Healthy Activities for Prize Incentives

HIV Infections Clinical Trial

— HAPI  

Official title:

Healthy Activities for Prize Incentives

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00717444
• Other study ID #: 08-251-2
• Secondary ID: 1R01DA022739-01A
• Status: Completed
• Phase: N/A
• Start date: September 2008
• Est. completion date: May 2013

Study information

• Verified date: December 2018
• Source: UConn Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections
• Substance Abuse
• Substance-Related Disorders

Intervention

Behavioral:
• contingency management
contingency management for abstinence plus 12-step facilitation therapy prizes awarded for target behaviors
• contingency management
contingency management for abstinence plus 12-step facilitation therapy and contingency management for completing healthy activities prizes awarded for target behaviors

Locations

Country	Name	City	State
United States	Connections, Inc.	Hartford	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
UConn Health	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	drug use		baseline and each follow-up
Secondary	physical activity		baseline and each follow-up
Secondary	psychological symptoms		baseline and each follow-up
Secondary	medical outcomes		baseline and each follow-up