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Healthy Activities for Prize Incentives (HAPI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00717444
Recruitment Status : Completed
First Posted : July 17, 2008
Last Update Posted : July 24, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

July 15, 2008
July 17, 2008
July 24, 2013
September 2008
May 2013   (Final data collection date for primary outcome measure)
drug use [ Time Frame: baseline and each follow-up ]
  • drug use [ Time Frame: baseline and each follow-up ]
  • 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 ]
Complete list of historical versions of study NCT00717444 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Healthy Activities for Prize Incentives
Healthy Activities for Prize Incentives
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Substance Abuse
  • HIV Infections
  • Behavioral: contingency management

    contingency management for abstinence plus 12-step facilitation therapy

    prizes awarded for target behaviors

  • Behavioral: contingency management

    contingency management for abstinence plus 12-step facilitation therapy and contingency management for completing healthy activities

    prizes awarded for target behaviors

  • Experimental: 1
    contingency management for abstinence plus 12-step facilitation therapy and contingency management for completing healthy activities
    Intervention: Behavioral: contingency management
  • Experimental: 2
    contingency management for abstinence plus 12-step facilitation therapy
    Intervention: Behavioral: contingency management
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
May 2013
May 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00717444
08-251-2
1R01DA022739-01A2 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
UConn Health
UConn Health
National Institute on Drug Abuse (NIDA)
Principal Investigator: Nancy M Petry, Ph.D. UConn Health
UConn Health
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP