Centralized Off-Site Adherence Enhancement Program

Patients who use drugs or alcohol who do not adequately adhere to antiretroviral medication
have sub-optimal outcomes, but effective interventions for them are lacking. In this R34
application, we seek to develop and pilot an intervention program delivered by phone and
supported by information technology that combines contingency management for medication
adherence and a cognitive-behavioral approach to both adherence to antiretroviral therapy
and abstinence from substances of abuse. The intervention, CARE (Centralized Off-site
AdheRence Enhancement Program), builds on the published finding that adherence was robustly
improved and viral load was significantly reduced among patients who received
cash-reinforcement for opening MEMS-capped bottles to take prescribed medication on time.
CARE involves transmission of bottle-opening data with real time operation from SimPill
bottles to a website system which generates messages to patients indicating the amount of
cash-reinforcement earned if medication was taken within a specified time window or forsaken
if medication was missed. Reinforcement for medication-taking will be wired to debit cards
that patients will be given to receive the payments. This contingent reinforcement of
medication-taking will be coupled with twelve sessions of cognitive-behavioral therapy (CBT)
conducted by phone, also assisted by the website which will generate CBT-related text
messages, reminders and scheduling information from a menu of choices negotiated by the
patient and therapist. Development of CARE will proceed in three stages, with revisions of
the intervention at each stage. First, the web system and therapy manuals will be developed.
Second, twelve weeks of CARE will be pre-piloted in 10 patients with sub-optimal adherence
and recent risky alcohol use and/or stimulant misuse. Qualitative and quantitative data will
be collected concerning acceptability, usability and perceived efficacy of components of
CARE; Procedures and logistics will be evaluated, and modified, if necessary. Third, CARE
will be pilot-tested in a twelve-week randomized controlled trial in which the control arm
only involves phone-based counseling focusing first on adherence and then on abstinence.
Retention of effects will be examined during a twelve-week follow-up period. CARE has the
potential to be among the first interventions that delivers both reinforcement and
counseling remotely, that improves outcomes among substance users without providing opioid
substitution or other extremely intensive interventions, and that utilizes a
cognitive-behavioral approach targeting both non-adherence and substance abuse. Because CARE
is delivered by a therapist who is off-site from the patient's clinic, CARE can be
effectively delivered from any distance and is a scalable treatment for patients in whom
medication adherence is crucial.

Inclusion Criteria:

- Current treatment with antiretroviral medications

- Within the last sixty days, either (a) Self-reported risky alcohol use (defined as
>14 drinks/week or >4 drinks/occasion for men 65 or younger; >7 drinks/week or >3
drinks/occasion for women); OR (b) >=two days of either cocaine or amphetamine use

- Able to provide voluntary informed consent as evidenced by ability to answer
questions about the consent form

- Able and willing to use SimPill caps to store at least one antiretroviral medication

Exclusion Criteria:

- Physiological dependence on alcohol, illicit opioids or sedatives as assessed by the
history and symptom review procedures

- Dispensed medications in a monitored setting

- Unable to speak English. The need for bilingual staff and cross-coverage to enroll
monolingual Hispanic people is beyond this study's scope.

- Will not be able to complete the study because of anticipated incarceration or move