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Counseling for Body Image in HIV-Positive Men Who Have Sex with Men (MSM) (BUILD Trial)

N/A
Waitlist Available
Led By Aaron J Blashill, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Reports having sex with men in the past 12 months
HIV-seropositive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.)
Awards & highlights

BUILD Trial Summary

This trial is looking to develop and test counseling strategies for men who have sex with men (MSM) who are living with HIV and are experiencing body dissatisfaction.

Who is the study for?
This trial is for HIV-positive men who have sex with men (MSM), aged 18 or older, currently experiencing body dissatisfaction and on antiretroviral therapy (ART) for at least two months. Participants must not be over age 65, require immediate treatment for significant mental health issues, or have had cognitive behavioral therapy for body dissatisfaction in the past year.Check my eligibility
What is being tested?
The study aims to develop and test counseling strategies tailored to HIV-infected MSM dealing with body dissatisfaction. Phase 1 involves creating the intervention through pilots and feedback from up to 9 participants. Phase 2 will compare this new intervention against standard treatment in a randomized control trial involving up to 60 participants.See study design
What are the potential side effects?
Since this trial focuses on counseling interventions rather than medications, traditional side effects are not a primary concern. However, discussing sensitive topics like body image could potentially cause emotional discomfort.

BUILD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had sexual relations with men in the past year.
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I am HIV positive.
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I have been on antiretroviral therapy for at least 2 months.
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I am 18 years old or older.

BUILD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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.) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Body Image Disturbance
Secondary outcome measures
Mental Depression

BUILD Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental InterventionExperimental Treatment1 Intervention
Group II: TAU ConditionActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Experimental Intervention
2018
N/A
~370

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,286 Total Patients Enrolled
The Fenway InstituteOTHER
14 Previous Clinical Trials
2,758 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,783 Previous Clinical Trials
2,689,080 Total Patients Enrolled

Media Library

Experimental Intervention Clinical Trial Eligibility Overview. Trial Name: NCT01817621 — N/A
Body Dysmorphic Disorder Research Study Groups: Experimental Intervention, TAU Condition
Body Dysmorphic Disorder Clinical Trial 2023: Experimental Intervention Highlights & Side Effects. Trial Name: NCT01817621 — N/A
Experimental Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT01817621 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are additional participants being sought out for this research project?

"Contrary to the information on clinicaltrials.gov, this study is not seeking participants at present. Initially posted February 1st 2013 and last updated April 6th 2015, it appears that no more patients are necessary for completion of the trial; however there remain 83 other trials actively recruiting volunteers."

Answered by AI

To whom is participation in this experiment open?

"This medical trial is recruiting 69 individuals aged 18-65 that adhere to the following requirements: an age of over 18, a current score of 2.48 or higher on the Body Image Disturbance Questionnaire, and have had sexual intercourse with men in the last 12 months."

Answered by AI

Does this investigation include participants aged 35 and over?

"This research project is limited to those aged 18-65, but there are complimentary studies recruiting patients younger and older than the present trial's stipulated age range."

Answered by AI
~6 spots leftby Apr 2025