- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01694121
Evaluating a Structural and Behavioral HIV Risk Reduction Program for Black Men (MENCount)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
District of Columbia
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Washington, District of Columbia, États-Unis, 20052
- George Washington University
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
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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Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Condom Use/Unprotected Sex - Redefined as Sexual Risk - 12 Month Follow-up
Délai: 12 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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12 month follow-up
|
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Condom Use/Unprotected Sex - Redefined as Sexual Risk - 6 Month Follow-up
Délai: 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.
|
6 month follow-up
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Non-viral STI - 12 Month Follow-up
Délai: 12 month follow-up
|
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
Délai: 6 month follow-up
|
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
|
6 month follow-up
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Anita Raj, PhD, UCSD
- Chercheur principal: Lisa Bowleg, PhD, George Washington University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- R01MH096657 (Subvention/contrat des NIH des États-Unis)
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