BUILDBody Image and Self-Care in HIV-Infected MSM
Experimental Intervention
+ TAU
Treatment Adherence and Compliance+3
+ Behavior
+ Patient Acceptance of Health Care
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.69 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy 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
Massachusetts General Hospital
Boston, United States