Healthy Choices to Promote Health and Reduce Risk in HIV-Infected Youth

HIV Infection Clinical Trial

Official title:

Motivational Enhancement to Promote Health and Reduce Risk in HIV-Infected Youth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00103532
• Other study ID #: ATN 004
• Status: Completed
• Phase: N/A
• Start date: March 2005
• Est. completion date: April 2008

Study information

• Verified date: March 2019
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: April 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections

Intervention

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

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland
United States	Children's Hospital of Michigan	Detroit	Michigan
United States	Children's Diagnostic and Teatment Center	Fort Lauderdale	Florida
United States	Children's Hospital of Los Angeles	Los Angeles	California
United States	University of Southern California	Los Angeles	California
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Determine the mediators and moderators of the intervention	Determine the mediators (e.g., self-efficacy, stage of change, decisional balance) and moderators (e.g., demographics, emotional distress) of the intervention	15 months
Secondary	Determine secondary intervention effects	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)	15 months
Secondary	Determine if intervention effects are maintained	Determine if intervention effects are maintained over 12 months post-intervention	15 months

External Links

•   description of the Adolescent Trials Network and contact information