A Medication Adherence Intervention for HIV Infected Veterans

HIV Infection Clinical Trial

Official title:

A Medication Adherence Intervention for HIV Infected Veterans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00013065
• Other study ID #: HII 99-054
• Status: Completed
• Phase: N/A
• First received: March 14, 2001
• Last updated: April 6, 2015
• Est. completion date: December 2003

Study information

• Verified date: January 2005
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

Description:

Background:

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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:

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV Infection

Locations

Country	Name	City	State
United States	VA Palo Alto Health Care System, Palo Alto, CA	Palo Alto	California
United States	VA San Diego Healthcare System, San Diego, CA	San Diego	California
United States	Southern Arizona VA Health Care System, Tucson, AZ	Tucson	Arizona
United States	VA Greater Los Angeles Healthcare System, West Los Angeles, CA	West Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (5)

Bormann J, Shively M, Smith TL, Gifford AL. Measurement of fatigue in HIV-positive adults: reliability and validity of the Global Fatigue Index. J Assoc Nurses AIDS Care. 2001 May-Jun;12(3):75-83. — View Citation

Gifford AL, Bormann JE, Shively MJ, Wright BC, Richman DD, Bozzette SA. Predictors of self-reported adherence and plasma HIV concentrations in patients on multidrug antiretroviral regimens. J Acquir Immune Defic Syndr. 2000 Apr 15;23(5):386-95. — View Citation

Gifford AL, Groessl EJ. Chronic disease self-management and adherence to HIV medications. J Acquir Immune Defic Syndr. 2002 Dec 15;31 Suppl 3:S163-6. — View Citation

Korthuis PT, Asch S, Mancewicz M, Shapiro MF, Mathews WC, Cunningham WE, McCutchan JA, Gifford A, Lee ML, Bozzette SA. Measuring medication: do interviews agree with medical record and pharmacy data? Med Care. 2002 Dec;40(12):1270-82. — View Citation

Shively M, Smith TL, Bormann J, Gifford A. Evaluating Self-Efficacy for HIV Disease Management Skills. AIDS and behavior. 2002 Dec 1; 6(4):371-379.