Healthy Choices to Promote Health and Reduce Risk in HIV-Infected Youth
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Purpose
| Condition | Intervention |
|---|---|
|
HIV Infection |
Behavioral: Healthy Choices - Motivational Enhancement Intervention Behavioral: Standard care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Motivational Enhancement to Promote Health and Reduce Risk in HIV-Infected Youth |
- Determine the efficacy of a motivational enhancement intervention [ Time Frame: 15 months ] [ Designated as safety issue: No ]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.
- Determine the mediators and moderators of the intervention [ Time Frame: 15 months ] [ Designated as safety issue: No ]Determine the mediators (e.g., self-efficacy, stage of change, decisional balance) and moderators (e.g., demographics, emotional distress) of the intervention
- Determine secondary intervention effects [ Time Frame: 15 months ] [ Designated as safety issue: No ]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)
- Determine if intervention effects are maintained [ Time Frame: 15 months ] [ Designated as safety issue: No ]Determine if intervention effects are maintained over 12 months post-intervention
| Enrollment: | 225 |
| Study Start Date: | March 2005 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Healthy Choices - Motivational Enhancement Intervention
Motivational enhancement 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.
|
|
Active Comparator: Standard Care
Standard care/individualized referrals
|
Behavioral: Standard care
Participants will receive standard care plus referrals at three months post-baseline
|
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| Ages Eligible for Study: | 16 Years to 24 Years (Child, Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00103532
| United States, California | |
| Children's Hospital of Los Angeles | |
| Los Angeles, California, United States, 90027 | |
| University of Southern California | |
| Los Angeles, California, United States, 90033 | |
| United States, Florida | |
| Children's Diagnostic and Teatment Center | |
| Fort Lauderdale, Florida, United States, 33316 | |
| United States, Maryland | |
| University of Maryland | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Michigan | |
| Children's Hospital of Michigan | |
| Detroit, Michigan, United States, 48201 | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Study Chair: | Sylvie Naar-King, PhD | Children's Hospital of Michigan |
More Information
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Westat |
| ClinicalTrials.gov Identifier: | NCT00103532 History of Changes |
| Other Study ID Numbers: | ATN 004 |
| Study First Received: | February 9, 2005 |
| Last Updated: | February 29, 2016 |
| Health Authority: | United States: Federal Government |
| Individual Participant Data | |
| Plan to Share IPD: | No |
Keywords provided by Westat:
|
motivational enhancement health behaviors risk behaviors |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
ClinicalTrials.gov processed this record on September 26, 2016