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	Treatment or Intervention	Phase
HIV Infection	Behavior: Healthy Choices - Motivational Enhancement Intervention	Phase II

Further Study Details: 

Primary Outcomes: Drug and alcohol use; Condom use; HIV medication adherence.
Secondary Outcomes: 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.
Expected Total Enrollment:  225

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).

Ages Eligible for Study:  16 Years   -   24 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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.

Julie Davidson, MSN      301-610-5521    JulieDavidson@westat.com

California
      Children's Hospital of Los Angeles, Los Angeles,  California,  90027,  United States
      University of Southern California, Los Angeles,  California,  90033,  United States
Florida
      Children's Diagnostic and Teatment Center, Fort Lauderdale,  Florida,  33316,  United States
Maryland
      University of Maryland, Baltimore,  Maryland,  21201,  United States
Michigan
      Children's Hospital of Michigan, Detroit,  Michigan,  48201,  United States
Pennsylvania
      Children's Hospital of Philadelphia, Philadelphia,  Pennsylvania,  19104,  United States

Study chairs or principal investigators

Sylvie Naar-King, PhD,  Study Chair

Study ID Numbers:  ATN 004
Record last reviewed:  February 2005
Last Updated:  February 9, 2005
Record first received:  February 9, 2005
ClinicalTrials.gov Identifier:  NCT00103532
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08