Healthy Choices to Promote Health and Reduce Risk in HIV-Infected Youth
Motivational Enhancement to Promote Health and Reduce Risk in HIV-Infected Youth
1 other identifier
interventional
225
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2005
Typical duration for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2005
CompletedFirst Posted
Study publicly available on registry
February 10, 2005
CompletedStudy Start
First participant enrolled
March 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedMarch 26, 2019
March 1, 2019
3 years
February 9, 2005
March 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine the efficacy of a motivational enhancement intervention
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.
15 months
Secondary Outcomes (3)
Determine the mediators and moderators of the intervention
15 months
Determine secondary intervention effects
15 months
Determine if intervention effects are maintained
15 months
Study Arms (2)
Healthy Choices - Motivational Enhancement Intervention
EXPERIMENTALMotivational enhancement intervention
Standard Care
ACTIVE COMPARATORStandard care/individualized referrals
Interventions
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.
Participants will receive standard care plus referrals at three months post-baseline
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Children's Hospital of Los Angeles
Los Angeles, California, 90027, United States
University of Southern California
Los Angeles, California, 90033, United States
Children's Diagnostic and Teatment Center
Fort Lauderdale, Florida, 33316, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Children's Hospital of Michigan
Detroit, Michigan, 48201, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Related Publications (1)
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.
PMID: 19996045DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Sylvie Naar-King, PhD
Children's Hospital of Michigan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2005
First Posted
February 10, 2005
Study Start
March 1, 2005
Primary Completion
March 1, 2008
Study Completion
April 1, 2008
Last Updated
March 26, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share