Impact of an adherence clinic on behavioral outcomes and virologic response in treatment of HIV infection: A prospective, randomized, controlled pilot study

R. Chris Rathbun, Kevin C. Farmer, Johnny Stephens, Staci M. Lockhart

Research output: Contribution to journalArticle

76 Citations (Scopus)

Abstract

Objective: The aim of this randomized, controlledpilot study was to examine the impact of a pharmacistoperated adherence clinic on adherence to highly active antiretroviral therapy (HAART) and viral suppression in patients with HIV over 28 weeks. Methods: Consecutive eligible patients initiatingHAART at an indigent-care clinic were randomized to an adherence clinic or to standard care (information provided by physician or nurse practitioner) for education and monitoring. Group assignment was stratified before randomization according to regimen complexity and potential tolerability. Adherence (electronic monitoring and patient self-report) and viral load (reverse-transcription polymerase chain reaction) were assessed at weeks 4, 16, and 28. Results: Thirty-three randomized patients (adherenceclinic, n = 16; standard care, n = 17) comprised the intent-to-treat population. The groups were well-matched for demographics and antiretroviral regimen. The median age was 38.0 years in both groups. Most patients were male (85%), had previously used HAART (78%), and had an AIDS diagnosis (79%). Mean (SD) adherence at weeks 4, 16, and 28 was 86% (27%), 77% (28%), and 74% (31%) in the adherence clinic group versus 73% (32%), 56% (39%), and 51% (41%) in the standard care group (week-16 difference, 21% [90% CI, 1%-42%]; week-28 difference, 23% [90% CI, 1%-44%]). Sixty-nine percent of patients in the adherence clinic group took their medication on schedule versus 42% in the standard care group (P = 0.025); mean decline in adherence from weeks 4 to 28 was 12% in the adherence clinic group (P = 0.15) versus 22% in the standard care group (P = 0.002). HIV-1 RNA levels were <400 copies/mL at weeks 4, 16, and 28 in 63%, 100%, and 94% of the adherence clinic group and 29% (P = NS), 71% (P = 0.04), and 65% (P = NS) of the standard care group. Conclusions: In this preliminary trial, an adherence clinic model improved adherence to HAART and virologic response over 28 weeks in the patients studied.

Original languageEnglish
Pages (from-to)199-209
Number of pages11
JournalClinical Therapeutics
Volume27
Issue number2
DOIs
StatePublished - 1 Jan 2005

Fingerprint

HIV Infections
Highly Active Antiretroviral Therapy
Uncompensated Care
Therapeutics
Nurse Practitioners
Physiologic Monitoring
Standard of Care
Patient Compliance
Random Allocation
Viral Load
Self Report
Reverse Transcription
HIV-1
Appointments and Schedules
Acquired Immunodeficiency Syndrome
Demography
HIV
RNA
Physicians
Education

Keywords

  • Adherence
  • Electronic monitoring
  • Highly active antiretroviral therapy
  • Patient compliance
  • Patient education
  • Virologic response

Cite this

@article{30bab01e3c6744f2b7d0a50e687dc82f,
title = "Impact of an adherence clinic on behavioral outcomes and virologic response in treatment of HIV infection: A prospective, randomized, controlled pilot study",
abstract = "Objective: The aim of this randomized, controlledpilot study was to examine the impact of a pharmacistoperated adherence clinic on adherence to highly active antiretroviral therapy (HAART) and viral suppression in patients with HIV over 28 weeks. Methods: Consecutive eligible patients initiatingHAART at an indigent-care clinic were randomized to an adherence clinic or to standard care (information provided by physician or nurse practitioner) for education and monitoring. Group assignment was stratified before randomization according to regimen complexity and potential tolerability. Adherence (electronic monitoring and patient self-report) and viral load (reverse-transcription polymerase chain reaction) were assessed at weeks 4, 16, and 28. Results: Thirty-three randomized patients (adherenceclinic, n = 16; standard care, n = 17) comprised the intent-to-treat population. The groups were well-matched for demographics and antiretroviral regimen. The median age was 38.0 years in both groups. Most patients were male (85{\%}), had previously used HAART (78{\%}), and had an AIDS diagnosis (79{\%}). Mean (SD) adherence at weeks 4, 16, and 28 was 86{\%} (27{\%}), 77{\%} (28{\%}), and 74{\%} (31{\%}) in the adherence clinic group versus 73{\%} (32{\%}), 56{\%} (39{\%}), and 51{\%} (41{\%}) in the standard care group (week-16 difference, 21{\%} [90{\%} CI, 1{\%}-42{\%}]; week-28 difference, 23{\%} [90{\%} CI, 1{\%}-44{\%}]). Sixty-nine percent of patients in the adherence clinic group took their medication on schedule versus 42{\%} in the standard care group (P = 0.025); mean decline in adherence from weeks 4 to 28 was 12{\%} in the adherence clinic group (P = 0.15) versus 22{\%} in the standard care group (P = 0.002). HIV-1 RNA levels were <400 copies/mL at weeks 4, 16, and 28 in 63{\%}, 100{\%}, and 94{\%} of the adherence clinic group and 29{\%} (P = NS), 71{\%} (P = 0.04), and 65{\%} (P = NS) of the standard care group. Conclusions: In this preliminary trial, an adherence clinic model improved adherence to HAART and virologic response over 28 weeks in the patients studied.",
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Impact of an adherence clinic on behavioral outcomes and virologic response in treatment of HIV infection : A prospective, randomized, controlled pilot study. / Rathbun, R. Chris; Farmer, Kevin C.; Stephens, Johnny; Lockhart, Staci M.

