Healthy Activities for Prize Incentives
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| City: |
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Hartford |
| State: |
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Connecticut |
| Zip Code: |
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06106 |
| Conditions: |
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Substance Abuse - HIV Infections |
| Purpose: |
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In this Stage 1 therapy development project, we plan to develop, formalize, and derive
effect size estimates of a contingency management (CM) therapy that focuses on improving
health, especially as related to increasing low intensity physical activities, such as
walking, resistance training, and stretching. The Healthy Activities for Prize Incentives
(HAPI) intervention will be targeted toward and tested within HIV-positive substance abusers
who attend HIV drop-in centers. After initial therapy development in a Stage 1a pilot
project with 9 patients, the therapy manuals and materials will be adapted and refined. In a
Stage 1b controlled trial, we will recruit and randomize 70 substance abusing HIV-positive
patients to (a) HAPI plus 12-step facilitation therapy or (b) contingency management for
abstinence plus 12-step facilitation therapy. Each intervention will consist of one weekly
individual therapy session for 16 weeks. All participants will provide urine and breath
specimens twice weekly that will be tested for opioids, cocaine, methamphetamine, marijuana
and alcohol. Patients in both conditions will earn the chance to win prizes for submitting
drug-negative specimens, and those randomized to the HAPI condition will also earn the
chance to win prizes for engaging in healthy activities. Physical activity levels, drug use,
psychological symptoms, and subjective and objective indicators of health (body mass index,
waist circumference, blood pressure, viral load) will be measured pre-treatment and at
months 2 and 4 (post-treatment), as well as at a 7-month (3 months after treatment)
follow-up evaluation. Compared to those receiving 12-step facilitation with contingency
management for abstinence, we expect that those in the HAPI condition will participate in
more physical activities, decrease drug use to a greater extent, evidence reduced
depression, and show trends toward improvements in health indices. If effect sizes in at
least the small to medium range are noted across all domains, we will consider the therapy
appropriate for further evaluation in a Stage 2 therapy development study.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- HIV+ and a member of Connections
- Age 18-65 years
- English speaking
- Past-year DSM-IV diagnosis of opioid, cocaine, methamphetamine, alcohol, or marijuana
abuse or dependence
- Written permission from one's primary care or infectious disease physician to
participate in the study and an exercise program
- Plans to reside in the local area for the next 8 months and
- Willing to sign informed consent
Exclusion Criteria:
- Inability to comprehend the study as assessed by the Informed Consent Quiz and
Mini-Mental Status Exam (MMSE)
- Severely disruptive behavior
- In recovery for pathological gambling (due to potential similarity between the
contingency management procedure and gambling)
- Serious uncontrolled psychiatric disorder other than substance use disorders that
require inpatient hospitalization (e.g., active bipolar disorder, psychosis,
suicidal)
- History of myocardial infarction, stroke, unstable angina, coronary artery bypass
grafting, angioplasty/stent, uncontrolled arrhythmia, or hyperthyroidism in the past
6 months as reported by patient or physician
- Blood pressure >165/95 mmHg and
- Grossly abnormal findings on indices of physical functioning (>2 SDs above means for
sedentary age/gender norms according to ACSM, 2006)
- Pregnancy
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| NCT ID: |
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NCT00717444 |
| Primary Contact: |
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Principal Investigator
Nancy M Petry, Ph.D.
University of Connecticut Health Center
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| Backup Contact: |
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N/A |
| Location Contact: |
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Hartford, Connecticut 06106
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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