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Healthy Activities for Prize Incentives (HAPI)

Primary Purpose

Substance Abuse, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
contingency management
contingency management
Sponsored by
UConn Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Abuse focused on measuring Substance Abuse, HIV, Contingency Management, Physical Activity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Connections, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

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

contingency management for abstinence plus 12-step facilitation therapy

Outcomes

Primary Outcome Measures

drug use

Secondary Outcome Measures

physical activity
psychological symptoms
medical outcomes

Full Information

First Posted
July 15, 2008
Last Updated
December 21, 2018
Sponsor
UConn Health
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00717444
Brief Title
Healthy Activities for Prize Incentives
Acronym
HAPI
Official Title
Healthy Activities for Prize Incentives
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UConn Health
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse, HIV Infections
Keywords
Substance Abuse, HIV, Contingency Management, Physical Activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
contingency management for abstinence plus 12-step facilitation therapy and contingency management for completing healthy activities
Arm Title
2
Arm Type
Experimental
Arm Description
contingency management for abstinence plus 12-step facilitation therapy
Intervention Type
Behavioral
Intervention Name(s)
contingency management
Intervention Description
contingency management for abstinence plus 12-step facilitation therapy prizes awarded for target behaviors
Intervention Type
Behavioral
Intervention Name(s)
contingency management
Intervention Description
contingency management for abstinence plus 12-step facilitation therapy and contingency management for completing healthy activities prizes awarded for target behaviors
Primary Outcome Measure Information:
Title
drug use
Time Frame
baseline and each follow-up
Secondary Outcome Measure Information:
Title
physical activity
Time Frame
baseline and each follow-up
Title
psychological symptoms
Time Frame
baseline and each follow-up
Title
medical outcomes
Time Frame
baseline and each follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy M Petry, Ph.D.
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Connections, Inc.
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States

12. IPD Sharing Statement

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Healthy Activities for Prize Incentives

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