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CompletedNCT00013065Updated Apr 7, 2015

A Medication Adherence Intervention for HIV Infected Veterans

An observational study in HIV Infection, sponsored by US Department of Veterans Affairs. Completed at 4 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-04-07.

Sponsored by US Department of Veterans Affairs · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
210
Ages
18 Years to 65 Years
Sex
All
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Study 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.

Read the detailed 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.

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Conditions studied

  • HIV Infection

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In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's planned enrollment of 210 is close to the median of 200 across 713 observational studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

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Study design

Time perspective
Prospective
Enrollment
210 participants (estimated)

Groups and cohorts

  • Group 1
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Study locations

4 sites
  • Southern Arizona VA Health Care System, Tucson, AZ
    Tucson, Arizona 85723, United States
  • VA Palo Alto Health Care System, Palo Alto, CA
    Palo Alto, California 94304-1290, United States
  • VA San Diego Healthcare System, San Diego, CA
    San Diego, California 92161, United States
  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA
    West Los Angeles, California 90073, United States
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References and documents

Publications

  • 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.
  • 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. PubMed 12562043 ↗
  • 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. PubMed 10866231 ↗
  • 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. PubMed 12458308 ↗
  • 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. PubMed 11387807 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00013065
Lead sponsor
US Department of Veterans Affairs
Responsible party
Sponsor
First posted
Mar 16, 2001
Completion
Dec 2003
Last update
Apr 7, 2015

Study contacts

Allen L. Gifford, MD
principal investigator · VA San Diego Healthcare System, San Diego, CA

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2005. You cannot join it, but the record below documents what was studied.

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