Testing a Secondary Prevention Intervention for HIV-Positive Black Young Men Who Have Sex With Men
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Undersøgelsestype
Tilmelding (Faktiske)
Tilmelding
Fase
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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California
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Los Angeles, California, Forenede Stater, 90027
- Children's Hospital of Los Angeles
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Illinois
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Chicago, Illinois, Forenede Stater, 60612
- Stroger Hospital and the CORE Center
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New York
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The Bronx, New York, Forenede Stater, 10467
- Montefiore Medical Center
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Tennessee
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Memphis, Tennessee, Forenede Stater, 38105
- St. Jude Children's Research Hospital
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Texas
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Houston, Texas, Forenede Stater, 77030
- Baylor College of Medicine - Texas Children's Hospital
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Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
To be considered eligible for enrollment into Trial 1 and Trial 2, an individual must meet the criteria listed below:
- Receives services at one of the selected AMTU sites or one of their community partners;
- Biological male at birth and self identifies as male gender at the time of consent;
- Self identifies as "Black" (including Black/African-American, Black Latino, Black/Afro-Caribbean, Black/African immigrant, or any self-identified member of the African Diaspora);
- HIV-infected as documented by medical record review or verification with referring medical professional;
- Between the ages of 16-24 years, inclusive, at the time of consent;
- HIV-infected through sexual behavior;
- At least one sexual encounter involving oral or anal sex with a male partner in the past year;
- Ability to understand both written and spoken English;
- Willingness to participate in a group-based intervention with other HIV-positive B-YMSM and agree to respect the privacy of other group members;
- Willingness and ability to attend the first group session on any of the date chosen by the site staff and;
- Willingness to provide signed informed consent or assent with parental/legal guardian permission as applicable.
To be considered eligible for enrollment, an individual must not meet any of the criteria listed below.
- Active psychiatric condition that in the opinion of the site personnel would interfere with the ability to give true informed consent and to adhere to the study requirements;
- Visibly distraught and/or visibly emotionally unstable (i.e., exhibiting suicidal, homicidal, or violent behavior);
- Active drug or alcohol use or dependence that, in the opinion of the site personnel, would interfere with the ability to give true informed consent and to adhere to the study requirements;
- Acute illness that, in the opinion of the treating clinician, would interfere with the participant's ability to adhere to the protocol requirements and/or interfere with the protocol objectives.
- Previous participation in ATN 090, "Development of a Secondary Prevention Intervention Targeting HIV-Positive Black Young Men Who have Sex with Men." (NOTE: YAB members from ATN090 cannot participate in ATN 104)
- Previous participation in Trial 1 of ATN104 and;
- Current enrollment in any other behavioral intervention study or program. Any cases that are uncertain require Protocol Team approval.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
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Aktiv komparator: H4L Comparison Intervention
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Health 4 Life (H4L) is a comparison intervention which will serve as the basis of comparison for Mobilizing Our Voices for Empowerment (MOVE), the treatment intervention.
H4L will be a health promotion and life skills intervention to account for time and attention.
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Eksperimentel: MOVE Intervention
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MOVE involves four sessions.
Sessions 1 and 2 occur over a two-day time frame and are each one day long (approximately 8 hours in length).
They will: lay the groundwork for the intervention; provide HIV and other sexual health-related information; introduce critical consciousness; Sessions 1 and 2 will begin the enhancement of critical consciousness and the action-reflection-action cycle.
Sessions 3 and 4 are also one-day sessions each (approximately 8 hours in length) and will be administered at one month intervals following the completion of sessions 1 and 2. These sessions will be used to provide continued enhancement of critical consciousness and guided support, feedback, and social reinforcement for behavior change and self-efficacy related to increasing health-promoting behaviors and reducing HIV-related health risk behaviors.
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Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Finalize and manualize a critical consciousness based intervention for HIV positive B-YMSM
Tidsramme: 2 years
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To finalize and manualize Mobilizing Our Voices for Empowerment (MOVE) resulting in an intervention with evidence of potential efficacy in reducing sexual risk and substance use behaviors and promoting treatment adherence and HIV status disclosure, as well as self-esteem, critical consciousness, and socio-political awareness.
At the same time a non-critical consciousness intervention Health 4 Life (H4L) which will be used as comparison will also be finalized and manualized.
H4L is primarily a health promotion and life skills intervention for HIV-positive B-YMSM.
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2 years
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Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Samarbejdspartnere
Samarbejdspartnere
Efterforskere
Efterforskere
- Studiestol: Gary Harper, PhD, DePaul University
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Studiestart
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
Studieafslutning (Faktiske)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- ATN 104
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