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

Helping Enhance Adherence to Antiretroviral Therapy (Project HEART)

GOOD-EVIDENCE

Intervention Description

Target Population
HIV-positive clinic patients who are antiretroviral treatment-naïve

Goals of Intervention

  • Improve initial adherence to antiretroviral therapy
  • Improve virologic outcomes (HIV viral load)

Brief Description

Brief Description
Project HEART is a 5-session individual/dyadic and group-level intervention. The social support/problem-solving intervention includes 5 individual/dyadic sessions delivered just before (2 sessions) and in the first two months after (3 sessions) initiation of antiretroviral therapy. The first two sessions substitute for standard of care pre-medication adherence counseling. There was also one booster session delivered at 6 months after initiation of medication. Participants are also contacted by phone five times between intervention sessions. Intervention sessions include a patient-identified support partner, who is required to attend at least 2 of the first 4 sessions, one of which needs to be a pre-medication session. Patients and support partners work through a series of problem-solving activities to identify and address adherence barriers. Patients (with or without support partners) are required to attend at least 2 of 6 rotating group educational sessions during the first 6 months. Session 1 includes (a) a structured adjunct needs assessment (housing, food, clinical management, dental, mental health, spiritual counseling, drug use, social work, child care, pharmacy, nutrition, financial, legal, or visiting nurse); (b) detailed medication education; and (c) mapping of the patient’s daily schedule, followed by tailoring the medication regimen to correspond with regularly occurring events or cues. Session 2 begins with a detailed examination of the practice experience, with an emphasis on identifying whether certain dosing times or days proved more difficult, the context of each dosing time (e.g., what happened just before, during, and after; where they were; who was present), the nature of the adherence barrier, and whether barriers varied or were consistent across days. The regimen schedule is adjusted if necessary, and the major potential barriers to adherence are identified. Strategies to overcome the barriers are generated through discussion with patient and partner, and an individualized adherence plan including these strategies is created. At each subsequent meeting (Sessions 3-6), the interventionist follows the Semi-Structured Interview for Developing Medication Adherence Plans (SIDMAP) to review current circumstances and barriers, evaluate whether the strategies have been enacted and are working, generate new strategies if necessary, and update the list of barriers. An abbreviated version of the SIDMAP is used in the brief follow-up calls between intervention sessions to calibrate the individualized adherence plan. Participants used the MEMS SMART cap, which provides three electronic cues: (a) an optional programmable beeper, (b) an indicator of the number of times the bottle has been opened that day, and (c) an indicator of the number of hours since the bottle was last opened.

Theoretic Basis

  • Problem-solving model
  • Self-determination theory
  • Social support model

Intervention Duration
Five sessions: two 2 – 3 hour sessions just prior to beginning medication; three 1.5 hour sessions (range, 45 minutes to 2 hours) at weeks 2, 4, and 8 following medication initiation, with 5 support phone calls between sessions (weeks 1, 6, and 10 and months 4 and 5 after) and a 1.5 hour booster session at 6 months.

Intervention Settings
Public HIV primary care outpatient clinic

Deliverer
A nurse interventionist, group discussion facilitator, and access to a peer advocate

Delivery Methods

  • Discussion
  • Individualized adherence plan
  • Practice
  • Video
  • Problem solving

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Intervention Package Information

An intervention package is not available at this time. Please contact Linda J. Koenig, PhD., Centers for  Disease Control and Prevention, 1600 Clifton Road, Mailstop D-21 Atlanta, GA 30333, email: LKoenig@cdc.gov, for details on intervention materials.

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Evaluation Study and Results

The original evaluation was conducted in Atlanta, GA between 1999 and 2002.

Key Intervention Effect

  • Achieved medication adherence

Study Sample
The baseline study sample of 226 men and women is characterized by the following:

  • 83% African American, 12% white, 3% Other, 2% Hispanic
  • 64% Male, 36% Female
  • 58% heterosexual, 32% gay or lesbian, 8% were bisexual, 1% undecided
  • Median age of 37 years, range: 31-43 years
  • 69% completed high school education or more
  • 100% treatment-naïve
  • Median viral load =  145,890 copies/mL, range: 600-750,000
  • 100% participants with detectable viral load (>400 copies/mL)

Recruitment Setting
Public HIV primary care outpatient clinic

Eligibility Criteria
Men and women were eligible if they were ≥18 years of age, receiving care for HIV at a local clinic, were newly prescribed HAART by their doctor but who had never previously taken a protease inhibitor, not currently self-reporting hard drug use, not pregnant or incarcerated, life expectancy of ≥12 months, and able to understand English and the consent form.

