NCT00103532

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2005

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 10, 2005

Completed
19 days until next milestone

Study Start

First participant enrolled

March 1, 2005

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

March 26, 2019

Status Verified

March 1, 2019

Enrollment Period

3 years

First QC Date

February 9, 2005

Last Update Submit

March 25, 2019

Conditions

Keywords

motivational enhancementhealth behaviorsrisk behaviors

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

EXPERIMENTAL

Motivational enhancement intervention

Behavioral: Healthy Choices - Motivational Enhancement Intervention

Standard Care

ACTIVE COMPARATOR

Standard care/individualized referrals

Behavioral: Standard care

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.

Healthy Choices - Motivational Enhancement Intervention
Standard careBEHAVIORAL

Participants will receive standard care plus referrals at three months post-baseline

Standard Care

Eligibility Criteria

Age16 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

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

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Children's Diagnostic and Teatment Center

Fort Lauderdale, Florida, 33316, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

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.

Related Links

MeSH Terms

Conditions

HIV InfectionsHealth BehaviorRisk-Taking

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Sylvie Naar-King, PhD

    Children's Hospital of Michigan

    STUDY CHAIR

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

Locations