Kevin D. Dieckhaus

Cue-dose Training with Monetary Reinforcement: Pilot Study of an Antiretroviral Adherence Intervention

AbstractOBJECTIVE: To assess the feasibility and efficacy of two interventions for improving adherence to antiretroviral therapy regimens in HIV-infected subjects compared with a control intervention. DESIGN: Randomized, controlled, pilot study. SETTING: Department of Veterans Affairs HIV clinic and community-based HIV clinical trials site. PARTICIPANTS: Fifty-five HIV-infected subjects on stable antiretroviral therapy regimens. Subjects were predominantly male (89%) and African American (69%), and had histories of heroin or cocaine use (80%). INTERVENTIONS: Four weekly sessions of either nondirective inquiries about adherence (control group, C), cue-dose training, which consisted of the use of personalized cues for remembering particular dose times, and feedback about medication taking using Medication Event Monitoring System (MEMS) pill bottle caps, which record time of bottle opening (CD group), or cue-dose training combined with cash reinforcement for correctly timed bottle opening (CD+CR). MEASUREMENTS: Opening of the pill bottle within 2 hours before or after a predetermined time was measured by MEMS. RESULTS: Adherence to the medication as documented by MEMS was significantly enhanced during the 4-week training period in the CD+CR group, but not in the CD group, compared with the control group. Improvement was also seen in adherence to antiretroviral drugs that were not the object of training and reinforcement. Eight weeks after training and reinforcement were discontinued, adherence in the cash-reinforced group returned to near-baseline levels. CONCLUSIONS: Cue-dose training with cash reinforcement led to transient improvement in adherence to antiretroviral therapy in a population including mostly African Americans and subjects with histories of drug abuse. However, we were not able to detect any sustained improvement beyond the active training period, and questions concerning the timing and duration of such an intervention require further study. Randomized, controlled clinical studies with objective measures of adherence can be conducted in HIV-infected subjects and should be employed for further evaluation of this and other adherence interventions.

Use of Electronic Monitoring Devices to Measure Antiretroviral Adherence: Practical Considerations

The purpose of this paper is to describe electronic monitoring device (EMD) (e.g., MEMS caps) use among HIV-infected adults enrolled in a randomized clinical trial and to make explicit some of the benefits and caveats of using electronic monitoring device technology. This is a descriptive, exploratory study of EMD use among 128 HIV-infected adults treated with at least three antiretroviral agents. Thirty-six percent of the sample admitted that they did not use the EMD consistently. Forty-one percent of the subjects reported taking out more than one dose at a time and 26% reported opening the EMD but not taking the medication. Special subject-related issues accounted for only a small percentage of all reported problems with EMD use (e.g., transient housing, incarceration, substance abuse relapse and drug treatment). Results of this study suggest that EMDs may underestimate antiretroviral adherence among HIV-infected adults. Recommendations for improving EMD data quality are presented.

Home visits to improve adherence to highly active antiretroviral therapy : A randomized controlled trial

Background: Few rigorously designed studies have documented the efficacy of interventions to improve medication adherence among patients prescribed highly active antiretroviral. Data are needed to justify the use of limited resources for these programs. Methods: A 2-arm, randomized, controlled trial evaluated the efficacy of a community-based, home-visit intervention to improve medication adherence. Participants were 171 HIV-infected adults prescribed a minimum of 3 antiretroviral agents. The majority had a past or current history of substance abuse. Subjects were randomly assigned to receive home visits for 1 year or usual care. Medication adherence was assessed with Medication Event Monitoring stem caps at 3-month intervals from randomization through 3 months after the conclusion of the intervention. Results: A larger proportion of subjects in the intervention group demonstrated adherence greater than 90% compared with the control group at each time point after baseline. The difference over time was statistically significant (Extended Mantel-Haenszel test: 5.80, P = 0.02). A statistically significant intervention effect on HIV-RNA level or CD4 cell count was not seen, but there was a statistically significant association between greater than 90% adherence and an undetectable HIV-RNA over time (P < 0.03). Conclusion: Home visits from a nurse and a community worker were associated with medication adherence greater than 90% among a cohort of socially vulnerable people living with HIV/AIDS in northeastern United States.

Group-Based Randomized Trial of Contingencies for Health and Abstinence in HIV Patients

OBJECTIVE Contingency management (CM) treatments are usually applied individually for drug abstinence, but CM can also be targeted toward health behaviors and implemented in groups. This study evaluated effects of a group-based CM intervention that focused on reinforcing health behaviors. METHOD HIV-positive patients with cocaine or opioid use disorders (n = 170) were randomized to weekly CM or 12-step (TS) groups for 24 weeks (mean attendance was 10.8 +/- 8.1 sessions for CM participants and 9.0 +/- 6.9 session for TS participants). During the treatment period, both groups received compensation for attendance (

An analysis of electronically monitored adherence to antiretroviral medications.

10 per session) and submission of urine samples (about

INFECTION CONTROL CONCEPTS IN CRITICAL CARE

2 per sample). In addition, participants received

Maternal and congenital syphilis in rural Haiti

25 for submitting samples and completing evaluations at Months 1, 3, 6, 9, and 12; 65-75 of the 81 participants assigned to TS and 71-80 of the 89 participants assigned to CM completed these evaluations. During the treatment period, patients in the CM group received chances to win prizes contingent upon completing health activities and submitting substance-free specimens (M =

Proactive infectious disease approach to dermatologic patients who are taking tumor necrosis factor–alfa antagonists: Part I. Risks associated with tumor necrosis factor–alfa antagonists

260, SD =

Clinical implications of elevated HIV-1 viral load results obtained from samples stored frozen in vacutainer plasma preparation tubes

267). RESULTS Mean attendance was 10.8 +/- 8.1 sessions for CM participants and 9.0 +/- 6.9 sessions for TS participants. CM participants submitted a significantly greater number of consecutive drug-free specimens than did TS participants (5.2 +/- 6.0 vs. 3.7 +/- 5.6), but proportions of negative samples did not differ between groups during treatment or at follow-up evaluations. From pre- to posttreatment, CM participants showed greater reductions in viral loads and HIV-risk behaviors than did TS participants, but these effects were not maintained throughout the follow-up period. CONCLUSIONS These data suggest the efficacy of group-based CM for HIV-positive substance abusers, but more research is needed to extend the long-term benefits.

Cytomegalovirus hepatitis in a nontransplant patient with autoimmune hepatitis taking immunosuppressants

Medication adherence studies increasingly collect data electronically, often using Medication Event Monitoring System (MEMS) caps. Analyses typically focus on summary adherence measures, although more complete analyses are possible using adaptive statistical methods. These methods were used to describe individual-subject adherence patterns for MEMS data from a clinical trial. Subjects were adaptively clustered into groups with similar adherence patterns and clusters were compared on a variety of subject characteristics. There were seven different adherence clusters: consistently high, consistently moderately high, consistently moderate, consistently moderately low, consistently low, deteriorating starting early, and deteriorating late. Compared to other subjects, subjects with consistently high and consistently moderately high adherence were more likely to be male, White, and older and to maintain during study participation a CD4 cell count over 500 and an HIV viral load of at most 400 copies/ml. These results demonstrate the effectiveness of adaptive methods for comprehensive analysis of MEMS data.