Recent illicit drug use is associated with non- compliance to prescribed regimens. In a pilot study, we found that contingent monetary reinforcement of medication compliance, with compliance measured by specialized pill caps which record date and time of bottle opening (MEMS), enhanced compliance. We propose a follow-up randomized clinical trial to evaluate an incentive-based intervention in drug-users. The intervention differs from that in the prior study in that it is longer in duration, more specifically addresses concomitant drug use, uses non-cash reinforcement and more broadly addresses barriers to compliance by providing MEMS-Feedback Therapy. The short-term application of contingencies is designed to """"""""prime"""""""" compliance to prescribed antiretroviral medications, allow secondary reinforcers (e.g. improved well-being) to become apparent and engage patients in MEMS-Feedback Therapy. One hundred patients with recent substance use and MEMS-demonstrated non-compliance during a baseline evaluation will be randomly assigned to either: 1) Control intervention: supportive advice around self-reported compliance and advice around the use of cues or 2) Incentives combined with MEMS-Feedback Therapy (IMF group) IMF patients will be reinforced for MEMS-verified compliance on an escalating schedule with vouchers. IMF patients will review their MEMS- generated printouts with therapists. Patients are encouraged to discuss what they thought, how they felt and what they were doing around the times that doses were missed. Onsite toxicology testing and substance abuse calendar review are used to explore temporal and other relationships between MEMS-demonstrated non- compliance and substance use. Training will be for 16 weeks. Retention of effects will be studied during an additional 16-week follow-up period when patients will download MEMS data at regularly scheduled clinic visits without receiving additional counseling. The primary outcome measure will be MEMS-measured compliance. Secondary outcome measures will include measures of service utilization and cost. Important process measures will be whether IMF (cues to remember doses, changes in substance use). A secondary aim will be to evaluate the temporal concordance between use of substances and medication non-compliance.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Research Project (R01)
Project #
1R01DA015215-01
Application #
6464159
Study Section
Special Emphasis Panel (ZDA1-MXG-S (03))
Program Officer
Mcnamara-Spitznas, Cecilia M
Project Start
2002-06-15
Project End
2005-05-31
Budget Start
2002-06-15
Budget End
2003-05-31
Support Year
1
Fiscal Year
2002
Total Cost
$286,901
Indirect Cost
Name
Yale University
Department
Psychiatry
Type
Schools of Medicine
DUNS #
082359691
City
New Haven
State
CT
Country
United States
Zip Code
06520
Erlen, Judith A; Tamres, Lisa K; Reynolds, Nancy et al. (2015) Assessing usual care in clinical trials. West J Nurs Res 37:288-98
Petersen, Maya L; LeDell, Erin; Schwab, Joshua et al. (2015) Super Learner Analysis of Electronic Adherence Data Improves Viral Prediction and May Provide Strategies for Selective HIV RNA Monitoring. J Acquir Immune Defic Syndr 69:109-18
Simoni, Jane M; Huh, David; Wang, Yan et al. (2014) The validity of self-reported medication adherence as an outcome in clinical trials of adherence-promotion interventions: Findings from the MACH14 study. AIDS Behav 18:2285-90
Rosen, M I; Black, A C; Arnsten, J H et al. (2013) Association between use of specific drugs and antiretroviral adherence: findings from MACH 14. AIDS Behav 17:142-7
Wilson, Ira B; Bangsberg, David R; Shen, Jie et al. (2013) Heterogeneity among studies in rates of decline of antiretroviral therapy adherence over time: results from the multisite adherence collaboration on HIV 14 study. J Acquir Immune Defic Syndr 64:448-54
Liu, Honghu; Wilson, Ira B; Goggin, Kathy et al. (2013) MACH14: a multi-site collaboration on ART adherence among 14 institutions. AIDS Behav 17:127-41
Simoni, Jane M; Huh, David; Wilson, Ira B et al. (2012) Racial/Ethnic disparities in ART adherence in the United States: findings from the MACH14 study. J Acquir Immune Defic Syndr 60:466-72
Genberg, Becky L; Wilson, Ira B; Bangsberg, David R et al. (2012) Patterns of antiretroviral therapy adherence and impact on HIV RNA among patients in North America. AIDS 26:1415-23
Wagner, Glenn J; Goggin, Kathy; Remien, Robert H et al. (2011) A closer look at depression and its relationship to HIV antiretroviral adherence. Ann Behav Med 42:352-60
Black, Ryan A; Serowik, Kristin L; Rosen, Marc I (2009) Associations between impulsivity and high risk sexual behaviors in dually diagnosed outpatients. Am J Drug Alcohol Abuse 35:325-8

Showing the most recent 10 out of 12 publications