Assignment Method
Participants (N = 236) were randomly assigned to 1 of 2 groups: HEART Intervention (n = 116) or enhanced standard of care (n = 120).

Comparison Group
Comparison participants received standard-of-care adherence counseling, including a minimum of two preparatory sessions provided by education nurses, followed by dispensing of medications. Education nurses were available to meet with patients for additional sessions on patient or provider request. Participants also watched a 10-minute educational video with their support partner, the same activity that intervention participants received, which constituted the enhanced component.

Relevant Outcomes Measured and Assessment Time

  • Medication adherence behavior (recorded by MEMS caps) was defined as the proportion of doses taken among doses prescribed. Medication adherence was categorized as <90% or >90% and assessed monthly for 6 months post-initiation of intervention.
  • Viral load was measured at 3 and 6 months post-initiation of intervention. Virologic success was defined as undetectable (<400 copies/mL) or achieving at least a 1-log10 drop in viral load.

Participant Retention

  • HEART Intervention:
    73% retained at 3 months post-initiation of intervention*
    70% retained at 6 months post-initiation of intervention*
  • Enhanced standard-of-care Control:
    70% retained at 3 months post-initiation of intervention*
    57% retained at 6 months post-initiation of intervention*

 Significant Findings on Relevant Outcomes

  • At 3-months post-initiation of intervention, a significantly greater proportion of intervention participants achieved ≥ 90% adherence, as assessed by MEMs caps, than comparison participants  (46% vs. 28%, OR = 2.40, 95% CI = 1.35 to 4.27, p = .0028; missing data imputed; 61% vs. 42%; OR = 2.41, 95% CI = 1.24 to 4.67, p = .0094: without imputation).*

Considerations

  • This study did not meet the best-evidence criteria due to assessment time point < 6 months post-initiation of intervention for the significant intervention effect.  Also, the study did not find a significant positive intervention effect on either viral load measure.
  • Several significant findings reported in the publication did not meet all the efficacy criteria:
    • A significantly larger proportion of intervention participants achieved ≥ 90% adherence than comparison participants (OR = 1.69, 95% CI = 1.08 to 2.64; p = .021: missing data imputed; OR = 1.66; 95% CI = 1.01 to 2.73; p = .04; missing data not imputed) using a weighted average across the 6 monthly assessments. However, this finding included the 6-month assessment, which had a retention rate for the standard-of-care comparison group that did not meet criterion.
    • A significantly larger percentage of intervention participants had undetectable viral load (<400 copies/mL) relative to comparison participants (OR = 1.65; 95% CI = 1.02 to 2.66; p = .04; missing data imputed) across 3- and 6-month post-initiation of intervention assessments. However, the retention rate for the standard-of-care comparison group at the 6-month assessment did not meet criterion. The re-analysis of this outcome at only the 3-month assessment provided by the authors did not show statistical significance (OR = 1.38, 95% CI = 0.78 to 2.42, p = .27; missing data imputed).*  The same analysis was also not significant when using observed data only.
  • The proportion of 90% adherent participants declined steadily and significantly over time.
  • MEMS caps were placed on one pill vial for each participant; protease inhibitor was the drug selected for 85% of participants.

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References and Contact Information

  • Koenig, L.J., Pals, S.L., Bush, T., Pratt Palmore, M., Stratford, D., & Ellerbrock, T. V. (2008). Randomized controlled trial of an intervention to prevent adherence failure among HIV-infected patients initiating antiretroviral therapy. Health Psychology, 27, 159-169.

Researcher: Linda J. Koenig, PhD.
Centers for Disease Control and Prevention
1600 Clifton Road, Mailstop D-21
Atlanta, GA 30333
email: lek5@cdc.gov 

*Information obtained from author

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