Trial record 9 of 32 for:    " July 02, 2008":" August 01, 2008"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Healthy Activities for Prize Incentives (HAPI)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT00717444
First received: July 15, 2008
Last updated: July 23, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Substance Abuse
HIV Infections
Behavioral: contingency management
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Healthy Activities for Prize Incentives

Resource links provided by NLM:


Further study details as provided by University of Connecticut Health Center:

Primary Outcome Measures:
  • drug use [ Time Frame: baseline and each follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • physical activity [ Time Frame: baseline and each follow-up ] [ Designated as safety issue: No ]
  • psychological symptoms [ Time Frame: baseline and each follow-up ] [ Designated as safety issue: No ]
  • medical outcomes [ Time Frame: baseline and each follow-up ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: September 2008
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
contingency management for abstinence plus 12-step facilitation therapy and contingency management for completing healthy activities
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: 2
contingency management for abstinence plus 12-step facilitation therapy
Behavioral: contingency management

contingency management for abstinence plus 12-step facilitation therapy

prizes awarded for target behaviors


  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00717444

Locations
United States, Connecticut
Connections, Inc.
Hartford, Connecticut, United States, 06106
Sponsors and Collaborators
University of Connecticut Health Center
Investigators
Principal Investigator: Nancy M Petry, Ph.D. University of Connecticut Health Center
  More Information

No publications provided

Responsible Party: University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT00717444     History of Changes
Other Study ID Numbers: 08-251-2, 1R01DA022739-01A2
Study First Received: July 15, 2008
Last Updated: July 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Connecticut Health Center:
Substance Abuse
HIV
Contingency Management
Physical Activity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
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
Slow Virus Diseases
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014