- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01751594
Testing a Secondary Prevention Intervention for HIV-Positive Black Young Men Who Have Sex With Men
28 juli 2017 uppdaterad av: University of North Carolina, Chapel Hill
The proposed research study aims to conduct a culturally-based secondary prevention intervention targeted toward HIV-positive Black young men who have sex with men (B-YMSM) to explore (1) feasibility and acceptability (Trial 1 and Trial 2) and (2) evidence of potential efficacy (Trial 2).
The primary outcomes will be health promotion behaviors (i.e., treatment adherence, sexual risk reduction, reduction in substance use behaviors, and HIV status disclosure).
Psychosocial factors (i.e.
self-esteem, critical consciousness, and socio-political awareness) will be examined as secondary outcomes.
Studieöversikt
Status
Avslutad
Intervention / Behandling
Detaljerad beskrivning
First, the protocol team will finalize the development and manualization of Health 4 Life (H4L) 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.
Following this the protocol team will then implement Trial 1.
In this trial, the intervention specialist and a "peer buddy" (intervention co-facilitator) from one AMTU will conduct one wave of both MOVE and H4L.
The team will then conduct an analysis of the process data and revise the two interventions (MOVE and H4L).
Upon revising the interventions, the protocol team will implement Trial 2. In this trial, the protocol co-chairs and the interventionist from Trial 1 will train interventionists and peer buddies from four new AMTUs; these interventionists and peer buddies will run the revised MOVE and H4L interventions.
Each site will be designated as either a treatment or comparison site, and they will conduct two waves of their assigned intervention.
The team at that time will conduct data analyses and then modify and manualize the final version of MOVE and H4L.
Studietyp
Interventionell
Inskrivning (Faktisk)
92
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
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California
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Los Angeles, California, Förenta staterna, 90027
- Children's Hospital of Los Angeles
-
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Illinois
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Chicago, Illinois, Förenta staterna, 60612
- Stroger Hospital and the CORE Center
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New York
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The Bronx, New York, Förenta staterna, 10467
- Montefiore Medical Center
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Tennessee
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Memphis, Tennessee, Förenta staterna, 38105
- St. Jude Children's Research Hospital
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Texas
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Houston, Texas, Förenta staterna, 77030
- Baylor College of Medicine - Texas Children's Hospital
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
16 år till 24 år (Barn, Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Manlig
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: H4L Comparison Intervention
|
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.
|
Experimentell: MOVE Intervention
|
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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Finalize and manualize a critical consciousness based intervention for HIV positive B-YMSM
Tidsram: 2 years
|
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.
|
2 years
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Studiestol: Gary Harper, PhD, DePaul University
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 april 2012
Primärt slutförande (Faktisk)
1 juni 2014
Avslutad studie (Faktisk)
1 juni 2014
Studieregistreringsdatum
Först inskickad
14 december 2012
Först inskickad som uppfyllde QC-kriterierna
14 december 2012
Första postat (Uppskatta)
18 december 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
1 augusti 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
28 juli 2017
Senast verifierad
1 mars 2016
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ATN 104
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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