Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT01817621

Conditions

Body Image Disturbance

Medication Adherence

Eligibility Criteria

Sex: Male

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Experimental Intervention

TAU

Study Details

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.

Conditions

Body Image Disturbance

Medication Adherence

Study ID

NCT01817621

Start date

Feb, 2013

Status verified date

Apr, 2015

Primary completion date

Jun, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

69 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental Intervention

active comparator: TAU Condition

Interventions

Experimental Intervention

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.

TAU

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.

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.) ]

Central Contacts and Locations

Central contacts

Aaron J Blashill, PhD

617-643-2148ablashill@partners.org

Locations

The Fenway Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Aaron J. Blashill, PhD

617-927-6465ablashill@partners.org

Jonathan Jampel, BA

617-927-6465jjampel@fenwayhealth.org

Principal Investigator:

Aaron J. Blashill, PhD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Apr 7, 2015

Last verified

Apr, 2015

Keywords

  • Body Image Disturbance
  • Medication Adherence
  • Sexual Risk Behavior
  • HIV
  • MSM

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2015-04-07.