Body Image and Self-Care in HIV-Infected MSM

Status unconfirmed · Not applicable

Conditions studied: Body Image Disturbance, Medication Adherence

In brief

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.

Key facts

Study ID

NCT01817621

Run by

Massachusetts General Hospital

People needed

69

Starts

2013-02-01

Last updated by the study team

2015-04-07

Who can join

Age: 18 and older, up to 65. Sex: male. Healthy volunteers: not accepted.

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

Where it is running

• The Fenway Institute — Boston, Massachusetts, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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