Intervention Description
Intervention Package Information
Evaluation Study and Results
References and Contact Information

Intervention Description

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

Goals of Intervention

• Improve adherence to antiretroviral therapy

Theoretic Basis

• Paolo Freire's educational model

Intervention Duration
Twenty-four home visits on a schedule of declining frequency over 12 months (weekly for 3 months, biweekly for 3 months, and monthly for 6 months)

Intervention Settings
Residence and community settings

Deliverer
Nurse and community/peer worker pair

Delivery Methods

• Discussion
• Drawing and song
• Goal setting/plan
• Printed material
• Problem solving

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Intervention Package Information

An intervention package is not available at this time. Please contact Karina Danvers, Connecticut AIDS Education and Training Center, Yale School of Nursing, 100 Church Street South, P.O. Box 9740, New Haven, CT 06536, email: karina.danvers@yale.edu for details on intervention materials.

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Evaluation Study and Results

The original evaluation was conducted in New Haven and Hartford Counties, CT between 1999 and 2002

Key Intervention Effects

• Increased medication adherence

Study Sample
The baseline study sample of 171 men and women is characterized by the following:

• 42% White, 35% African American, 19% Hispanic, 4% Other
• 52% Male, 48% Female
• 100% treatment-experienced
• 41% participants with >90% medication adherence measured by MEMS; 70% participants with >90% self-reported medication adherence
• 53% participants with undetectable viral load (<400 copies/mL)

Recruitment Settings
HIV outpatient clinics, community-based organizations, and patient support groups

Eligibility Criteria
Men and women were eligible if they were HIV-infected, English and Spanish speakers, had been prescribed combination therapy with at least 3 antiretroviral agents, and intended to take their medications

Assignment Method
Participants (N = 171) were randomly assigned to 1 of 2 groups: ATHENA intervention (n = 87) or usual care comparison (n = 84)

Comparison Group
Comparison participants received usual care from HIV-dedicated clinical services which were also offered to intervention participants. Usual care included individual review of patient medications by the prescribing clinician and the clinic nurses, assistance with the development of individual medication schedules, identification of strategies to improve adherence, and individualized patient education regarding medication (e.g., dose, side effects, and the need for adherence)

Relevant Outcomes Measured and Assessment Time 

• Medication adherence behavior (recorded using MEMs caps) was defined as the proportion of prescribed doses taken. MEMS cap data was downloaded at each clinic visit (every three months). Medication adherence was categorized as <90% or >90% and was assessed at 3, 6, 9, 12 and 15 months post-initiation of intervention.
• Viral load was measured at 3, 6, 9, 12 and 15 months post-initiation of intervention and was assessed as undetectable (<400 copies/mL) and categorized as <400, 400-10,000, and >10,000 copies/mL.   

Participant Retention

• ATHENA Intervention:

84% retained at 3 months post-initiation of intervention
79% retained at 6 months post-initiation of intervention
68% retained at 9 months post-initiation of intervention
72% retained at 12 months post-initiation of intervention
54% retained at 15 months post-initiation of intervention

• Usual care Control:

87% retained at 3 months post-initiation of intervention
83% retained at 6 months post-initiation of intervention
80% retained at 9 months post-initiation of intervention
75% retained at 12 months post-initiation of intervention
48% retained at 15 months post-initiation of intervention

Significant Findings on Relevant Outcomes

• Over the 12 months post-initiation of intervention, the proportion of participants who demonstrated >90% adherence, as assessed by MEMs caps, was significantly greater in the intervention arm than in the comparison arm (extended Mantel-Haenszel test: 4.61, p =.03; missing data not imputed).*

Considerations

• This study did not meet the best-evidence criteria due to <70% retention rate per arm at each assessment and no imputation of missing data.  Also, the study did not find a significant positive intervention effect on viral load.
• The finding on >90% adherence over the 15 months reported in the publication (extended Mantel-Haenszel test: 5.80, p = .02; missing data not imputed) was not considered as evidence of efficacy because the retention rates at 15 months post-initiation of intervention were <60% in each arm, due to the study closing before all participants had the opportunity to return for the assessment.
• The median number of home visits was 19 out of a possible 24 visits.
• The MEMS cap was placed on one of the participant’s medications, selected at random from all those that required twice a day administration. 
• At baseline, 32% were on a nonnucleoside reverse transcriptase inhibitor (NNRTI)-based regimen and 43% on a protease inhibitor (PI)-based regimen.

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References and Contact Information

• Williams, A. B., Fennie, K. P., Bova, C. A., Burgess, J. D., Danvers, K. A., & Dieckhaus, K. D. (2006). Home visits to improve adherence to highly active antiretroviral therapy: A randomized controlled trial. JAIDS Journal of Acquired Immune Deficiency Syndromes, 42, 314-321.

Researcher: Ann Williams, PhD.
Yale School of Nursing
100 Church Street South
P.O. Box 9740
New Haven, CT 06536
email: ann.williams@yale.edu

* Information obtained from author

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