A Medication Adherence Intervention for HIV Infected Veterans

NCT ID: NCT00013065

Last Updated: 2015-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

210 participants

Study Classification

OBSERVATIONAL

Study Completion Date

2003-12-31

Brief Summary

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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

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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.

Conditions

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HIV Infection

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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US Department of Veterans Affairs

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Allen L. Gifford, MD

Role: PRINCIPAL_INVESTIGATOR

VA San Diego Healthcare System, San Diego, CA

Locations

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Southern Arizona VA Health Care System, Tucson, AZ

Tucson, Arizona, United States

Site Status

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, United States

Site Status

VA San Diego Healthcare System, San Diego, CA

San Diego, California, United States

Site Status

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT

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. doi: 10.1097/00126334-200212153-00016.

Reference Type RESULT
PMID: 12562043 (View on PubMed)

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. doi: 10.1097/00126334-200004150-00005.

Reference Type RESULT
PMID: 10866231 (View on PubMed)

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. doi: 10.1097/01.MLR.0000036410.86742.27.

Reference Type RESULT
PMID: 12458308 (View on PubMed)

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. doi: 10.1016/S1055-3290(06)60146-5.

Reference Type RESULT
PMID: 11387807 (View on PubMed)

Other Identifiers

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HII 99-054

Identifier Type: -

Identifier Source: org_study_id

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