Body Image DisturbanceBUILDNCT01817621
Body Image and Self-Care in HIV-Infected MSM
A study testing Experimental Intervention and TAU in people with Body Image Disturbance and Medication Adherence, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
The purpose of this study is to develop and test counseling strategies for men who have sex with men (MSM) who are living with HIV and are experiencing body dissatisfaction. Two phases will be conducted throughout the course of the study. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Body Image Disturbance, Medication Adherence
- What is being tested?
- Experimental Intervention and TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2013to Jun 2017
- Phase
- Interventional
- 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 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-seropositive
- Prescribed ART for at least the last two months
- Reports having sex with men in the past 12 months
- Reports current body dissatisfaction (a score of 2.48 or more on the Body Image Disturbance Questionnaire)
- Age 18 and older
- Capable of completing and fully understanding the informed consent process and the study procedures
Who cannot join
- Over age 65
- Significant mental health diagnosis requiring immediate treatment (e.g., unstable bipolar disorder; any psychotic disorder)
- Has received cognitive behavioral therapy for body dissatisfaction within the past 12 months
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Not yet recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114-2919
Aaron J. Blashill, PhD, 617-643-2148, ablashill@partners.org
Peter P Ehlinger, BA, 617-643-1168, pehlinger@mgh.harvard.edu
- Recruiting
The Fenway Institute
Boston, Massachusetts, 02215
Aaron J. Blashill, PhD, 617-927-6465, ablashill@partners.org
Jonathan Jampel, BA, 617-927-6465, jjampel@fenwayhealth.org
About this study
The purpose of this study is to develop and test counseling strategies for men who have sex with men (MSM) who are living with HIV and are experiencing body dissatisfaction.
Two phases will be conducted throughout the course of the study.
Read more
Phase 1: Develop an intervention for HIV-infected MSM that addresses body dissatisfaction and self-care. (NOTE: currently, only Phase 1 will be recruiting participants, Phase 2 will not be active for several months)
Because of the prospective syndemic relationship between body dissatisfaction and depression, the investigator will integrate the most efficacious interventions for body dissatisfaction, depression, adherence, and sexual risk reduction, and tailor them to HIV-infected MSM. The investigator will then conduct an iterative process of pilots and exit interviews about feasibility, acceptability, and the strengths and weaknesses of the intervention until the intervention is maximized. Up to 9 participants will be involved in Phase 1.
Phase 2: Conduct a two-arm randomized control trial comparing the newly developed intervention to a treatment-as-usual condition.
As a first step in addressing the efficacy of the newly developed intervention, the investigator plans on randomizing up to 60 participants into either the newly-developed intervention or a treatment-as-usual condition. Participants will be assessed at baseline, 3 months (acute outcome), and 6 months postrandomization. The primary outcome variable is body image disturbance. Depression, HIV sexual transmission risk behaviors, and highly active antiretroviral therapy (HAART) adherence will serve as secondary outcomes.
Study hypotheses for the two phases include:
- The investigator will be able to develop and implement a feasible intervention that integrates addressing and relieving body dissatisfaction with increasing health related behavior change in MSM with HIV. Adequate recruitment (at least 80% of goal) and retention (at least 80% to follow up) in the trial will be an indicator of success for this aim.
- Those who receive the intervention will show improvements in health behavior outcomes (medication adherence, HIV transmission risk behavior) and will show reduced body dissatisfaction and depressive symptoms.
Read the detailed description
Among men who have sex with men (MSM), the largest population living with HIV in the U.S., poor self-care behaviors occur within the context of intertwined psychosocial problems, called syndemics. Important affected health behaviors include sexual transmission risk and adherence to antiretroviral therapy. In major cities, one in five MSM are living with HIV/AIDS, making these domestic MSM rates comparable to many endemic settings such as Sub-Saharan Africa. Because of antiretroviral therapy, HIV-infected individuals are living with the virus longer and the population of HIV-infected MSM continues to grow.
