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Test of an Intervention to Improve HIV Care

20 juin 2016 mis à jour par: Thomas Giordano, Baylor College of Medicine
At Thomas Street Health Center (TSHC), one of the largest outpatient HIV clinics in the country, we developed a structured, theory-based, Patient Mentor Program to improve retention in HIV primary care. Many patients with HIV infection hospitalized at Ben Taub General Hospital (BTGH) do not successfully return to TSHC after discharge from the hospital. The purpose of this study is to test the efficacy of a patient mentor intervention in a 5-year randomized, controlled trial in more than 430 socio-economically and racially diverse HIV-infected patients hospitalized at BTGH. We hypothesize that the intervention will meaningfully increase retention in HIV primary care after discharge compared to an attention control.

Aperçu de l'étude

Type d'étude

Interventionnel

Inscription (Réel)

460

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

    • Texas
      • Houston, Texas, États-Unis, 77030
        • Ben Taub General 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

La description

Inclusion Criteria:

1) Hospitalized at BTGH; 2) expected to be in the hospital for at least one more night at the time of enrollment; 3) at least 18 years of age at enrollment; 4) able to speak English or Spanish; 5) HIV infected, whether previously diagnosed or diagnosed this hospital stay; 6) cognitively aware enough to provide informed consent and participate in the study. Patients who are temporarily cognitively incapacitated (e.g., from an acute process) will be followed and approached for enrollment if and when they are cognitively and physically capable of participating in the study.

Exclusion Criteria:

1) Intending to use a source of HIV primary care other than TSHC after discharge from the hospital, because TSHC-specific mentoring is not relevant to them and the data on their appointments after discharge cannot be tracked; 2) in the opinion of the primary medical team, likely to be discharged to an institutional setting; 3) in the opinion of the primary medical team caring for the patient, likely to die in the hospital or be discharged to hospice; 4) cognitive impairment that in the opinion of the primary medical team caring for the patient is not expected to improve by discharge; 5) prisoner at admission and expected to be discharged back to prison or jail; 6) having had an HIV primary care visit in at least 3 of the 4 previous quarter-years AND having had at least 3 consecutive HIV VL<400 c/mL over at least 6 months, the most recent of which is within 3 months of enrollment; 7) enrolled in any other research project with prospective follow-up; 8) already enrolled in this study at any time.

For the purposes of this study, "prisoner" will be defined in accordance with Federal regulations, as "any individual involuntarily confined or detained in a penal institution...[including] individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing…Parolees who are detained in a treatment center as a condition of parole are prisoners; however, persons living in the community and sentenced to community-supervised monitoring, including parolees, are not prisoners." Parolees meeting the definition of prisoner will be ineligible for the 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

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Patient Mentor Intervention
The patient mentor intervention from TSHC has been adapted to the inpatient setting. Participants randomized to that arm will receive 2 sessions with a patient mentor during their hospitalization, as well as 5 phone call sessions over the 10 weeks after discharge and a brief meeting between the subject and the mentor when the subject attends their first outpatient visit at TSHC after discharge.
The first session includes an exploration of needs, barriers, and facilitators to HIV care. HIV educational materials are introduced to identify areas of need. Mentors will address concerns and possible barriers to care using their own experiences. Mentors will encourage participants to set goals related to acquisition of care following discharge and how to address possible barriers to that goal. The second session will reinforce the first session. Mentors will call the patient 5 times over the 10 weeks after discharge. These phone calls will be brief and goal centered, to either reinforce positive behavior if the patient is in care, or continue to help the patient re-engage in outpatient HIV care.
Autres noms:
  • MAPPS
  • Mentor Approach for Promoting Patient Self-care
Comparateur placebo: HIV transmission risk reduction
Participants randomized to the control arm will receive an attention control intervention delivered by a patient educator who is not an HIV patient mentor. We will use a modified version of the RESPECT intervention for our attention control group. Similar to the active intervention, these patients will receive 2 sessions in the hospital and 5 phone calls over 10 weeks after discharge.
The control intervention is a modification of the project RESPECT intervention. We will use material from sessions 1, 2, and 3 of the RESPECT enhanced counseling intervention. These interactions will include a personalized assessment of risk behaviors and changing condom use self-efficacy. The second interaction will build on material covered during the first interaction, with additional focus on condom use attitudes. The counselors will call the patient 5 times in the 10 weeks after discharge. These phone-based sessions will be brief and goal centered, to reinforce safe HIV transmission behaviors.
Autres noms:
  • RESPECT

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Engaged in outpatient HIV care
Délai: 6 Months
A composite of attending at least one HIV primary care visit within 30 days of discharge AND at least one between 31 and 180 days AND, for patient with an indication for ART, achieving a one log10 decrease in HIV VL or maintaining a VL <400 c/mL at 180 days after discharge.
6 Months

Mesures de résultats secondaires

Mesure des résultats
Délai
Completion of at least one HIV primary care visit at TSHC within 30 days of discharge, health services use, changes in CD4 cell count and HIV VL, and quality of life.
Délai: 6 Months
6 Months

Collaborateurs et enquêteurs

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

Les enquêteurs

  • Chercheur principal: Thomas P Giordano, MD, MPH, Baylor College 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 2010

Achèvement primaire (Réel)

1 juin 2015

Achèvement de l'étude (Réel)

1 mai 2016

Dates d'inscription aux études

Première soumission

13 avril 2010

Première soumission répondant aux critères de contrôle qualité

13 avril 2010

Première publication (Estimation)

15 avril 2010

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

22 juin 2016

Dernière mise à jour soumise répondant aux critères de contrôle qualité

20 juin 2016

Dernière vérification

1 juin 2016

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 .

Essais cliniques sur Infection par le VIH

Essais cliniques sur Patient Mentor Intervention

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