In: Clinical Therapeutics, Vol. 27, No. 2, 01.01.2005, p. 199-209.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Impact of an adherence clinic on behavioral outcomes and virologic response in treatment of HIV infection

T2 - A prospective, randomized, controlled pilot study

AU - Rathbun, R. Chris

AU - Farmer, Kevin C.

AU - Stephens, Johnny

AU - Lockhart, Staci M.

PY - 2005/1/1

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N2 - Objective: The aim of this randomized, controlledpilot study was to examine the impact of a pharmacistoperated adherence clinic on adherence to highly active antiretroviral therapy (HAART) and viral suppression in patients with HIV over 28 weeks. Methods: Consecutive eligible patients initiatingHAART at an indigent-care clinic were randomized to an adherence clinic or to standard care (information provided by physician or nurse practitioner) for education and monitoring. Group assignment was stratified before randomization according to regimen complexity and potential tolerability. Adherence (electronic monitoring and patient self-report) and viral load (reverse-transcription polymerase chain reaction) were assessed at weeks 4, 16, and 28. Results: Thirty-three randomized patients (adherenceclinic, n = 16; standard care, n = 17) comprised the intent-to-treat population. The groups were well-matched for demographics and antiretroviral regimen. The median age was 38.0 years in both groups. Most patients were male (85%), had previously used HAART (78%), and had an AIDS diagnosis (79%). Mean (SD) adherence at weeks 4, 16, and 28 was 86% (27%), 77% (28%), and 74% (31%) in the adherence clinic group versus 73% (32%), 56% (39%), and 51% (41%) in the standard care group (week-16 difference, 21% [90% CI, 1%-42%]; week-28 difference, 23% [90% CI, 1%-44%]). Sixty-nine percent of patients in the adherence clinic group took their medication on schedule versus 42% in the standard care group (P = 0.025); mean decline in adherence from weeks 4 to 28 was 12% in the adherence clinic group (P = 0.15) versus 22% in the standard care group (P = 0.002). HIV-1 RNA levels were <400 copies/mL at weeks 4, 16, and 28 in 63%, 100%, and 94% of the adherence clinic group and 29% (P = NS), 71% (P = 0.04), and 65% (P = NS) of the standard care group. Conclusions: In this preliminary trial, an adherence clinic model improved adherence to HAART and virologic response over 28 weeks in the patients studied.

AB - Objective: The aim of this randomized, controlledpilot study was to examine the impact of a pharmacistoperated adherence clinic on adherence to highly active antiretroviral therapy (HAART) and viral suppression in patients with HIV over 28 weeks. Methods: Consecutive eligible patients initiatingHAART at an indigent-care clinic were randomized to an adherence clinic or to standard care (information provided by physician or nurse practitioner) for education and monitoring. Group assignment was stratified before randomization according to regimen complexity and potential tolerability. Adherence (electronic monitoring and patient self-report) and viral load (reverse-transcription polymerase chain reaction) were assessed at weeks 4, 16, and 28. Results: Thirty-three randomized patients (adherenceclinic, n = 16; standard care, n = 17) comprised the intent-to-treat population. The groups were well-matched for demographics and antiretroviral regimen. The median age was 38.0 years in both groups. Most patients were male (85%), had previously used HAART (78%), and had an AIDS diagnosis (79%). Mean (SD) adherence at weeks 4, 16, and 28 was 86% (27%), 77% (28%), and 74% (31%) in the adherence clinic group versus 73% (32%), 56% (39%), and 51% (41%) in the standard care group (week-16 difference, 21% [90% CI, 1%-42%]; week-28 difference, 23% [90% CI, 1%-44%]). Sixty-nine percent of patients in the adherence clinic group took their medication on schedule versus 42% in the standard care group (P = 0.025); mean decline in adherence from weeks 4 to 28 was 12% in the adherence clinic group (P = 0.15) versus 22% in the standard care group (P = 0.002). HIV-1 RNA levels were <400 copies/mL at weeks 4, 16, and 28 in 63%, 100%, and 94% of the adherence clinic group and 29% (P = NS), 71% (P = 0.04), and 65% (P = NS) of the standard care group. Conclusions: In this preliminary trial, an adherence clinic model improved adherence to HAART and virologic response over 28 weeks in the patients studied.

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KW - Electronic monitoring

KW - Highly active antiretroviral therapy

KW - Patient compliance

KW - Patient education

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