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Compendium of Evidence-Based Interventions and
Best Practices for HIV Prevention

Directly Administered Antiretroviral Therapy (DAART) in a Methadone Clinic

GOOD-EVIDENCE

Intervention Description

Target Population
HIV-positive injection drug users in treatment who are antiretroviral treatment-experienced or -naïve

Goals of Intervention

  • Improve adherence to antiretroviral therapy
  • Improve virologic and immunologic responses to antiretroviral therapy (HIV viral load and CD4 cell count)

Brief Description

Brief Description
DAART in a Methadone Clinic is an individual-level intervention. A nurse or medical assistant observes patients taking their HIV medications in a private room that is distinct from the methadone-dispensing window each morning the patients attend the methadone clinic. Evening doses and doses to be taken on methadone take-home days are prepackaged and given to patients for self-administration. An emergency 3-day packet of medications is provided in case of a missed methadone visit. The treatment goal is to provide DAART for at least 1 year, but if patients wish, they can continue DAART for longer.

Theoretic Basis

  • None specified

Intervention Duration
Every morning of methadone clinic visit, over at least one year

Intervention Setting
Methadone clinic

Deliverer
Nurse or medical assistant

Delivery Methods

  • Directly observed medication administration

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Intervention Package Information

An intervention package is not available at this time. Please contact Gregory M. Lucas, PhD., 1830 E. Monument St., Rm. 421, Baltimore, MD 21287, email: glucas@jhmi.edu, for details on intervention materials.

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Evaluation Study and Results

The original evaluation was conducted in Baltimore, MD between 2001 and 2003.

Key Intervention Effects

  • Reduced viral load
  • Achieved undetectable viral load

Study Sample
The baseline study sample of 891 men and women is characterized by the following:

  • 79% African American
  • 65% Male, 35% Female
  • Median age of 43 years, range: 38-49
  • 27% treatment-naïve
  • Median viral load = 100,000, range: 20,000-250,000
  • 100% participants with detectable viral load (>500 copies/mL)

Recruitment Settings
Methadone clinic and HIV clinic

Eligibility Criteria
DAART intervention participants were HIV infected men and women ≥18 years of age who had a regular HIV treatment provider, had received methadone therapy for >30 days with no plans to discontinue, were starting a first or subsequent HAART regimen in which doses were not administered more frequently than twice daily, had a detectable HIV-1 RNA viral load (>500 copies/mL) at baseline, and did not have known triple-class antiretroviral drug resistance (as determined from a prior resistance test performed in clinical practice). All comparison participants were HIV infected men and women ≥18 years of age who were starting a first or subsequent HAART regimen on or after January 1, 2001, had a detectable HIV-1 RNA viral load (>500 copies/mL) at baseline, and did not have known triple-class antiretroviral drug resistance (using the same genotypic criteria as the DAART intervention participants).

Assignment Method
Participants (N = 891) were from 1 of 2 groups: DAART Intervention (3 clinics; n = 82 participants) or a non-concurrent comparison (1 clinic; n = 809 participants). Participants in the non-concurrent comparison were divided into 3 groups based on participant characteristics: IDU-methadone group [n = 75], IDU-non-methadone group [n = 244], and non-IDU group [n = 490]).  

Comparison Groups
The IDU-methadone comparison group received methadone therapy, HAART, and usual clinical care. The IDU-nonmethadone and non-IDU comparison groups received HAART and usual clinical care.

Relevant Outcomes Measured and Assessment Time 

  • Viral load was measured at 6 and 12 months post-initiation of intervention and was assessed as log10 copies/mL and as undetectable (<400 copies/mL).

Participant Retention

  • DAART Intervention:
    94% retained at 6 months post-initiation of intervention*
    74% retained at 12 months post-initiation of intervention*
  • IDU-methadone Comparison:
    97% retained at 6 months post-initiation of intervention*
    83% retained at 12 months post-initiation of intervention*
  • IDU-nonmethadone Comparison:
    97% retained at 6 months post-initiation of intervention*
    86% retained at 12 months post-initiation of intervention*
  • Non-IDU Comparison:
    94% retained at 6 months post-initiation of intervention*
    82% retained at 12 months post-initiation of intervention*

Significant Findings on Relevant Outcomes

  • The decrease from baseline in median log10 viral load level at 6 months post-initiation of intervention was significantly greater among the DAART intervention participants than the IDU-methadone comparison participants (2.5 vs. 1.3 log10 copies/mL, p = .001; missing data imputed).
  • The proportion of participants achieving an undetectable viral load (<400 copies/mL) was significantly higher in the DAART intervention arm than IDU-methadone comparison arm at 6 months post-initiation of intervention (74% vs. 41%, p <.001, missing data imputed; 78% vs. 52%, p = .002, without imputation). 

Considerations

  • This study did not meet the best-evidence criteria due to a quasi-prospective study design, non-concurrent comparison, non-randomized allocation with moderate bias, no adjustment for cluster allocation (i.e., clinic), and no measurement of medication adherence behaviors.
  • Two significant findings reported in the publication did not meet all the efficacy criteria because the attrition plus missing data for the IDU-methadone comparison arm at the 12-month assessment were 47%, which exceeds the <40% requirement.
    • At 12 months, the percentage of participants achieving an undetectable viral load (<400 copies/mL) was significantly higher in the DAART intervention arm than the IDU-methadone comparison arm (56% vs. 32%, p = .009; missing data imputed)
    • At both 6 and 12 months, the DAART participants were significantly more likely to achieve viral suppression (<400 copies/mL) than the IDU-methadone comparison participants (OR = 0.3, 95% CI = 0.2 to 0.6; p < .05; without imputation).   
  • The DAART Intervention participants had a significantly greater median increase in CD4 cell count at 12 months than IDU-methadone comparison participants (74 vs. 21 cells/mm3, p = .04; missing data imputed). No significant effect on CD4 cell count at the 6-month assessment.
  • The DAART Intervention participants has a significantly greater median decrease in viral load at 6 months than the other two comparison arms (IDU-nonmethadone arm, p = .001;non-IDU arm, p = .05).
  • At baseline, a significantly larger percentage of the IDU-methadone participants took NNRTI than the DAART intervention participants (31% vs. 14%, p < .05).

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References and Contact Information

  • Lucas, G. M., Mullen, B. A., Weidle, P. J., Hader, S., McCaul, M. E., & Moore, R. D. (2006). Directly administered antiretroviral therapy in methadone clinics is associated with improved HIV treatment outcomes among concurrent comparison groups. Clinical Infectious Diseases, 42, 1628-1635.

Researcher: Gregory Lucas, PhD.
Department of Medicine
Johns Hopkins University
E. Monument St., Rm. 421
Baltimore, MD 21287
email: glucas@jhmi.edu

*Information obtained from author

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