Healthy Activities for Prize Incentives (HAPI)
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| ClinicalTrials.gov Identifier: NCT00717444 |
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Recruitment Status :
Completed
First Posted : July 17, 2008
Last Update Posted : July 24, 2013
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Sponsor:
UConn Health
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
UConn Health
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Substance Abuse HIV Infections | Behavioral: contingency management | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 75 participants |
| Allocation: | Randomized |
| Intervention Model: | Factorial Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Healthy Activities for Prize Incentives |
| Study Start Date : | September 2008 |
| Actual Primary Completion Date : | May 2013 |
| Actual Study Completion Date : | May 2013 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1
contingency management for abstinence plus 12-step facilitation therapy and contingency management for completing healthy activities
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Behavioral: contingency management
contingency management for abstinence plus 12-step facilitation therapy and contingency management for completing healthy activities prizes awarded for target behaviors |
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Experimental: 2
contingency management for abstinence plus 12-step facilitation therapy
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Behavioral: contingency management
contingency management for abstinence plus 12-step facilitation therapy prizes awarded for target behaviors |
Primary Outcome Measures :
- drug use [ Time Frame: baseline and each follow-up ]
Secondary Outcome Measures :
- physical activity [ Time Frame: baseline and each follow-up ]
- psychological symptoms [ Time Frame: baseline and each follow-up ]
- medical outcomes [ Time Frame: baseline and each follow-up ]
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00717444
Locations
| United States, Connecticut | |
| Connections, Inc. | |
| Hartford, Connecticut, United States, 06106 | |
Sponsors and Collaborators
UConn Health
National Institute on Drug Abuse (NIDA)
Investigators
| Principal Investigator: | Nancy M Petry, Ph.D. | UConn Health |
| Responsible Party: | UConn Health |
| ClinicalTrials.gov Identifier: | NCT00717444 History of Changes |
| Other Study ID Numbers: |
08-251-2 1R01DA022739-01A2 ( U.S. NIH Grant/Contract ) |
| First Posted: | July 17, 2008 Key Record Dates |
| Last Update Posted: | July 24, 2013 |
| Last Verified: | July 2013 |
Keywords provided by UConn Health:
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Substance Abuse HIV Contingency Management Physical Activity |
Additional relevant MeSH terms:
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HIV Infections Substance-Related Disorders Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Chemically-Induced Disorders Mental Disorders |