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HIV Counseling and Testing and Linkage to Care in Uganda

11 décembre 2013 mis à jour par: Thomas J. Coates, University of California, Los Angeles
This study will compare the effectiveness of brief versus detailed HIV counseling sessions, paired with referrals to either HIV-specific medical care or usual care, in reducing HIV risk behavior and in increasing treatment adherence in Uganda.

Aperçu de l'étude

Description détaillée

HIV is a virus that can lead to acquired immunodeficiency syndrome (AIDS), a disease that breaks down the immune system and allows for entry of life-threatening secondary infections. HIV is a major global health concern, with countries in Africa undergoing a severe HIV/AIDS crisis. The number of new cases of HIV infection in Africa continues to rise, making disease prevention methods imperative. Important to the prevention process are early testing, educational counseling on HIV and how to reduce sexual-risk behavior, and connecting people with HIV infection to services that offer medical treatment and social support. However, the most effective strategy for fully integrating HIV counseling, testing, and medical care access is not known. This study will compare the effectiveness of brief versus detailed HIV counseling sessions, paired with either referrals to HIV-specific medical care or usual care, in reducing HIV risk behavior and in increasing treatment adherence in Uganda.

Participation in this study will last 12 months. All participants will undergo an initial interview to obtain basic information on previous HIV testing and status. Participants will then be assigned randomly to receive a brief or more detailed counseling session given before and after HIV testing. Participants assigned to the brief counseling session will receive 10 to 15 minutes of pretest counseling on the importance of HIV testing and available services for people infected with HIV. Participants assigned to the detailed counseling session will receive 45 to 60 minutes of pretest counseling on general HIV/AIDS information and testing for HIV. After pretest counseling, participants in both groups will undergo a blood draw for HIV testing. All participants will receive test results and additional counseling 1 hour after the blood sample is drawn.

Participants who are found to be infected with HIV will be assigned randomly to receive enhanced referrals to HIV-specific medical care or referrals to usual care. Participants receiving the enhanced referrals will be provided with more detailed counseling on how to access HIV services, will be introduced to a specific HIV clinic, and will be given a list of other HIV services available in the area. After leaving the hospital, participants will receive reminder telephone calls 1 week before their first scheduled visits at the HIV clinics. Participants receiving referrals to usual care will be provided with information on the importance of receiving HIV care and will be given a list of available HIV area services. At Months 3, 6, 9, and 12, participants in both groups will be interviewed about contact information, overall health, current medications, sexual history, health services utilized, and any repeat HIV tests. Participants who are not infected with HIV may be randomly selected to undergo the same follow-up interviews as the HIV infected participants.

Type d'étude

Interventionnel

Inscription (Réel)

3415

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

      • Kampala, Ouganda, 7072
        • Makerere University/Mulago Teaching Hospital, Uganda

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Willing to receive HIV test results
  • Willing to provide adequate contact information
  • Possesses sufficient cognitive ability to provide informed consent and participate in the interventions, as determined subjectively by the Regulatory Coordinator (patient with altered mental status or who is otherwise too ill to participate in the consent process will be excluded)
  • Planned local residence over the next year after study entry (within a reasonable distance; approximate radius of 25 km of Kampala city center)
  • Fluent in Luganda or English

Exclusion Criteria:

  • Self-reported HIV-infected serostatus (defined as ever receiving an HIV-positive test result)
  • Self-reported HIV test within the 12 months before study entry
  • Any condition that, in the opinion of the study staff, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: A
Participants will receive voluntary brief HIV counseling and testing plus enhanced linkage to care.
Participants will receive 10 to 15 minutes of pretest counseling on the importance of HIV testing and on available services for people infected with HIV. After pretest counseling, participants will undergo a blood draw for HIV testing. Participants will receive test results and additional counseling 1 hour after the blood sample is drawn.
Participants will be provided with more detailed counseling on how to access HIV services, will be introduced to a specific HIV clinic, and will be given a list of other HIV services available in the area. After leaving the hospital, participants will receive reminder telephone calls 1 week before their scheduled visits at the HIV clinics.
Expérimental: B
Participants will receive voluntary brief HIV counseling and testing plus routine referral to care.
Participants will receive 10 to 15 minutes of pretest counseling on the importance of HIV testing and on available services for people infected with HIV. After pretest counseling, participants will undergo a blood draw for HIV testing. Participants will receive test results and additional counseling 1 hour after the blood sample is drawn.
Participants will be provided with information on the importance of receiving HIV care and will be given a list of available HIV area services.
Expérimental: C
Participants will receive voluntary longer, more detailed HIV counseling and testing plus enhanced linkage to care.
Participants will be provided with more detailed counseling on how to access HIV services, will be introduced to a specific HIV clinic, and will be given a list of other HIV services available in the area. After leaving the hospital, participants will receive reminder telephone calls 1 week before their scheduled visits at the HIV clinics.
Participants will receive 45 to 60 minutes of pretest counseling on general HIV/AIDS information and testing for HIV. After pretest counseling, participants will undergo a blood draw for HIV testing. Participants will receive test results and additional counseling 1 hour after the blood sample is drawn.
Expérimental: D
Participants will receive voluntary longer, more detailed HIV counseling and testing plus routine referral to care.
Participants will be provided with information on the importance of receiving HIV care and will be given a list of available HIV area services.
Participants will receive 45 to 60 minutes of pretest counseling on general HIV/AIDS information and testing for HIV. After pretest counseling, participants will undergo a blood draw for HIV testing. Participants will receive test results and additional counseling 1 hour after the blood sample is drawn.
Comparateur actif: E
Participants who are found to be healthy will receive voluntary brief HIV counseling and testing only.
Participants will receive 10 to 15 minutes of pretest counseling on the importance of HIV testing and on available services for people infected with HIV. After pretest counseling, participants will undergo a blood draw for HIV testing. Participants will receive test results and additional counseling 1 hour after the blood sample is drawn.
Comparateur actif: F
Participants who are found to be healthy will receive voluntary longer, more detailed HIV counseling and testing only.
Participants will receive 45 to 60 minutes of pretest counseling on general HIV/AIDS information and testing for HIV. After pretest counseling, participants will undergo a blood draw for HIV testing. Participants will receive test results and additional counseling 1 hour after the blood sample is drawn.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Reduction in HIV risk behavior among inpatients after discharge
Délai: Measured at Months 3, 6, 9, and 12
Measured at Months 3, 6, 9, and 12
Receipt of opportunistic infection (OI) prophylaxis, adherence to antiretroviral therapy (ART), and reduction in mortality
Délai: Measured at Months 3, 6, 9, and 12
Measured at Months 3, 6, 9, and 12

Mesures de résultats secondaires

Mesure des résultats
Délai
Number of infections averted per patient randomized to each of the four intervention strategies
Délai: Measured at Month 12
Measured at Month 12

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Thomas J. Coates, PhD, UCLA David Geffen School of Medicine

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 mai 2008

Achèvement primaire (Réel)

1 juin 2011

Achèvement de l'étude (Réel)

1 juin 2011

Dates d'inscription aux études

Première soumission

28 mars 2008

Première soumission répondant aux critères de contrôle qualité

28 mars 2008

Première publication (Estimation)

1 avril 2008

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

12 décembre 2013

Dernière mise à jour soumise répondant aux critères de contrôle qualité

11 décembre 2013

Dernière vérification

1 décembre 2013

Plus d'information

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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