Intervention for Newly Diagnosed Youth With HIV

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.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Behavioral: "Adolescents Coping, Connecting, Empowering, and Protecting Together" (Project ACCEPT)

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33101
      • University of Miami School of Medicine
  • Illinois
    • Chicago, Illinois, United States, 60612
      • John Stroger Jr. Hospital of Cook County
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • St. Jude Children's Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 24 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1; 5-7 females per group at each of the four sites.	Behavioral: "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.
EXPERIMENTAL: 2; 5-7 males per group at each of the four sites.	Behavioral: "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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The best procedures for a larger trial (e.g. timing, content etc. of ACASI administration)	7 months
The appropriateness of specific instruments proposed.	7 months
The perceived sensitivity of measures to change over time.	7 months

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institute on Drug Abuse (NIDA); National Institute of Mental Health (NIMH)
• Investigators: Study Chair: Sybil Hosek, PhD, John Stroger Jr. Hospital of Cook County

Publications and helpful links

Helpful Links

• Website for the Adolescents Trials Network for HIV/AIDS Interventions

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (ACTUAL): June 1, 2008
• Study Completion (ACTUAL): January 1, 2009

Study Registration Dates

• First Submitted: July 31, 2007
• First Submitted That Met QC Criteria: July 31, 2007
• First Posted (ESTIMATE): August 1, 2007

Study Record Updates

• Last Update Posted (ACTUAL): March 6, 2017
• Last Update Submitted That Met QC Criteria: March 2, 2017
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: HIV; Adolescents newly diagnosed with HIV
• Other Study ID Numbers: ATN 068