Body Image and Self-Care in HIV-Infected MSM
BUILD
2 other identifiers
interventional
69
1 country
2
Brief 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. 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:
- 1.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.
- 2.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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 13, 2013
CompletedFirst Posted
Study publicly available on registry
March 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedApril 7, 2015
April 1, 2015
4.3 years
February 13, 2013
April 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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
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.)
Study Arms (2)
Experimental Intervention
EXPERIMENTALTAU Condition
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- The Fenway Institutecollaborator
- National Institute of Mental Health (NIMH)collaborator
Study Sites (2)
Massachusetts General Hospital
Boston, Massachusetts, 02114-2919, United States
The Fenway Institute
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aaron J Blashill, PhD
Massachusetts General Hospital, Fenway Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ph.D.
Study Record Dates
First Submitted
February 13, 2013
First Posted
March 25, 2013
Study Start
February 1, 2013
Primary Completion
June 1, 2017
Last Updated
April 7, 2015
Record last verified: 2015-04