Stress Disorders, Post-Traumatic Clinical Trial
Brief Summary: The specific aims of this study are:
1. To test, in a two-arm randomized controlled trial, the efficacy of cognitive processing
therapy for sexual risk and posttraumatic symptom severity reduction (CPT-SR) in
HIV-uninfected men who have sex with men (MSM) who have histories of childhood sexual
abuse (CSA). The primary outcome is reduction in unprotected anal/vaginal intercourse
(number and proportion) with serodiscordant partners. The investigators will also
examine the intervention effect on CSA-related trauma symptom severity and cognitions
and behaviors.
2. To examine the degree to which intervention-related reductions in sexual risk behavior
are mediated by reductions in CSA-related symptom severity, cognitions, and behaviors.
3. To examine the degree to which the intervention reduces incident sexually transmitted
infections (STIs) during the study period, as well as to explore additional potential
moderators and mediators of intervention efficacy.
Study hypotheses:
1. For the primary outcome, the investigators hypothesize that those who receive the
intervention will have reduced transmission-risk behavior.
2. For the secondary outcome, the investigators hypothesize that those who receive the
intervention will have reduced trauma symptom severity (cognitions and behaviors).
The prevalence of HIV among men who have sex with men (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. Studies
have also demonstrated a staggeringly high prevalence of childhood sexual abuse (CSA) in MSM,
and shown an association between CSA and 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. Notwithstanding the ability of
the existing HIV prevention interventions to show reductions in sexual risk taking, the
recent successes of chemoprophylaxis, current policy initiatives, and empirically supported
recommendations, all support development of combination prevention interventions that can
specify multiple prevention targets, address related risk factors and barriers, and are
grounded in a community context. The pathways from CSA to adult sexual risk behavior are
varied and complex and this complexity is appropriately addressed in individual-based
interventions where empirically supported interventions for CSA related trauma were efficacy
tested. The development of an integrated prevention intervention that utilizes cognitive
behavioral technologies to address co-occurring and interfering CSA and sexual risk
represents a novel and largely untested innovative application that is theoretically designed
to address sexual risk directly and indirectly through reductions in CSA-related trauma
symptoms. The flexibility of integrated and combination prevention programs has the potential
to support triage of MSM with particular risk profiles to the programs that best meet their
prevention needs.
This two-arm RCT is designed to test the efficacy of a psycho-social intervention that
addresses intersecting epidemics among MSM, HIV and CSA. 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 through rehearsals of
sexual safety behaviors. The active and time-matched comparison condition is risk reduction
counseling plus supportive psychotherapy. The investigators 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 a computer-based questionnaire. Secondary
outcomes include trauma symptom severity, both cognitive and behavioral. Study assessment
points are at baseline, 3 (post treatment), 6, 9, and 12-month follow-ups.
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