Concern about adherence to anti-retroviral therapy is at the forefront of HIV care. This concern is paramount in methamphetamine and other drug-dependent individuals, who are at high risk for non-adherence. Restriction in use of newer therapies is a common response among HIV clinicians, at least until there is stable abstinence from drugs, but relapse rates are high and few data are available to guide therapeutic efforts. This study has two objectives. First, to conduct a three-arm randomized clinic trial comparing the efficacy of Usual Medical Care to two alternatives for facilitating adherence to anti-retrovirals in HIV-infected, methamphetamine-dependent persons in early recovery. One intervention is Adherence Training alone, and the other combines Adherence Training with Stimulant Relapse Prevention. The second objective is to relate adherence to neurocognitive status, anti-retroviral experience, life adversity, psychiatric disorder and substance use. The proposed Adherence and Stimulant Relapse Prevention Interventions are based on the Information-Motivation-Behavioral Skills Model (IMB). Subjects (N=75 in each arm) will be randomized into eight weeks of Usual Medical Care, or into either of two experimental treatments (Adherence Training + Usual Care vs. Adherence Training + Stimulant Relapse Prevention + Usual Care). Efficacy will be determined at conclusion of treatment (e.g., 2 months post-baseline), and four and six months post-baseline. At baseline, end of treatment, and four and six months after baseline the investigators will measure self-report adherence, HIV RNA, urine toxicology, substance use, life quality, and neuropsychiatric status. Adherence to anti-retrovirals will be measured by continuous electronic monitoring (Medication Event Monitoring System-MEMS), and serum anti-retroviral drug concentrations. The investigators hypothesize that Adherence Training + Relapse Prevention will outperform Adherence Training, and Adherence Training will outperform Usual Care. They hypothesize that neurocognitive impairment and stimulant use will predict non-adherence, as will antisocial personality disorder, mood disorder, antisocial personality, and substance use predict non-adherence, and subsequent elevated plasma HIV RNA and reduced life quality.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Research Project (R01)
Project #
5R01DA012800-02
Application #
6378944
Study Section
Special Emphasis Panel (ZRG1-VACC (05))
Program Officer
Davenny, Katherine
Project Start
2000-08-01
Project End
2004-07-31
Budget Start
2001-08-01
Budget End
2002-07-31
Support Year
2
Fiscal Year
2001
Total Cost
$306,863
Indirect Cost
Name
University of California San Diego
Department
Psychiatry
Type
Schools of Medicine
DUNS #
077758407
City
La Jolla
State
CA
Country
United States
Zip Code
92093