- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01694121
Evaluating a Structural and Behavioral HIV Risk Reduction Program for Black Men (MENCount)
Studieöversikt
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
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District of Columbia
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Washington, District of Columbia, Förenta staterna, 20052
- George Washington University
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria: Black men aged 18 and older, reporting heterosexual risk for HIV [unprotected sex with a woman and 2+ female sex partners in the past 6 months] and either current unemployment or homeless in the past 6 months.
Exclusion Criteria: planned to leave Washington D.C., Maryland, or Virginia in the next 6 months, were cognitively impaired (based on Folstein Mini-Mental Exam at recruitment or baseline testing), and/or had self-reported health status that prohibited them from participating in the program
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: MEN Count
3 session HIV intervention including a) HIV risk reduction, inclusive of gender equity and healthy relationship counseling and b) case management support for stable employment and housing.
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The MEN Count model integrates HIV risk reduction and gender-equity counseling with housing and employment case management via multiple one-on-one sessions delivered by a peer case manager over 60-90 day period.
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Aktiv komparator: Comparison
An attention comparison program similar to the MEN Count intervention in structure (3 one-on-one sessions delivered over 60-90 days) but focused on stress reduction and healthy lifestyle.
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general health intervention for men, not inclusive of HIV or relationship health
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Condom Use/Unprotected Sex - Redefined as Sexual Risk - 12 Month Follow-up
Tidsram: 12 month follow-up
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Behavioral assessment of the ratio of protected to total number of sex episodes -- changed to sexual risk inclusive of inconsistent condom use in past 90 days + multiple sex partners + sex trade involvement.
Very low sexual risk was defined as having one partner and consistent condom use.
Low sexual risk was defined as having multiple partners and consistent condom use OR one partner and no/inconsistent condom use.
Medium sexual risk was defined as having multiple partners, no/inconsistent condom use and not participating in transactional sex.
High risk was defined as having multiple partners, no/inconsistent condom use, and participating in transactional sex.
Participants reporting sex with men in the prior 90 days or who reported that they themselves or (one of) their partner(s) was HIV-positive were excluded from the sexual risk outcome given the known differential HIV risk profile for these subpopulations and small numbers of participants in each.
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12 month follow-up
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Condom Use/Unprotected Sex - Redefined as Sexual Risk - 6 Month Follow-up
Tidsram: 6 month follow-up
|
Behavioral assessment of the ratio of protected to total number of sex episodes -- changed to sexual risk inclusive of inconsistent condom use in past 90 days + multiple sex partners + sex trade involvement.
Very low sexual risk was defined as having one partner and consistent condom use.
Low sexual risk was defined as having multiple partners and consistent condom use OR one partner and no/inconsistent condom use.
Medium sexual risk was defined as having multiple partners, no/inconsistent condom use and not participating in transactional sex.
High risk was defined as having multiple partners, no/inconsistent condom use, and participating in transactional sex.
Participants reporting sex with men in the prior 90 days or who reported that they themselves or (one of) their partner(s) was HIV-positive were excluded from the sexual risk outcome given the known differential HIV risk profile for these subpopulations and small numbers of participants in each.
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6 month follow-up
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Non-viral STI - 12 Month Follow-up
Tidsram: 12 month follow-up
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HIV and STI testing via blood and urine tests was conducted; outcome based on non-viral STI to allow for incidence assessment and change over time
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12 month follow-up
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Non-viral STI - 6 Month Follow-up
Tidsram: 6 month follow-up
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HIV and STI testing via blood and urine tests was conducted; outcome based on non-viral STI to allow for incidence assessment and change over time
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6 month follow-up
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Samarbetspartners och utredare
Utredare
- Huvudutredare: Anita Raj, PhD, UCSD
- Huvudutredare: Lisa Bowleg, PhD, George Washington University
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- R01MH096657 (U.S.S. NIH-anslag/kontrakt)
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