HIV InfectionNCT00103532
Healthy Choices to Promote Health and Reduce Risk in HIV-Infected Youth
A study testing Healthy Choices - Motivational Enhancement Intervention in people with HIV Infection, run by University of North Carolina, Chapel Hill at 6 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 16 to 24 years
- Conditions the study is for
- HIV Infection
- What is being tested?
- Healthy Choices - Motivational Enhancement Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 6 sitesUnited States
- Study dates
- Mar 2005to Apr 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Maryland
Baltimore, Maryland, 21201
Children's Hospital of Michigan
Detroit, Michigan, 48201
Children's Diagnostic and Teatment Center
Fort Lauderdale, Florida, 33316
Children's Hospital of Los Angeles
Los Angeles, California, 90027
University of Southern California
Los Angeles, California, 90033
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Motivational Enhancement to Promote Health and Reduce Risk in HIV-Infected Youth
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.
Read the 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).
- Conditions
- HIV Infection
- Being tested
- Healthy Choices - Motivational Enhancement Intervention, Standard care
- Keywords
- motivational enhancement, health behaviors, risk behaviors
- Medical subject headings
- HIV Infections, Health Behavior, Risk-Taking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Choices - Motivational Enhancement InterventionBehavioural
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 careBehavioural
Participants will receive standard care plus referrals at three months post-baseline
| Study group | Role | What they receive |
|---|---|---|
| Healthy Choices - Motivational Enhancement Intervention | Experimental | Motivational enhancement intervention Receives: Behavioral: Healthy Choices - Motivational Enhancement Intervention |
| Standard Care | Active comparator | Standard care/individualized referrals Receives: Behavioral: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 months
Secondary outcomes (3)
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
Measured: 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)
Measured: 15 months
Determine if intervention effects are maintained
Determine if intervention effects are maintained over 12 months post-intervention
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2005 (estimated)
- Study startMar 2005
- Primary completionMar 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Sylvie Naar-King, PhD, Study chair, Children's Hospital of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00103532
- Sponsor's protocol ID
- ATN 004
- Status last verified
- Mar 2019
- First submitted
- 9 Feb 2005
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 19996045
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Enhancement to Promote Health and Reduce Risk in HIV-Infected Youth
- ClinicalTrials.gov ID
- NCT00103532
- Acronym / sponsor ID
- ATN 004
- Conditions
- HIV Infection
- Keywords
- motivational enhancement, health behaviors, risk behaviors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Mar 2005
- Primary completion
- Mar 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 10 Feb 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Choices - Motivational Enhancement Intervention | Experimental | Behavioral: Healthy Choices - Motivational Enhancement InterventionMotivational enhancement intervention |
| Standard Care | Active comparator | Behavioral: Standard careStandard care/individualized referrals |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy Choices - Motivational Enhancement InterventionParticipants 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. | Behavioural | Healthy Choices - Motivational Enhancement Intervention |
| Standard careParticipants will receive standard care plus referrals at three months post-baseline | Behavioural | Standard Care |
Primary outcome
Determine the efficacy of a motivational enhancement intervention
Time frame: 15 months
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.
3 secondary outcomes
Determine the mediators and moderators of the intervention
Time frame: 15 months
Determine secondary intervention effects
Time frame: 15 months
Determine if intervention effects are maintained
Time frame: 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Derived from this study: PubMed 19996045Naar-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.
- description of the Adolescent Trials Network and contact informationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvie Naar-King, PhD study chair
Children's Hospital of Michigan
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Choices - Motivational Enhancement Intervention in people with HIV Infection, run by University of North Carolina, Chapel Hill at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the efficacy of a motivational enhancement intervention (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00103532, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2019.