Healthy Activities for Prize Incentives - Full Text View

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:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

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 (Adult)
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

National Institute on Drug Abuse (NIDA)

Investigators


Principal Investigator:	Nancy M Petry, Ph.D.	University of Connecticut Health Center

More Information


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 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

ClinicalTrials.gov processed this record on September 23, 2016