Study after study concludes that psychosocial problems/intertwined syndemics such as depression, substance abuse, and childhood sexual abuse significantly contribute to poor self-care behaviors such as sexual risk behaviors among MSM. Despite this, one reason for the modest effects of behavioral interventions for HIV is that they generally do not address the unique and varied psychosocial context of living with HIV for various risk groups. One example of a highly prevalent psychosocial problem among HIV-infected MSM is dissatisfaction with one's appearance. Body dissatisfaction is frequently syndemic to depression in HIV-infected MSM and is related to both sexual transmission risk and HAART non-adherence. Recent evidence indicates that MSM with high body dissatisfaction are 60% less likely to use condoms during anal intercourse compared to MSM with low body dissatisfaction.
The goal is to study multiple health behaviors in the context of psychosocial problems among HIV-infected and uninfected MSM. This includes designing and testing interventions aimed at reducing health problems (e.g., sexual risk, medication adherence, self-care) and co-occurring mental health disorders/syndemics. In this context, the current research plan, focusing on body dissatisfaction, depression, sexual risk reduction and HAART adherence provides one example of applying this goal to a discrete syndemic-oriented intervention development research project. This has relevance for both behavioral interventions for adherence and HIV risk behavior in MSM, which may be moderated by syndemics, but also has important application for the eventual roll-out of emerging biomedical prevention interventions. For example, HIV chemoprophylaxis (pre-exposure prophylaxis; PrEP) has recently been shown to reduce HIV transmission risk in high risk MSM. If this or other biomedical interventions are adequately disseminated to the highest risk MSM, the field will likely need plans for addressing mental health and, potentially, substance use, in the context of prescribing biomedical agents.
- Conditions
- Body Image Disturbance, Medication Adherence
- Being tested
- Experimental Intervention, TAU
- Keywords
- Body Image Disturbance, Medication Adherence, Sexual Risk Behavior, HIV, MSM
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental InterventionBehavioural
Also called Cognitive Behavior Therapy for Body Image and Self-Care (CBT-BISC)
The experimental intervention arm will include the same measures as the TAU comparison study arm. In addition, participants will attend several sessions addressing body dissatisfaction, including psychoeducation on the antecedents and consequences of body dissatisfaction, the common comorbidity of depressed mood, and how these factors can affect HIV self-care behaviors.
TAUBehavioural
Participants assigned to the TAU condition will receive appropriate services and referrals as needed, as would be typical of patients at Fenway Health or MGH, and will attend bi-weekly appointments with a study research assistant (RA) to complete study questionnaires and assess pocketed adherence, including HAART doses that participants may have taken outside of Wisepill.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Intervention | Experimental | Not described Receives: Behavioral: Experimental Intervention |
| TAU Condition | Active comparator | Not described Receives: Behavioral: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Image Disturbance
Measures of body image disturbance and impairment. Body Dysmorphic Disorder Modification of the Y-BOCS (BDD-YBOCS) a 12-item semistructured clinician-rated instrument designed to rate severity of body image disturbance and impairment will be used as the primary outcome measure.
Measured: Baseline Assessment; Active Treatment Sessions; Post Treatment Assessment (Active treatment sessions will take place on a weekly basis starting 2 weeks after baseline and will continue for an average of 3 to 4 months.)
Secondary outcomes (1)
Change in HIV Self-Care Behavior and Depression
HIV medication adherence and sexual risk behaviors. HIV medication adherence will be recorded by use of Wisepill. The Wisepill portable medication dispenser sends an electronic medication event record to a central management system (Wisepill Web Server) whenever medication is taken. Medication adherence will be used as a secondary outcome measure. The Montgomery-Asberg Depression Rating Scale (MADRS) measure will be given at each assessment to determine change in Derpession. The MADRS is a clinician administered semi-structured interview used to measure the severity of depressive episodes in patients with mood disorders.
Measured: Baseline Assessment; Active Treatment Sessions; Post Treatment Assessment (Active treatment sessions will take place on a weekly basis starting 2 weeks after baseline and will continue for an average of 3 to 4 months.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Image DisturbanceStudies of the same condition, open and under way.
