive standard-of-care counseling, testing, and treatment for HIV and STDs.
|
People receive standard-of-care HIV/STD counseling, testing, and treatment
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Reduction of unprotected anal intercourse with nonexclusive partners
Lasso di tempo: 24 months
|
We will compare the prevalence and frequency of unprotected anal intercourse with nonexclusive partners pre- and post-intervention.
|
24 months
|
|
Condom use
Lasso di tempo: 24 months
|
We will measure rates of condom pre- and post-intervention
|
24 months
|
|
HIV/STD incidence rates
Lasso di tempo: 24 months
|
We will compare HIV/STD incidence rates pre- and post-intervention
|
24 months
|
Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Pubblicazioni generali
- Dickson-Gomez J, Owczarzak J, St Lawrence J, Sitzler C, Quinn K, Pearson B, Kelly JA, Amirkhanian YA. Beyond the ball: implications for HIV risk and prevention among the constructed families of African American men who have sex with men. AIDS Behav. 2014 Nov;18(11):2156-68. doi: 10.1007/s10461-014-0836-6.
- St Lawrence JS, Kelly JA, Dickson-Gomez J, Owczarzak J, Amirkhanian YA, Sitzler C. Attitudes Toward HIV Voluntary Counseling and Testing (VCT) Among African American Men Who Have Sex With Men: Concerns Underlying Reluctance to Test. AIDS Educ Prev. 2015 Jun;27(3):195-211. doi: 10.1521/aeap.2015.27.3.195.
- Quinn K, Dickson-Gomez J, DiFranceisco W, Kelly JA, St Lawrence JS, Amirkhanian YA, Broaddus M. Correlates of internalized homonegativity among black men who have sex with men. AIDS Educ Prev. 2015 Jun;27(3):212-26. doi: 10.1521/aeap.2015.27.3.212.
- Broaddus MR, DiFranceisco WJ, Kelly JA, St Lawrence JS, Amirkhanian YA, Dickson-Gomez JD. Social Media Use and High-Risk Sexual Behavior Among Black Men Who Have Sex with Men: A Three-City Study. AIDS Behav. 2015 Jun;19 Suppl 2(0 2):90-7. doi: 10.1007/s10461-014-0980-z.
- Kelly JA, Amirkhanian YA, Seal DW, Galletly CM, Difranceisco W, Glasman LR, Stevenson LY, Rosado N. Levels and Predictors of Sexual HIV Risk in Social Networks of Men who Have Sex with Men in the Midwest. AIDS Educ Prev. 2010 Dec;22(6):483-95. doi: 10.1521/aeap.2010.22.6.483.
- Kelly JA, St Lawrence JS, Tarima SS, DiFranceisco WJ, Amirkhanian YA. Correlates of Sexual HIV Risk Among African American Men Who Have Sex With Men. Am J Public Health. 2016 Jan;106(1):96-102. doi: 10.2105/AJPH.2015.302945. Epub 2015 Nov 12.
- Kelly JA, St Lawrence JS, Amirkhanian YA, DiFranceisco WJ, Anderson-Lamb M, Garcia LI, Nguyen MT. Levels and predictors of HIV risk behavior among Black men who have sex with men. AIDS Educ Prev. 2013 Feb;25(1):49-61. doi: 10.1521/aeap.2013.25.1.49.
- Kelly JA, DiFranceisco WJ, St Lawrence JS, Amirkhanian YA, Anderson-Lamb M. Situational, partner, and contextual factors associated with level of risk at most recent intercourse among Black men who have sex with men. AIDS Behav. 2014 Jan;18(1):26-35. doi: 10.1007/s10461-013-0532-y.
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 (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
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
- R01MH089128 (Sovvenzione/contratto NIH degli Stati Uniti)
- PRO12662 (Altro identificatore: Medical College of Wisconsin)
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 .
Prove cliniche su HIV
-
Federal University of São PauloGilead SciencesCompletato
-
University of MinnesotaRitiratoInfezioni da HIV | HIV/AIDS | HIV | AIDS | Problema di Aids/Hiv | AIDS e infezioniStati Uniti
-
National Institute of Allergy and Infectious Diseases...Duke University; Department of Health and Human Services (HHS)Non ancora reclutamento
-
Jecho Biopharmaceuticals Co., Ltd.Non ancora reclutamento
-
Boston UniversityBill and Melinda Gates Foundation; HE2RO, University of the WitwatersrandReclutamento
-
National Institute of Allergy and Infectious Diseases...National Institutes of Health (NIH); Department of Health and Human ServicesReclutamento
-
University of California, Los AngelesNational Institute of Mental Health (NIMH); Partners in Hope, Inc.Reclutamento
-
Kelley-Ross & Associates, Inc.Gilead SciencesAttivo, non reclutante
-
Center for Innovative Public Health ResearchNational Institute of Mental Health (NIMH); Makerere University; Internet Solutions...Non ancora reclutamento
Prove cliniche su Social Network Intervention
-
Johns Hopkins UniversityNational Heart, Lung, and Blood Institute (NHLBI)CompletatoSovrappeso e obesitàStati Uniti
-
Lisa DixonRitiratoSchizofrenia | Primo episodio di psicosiStati Uniti
-
Nopparatrajathanee HospitalCompletatoNascita prematuraTailandia
-
Medical College of WisconsinNational Institute of Mental Health (NIMH)Completato
-
Brigham and Women's HospitalNational Institute on Aging (NIA)TerminatoIpertensione | Ictus, ischemico acutoStati Uniti
-
Medical College of WisconsinEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletatoSindrome da immunodeficienza acquisita | HIVBulgaria
-
Buddhist Tzu Chi General HospitalSconosciutoQualità del sonnoTaiwan
-
Medical College of WisconsinNational Institute of Mental Health (NIMH)CompletatoHIV | AIDSStati Uniti, Federazione Russa
-
Northwestern UniversityRitirato
-
University of California, Los AngelesBrown University; Asociación Civil Impacta Salud y Educación, Peru; The Fenway...Completato