Healthy Activities for Prize Incentives (HAPI)

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Substance Abuse
• Intervention / Treatment: Behavioral: contingency management; Behavioral: contingency management

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Connections, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 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: 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; Behavioral: contingency management; contingency management for abstinence plus 12-step facilitation therapy and contingency management for completing healthy activities prizes awarded for target behaviors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
drug use	baseline and each follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
physical activity	baseline and each follow-up
psychological symptoms	baseline and each follow-up
medical outcomes	baseline and each follow-up

Collaborators and Investigators

• Sponsor: UConn Health
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Nancy M Petry, Ph.D., UConn Health

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: July 15, 2008
• First Submitted That Met QC Criteria: July 16, 2008
• First Posted (Estimate): July 17, 2008

Study Record Updates

• Last Update Posted (Actual): December 26, 2018
• Last Update Submitted That Met QC Criteria: December 21, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Physical Activity; HIV; Substance Abuse; Contingency Management
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 08-251-2; 1R01DA022739-01A2 (U.S. NIH Grant/Contract)