- More trials run by Massachusetts General 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Fenway Institute, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Aaron Blashill, Massachusetts General Hospital
- Investigators
- Aaron J Blashill, PhD, Principal investigator, Massachusetts General Hospital, Fenway Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01817621
- Sponsor's protocol ID
- 399055-1
- Other IDs
- 1K23MH096647-01A1
- Acronym
- BUILD
- Status last verified
- Apr 2015
- First submitted
- 13 Feb 2013
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Image and Self-Care in HIV-Infected MSM
- ClinicalTrials.gov ID
- NCT01817621
- Acronym / sponsor ID
- BUILD / 399055-1
- Conditions
- Body Image Disturbance, Medication Adherence
- Keywords
- Body Image Disturbance, Medication Adherence, Sexual Risk Behavior, HIV, MSM
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- The Fenway Institute, National Institute of Mental Health (NIMH)
- Study start
- Feb 2013
- Primary completion
- Jun 2017 (estimated)
- First posted
- 25 Mar 2013 (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.
The purpose of this study is to develop and test counseling strategies for men who have sex with men (MSM) who are living with HIV and are experiencing body dissatisfaction.
Two phases will be conducted throughout the course of the study.
Phase 1: Develop an intervention for HIV-infected MSM that addresses body dissatisfaction and self-care. (NOTE: currently, only Phase 1 will be recruiting participants, Phase 2 will not be active for several months)
Because of the prospective syndemic relationship between body dissatisfaction and depression, the investigator will integrate the most efficacious interventions for body dissatisfaction, depression, adherence, and sexual risk reduction, and tailor them to HIV-infected MSM. The investigator will then conduct an iterative process of pilots and exit interviews about feasibility, acceptability, and the strengths and weaknesses of the intervention until the intervention is maximized. Up to 9 participants will be involved in Phase 1.
Phase 2: Conduct a two-arm randomized control trial comparing the newly developed intervention to a treatment-as-usual condition.
As a first step in addressing the efficacy of the newly developed intervention, the investigator plans on randomizing up to 60 participants into either the newly-developed intervention or a treatment-as-usual condition. Participants will be assessed at baseline, 3 months (acute outcome), and 6 months postrandomization. The primary outcome variable is body image disturbance. Depression, HIV sexual transmission risk behaviors, and highly active antiretroviral therapy (HAART) adherence will serve as secondary outcomes.
Study hypotheses for the two phases include:
- The investigator will be able to develop and implement a feasible intervention that integrates addressing and relieving body dissatisfaction with increasing health related behavior change in MSM with HIV. Adequate recruitment (at least 80% of goal) and retention (at least 80% to follow up) in the trial will be an indicator of success for this aim.
- Those who receive the intervention will show improvements in health behavior outcomes (medication adherence, HIV transmission risk behavior) and will show reduced body dissatisfaction and depressive symptoms.
Detailed description
Among men who have sex with men (MSM), the largest population living with HIV in the U.S., poor self-care behaviors occur within the context of intertwined psychosocial problems, called syndemics. Important affected health behaviors include sexual transmission risk and adherence to antiretroviral therapy. In major cities, one in five MSM are living with HIV/AIDS, making these domestic MSM rates comparable to many endemic settings such as Sub-Saharan Africa. Because of antiretroviral therapy, HIV-infected individuals are living with the virus longer and the population of HIV-infected MSM continues to grow.
Study after study concludes that psychosocial problems/intertwined syndemics such as depression, substance abuse, and childhood sexual abuse significantly contribute to poor self-care behaviors such as sexual risk behaviors among MSM. Despite this, one reason for the modest effects of behavioral interventions for HIV is that they generally do not address the unique and varied psychosocial context of living with HIV for various risk groups. One example of a highly prevalent psychosocial problem among HIV-infected MSM is dissatisfaction with one's appearance. Body dissatisfaction is frequently syndemic to depression in HIV-infected MSM and is related to both sexual transmission risk and HAART non-adherence. Recent evidence indicates that MSM with high body dissatisfaction are 60% less likely to use condoms during anal intercourse compared to MSM with low body dissatisfaction.
