Background. Despite nearly 30 years of the HIV epidemic in the U.S., HIV incidence and prevalence continues to grow. Men who have sex with men (MSM) are, by far, the population most affected, as they make up the majority of new infections and the majority of individuals living with HIV in the U.S. The prevalence of HIV among MSM is estimated at an alarming 19% domestically (CDC 2010), rates comparable to endemic settings in certain regions of sub-Saharan Africa where approximately 20% of the adult population is HIV- infected. Study after study has demonstrated a staggeringly high prevalence of childhood sexual abuse (CSA) in MSM, and study after study has shown an association of CSA to HIV risk in MSM. A successful intervention for MSM with a CSA history to prevent HIV has the potential to avert infections among some of the riskiest members of the most HIV vulnerable group in the U.S. Design. This two-arm RCT is to test the efficacy of a psycho-social intervention that addresses intersecting epidemics among MSM: HIV and CSA. It follows directly from our successful r34 in which the integrated intervention was developed and piloted in a mini, randomized study. The experimental condition integrates sexual risk reduction counseling with Cognitive Processing Therapy for Sexual Risk (CPT-SR). CPT-SR has been specifically piloted on MSM with CSA histories and sexual risk to reduce interfering negative CSA-related thoughts about self, to more accurately appraise sexual risk, and to decrease avoidance of sexual safety considerations, and through rehearsals of sexual safety behaviors. The active and time-matched comparison condition is risk reduction counseling plus supportive psychotherapy. We will randomize HIV-uninfected MSM who report a history of CSA and multiple recent sexual risk episodes for HIV (unprotected anal/vaginal intercourse) across two sites (Boston and Miami). The primary outcome will be self-reported sexual risk taking as assessed via ACASI. Secondary outcomes include CSA-related trauma symptom severity, and CSA-trauma related cognitions (perceived HIV risk, negative thoughts about self, self -efficacy) and behaviors (avoidant coping substance use, dissociation). Reductions in incident STIs will be an exploratory outcome. Trauma characteristics and demographics will be examined as moderators of the treatment effect and secondary outcomes will be examined as mediators of the treatment effect on sexual risk. Study assessment points are at baseline, 3 (post treatment), 6, 9, and 12-month follow-ups. Efficacy testing in community settings, with master level clinicians, using short term therapy are design features to support community uptake and sustainability. Innovation. The use of cognitive-behavioral technologies to address mental health issues that interfere with the sexual safety of MSM is an innovative application, theoretically designed to increase the modest efficacy of previous prevention work. This innovation also supports the mental and physical health of MSM more broadly, and may be a model for addressing other HIV prevention targets impacted by interfering mental health issues.

Public Health Relevance

The purpose of this research application is to establish the efficacy of an integrated treatment to reduce HIV sexual risk behavior in a group of men who have sex with men at high risk for HIV infection (MSM with a history of childhood sexual abuse with recent sexual risk for HIV). The public health goal of this application is that by reducing sexual HIV risk behavior new HIV infections and other sexually transmitted diseases will be reduced.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Research Project (R01)
Project #
5R01MH095624-03
Application #
8472537
Study Section
Special Emphasis Panel (ZMH1-ERB-D (02))
Program Officer
Grossman, Cynthia I
Project Start
2011-08-15
Project End
2016-05-31
Budget Start
2013-06-01
Budget End
2014-05-31
Support Year
3
Fiscal Year
2013
Total Cost
$668,418
Indirect Cost
$76,574
Name
Massachusetts General Hospital
Department
Type
DUNS #
073130411
City
Boston
State
MA
Country
United States
Zip Code
02199