An interventional study of Healthy Choices - Motivational Enhancement Intervention and Standard care in HIV Infection, sponsored by University of North Carolina, Chapel Hill. Completed at 6 sites in United States. Open to participants aged 16 Years to 24 Years. Per ClinicalTrials.gov, last updated 2019-03-26.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Treatment
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).
4,257 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 225 is above the median of 83 across 3,250 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Exclusion Criteria:
Motivational enhancement intervention
Behavioral: Healthy Choices - Motivational Enhancement Intervention
Standard care/individualized referrals
Behavioral: Standard care
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
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.
Time frame: 15 months
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
Time frame: 15 months
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)
Time frame: 15 months
Determine if intervention effects are maintained
Determine if intervention effects are maintained over 12 months post-intervention
Time frame: 15 months
Plan to share: No
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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University of North Carolina, Chapel Hill