Skip to main content
OpenTrials
Completed

NCT Number: NCT00717444

Healthy Activities for Prize Incentives

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.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Contingency Management

Behavioral

contingency management for abstinence plus 12-step facilitation therapy

prizes awarded for target behaviors

Primary outcomes

  1. drug use

    Time frame: baseline and each follow-up

Secondary outcomes

  1. physical activity

    Time frame: baseline and each follow-up

  2. psychological symptoms

    Time frame: baseline and each follow-up

  3. medical outcomes

    Time frame: baseline and each follow-up

Sponsors and collaborators

Lead sponsor

UConn Health

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: HAPI

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Jul 17, 2008
Registry last updated
Dec 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.