NCT01673750

Brief Summary

This is an observational study that seeks to gather information about perceptions of body image through the use of a one-time questionnaire completed by participants at the time of study enrollment. Effective management of Human Acquired Immune Deficiency Syndrome (AIDS) caused by the Human Immunodeficiency Virus (HIV) has become possible through the use of Highly Active Antiretroviral Treatment (HAART). As a result of more successful treatment options, HIV/AIDS has transitioned from a terminal illness to one which is treated as a chronic condition. One particular group that has been impacted tremendously by HIV in the United States is the adolescent population. As youth are living longer with HIV/AIDS, clinicians and researchers are beginning to examine ways in which the disease can affect one's physical health, mental health, and other psychosocial factors. Research emerging involving adults with HIV/AIDS has suggested that increased attention to and negative views of one's body image may be found at a higher rate in this group. To our knowledge, very few studies have examined this relationship in adolescents with HIV.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 28, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 14, 2014

Status Verified

April 1, 2014

Enrollment Period

1.2 years

First QC Date

August 21, 2012

Last Update Submit

April 11, 2014

Conditions

Keywords

AdolescentsBody Image

Outcome Measures

Primary Outcomes (1)

  • Reported level of normative body image and discrepancy between perceived body image and preferred body image

    The MBSRQ-AS is a well-validated self-report inventory for the assessment of body image (BI). It has five subscales: Appearance Evaluation, Appearance Orientation, Overweight Preoccupation, Self-Classified Weight, Body Areas Satisfaction Scale. Descriptive analyses (means and standard deviations of overall scores and means for each subscale) will be reported. The Figure Rating Scale is a culturally relevant measure modeled after Stunkard's widely used nine-figure scale of schematic figures of varying size. Participants will be asked to identify which BI they find most similar to their current body type and which BI would be ideal or preferred. A BI discrepancy (BID) score will be calculated for each subject based on their responses on the Figure Rating Scale: negative BID score indicates the subject's ideal BI is larger than perceived; positive BID score indicates the subject wants to be smaller/thinner than perceived; score of zero indicates the subject prefers his/her perceived BI.

    Once at time of participant enrollment

Study Arms (1)

Participants

Participants will have documented HIV infection and are aware of their diagnosis. They will complete a one-time questionnaire.

Other: Questionnaire

Interventions

The primary outcome, characterizing body image among HIV infected adolescents, will be measured using a questionnaire administered to study participants through Audio Computer Assisted Self-Interview (ACASI) technology.

Also known as: Audio Computer Assisted Self-Interview, ACASI
Participants

Eligibility Criteria

Age16 Years - 23 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with documented HIV infection between the ages of 16 and 24 who are willing and able to consent.

You may qualify if:

  • Diagnosis of HIV infection as documented in adolescent's medical record
  • Adolescent is aware of his/her HIV diagnosis
  • The adolescent/caregiver's primary language in English
  • Adolescent is ≥ 16 and \< 24 years old
  • Adolescent is willing and able to provide consent per institutional guidelines

You may not qualify if:

  • Adolescent has documented diagnosis of mental retardation or a significant motor or sensory impairment that would preclude participation in the study survey.
  • Adolescent has known acute psychiatric illness, including suicidal ideation, homicidal ideation or active psychosis.
  • Adolescent is a pregnant female.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Megan Wilkins, PhD

    St. Jude Children's Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2012

First Posted

August 28, 2012

Study Start

October 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

April 14, 2014

Record last verified: 2014-04

Locations