Clinical trial NCT00103532: Healthy Choices to Promote Health and Reduce Risk in HIV-Infected Youth
Official title: Motivational Enhancement to Promote Health and Reduce Risk in HIV-Infected Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infection
Keywords: motivational enhancement
health behaviors
risk behaviors
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Institute of Mental Health (NIMH)
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2005-02-10
Enrollment: 225
Sex: ALL
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Primary outcomes:
measure: Determine the efficacy of a motivational enhancement intervention
timeFrame: 15 months
Secondary outcomes:
measure: Determine the mediators and moderators of the intervention
timeFrame: 15 months
measure: Determine secondary intervention effects
timeFrame: 15 months
measure: Determine if intervention effects are maintained
timeFrame: 15 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Fort Lauderdale
country: United States
facility: Children's Diagnostic and Teatment Center
state: Florida
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Detroit
country: United States
facility: Children's Hospital of Michigan
state: Michigan
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Michigan
name: Sylvie Naar-King, PhD
role: STUDY_CHAIR
References:
citation: 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. doi: 10.1001/archpediatrics.2009.212.