Medications for Chronic HIV: Education and Collaboration

NCT01038076 | Completed DMC

• 2 other identifiers: H-26736R01MH076911-02
• Study Type: interventional
• Target: 371
• Locations: 1 country
• Sites: 3

Brief Summary

This study will examine whether a computerized, self-administered assessment of patient medication adherence and health behaviors, plus support for adherence, improves the ability of clinicians to identify adherence problems and leads to better adherence.

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; Medication Adherence

Keywords

HIV; AIDS; adherence; antiretroviral; aCASI; HAART; Complementary Therapies; Adherence Care Manager

Outcome Measures

Primary Outcomes (1)

• Patient adherence to HIV medications, as measured by MEMS data, and by self-report questionnaires.

  1 year

Study Arms (2)

MedCHEC Tablet Computer & Adherence Care

EXPERIMENTAL

Patients assigned to the intervention answer questions about their medication, medication-taking behavior and risks for non-adherence on the MedCHEC tablet touch-screen computer, which generates provider and patient reports. Patients may be referred to an Adherence Care Manager on the basis of the reports. In addition, patients will receive standard information about adherence.

Behavioral: MedCHEC Tablet Computer & Adherence Care

Adherence Information Only

NO INTERVENTION

Patients assigned to the active comparator arm will receive standard information about adherence.

Interventions

MedCHEC Tablet Computer & Adherence Care BEHAVIORAL

Patients answer questions about their medication, medication-taking behavior and risks for non-adherence on the MedCHEC tablet touch-screen computer, which generates patient and provider reports. Patients may be referred to an Adherence Care Manager on the basis of the reports.

Also known as: HIV/Adhere, aCASI

MedCHEC Tablet Computer & Adherence Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years of age
• Confirmed HIV-positive
• On or newly starting antiretroviral medication for HIV
• Under treatment at one of the study sites
• Available by telephone

You may not qualify if:

• Clinically diagnosed by provider with significant cognitive impairment, or Mini-Mental Status Exam score less than or equal to 22
• Inability to read English
• Inability or refusal to use MedCHEC touch-screen computer
• Inability or refusal to use any form of electronic drug monitoring device (MEMS)
• Never available by telephone

Sponsors & Collaborators

• Boston University: lead
• National Institute of Mental Health (NIMH): collaborator
• VA Office of Research and Development: collaborator
• VA Boston Healthcare System: collaborator
• VA Greater Los Angeles Healthcare System: collaborator
• San Diego State University: collaborator
• Tufts University: collaborator

Study Sites (3)

VA Greater Los Angeles

Los Angeles, California, 90073, United States

Location

VA Boston

Boston, Massachusetts, 02030, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; Medication Adherence

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Allen L Gifford, M.D.

  Boston University School of Public Health and School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Public Health and Medicine

Study Record Dates

• First Submitted: December 19, 2009
• First Posted: December 23, 2009
• Study Start: December 1, 2009
• Primary Completion: June 1, 2013
• Study Completion: December 1, 2017
• Last Updated: February 20, 2018

Record last verified: 2018-02

Locations

US (3)