Suspended

BUILDBody Image and Self-Care in HIV-Infected MSM

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What is being tested

Experimental Intervention

+ TAU

Behavioral
Who is being recruted

Treatment Adherence and Compliance+3

+ Behavior

+ Patient Acceptance of Health Care

From 18 to 65 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: February 2013
See protocol details

Summary

Principal SponsorMassachusetts General Hospital
Study ContactAaron J Blashill, PhDMore contacts
Last updated: April 7, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01817621
Principal SponsorMassachusetts General Hospital
Study ContactAaron J Blashill, PhDMore contacts
Last updated: April 7, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

69 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Treatment Adherence and ComplianceBehaviorPatient Acceptance of Health CarePatient ComplianceHealth BehaviorMedication Adherence

Criteria

6 inclusion criteria required to participate
Age 18 and older

Capable of completing and fully understanding the informed consent process and the study procedures

HIV-seropositive

Prescribed ART for at least the last two months

Show More Criteria

3 exclusion criteria prevent from participating
Has received cognitive behavioral therapy for body dissatisfaction within the past 12 months

Over age 65

Significant mental health diagnosis requiring immediate treatment (e.g., unstable bipolar disorder; any psychotic disorder)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Active Comparator

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

The Fenway Institute

Boston, United StatesOpen The Fenway Institute in Google Maps
Recruiting soon

Massachusetts General Hospital

Boston, United States
Suspended2 Study Centers