A Medication Adherence Intervention for HIV Infected Veterans - Tabular View

Tracking Information

First Received Date ^ICMJE

March 14, 2001

Last Updated Date

August 6, 2009

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00013065 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

A Medication Adherence Intervention for HIV Infected Veterans

Official Title ^ICMJE

A Medication Adherence Intervention for HIV Infected Veterans

Brief Summary

It is estimated that the VHA is caring for nearly 40 percent of all HIV-infected veterans. To benefit from recent improvements in anti-HIV therapy, patients need to take their medications consistently.

Detailed Description

Background:

Objectives:

Optimizing health for HIV patients requires excellent adherence to antiretroviral medication regimens. However, its unclear how best to incorporate adherence education and support programs into VA HIV outpatient care. We implemented and evaluated a pharmacist program (ACE) and a Pager reminder program to support adherence in veterans with HIV.

Methods:

We used a quasi-experimental design with pre-post evaluation at four VA Centers. Three treatment conditions (ACE, Pager, Usual Care) were rolled-in sequentially over two study phases, allowing for group comparisons between conditions. ACE is a multi-component manualized 4-session, individual patient education and support program by trained pharmacists. The Pager intervention used alphanumeric pagers to remind patients of dosing times. Electronically-monitored medication adherence (MEMS), self-report questionnaires, and pharmacy refill records were collected. Qualitative site interviews were collected before and after interventions to assist with program evaluation. Multilevel mixed models were used to analyze main study outcomes over time. Secondary analyses compared subgroup who actually received all ACE sessions (�as treated�) to controls.

Status:

Project has been completed and Final Report submitted to HSR&D CO.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Prospective

Condition ^ICMJE

HIV Infection

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

210

Completion Date

December 2003

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients must be greater than or equal to 18 years old, must be enrolled in HIV Primary care at one of 4 VA study sites and be taking antiretroviral therapy.

Exclusion Criteria:

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00013065

Responsible Party

Gifford, Allen - Principal Investigator, Department of Veterans Affairs

Study ID Numbers ^ICMJE

HII 99-054

Study Sponsor ^ICMJE

Department of Veterans Affairs

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Allen L. Gifford, MD

Edith Nourse Rogers Memorial Veterans Hospital, Be

Information Provided By

Department of Veterans Affairs

Verification Date

January 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP