Development of a Life Skills Intervention for Young Adolescents Perinatally-Infected With HIV and Their Caregivers

February 27, 2017 updated by: University of North Carolina, Chapel Hill

Development of a Life Skills Intervention for Young Adolescents Perinatally-Infected With HIV and Their Caregivers Part A: Focus Group And Measurement Evaluation

During this phase of the study, a focus group will be conducted with young adolescents perinatally infected with HIV and with their caregivers to develop and evaluate the content of the proposed intervention. The purpose of the focus groups is to identify key issues and challenges that often face young adolescents perinatally infected with HIV and their caregivers as well as to elicit suggestions to enhance the feasibility and acceptability of the proposed intervention. The focus groups will be audio recorded and transcribed and reviewed by all involved in future protocol development. Themes will be pulled directly from the focus groups to guide examples and areas of emphasis in the intervention. In addition, proposed measures will be administered to the adolescents and their caregivers and assessed for appropriateness for this population.

Study Overview

Status

Terminated

Conditions

Detailed Description

This study is designed to collect information from HIV-1 perinatally infected adolescents for the development of a pilot study that will use a life skills intervention model. One focus group comprised of adolescents and one focus group comprised of their caregivers will use a series of open-ended questions to facilitate a group discussion to define the life skills intervention model. Ten young adolescents, ages 11 to 14 years, and their caregivers will participate in these focus groups at Rainbow Babies and Children's Hospital in Cleveland, Ohio. The protocol will be site-restricted for participation. The responses from the focus group will be used to tailor the proposed life skills intervention model and to provide a detailed description of intervention content including: common peer issues of young adolescents perinatally infected with HIV, typical sexual knowledge and behaviors, typical areas of conflict between adolescents and caregivers, and common ways of managing conflict. In addition, those that participate in the focus group will be asked to complete a series of questionnaires in order to assess the appropriateness of the proposed measurement battery for adolescents perinatally infected with HIV and their caregivers.

Findings from this study (ATN 045- Part A) will be used in the development of a proposal for a pilot study of the life skills intervention model (ATN 045-Part B). The pilot study will examine the feasibility of successfully providing a life skills intervention to HIV-1 infected young adolescents at an ATN clinical site, the acceptability of such an intervention in young adolescents, as well as the logistics of providing such an intervention.

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Young adolescents perinatally infected with HIV, 11 to 14 years of age and their caregivers.

Description

Inclusion Criteria:

  • Clinically-identified HIV-1 infected subjects 11-14 years of age and their caregivers.
  • HIV status has been disclosed to the adolescent.
  • HIV-1 infection transmission due to perinatal infection as identified by treating physician.
  • Caregiver is legal guardian of the adolescent as indicated by the medical team in the clinic from which recruitment will be conducted.
  • Adolescent lives with the caregiver.
  • Adolescent and caregiver speak English.

Exclusion Criteria:

  • Caregiver permission denied or adolescent does not assent.
  • Adolescent previously diagnosed as mentally retarded as reported by caregiver through school and/or other psychological testing.
  • Adolescent and/or caregiver too medically fragile. Medically fragile is functionally defined as being physically unable to attend the group.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Ahna L Hoff, Ph.D., Case Western Reserve University School of Medicine and Rainbow Babies and Childrens Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

September 21, 2005

First Submitted That Met QC Criteria

September 21, 2005

First Posted (Estimate)

September 23, 2005

Study Record Updates

Last Update Posted (Actual)

February 28, 2017

Last Update Submitted That Met QC Criteria

February 27, 2017

Last Verified

February 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infection

3
Subscribe