- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01160575
A Semi-Factorial Cluster-Randomized Trial to Estimate the Effect Size of Community Mobilization and VCT Vans on the Adoption of Voluntary Counseling and Testing (VCT) Services in Andhra Pradesh, India: THE MCVCT STUDY
13 décembre 2019 mis à jour par: National Institute of Allergy and Infectious Diseases (NIAID)
With an estimated 2.5 million HIV-infected persons, India is home to one of the largest populations of HIV-infected persons in the world.
Yet, it is estimated that less than 20% of the people living with HIV in India are aware of their status.
Andhra Pradesh (AP), situated in south India, is the state with the highest HIV burden in India.
Reports from AP suggest usage of voluntary counseling and testing (VCT) is low, especially among high-risk groups.
VCT has been shown to have many benefits in addition to diagnosis of HIV infection such as reduction in risk behavior, partner referral, and serving as an entry point to the health care system.
Community mobilization and VCT vans have been shown in the past to play a role in increasing utilization of VCT services in various developing countries similar to India.
The primary objective of this protocol is to arrive at an effect size of community mobilization alone, and both community mobilization and VCT vans, on the adoption of VCT services in Andhra Pradesh, India.
Secondary objectives include identifying barriers to VCT, assessing stigma in the community, and establishing a specimen repository at the YRGCARE infectious disease laboratory in Chennai, India.
We will achieve these objectives by conducting a cluster randomized clinical trial with 3 arms: ARM 1: standard of care with pre-existing VCT centers (SVCT); ARM 2: community mobilization in the setting of pre-existing VCT centers (CVCT); ARM 3: community mobilization plus VCT van in addition to the pre-existing VCT centers (MCVCT).
The overall study duration will be 6 months from randomization.
To our knowledge, this is the first study to examine the role of community mobilization and VCT vans on the adoption of VCT in the Indian context.
It will provide us with vital data that will be used to plan a larger powered study to evaluate the effectiveness of these interventions including sites from other parts of India.
Additionally, this study will also provide us with important information on barriers to VCT in these communities.
Aperçu de l'étude
Statut
Retiré
Les conditions
Description détaillée
With an estimated 2.5 million HIV-infected persons, India is home to one of the largest populations of HIV-infected persons in the world.
Yet, it is estimated that less than 20% of the people living with HIV in India are aware of their status.
Andhra Pradesh (AP), situated in south India, is the state with the highest HIV burden in India.
Reports from AP suggest usage of voluntary counseling and testing (VCT) is low, especially among high-risk groups.
VCT has been shown to have many benefits in addition to diagnosis of HIV infection such as reduction in risk behavior, partner referral, and serving as an entry point to the health care system.
Community mobilization and VCT vans have been shown in the past to play a role in increasing utilization of VCT services in various developing countries similar to India.
The primary objective of this protocol is to arrive at an effect size of community mobilization alone, and both community mobilization and VCT vans, on the adoption of VCT services in Andhra Pradesh, India.
Secondary objectives include identifying barriers to VCT, assessing stigma in the community, and establishing a specimen repository at the YRGCARE infectious disease laboratory in Chennai, India.
We will achieve these objectives by conducting a cluster randomized clinical trial with 3 arms: ARM 1: standard of care with pre-existing VCT centers (SVCT); ARM 2: community mobilization in the setting of pre-existing VCT centers (CVCT); ARM 3: community mobilization plus VCT van in addition to the pre-existing VCT centers (MCVCT).
The overall study duration will be 6 months from randomization.
To our knowledge, this is the first study to examine the role of community mobilization and VCT vans on the adoption of VCT in the Indian context.
It will provide us with vital data that will be used to plan a larger powered study to evaluate the effectiveness of these interventions including sites from other parts of India.
Additionally, this study will also provide us with important information on barriers to VCT in these communities.
Type d'étude
Observationnel
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 à 99 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
INCLUSION CRITERIA:
- Greater than or equal to 18 years of age
- Client to the clinic based standard VCT center or the VCT van during the study period
- Provides informed consent
- Must be a resident of the community for at least 6 months.
- Willing to complete survey
- Willing to provide a blood sample obtained by finger-stick or venipuncture for HIV testing.
- Willing to have blood samples stored.
EXCLUSION CRITERIA:
- Participant is less than 18 years of age.
- Study staff feels participant is psychologically unfit to understand the consent
- Participant has already been enrolled in this study
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
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
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.
Publications générales
- Newmann S, Sarin P, Kumarasamy N, Amalraj E, Rogers M, Madhivanan P, Flanigan T, Cu-Uvin S, McGarvey S, Mayer K, Solomon S. Marriage, monogamy and HIV: a profile of HIV-infected women in south India. Int J STD AIDS. 2000 Apr;11(4):250-3. doi: 10.1258/0956462001915796.
- Dandona L, Dandona R, Gutierrez JP, Kumar GA, McPherson S, Bertozzi SM; ASCI FPP Study Team. Sex behaviour of men who have sex with men and risk of HIV in Andhra Pradesh, India. AIDS. 2005 Mar 24;19(6):611-9. doi: 10.1097/01.aids.0000163938.01188.e4.
- Simoes EA, Babu PG, John TJ, Nirmala S, Solomon S, Lakshminarayana CS, Quinn TC. Evidence for HTLV-III infection in prostitutes in Tamil Nadu (India). Indian J Med Res. 1987 Apr;85:335-8.
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
23 juin 2010
Achèvement de l'étude
9 septembre 2014
Dates d'inscription aux études
Première soumission
9 juillet 2010
Première soumission répondant aux critères de contrôle qualité
9 juillet 2010
Première publication (Estimation)
12 juillet 2010
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
16 décembre 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
13 décembre 2019
Dernière vérification
9 septembre 2014
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 999910158
- 10-I-N158
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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