Healthy Choices to Promote Health and Reduce Risk in HIV-Infected Youth

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00103532
First received: February 9, 2005
Last updated: June 23, 2014
Last verified: April 2014
  Purpose

Risk behaviors and their associated adverse health outcomes are becoming increasingly problematic among HIV-infected youth. This study is being conducted to test whether a brief motivational enhancement (ME) intervention will help reduce health risk behaviors (drug and alcohol use, sexual risk behavior, poor adherence to medications) among HIV+ youth.


Condition Intervention
HIV Infection
Behavioral: Healthy Choices - Motivational Enhancement Intervention
Behavioral: Standard care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Motivational Enhancement to Promote Health and Reduce Risk in HIV-Infected Youth

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Determine the efficacy of a motivational enhancement intervention [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    The primary objective is to determine the efficacy of a motivational enhancement intervention in reducing health risk behaviors (drug and alcohol use, sexual risk behavior, poor adherence to medications) among HIV+ youth.


Secondary Outcome Measures:
  • Determine the mediators and moderators of the intervention [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    Determine the mediators (e.g., self-efficacy, stage of change, decisional balance) and moderators (e.g., demographics, emotional distress) of the intervention

  • Determine secondary intervention effects [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    Determine secondary intervention effects such as improved health status (through measurements of CD4+ counts and viral load levels), decreased levels of psychological distress, and increased engagement with providers (both medical and ancillary services)

  • Determine if intervention effects are maintained [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    Determine if intervention effects are maintained over 12 months post-intervention


Enrollment: 225
Study Start Date: March 2005
Study Completion Date: April 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention group
Healthy Choices
Behavioral: Healthy Choices - Motivational Enhancement Intervention
Participants who are randomized to the intervention group will participate in four sessions (over approximately 3 months) of Healthy Choices; a motivational enhancement intervention specifically designed to target multiple risk behaviors in HIV+ youth. Participants will receive individualized referrals at the fourth session.
Active Comparator: Standard Care Behavioral: Standard care
Participants will receive standard care plus referrals at three months post-baseline

Detailed Description:

Healthy Choices is a randomized clinical trial examining the efficacy of motivational enhancement in reducing risk and promoting healthy behaviors. This study will use a sample of 225 youth (180 after attrition), ages 16-24, of whom 90 will receive the intervention, referral, and standard care, and 90 will receive referral plus standard care. The sample will be drawn from five study sites. Using parallel screening, recruitment will target 100 youth with an adherence problem, 100 youth with a substance use problem, and 25 youth with a sexual risk problem. A repeated measures design will be used for the proposed study. Primary outcome measures are drug and alcohol use, condom use, and HIV medication adherence. Youth will complete an initial data collection session (baseline) during which questionnaire and interview measures will be administered. Blood specimens for viral load and CD4+ count will also be obtained.

Randomization procedures will take place after completion of the baseline assessment. Participants who are randomized to the intervention group will participate in four sessions for approximately 3 months and will also receive standard care plus individualized referrals. The control group will receive standard care and individualized referrals. All five sites offer comprehensive, multidisciplinary care including social work and case management services and access to mental health services. Participants will receive a three-month post-test designed to coincide with ME completion. Subsequent post-tests will occur at 6, 9, 12, and 15 months after baseline data collection (3, 6, 9, and 12 months after ME completion).

  Eligibility

Ages Eligible for Study:   16 Years to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV infection as documented by professional referral and medical record review. HIV+ participants who are self-referred and not in medical care will be required to provide documentation of test results.
  • Males or females between the age of 16 years and 0 days and 24 years and 364 days at the time of study enrollment.
  • Reports having ever engaged in at least 2 of the following 3 behaviors based on screening questionnaire:

    • taken prescribed antiretroviral medications, OR been told by his/her physician that he/she should be on antiretroviral medications (whether he/she takes them or not);
    • vaginal or anal sex, OR
    • alcohol or drug use.
  • At least one of the 3 aforementioned behaviors are currently at a problem level, based on screening questionnaire:

    • taking currently prescribed antiretroviral medications <90 % of the time in the last month,
    • having unprotected intercourse within the last 3 months,
    • demonstrating problem level alcohol and/or drug use as measured during screening.
  • Able to understand spoken and written English sufficiently to provide consent/assent and be interviewed and participate in study intervention.
  • Not intending to relocate out of the current geographical area for the duration of study participation.

Exclusion Criteria:

  • History of any psychiatric thought disorder (e.g., schizophrenia, schizoaffective disorder).
  • Currently involved in behavioral research (assessment or intervention) targeting adherence, sexual risk, or alcohol and/or drug substance abuse OR currently involved in a substance abuse treatment program.
  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: NCT00103532

Locations
United States, California
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
University of Southern California
Los Angeles, California, United States, 90033
United States, Florida
Children's Diagnostic and Teatment Center
Fort Lauderdale, Florida, United States, 33316
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Michigan
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Investigators
Study Chair: Sylvie Naar-King, PhD Children's Hospital of Michigan
  More Information

Additional Information:
No publications provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00103532     History of Changes
Other Study ID Numbers: ATN 004
Study First Received: February 9, 2005
Last Updated: June 23, 2014
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
motivational enhancement
health behaviors
risk behaviors

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on August 25, 2014