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Multi-level Determinants of Starting ART Late: Aim 3 (LSTART)

15 décembre 2014 mis à jour par: Batya Elul, Columbia University

Multi-level Determinants of Starting ART Late in Sub-Saharan Africa (LSTART Study): A Case-control Study to Identify Individual-level Risk Factors for Late ART Initiation in Ethiopia

The availability of HIV care and treatment programs is increasing in sub-Saharan Africa. However more than half the patients who need HIV treatment are still not receiving antiretroviral therapy (ART). This can lead to early death from AIDS. Additionally, many patients start ART late after the HIV disease is very advanced. This results in high death rates soon after starting ART. The factors that contribute to late ART initiation are still unclear. This study will identify factors that help patients to enroll or prevent them from enrolling into HIV care and starting ART on time. We will examine the characteristics of all patients initiating ART at study sites. We will also look at potential risk factors among patients who initiate ART late (cases) compared to patients who initiate earlier (controls) at 6 HIV care and treatment clinics in Ethiopia. Data will be collected using 2 methods:

  1. Face-to-face interviews with participants using questionnaires
  2. Obtaining clinical data from the electronic patient-level database

Identifying factors that help patients to start or prevent them from starting ART on time will help to direct interventions, programs and policies to reduce early death.

Aperçu de l'étude

Description détaillée

Background: Although HIV care and treatment programs are being scaled up in sub-Saharan Africa, more than 50% of the patients in need of ART are not receiving it and there is still significant mortality from AIDS. One of the major challenges is high rates of late ART initiation (i.e., in the advanced stages of HIV disease) which results in high rates of mortality soon after initiation of ART. The individual-level factors that contribute to late ART initiation are still unclear. Objective: As the 3rd part of a 3-phase NIH-sponsored project, this study aims to identify individual-level enablers and barriers to timely enrollment into HIV care and ART initiation.

Methods: We will be recruiting all patients newly initiating ART at the study sites for descriptive analysis (approximately 1,200). As a sub-analysis, we will be utilizing a case-control approach to examine potential individual risk factors (e.g. knowledge and behaviors around HIV care and treatment, experience of stigma, and other perceived barriers and enablers to earlier HIV diagnosis, enrollment into care, and ART initiation) among 360 patients who initiated ART late (CD4 count <150 cells/µL compared to 360 patients who initiated earlier (CD4≥200) at 6 HIV care and treatment clinics in Ethiopia. For both the descriptive study and case-control study, data will be collected using 2 methods:

  1. Face-to-face interviews with participants using structured questionnaires
  2. Abstraction of clinical data from the electronic patient-level database to capture patient information at baseline, 6 and 12 months after enrollment in the study

Expected use of results: Identifying individual-level enablers and barriers of timely ART initiation will facilitate implementation of interventions, programs and policies to mitigate the problem of late ART initiation.

Type d'étude

Observationnel

Inscription (Réel)

1214

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

      • Ambo, Ethiopie
        • Ambo Hospital
      • Bishoftu, Ethiopie
        • Bishoftu hospital
      • Fitche, Ethiopie
        • Fitche Hospital
      • Goba, Ethiopie
        • Goba Hospital
      • Nekemte, Ethiopie
        • Nekemte Hospital
      • Shashamene, Ethiopie
        • Shashamene Hospital

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

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

The prospective cohort will include all patients initiating ART at one of the six study sites, estimated at 1,200 patients. Cases will be adults initiating ART with either: CD4 count <150 cells/µL. Controls will be adults who initiate ART with CD4≥200 . Individuals initiating ART with CD4 counts of 150-199 cells per µL and at WHO Stage I-III will be excluded from the case-control analysis in order to ensure meaningful distinction between the two groups. We will enroll 720 patients for the case control study nested in the prospective cohort, which will include 360 cases and 360 controls, who will be frequency matched by sex, month of ART initiation, and clinic.

La description

Inclusion Criteria:

  • Aged 18 years (the age of majority in Ethiopia) or older.
  • ART naïve.
  • Eligible for ART according to Ethiopia's National ART guideline criteria.
  • Have received a prescription for ART during the study period.
  • Speak either Oromiffa or Amharic.
  • Special inclusion criteria for case-control sub-analysis:

    • Cases: CD4 count <150 cells/µL (regardless of WHO stage)
    • Controls: CD4 ≥200.

Exclusion Criteria:

  • Overtly cognitively impaired
  • Inability or unwillingness to provide informed consent
  • Actively incarcerated

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

Cohortes et interventions

Groupe / Cohorte
Key Informant Interviews
Eligible patients will undergo a one hour structured interview about barriers and facilitators to early ART initiation.
Prospective Cohort
The prospective cohort will include all patients initiating ART at one of the six study sites, estimated at 1,200 patients. Cases will be adults initiating ART with either: CD4 count <150 cells/µL. Controls will be adults who initiate ART with CD4≥200 . Individuals initiating ART with CD4 counts of 150-199 cells per µL and at WHO Stage I-III will be excluded from the case-control analysis in order to ensure meaningful distinction between the two groups. We will enroll 720 patients for the case control study nested in the prospective cohort, which will include 360 cases and 360 controls, who will be frequency matched by sex, month of ART initiation, and clinic.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Proportion of Persons Initiating ART Late
Délai: 12 months
12 months

Collaborateurs et enquêteurs

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

Les enquêteurs

  • Chercheur principal: Batya Elul, PhD, MSc, ICAP-NY, Columbia University

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 juin 2012

Achèvement primaire (Réel)

1 avril 2014

Achèvement de l'étude (Réel)

1 avril 2014

Dates d'inscription aux études

Première soumission

8 novembre 2013

Première soumission répondant aux critères de contrôle qualité

22 novembre 2013

Première publication (Estimation)

28 novembre 2013

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

16 décembre 2014

Dernière mise à jour soumise répondant aux critères de contrôle qualité

15 décembre 2014

Dernière vérification

1 décembre 2014

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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