Culturally-Tailored HIV Risk Reduction for African-American MSM (Project ABLE)
10. marts 2010 opdateret af: Medical College of Wisconsin
Culturally-Tailored HIV Risk Reduction for African-American MSM (Project ABLE: African-Americans Building Life Empowerment
The purpose of this study to conduct a small randomized control trial to compare the relative effectiveness of a single-session of HIV testing and counseling risk reduction intervention (HCT-only) to an enhanced intervention that includes the standard HCT intervention plus a theory-based and culturally-tailored group-level intervention designed to reduce or eliminate HIV and STI risk behaviors (HCT-plus) among African-American men who have sex with men (AA-MSM).
Studieoversigt
Detaljeret beskrivelse
The HCT-plus intervention will consist of the HCT-only intervention, as well as 8 small group intervention sessions focused on HIV risk reduction.
Small groups will consist of 10 men who will meet once-a-week for 8 consecutive weeks.
Each meeting will last approximately 2 hours.
In each small group session, staff will work with men to reassess their HIV risk behavior, re-prioritize their goals as appropriate, and provide motivational support for their risk reduction accomplishments.
Participants will be asked to discuss ways they have successfully avoided HIV risk behavior since the previous session, as well as to discuss situations in which they found it difficult to avoid risk.
Staff will reinforce successful risk avoidance, and problem-solve with men to overcome barriers to risk reduction.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
220
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Wisconsin
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Milwaukee, Wisconsin, Forenede Stater, 53202
- Diverse and Resilient
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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 og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Han
Beskrivelse
Inclusion Criteria:
- reside in Milwaukee county;
- are at least 18 years of age;
- self-identify as male;
- self-identify as Black or African-American;
- can provide informed consent;
- report unprotected anal sex with a man in the past 3 months;
- report at least two sexual partners with whom they have had unprotected anal or vaginal sex in the past 3 months;
- are willing to be tested for HIV using rapid oral fluid procedures or willing to provide evidence of HIV seropositivity
Exclusion Criteria:
- Under 18 years of age,
- involvement in a HIV prevention study currently or in the past 6 months,
- Participation in the pilot phase
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: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 1
Participants receive HIV counseling and testing and 8 intervention sessions to assist them with reducing unsafe sexual behaviors.
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Participants will receive HIV counseling and testing.
Those selected for the intervention arm will attend small groups consisting of 10 men who meet once a week for 8 consecutive weeks.
The weekly two hour discussion sessions will address HIV risk behavior within a framework of contextual influences that may moderate men's risk reduction motivation and behavior.
The factors include identity, stigma, connections to community, and situation factors.
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Ingen indgriben: 2
Participants receive HIV counseling and testing only.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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The HCT-plus intervention will result in a greater proportion of men who abstain from anal and vaginal intercourse.
Tidsramme: 3 months after completing intervention
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3 months after completing intervention
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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The HCT-plus intervention will result in a smaller proportion of men who had an act of anal or vaginal intercourse without the use of a condom.
Tidsramme: 3 months after completing the intervention
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3 months after completing the intervention
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: David Seal, PhD, Medical College of Wisconsin
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. juni 2008
Primær færdiggørelse (Faktiske)
1. marts 2010
Studieafslutning (Faktiske)
1. marts 2010
Datoer for studieregistrering
Først indsendt
3. juni 2008
Først indsendt, der opfyldte QC-kriterier
4. juni 2008
Først opslået (Skøn)
5. juni 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
11. marts 2010
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. marts 2010
Sidst verificeret
1. marts 2010
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CDC-NCHHSTP-5394
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 .