The goal is to study multiple health behaviors in the context of psychosocial problems among HIV-infected and uninfected MSM. This includes designing and testing interventions aimed at reducing health problems (e.g., sexual risk, medication adherence, self-care) and co-occurring mental health disorders/syndemics. In this context, the current research plan, focusing on body dissatisfaction, depression, sexual risk reduction and HAART adherence provides one example of applying this goal to a discrete syndemic-oriented intervention development research project. This has relevance for both behavioral interventions for adherence and HIV risk behavior in MSM, which may be moderated by syndemics, but also has important application for the eventual roll-out of emerging biomedical prevention interventions. For example, HIV chemoprophylaxis (pre-exposure prophylaxis; PrEP) has recently been shown to reduce HIV transmission risk in high risk MSM. If this or other biomedical interventions are adequately disseminated to the highest risk MSM, the field will likely need plans for addressing mental health and, potentially, substance use, in the context of prescribing biomedical agents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Intervention | Experimental | Behavioral: Experimental Intervention |
| TAU Condition | Active comparator | Behavioral: TAU |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- HIV-seropositive
- Prescribed ART for at least the last two months
- Reports having sex with men in the past 12 months
- Reports current body dissatisfaction (a score of 2.48 or more on the Body Image Disturbance Questionnaire)
- Age 18 and older
Key exclusion criteria (3 listed)
- Over age 65
- Significant mental health diagnosis requiring immediate treatment (e.g., unstable bipolar disorder; any psychotic disorder)
- Has received cognitive behavioral therapy for body dissatisfaction within the past 12 months
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 |
|---|---|---|
| Experimental InterventionAlso: Cognitive Behavior Therapy for Body Image and Self-Care (CBT-BISC)The experimental intervention arm will include the same measures as the TAU comparison study arm. In addition, participants will attend several sessions addressing body dissatisfaction, including psychoeducation on the antecedents and consequences of body dissatisfaction, the common comorbidity of depressed mood, and how these factors can affect HIV self-care behaviors. | Behavioural | Experimental Intervention |
| TAUParticipants assigned to the TAU condition will receive appropriate services and referrals as needed, as would be typical of patients at Fenway Health or MGH, and will attend bi-weekly appointments with a study research assistant (RA) to complete study questionnaires and assess pocketed adherence, including HAART doses that participants may have taken outside of Wisepill. | Behavioural | TAU Condition |
Primary outcome
Change in Body Image Disturbance
Time frame: Baseline Assessment; Active Treatment Sessions; Post Treatment Assessment (Active treatment sessions will take place on a weekly basis starting 2 weeks after baseline and will continue for an average of 3 to 4 months.)
Measures of body image disturbance and impairment. Body Dysmorphic Disorder Modification of the Y-BOCS (BDD-YBOCS) a 12-item semistructured clinician-rated instrument designed to rate severity of body image disturbance and impairment will be used as the primary outcome measure.
1 secondary outcome
Change in HIV Self-Care Behavior and Depression
Time frame: Baseline Assessment; Active Treatment Sessions; Post Treatment Assessment (Active treatment sessions will take place on a weekly basis starting 2 weeks after baseline and will continue for an average of 3 to 4 months.)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
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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.
Aaron J Blashill, PhD principal investigator
Massachusetts General Hospital, Fenway Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Intervention and TAU in people with Body Image Disturbance and Medication Adherence, run by Massachusetts General Hospital at 2 sites 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 6 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: status not confirmed, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aaron J Blashill, PhD (617-643-2148, ablashill@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Image Disturbance (time frame: Baseline Assessment; Active Treatment Sessions; Post Treatment Assessment (Active treatment sessions will take place on a weekly basis starting 2 weeks after baseline and will continue for an average of 3 to 4 months.)). 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 7 Apr 2015.