Human Immunodeficiency VirusNCT01673750
Body Image in Youth With HIV
An observational study of Human Immunodeficiency Virus and HIV, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 23 years
- Conditions the study is for
- Human Immunodeficiency Virus, HIV
- What is being tested?
- Questionnaire
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Dec 2013
- Phase
- Observational
- 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 23 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with documented HIV infection between the ages of 16 and 24 who are willing and able to consent.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
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.
Read the detailed description
The purpose of this exploratory study is to characterize body image perceptions among youth with perinatally and behaviorally acquired HIV. In a cross-sectional design, adolescents will be asked to complete an ACASI questionnaire that will assess body image, medication adherence, depressive symptoms, medical, and other sociodemographic variables which may relate to adolescents with HIV. Information regarding the adolescents' medical history, medications, and physical functioning also will be abstracted from his or her medical record. Guided by the Intervention Mapping (IM) approach, findings from this study will inform future intervention studies designed to enhance HIV disease management among adolescents.
PRIMARY OBJECTIVE:
To characterize body image perceptions among youth with HIV.
- Conditions
- Human Immunodeficiency Virus, HIV
- Being tested
- Questionnaire
- Keywords
- Adolescents, Body Image
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Also called Audio Computer Assisted Self-Interview, ACASI
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Participants will have documented HIV infection and are aware of their diagnosis. They will complete a one-time questionnaire. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Once at time of participant enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Megan Wilkins, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673750
- Sponsor's protocol ID
- HIVBI
- Status last verified
- Apr 2014
- First submitted
- 21 Aug 2012
- Last updated
- 14 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Image in Youth With HIV
- ClinicalTrials.gov ID
- NCT01673750
- Acronym / sponsor ID
- HIVBI
- Conditions
- Human Immunodeficiency Virus, HIV
- Keywords
- Adolescents, Body Image
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 28 Aug 2012 (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 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.
Detailed description
The purpose of this exploratory study is to characterize body image perceptions among youth with perinatally and behaviorally acquired HIV. In a cross-sectional design, adolescents will be asked to complete an ACASI questionnaire that will assess body image, medication adherence, depressive symptoms, medical, and other sociodemographic variables which may relate to adolescents with HIV. Information regarding the adolescents' medical history, medications, and physical functioning also will be abstracted from his or her medical record. Guided by the Intervention Mapping (IM) approach, findings from this study will inform future intervention studies designed to enhance HIV disease management among adolescents.
PRIMARY OBJECTIVE:
To characterize body image perceptions among youth with HIV.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Other: QuestionnaireParticipants will have documented HIV infection and are aware of their diagnosis. They will complete a one-time questionnaire. |
Who may qualify
- Ages
- 16 to 23 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with documented HIV infection between the ages of 16 and 24 who are willing and able to consent.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| QuestionnaireAlso: Audio Computer Assisted Self-Interview, ACASIThe 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. | Other | Participants |
Primary outcome
Reported level of normative body image and discrepancy between perceived body image and preferred body image
Time frame: Once at time of participant enrollment
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.
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 14 Apr 2014.
- St. Jude Children's Research HospitalLink provided by the sponsor.
Related trials for Human Immunodeficiency Virus
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Megan Wilkins, PhD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Immunodeficiency Virus and HIV, run by St. Jude Children's Research Hospital at 1 site 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 5 inclusion and 3 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 14 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Reported level of normative body image and discrepancy between perceived body image and preferred body image (time frame: Once at time of participant enrollment). 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 14 Apr 2014.