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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| National Institute of Mental Health (NIMH) | NIH |
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Choices - Motivational Enhancement Intervention | Experimental | Motivational enhancement intervention |
|
| Standard Care | Active Comparator | Standard care/individualized referrals |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healthy Choices - Motivational Enhancement Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Determine secondary intervention effects |
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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:
At least one of the 3 aforementioned behaviors are currently at a problem level, based on screening questionnaire:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Sylvie Naar-King, PhD | Children's Hospital of Michigan | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Los Angeles | Los Angeles | California | 90027 | United States | ||
| University of Southern California |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19996045 | Derived | 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. |
| Label | URL |
|---|---|
| description of the Adolescent Trials Network and contact information | View source |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D015438 | Health Behavior |
| D012309 | Risk-Taking |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| Standard care | Behavioral | Participants will receive standard care plus referrals at three months post-baseline |
|
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 |
| Determine if intervention effects are maintained | Determine if intervention effects are maintained over 12 months post-intervention | 15 months |
| 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 |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D001519 | Behavior |