HIV Positive Youth That Are Newly Engaged in CareNCT01751620
Project ACCEPT: Engaging Newly Diagnosed HIV+ Youth in Care
A study testing Project ACCEPT and HEALTH in people with HIV Positive Youth That Are Newly Engaged in Care, run by University of North Carolina, Chapel Hill at 4 sites in United States.
Trial summary
The proposed study is a two-group randomized repeated measures design that will examine the efficacy of Project ACCEPT (Adolescents Coping, Connecting, Empowering and Protecting Together) to improve engagement in care among youth newly diagnosed with HIV at five AMTU sites across the United States. Read more about this study
- Who is it for?
- Ages 16 to 24 years
- Conditions the study is for
- HIV Positive Youth That Are Newly Engaged in Care
- What is being tested?
- Project ACCEPT and HEALTH
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2013to Jun 2015
- 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-infected and aware of his/her status as documented by medical record review or verbal verification by provider (i.e., medical or mental health care provider, case manager, social worker, etc.);
- Received HIV diagnosis within the past 12 months (+ 3 months) at the time of consent/assent as documented by medical record review or verbal verification with referring professional (i.e., medical or mental health care provider, case manager, social worker, etc.);
- Between the ages of 16-24 (inclusive) at the time of informed consent/assent;
- Receives services at one of the selected AMTUs or one of their community partners;
- Willing to participate in both the individual and group sessions;
- Ability to speak and understand spoken English;
- Able to understand and willing to provide signed informed consent/assent in English or Spanish; and
- Willingness to provide signed informed consent or assent with parental/legal guardian permission as applicable.
Who cannot join
- Participated in a previous wave, if enrolling into Wave 2 or 3;
- Intoxicated or under the influence of alcohol or other substances at the time of consent/assent;
- Visibly distraught and/or visibly emotionally unstable (i.e., exhibiting suicidal, homicidal, or violent behavior) in the opinion of the site personnel would interfere with the ability to give true informed consent; and
- Any concurrent participation in other behavioral studies. Permission from the protocol team may be provided for uncertain cases.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Stroger Hospital and the CORE Center
Chicago, Illinois, 60612
Wayne State University
Detroit, Michigan, 48201
St. Jude Childrens Research Hospital
Memphis, Tennessee, 38105
University of Miami School of Medicine
Miami, Florida, 33101
About this study
The proposed study is a two-group randomized repeated measures design that will examine the efficacy of Project ACCEPT (Adolescents Coping, Connecting, Empowering and Protecting Together) to improve engagement in care among youth newly diagnosed with HIV at five AMTU sites across the United States. Youth will be randomized into one of two study arms; Project ACCEPT, the intervention, or HEALTH, the health education attention-controlled comparison condition. Both arms consist of two individual sessions followed by six group sessions and a final individual session which is expected to take approximately nine weeks after which youth will have four follow-up visits at the following time points:
- post intervention (immediately after the last session);
- 3 months post the last session;
- 6 months post the last session; and
- 12 months post the last session. The trial will be repeated in up to three waves.
- Being tested
- Project ACCEPT, HEALTH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project ACCEPTBehavioural
Also called Adolescents Coping, Connecting, Empowering and Protecting Together
The intervention, Project ACCEPT, combines weekly individual and group sessions that address a range of issues that impact engagement in care for youth living with HIV, including stigma, disclosure, health relationships, substance use, and future life plans.
HEALTHBehavioural
The comparison condition, HEALTH, matches Project ACCEPT in number of sessions and duration. The weekly sessions will cover information on alcohol, drugs, HIV and other sexually transmitted diseases (STDs) to meet the ethical responsibility to provide risk reduction information to youth assigned.
| Study group | Role | What they receive |
|---|---|---|
| Project ACCEPT | Experimental | Participants randomized to the intervention (Project ACCEPT) arm. Receives: Behavioral: Project ACCEPT |
| HEALTH | Active comparator | Participants randomized to the comparison (HEALTH) arm. Receives: Behavioral: HEALTH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examine the efficacy of Project ACCEPT compared with an attention-controlled health education comparison intervention
Conduct a randomized controlled trial to examine the efficacy of Project ACCEPT compared with an attention-controlled health education comparison intervention (HEALTH). The goals of the intervention are to improve engagement in care, decrease psychosocial barriers to care, and decrease sexual risk for youth newly diagnosed with HIV.
Measured: 3 years
Secondary outcomes (1)
Explore the relationship between HIV biomarkers and participant's level of engagement in care
Explore the relationship between HIV biomarkers (i.e., CD4 and viral load) and participant's level of engagement in care.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV Positive Youth That Are Newly Engaged in CareStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 167 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)
- Responsible party
- Sponsor
- Investigators
- Sybil Hosek, PhD, Study chair, Adolescent Trials NetworkGary Harper, PhD, Study chair, Adolescent Trials Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01751620
- Sponsor's protocol ID
- ATN 108
- Status last verified
- Oct 2016
- First submitted
- 14 Dec 2012
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project ACCEPT: Engaging Newly Diagnosed HIV+ Youth in Care
- ClinicalTrials.gov ID
- NCT01751620
- Acronym / sponsor ID
- ATN 108
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 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)
- Study start
- Jan 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 18 Dec 2012 (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.
The proposed study is a two-group randomized repeated measures design that will examine the efficacy of Project ACCEPT (Adolescents Coping, Connecting, Empowering and Protecting Together) to improve engagement in care among youth newly diagnosed with HIV at five AMTU sites across the United States. Youth will be randomized into one of two study arms; Project ACCEPT, the intervention, or HEALTH, the health education attention-controlled comparison condition. Both arms consist of two individual sessions followed by six group sessions and a final individual session which is expected to take approximately nine weeks after which youth will have four follow-up visits at the following time points:
- post intervention (immediately after the last session);
- 3 months post the last session;
- 6 months post the last session; and
- 12 months post the last session. The trial will be repeated in up to three waves.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Project ACCEPT | Experimental | Behavioral: Project ACCEPTParticipants randomized to the intervention (Project ACCEPT) arm. |
| HEALTH | Active comparator | Behavioral: HEALTHParticipants randomized to the comparison (HEALTH) arm. |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- HIV-infected and aware of his/her status as documented by medical record review or verbal verification by provider (i.e., medical or mental health care provider, case manager, social worker, etc.);
- Received HIV diagnosis within the past 12 months (+ 3 months) at the time of consent/assent as documented by medical record review or verbal verification with referring professional (i.e., medical or mental health care provider, case manager, social worker, etc.);
- Between the ages of 16-24 (inclusive) at the time of informed consent/assent;
- Receives services at one of the selected AMTUs or one of their community partners;
- Willing to participate in both the individual and group sessions;
Key exclusion criteria (4 listed)
- Participated in a previous wave, if enrolling into Wave 2 or 3;
- Intoxicated or under the influence of alcohol or other substances at the time of consent/assent;
- Visibly distraught and/or visibly emotionally unstable (i.e., exhibiting suicidal, homicidal, or violent behavior) in the opinion of the site personnel would interfere with the ability to give true informed consent; and
- Any concurrent participation in other behavioral studies. Permission from the protocol team may be provided for uncertain cases.
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 |
|---|---|---|
| Project ACCEPTAlso: Adolescents Coping, Connecting, Empowering and Protecting TogetherThe intervention, Project ACCEPT, combines weekly individual and group sessions that address a range of issues that impact engagement in care for youth living with HIV, including stigma, disclosure, health relationships, substance use, and future life plans. | Behavioural | Project ACCEPT |
| HEALTHThe comparison condition, HEALTH, matches Project ACCEPT in number of sessions and duration. The weekly sessions will cover information on alcohol, drugs, HIV and other sexually transmitted diseases (STDs) to meet the ethical responsibility to provide risk reduction information to youth assigned. | Behavioural | HEALTH |
Primary outcome
Examine the efficacy of Project ACCEPT compared with an attention-controlled health education comparison intervention
Time frame: 3 years
Conduct a randomized controlled trial to examine the efficacy of Project ACCEPT compared with an attention-controlled health education comparison intervention (HEALTH). The goals of the intervention are to improve engagement in care, decrease psychosocial barriers to care, and decrease sexual risk for youth newly diagnosed with HIV.
1 secondary outcome
Explore the relationship between HIV biomarkers and participant's level of engagement in care
Time frame: 3 years
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 28 Feb 2017.
- ATN websiteLink provided by the sponsor.
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.
Sybil Hosek, PhD study chair
Adolescent Trials Network
Gary Harper, PhD study chair
Adolescent Trials Network
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project ACCEPT and HEALTH in people with HIV Positive Youth That Are Newly Engaged in Care, run by University of North Carolina, Chapel Hill at 4 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 8 inclusion and 4 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 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Examine the efficacy of Project ACCEPT compared with an attention-controlled health education comparison intervention (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2017.