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Implementing Eban II: An Evidence-Based Intervention for HIV Sero-Discordant Couples

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Ce qui est testé

Risk Reduction

+ Risk Reduction

Comportemental
Qui peut participer

Maladies génito-urinaires+5

+ Maladies Génitales

+ Infections

De 18 à 60 ans
+17 critères d'éligibilité
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Étude de prévention

Interventionnel
Date de début : juillet 2012
Voir le détail du protocole

Résumé

Sponsor principalUniversity of California, Los Angeles
Contacts de l'étudeAlicia M Eccles, MPHVoir plus de contacts
Dernière mise à jour : 10 février 2016
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 1 juillet 2012

Date à laquelle le premier participant a commencé l'étude.

The HIV/AIDS epidemic continues to disproportionately affect African Americans. The rate of HIV among African American men is six times the rate for White men and the rate among African American women is almost 15 times the rate for White women. An estimated 56,300 new HIV cases was reported in 2006, of which 49% were among African Americans and 80% were from heterosexual transmission. Sexually transmitted infections (STIs) also disproportionately affect African Americans, further increasing the risk for HIV transmission. Despite the fact that HIV and STIs are primarily transmitted in the context of relationships, few interventions address HIV risk in couples. Furthermore, few evidence-based HIV prevention interventions have been implemented in community-based organizations (CBOs). Thus, there is a substantial need to strengthen the availability and use of relationship oriented prevention interventions in community-based treatment settings. This study focuses on the implementation of an evidence-based HIV risk reduction intervention for HIV-serodiscordant, heterosexual African American couples ("Eban II") in two geographic areas (Northern and Southern California - roughly, Alameda and Los Angeles Counties) that have a high prevalence of HIV infection and risk conditions among African Americans. This study builds upon the multi-site, NIMH-funded "Eban" (a Yoruba term for "fence") trial, which tested this culturally congruent intervention versus a control condition among 535 heterosexual HIV serodiscordant couples in four cities. Couples in the intervention had significantly reduced incidents of unprotected sex and an increased proportion of condom use compared to couples in the control condition. Statistical projections from that study suggest that if Eban participants had not received the intervention, six female and four males would have been infected in one year, and 25 females and 15 males would have become HIV-infected in the next 5 years. Based on these successful outcomes in a controlled trial, it is now appropriate to test the effectiveness of the intervention as delivered in community-based setting. Thus, we propose to conduct a study of implementation - a study of methods to promote the uptake of Eban into community-based organizations (CBOs). The Specific Aims are as follows: To evaluate implementation of Eban for HIV serodiscordant African American couples in 10 CBOs in California. To do this, we will document the implementation process and identify barriers and facilitators to Eban's adoption and use by the CBOs. We will interview 200 staff at CBOs to obtain this information. To evaluate the effect of Eban on behavioral and biological outcomes among 180 couples, specifically incidents of protected sex, proportion of condom use, and incident sexually transmitted infections. Eban will be assessed using a randomized delayed enrollment (waitlist) control design to evaluate the impact of treatment on outcomes at posttest and 3-month follow-up (i.e., at these 10 CBOs, Eban will be conducted and offered to couples and evaluated for effectiveness - that is, how well it works in the real world.) To determine the cost-effectiveness of implementation of Eban, based on implementation costs and potential cost savings. So please note, there are essentially two levels to this study -- first to see how well community agencies can implement or take up and execute the intervention (thus, the interviews with staff) - and the second, to see how effective Eban is in real world setting. We know it was highly effective in a controlled study but now we need to test how well it works in the "real" world(thus, the testing of the intervention with 180 couples). While doing this, we will also be examining the cost-effectiveness of the intervention in the "real" world setting.

NCT01829282
Sponsor principalUniversity of California, Los Angeles
Contacts de l'étudeAlicia M Eccles, MPHVoir plus de contacts
Dernière mise à jour : 10 février 2016
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

400 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Prévention

Cette étude cherche à prévenir l'apparition d'une maladie ou d'un trouble chez des personnes qui ne l'ont pas encore développé. Elles concernent souvent des personnes à risque et testent des vaccins, des changements de mode de vie ou des traitements préventifs.



Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

De 18 à 60 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

Maladies génito-urinairesMaladies GénitalesInfectionsProcessus pathologiquesConditions pathologiques, signes et symptômesAttributs de la maladieMaladies TransmissiblesMaladies Sexuellement Transmissibles

Critères

6 critères d'inclusion nécessaires pour participer
At least one partner must identify as African American/Black

Both partners must be 18 years or older

Must be a heterosexual couple (one biological female and one biological man)

Must be in a relationship with study partner for at least 3 months

Voir plus de critères

11 critères d'exclusion empêchent la participation
Couple is not heterosexual

Couple is not serodiscordant

HIV diagnosis received recently (less than 3 months)

Insufficient relationship length/commitment

Voir plus de critères

Plan de l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Groupes de traitement
Objectifs de l'étude

2 groupes d'intervention sont désignés dans cette étude

Cette étude ne comporte pas de groupe placebo. 

Groupes de traitement

Groupe I

Expérimental
The Risk Reduction group will receive the Eban II Intervention upon enrollment. This group will do the following: Provide HIV and STI test results First Interview Attend 8 sessions - 1 session per week Second interview occurs immediately following the 8th session with HIV and STI tests Third interview occurs 3 months after the 8th session with HIV and STI tests

Groupe II

Comparateur actif
The Waitlist group will receive the same intervention after waiting for the Risk Reduction group to complete the entire intervention. Provide HIV and STI test results First Interview No sessions for 8 weeks Second interview and proof of HIV and STI status occurs after the 8 weeks from when you were enrolled Third interview occurs 3 months after the 8th session with HIV and STI tests The Waitlist Group will then be invited to participate in the Risk Reduction group activities. Attend 8 sessions - 1 session per week Fourth interview occurs immediately after the 8th session with HIV and STI tests Fifth interview occurs 3 months after the 8th session with HIV and STI tests

Objectifs de l'étude

Objectifs principaux

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.

Cette étude comporte 8 sites

Recrutement en cours

HIV Education & Prevention Project of Alameda County

Oakland, United StatesOuvrir HIV Education & Prevention Project of Alameda County dans Google Maps
Recrutement imminent

Tarzana Treatment Centers

Long Beach, United States
Recrutement imminent

AIDS Project Los Angeles

Los Angeles, United States
Recrutement imminent

AIDS Healthcare Foundation

Los Angeles, United States
Suspendu8 Centres d'Étude