HIVNCT00510237
Intervention for Newly Diagnosed Youth With HIV
A study testing "Adolescents Coping, Connecting, Empowering, and Protecting Together" (Project ACCEPT) in people with HIV, run by University of North Carolina, Chapel Hill at 4 sites in United States.
Trial summary
This study will pilot test an HIV intervention for newly diagnosed youth (diagnosed for less than 15 months) to assess its acceptability and feasibility preliminary to and leading up to a full-scale, randomized trial. Read more about this study
- Who is it for?
- Ages 16 to 24 years
- Conditions the study is for
- HIV
- What is being tested?
- "Adolescents Coping, Connecting, Empowering, and Protecting Together" (Project ACCEPT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 4 sitesUnited States
- Study dates
- Feb 2007to Jan 2009
- 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
- To be considered eligible for enrollment in ATN 068, a participant must meet the criteria listed below:
- Receive services at one of the 4 selected ATN sites or their community partners;
- HIV-infected as documented by medical record review or verbal verification with referring professional;
- Received HIV diagnosis less than 15 months ago as documented by medical record review or verbal verification with referring professional;
- Fall between the ages of 16-24 (inclusive) at the time of informed consent/assent;
- Must be willing to participate in the both the individual and group sessions;
- Give informed consent/assent for study participation.
Who cannot join
- Participants who meet any of the exclusion criteria listed below are considered ineligible:
- Acquired HIV through perinatal infection;
- Presence of serious psychiatric symptoms (active hallucinations, thought disorder);
- Visibly distraught (suicidal, homicidal, exhibiting violent behavior);
- Intoxicated or under the influence of alcohol or other substances at the time of study enrollment.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
John Stroger Jr. Hospital of Cook County
Chicago, Illinois, 60612
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
University of Miami School of Medicine
Miami, Florida, 33101
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: Intervention Development for Newly Diagnosed Youth With HIV
This study will pilot test an HIV intervention for newly diagnosed youth (diagnosed for less than 15 months) to assess its acceptability and feasibility preliminary to and leading up to a full-scale, randomized trial. The general focus of the intervention is to aid in the psychosocial adjustment of adolescents who have recently been diagnosed with HIV.
Read the detailed description
The intervention will consist of a combination of individual and group-based sessions in which the youth will participate. This combination allows for more intensive individualized attention as well as supportive group sessions. Youth will first participate in two individual sessions, followed by nine group sessions, and end with one additional individual session.
Individual Session I: Orientation I
Part A - meet with interventionist for ecological assessment, rapport building, and preparation for meeting with medical provider Part B - meet with medical provider to answer HIV specific medical questions (i.e., transmission information, viral load/t-cells, opportunistic infections,etc.). The interventionist will be present in Part B as well.
Individual Session II: Orientation II
Part A - meet with interventionist for continued debriefing, question/answer, preparation for group participation.
Part B - meet with peer facilitator to discuss individual experiences living with HIV, rapport building, peer-specific questions. The interventionist will be present in Part B as well.
Individual session III: Wrap-up and Action Planning (to take place after group sessions are complete)
Part A - action plan with linkage to identified agencies via facilitated referrals Part B - (optional) support building - participants may bring parents, partner, friend, or other potential source of support for question/answer session with interventionist
Session I: Developing Group Cohesion
- Icebreaker, team building, group rules, facilitation of group "ownership" by participants.
Session II: Disclosure, Stigma \& Relationships
- Disclosure to family, friends, peers and co-workers as well as dealing with stigma associated with HIV/AIDS;
- Concerns about current or future romantic and/or sexual relationships, including discussion of safer sex, condom use, sero-discordant couples.
Session III: Preparing for Medical Intervention
- Working with medical providers, an overview of clinic appointments and expectations surrounding attendance, a preliminary discussion of medications, side effects, and medical management as well as strategies for adherence.
Session IV: Healthy Living
- Issues related to drugs and alcohol;
- Leisure activities such as sports and entertainment;
- Self-care including nutrition and exercise;
- The importance of school and work.
Session V: Stress Reduction/Relaxation \& Spirituality
- Techniques including deep breathing, progressive muscle relaxation, visualization, meditation and self-hypnosis;
- Self-care including complimentary therapies such as massage and acupuncture
- Spirituality;
- Planning social outings and activities.
Session VI: Gender Specific
- Males: issues surrounding sexuality and sexual orientation, male role of caring for self, loved ones, and the community;
- Females: issues surrounding sexuality, pregnancy and parenting, female role of caring for self, loved ones, and the community.
Session VII: Self-Esteem/Self-Worth
- Strategies to improve self-esteem and self-worth;
Session VIII: Legal Issues/Advocacy
- Legal rights and advocacy;
- Linkage to community advocacy groups;
- Preparing to become a speaker/advocate;
- Health insurance/life insurance.
Session IX: Future Planning
- Planning for the future including issues related to work and school (e.g., job application process, applying for financial aid), job training and career choices.
- Conditions
- HIV
- Being tested
- "Adolescents Coping, Connecting, Empowering, and Protecting Together" (Project ACCEPT)
- Keywords
- HIV, Adolescents newly diagnosed with HIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Adolescents Coping, Connecting, Empowering, and Protecting Together" (Project ACCEPT)Behavioural
The intervention will consist of a combination of individual and group-based sessions in which the youth will participate. This combination allows for more intensive individualized attention as well as supportive group sessions. Youth will first participate in two individual sessions, followed by nine group sessions, and end with one additional individual session.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 5-7 females per group at each of the four sites. Receives: Behavioral: "Adolescents Coping, Connecting, Empowering, and Protecting Together" (Project ACCEPT) |
| 2 | Experimental | 5-7 males per group at each of the four sites. Receives: Behavioral: "Adolescents Coping, Connecting, Empowering, and Protecting Together" (Project ACCEPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The best procedures for a larger trial (e.g. timing, content etc. of ACASI administration)
Measured: 7 months
The appropriateness of specific instruments proposed.
Measured: 7 months
The perceived sensitivity of measures to change over time.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2007 (estimated)
- Study startFeb 2007
- Primary completionJun 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 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, John Stroger Jr. Hospital of Cook County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00510237
- Sponsor's protocol ID
- ATN 068
- Status last verified
- Aug 2016
- First submitted
- 31 Jul 2007
- Last updated
- 6 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Development for Newly Diagnosed Youth With HIV
- ClinicalTrials.gov ID
- NCT00510237
- Acronym / sponsor ID
- ATN 068
- Conditions
- HIV
- Keywords
- HIV, Adolescents newly diagnosed with HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 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
- Feb 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 1 Aug 2007 (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.
This study will pilot test an HIV intervention for newly diagnosed youth (diagnosed for less than 15 months) to assess its acceptability and feasibility preliminary to and leading up to a full-scale, randomized trial. The general focus of the intervention is to aid in the psychosocial adjustment of adolescents who have recently been diagnosed with HIV.
Detailed description
The intervention will consist of a combination of individual and group-based sessions in which the youth will participate. This combination allows for more intensive individualized attention as well as supportive group sessions. Youth will first participate in two individual sessions, followed by nine group sessions, and end with one additional individual session.
Individual Session I: Orientation I
Part A - meet with interventionist for ecological assessment, rapport building, and preparation for meeting with medical provider Part B - meet with medical provider to answer HIV specific medical questions (i.e., transmission information, viral load/t-cells, opportunistic infections,etc.). The interventionist will be present in Part B as well.
Individual Session II: Orientation II
Part A - meet with interventionist for continued debriefing, question/answer, preparation for group participation.
Part B - meet with peer facilitator to discuss individual experiences living with HIV, rapport building, peer-specific questions. The interventionist will be present in Part B as well.
Individual session III: Wrap-up and Action Planning (to take place after group sessions are complete)
Part A - action plan with linkage to identified agencies via facilitated referrals Part B - (optional) support building - participants may bring parents, partner, friend, or other potential source of support for question/answer session with interventionist
Session I: Developing Group Cohesion
- Icebreaker, team building, group rules, facilitation of group "ownership" by participants.
Session II: Disclosure, Stigma \& Relationships
- Disclosure to family, friends, peers and co-workers as well as dealing with stigma associated with HIV/AIDS;
- Concerns about current or future romantic and/or sexual relationships, including discussion of safer sex, condom use, sero-discordant couples.
Session III: Preparing for Medical Intervention
- Working with medical providers, an overview of clinic appointments and expectations surrounding attendance, a preliminary discussion of medications, side effects, and medical management as well as strategies for adherence.
Session IV: Healthy Living
- Issues related to drugs and alcohol;
- Leisure activities such as sports and entertainment;
- Self-care including nutrition and exercise;
- The importance of school and work.
Session V: Stress Reduction/Relaxation \& Spirituality
- Techniques including deep breathing, progressive muscle relaxation, visualization, meditation and self-hypnosis;
- Self-care including complimentary therapies such as massage and acupuncture
- Spirituality;
- Planning social outings and activities.
Session VI: Gender Specific
- Males: issues surrounding sexuality and sexual orientation, male role of caring for self, loved ones, and the community;
- Females: issues surrounding sexuality, pregnancy and parenting, female role of caring for self, loved ones, and the community.
Session VII: Self-Esteem/Self-Worth
- Strategies to improve self-esteem and self-worth;
Session VIII: Legal Issues/Advocacy
- Legal rights and advocacy;
- Linkage to community advocacy groups;
- Preparing to become a speaker/advocate;
- Health insurance/life insurance.
Session IX: Future Planning
- Planning for the future including issues related to work and school (e.g., job application process, applying for financial aid), job training and career choices.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: "Adolescents Coping, Connecting, Empowering, and Protecting Together" (Project ACCEPT)5-7 females per group at each of the four sites. |
| 2 | Experimental | Behavioral: "Adolescents Coping, Connecting, Empowering, and Protecting Together" (Project ACCEPT)5-7 males per group at each of the four sites. |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- To be considered eligible for enrollment in ATN 068, a participant must meet the criteria listed below:
- Receive services at one of the 4 selected ATN sites or their community partners;
- HIV-infected as documented by medical record review or verbal verification with referring professional;
- Received HIV diagnosis less than 15 months ago as documented by medical record review or verbal verification with referring professional;
- Fall between the ages of 16-24 (inclusive) at the time of informed consent/assent;
Key exclusion criteria (5 listed)
- Participants who meet any of the exclusion criteria listed below are considered ineligible:
- Acquired HIV through perinatal infection;
- Presence of serious psychiatric symptoms (active hallucinations, thought disorder);
- Visibly distraught (suicidal, homicidal, exhibiting violent behavior);
- Intoxicated or under the influence of alcohol or other substances at the time of study enrollment.
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 |
|---|---|---|
| "Adolescents Coping, Connecting, Empowering, and Protecting Together" (Project ACCEPT)The intervention will consist of a combination of individual and group-based sessions in which the youth will participate. This combination allows for more intensive individualized attention as well as supportive group sessions. Youth will first participate in two individual sessions, followed by nine group sessions, and end with one additional individual session. | Behavioural | 1, 2 |
Primary outcome
The best procedures for a larger trial (e.g. timing, content etc. of ACASI administration)
Time frame: 7 months
The appropriateness of specific instruments proposed.
Time frame: 7 months
The perceived sensitivity of measures to change over time.
Time frame: 7 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 6 Mar 2017.
- Website for the Adolescents Trials Network for HIV/AIDS InterventionsLink provided by the sponsor.
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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.
Sybil Hosek, PhD study chair
John Stroger Jr. Hospital of Cook County
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Adolescents Coping, Connecting, Empowering, and Protecting Together" (Project ACCEPT) in people with HIV, 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 7 inclusion and 5 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 6 Mar 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?
The best procedures for a larger trial (e.g. timing, content etc. of ACASI administration) (time frame: 7 months). The study lists 3 primary outcomes in all. 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 6 Mar 2017.