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

February 9, 2005
June 23, 2014
March 2005
March 2008   (final data collection date for primary outcome measure)
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.
  • Drug and alcohol use
  • Condom use
  • HIV medication adherence.
Complete list of historical versions of study NCT00103532 on ClinicalTrials.gov Archive Site
  • 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
  • Secondary outcomes are based on each of the three individual behaviors, with focused analyses of risk reduction in regard to a particular behavior that may, or may not, use information on other behaviors from the list of the three primary outcomes
  • Outcomes are recorded at six time points: baseline, immediately post-intervention at month 3, and at months 6, 9, 12, and 15.
Not Provided
Not Provided
 
Healthy Choices to Promote Health and Reduce Risk in HIV-Infected Youth
Motivational Enhancement to Promote Health and Reduce Risk in HIV-Infected Youth

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.

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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infection
  • 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.
  • Behavioral: Standard care
    Participants will receive standard care plus referrals at three months post-baseline
  • Experimental: Intervention group
    Healthy Choices
    Intervention: Behavioral: Healthy Choices - Motivational Enhancement Intervention
  • Active Comparator: Standard Care
    Intervention: Behavioral: Standard care
Naar-King S, Parsons JT, Murphy DA, Chen X, Harris DR, Belzer ME. Improving health outcomes for youth living with the human immunodeficiency virus: a multisite randomized trial of a motivational intervention targeting multiple risk behaviors. Arch Pediatr Adolesc Med. 2009 Dec;163(12):1092-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
225
April 2008
March 2008   (final data collection date for primary outcome measure)

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.
Both
16 Years to 24 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00103532
ATN 004
Yes
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute on Drug Abuse (NIDA)
  • National Institute of Mental Health (NIMH)
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study Chair: Sylvie Naar-King, PhD Children's Hospital of Michigan
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP