Intervention for Newly Diagnosed Youth With HIV

NCT ID: NCT00510237

Last Updated: 2017-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2009-01-31

Brief Summary

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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

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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

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HIV

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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1

5-7 females per group at each of the four sites.

Group Type EXPERIMENTAL

"Adolescents Coping, Connecting, Empowering, and Protecting Together" (Project ACCEPT)

Intervention Type BEHAVIORAL

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.

2

5-7 males per group at each of the four sites.

Group Type EXPERIMENTAL

"Adolescents Coping, Connecting, Empowering, and Protecting Together" (Project ACCEPT)

Intervention Type BEHAVIORAL

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.

Interventions

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"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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

* 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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sybil Hosek, PhD

Role: STUDY_CHAIR

John Stroger Jr. Hospital of Cook County

Locations

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University of Miami School of Medicine

Miami, Florida, United States

Site Status

John Stroger Jr. Hospital of Cook County

Chicago, Illinois, United States

Site Status

Montefiore Medical Center

The Bronx, New York, United States

Site Status

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Site Status

Countries

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United States

Related Links

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http://www.atnonline.org

Website for the Adolescents Trials Network for HIV/AIDS Interventions

Other Identifiers

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ATN 068

Identifier Type: -

Identifier Source: org_study_id

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