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| Name | Class |
|---|---|
| Fenway Community Health | OTHER |
| University of Miami | OTHER |
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Brief Summary: The specific aims of this study are:
Study hypotheses:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Processing Therapy for Sexual Risk (CPT-SR) | Experimental | The CPT-SR condition will be comprised of 10 individual therapy sessions fully integrating sexual risk reduction counseling into cognitive therapy for sexual abuse-related trauma. |
|
| Time-Matched Control (TMC) | Active Comparator | The TMC will be comprised of sexual risk reduction counseling/education and supportive psychotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Processing Therapy for Sexual Risk | Behavioral | Eight weekly sessions, 4 modules. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes from Baseline in Sexual Risk Behavior for HIV Acquisition | Number of unprotected (no condom was used) insertive or receptive anal or vaginal intercourse acts reported in the past 3 months with casual partners or with partners with unknown or positive HIV status. | Baseline, (2 weeks post-baseline pre-randomization), 3,6, 9, and 12 month follow ups |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from Baseline in Trauma Symptom Severity | Davidson Trauma Scale which has been correlated with measures of Post-Traumatic Stress Disorder (PTSD) severity, depression, and general anxiety, and discriminated well between traumatized individuals with and without PTSD. | Baseline assessment, 3, 6, and 9-month follow-up assessments |
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Eligibility Criteria:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Conall O'Cleirigh, Ph.D. | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Coral Gables | Florida | 33124-0751 | United States | ||
| Massachusetts General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34676467 | Derived | Batchelder AW, Fitch C, Feinstein BA, Thiim A, O'Cleirigh C. Psychiatric, Substance Use, and Structural Disparities Between Gay and Bisexual Men with Histories of Childhood Sexual Abuse and Recent Sexual Risk Behavior. Arch Sex Behav. 2021 Oct;50(7):2861-2873. doi: 10.1007/s10508-021-02037-1. Epub 2021 Oct 21. | |
| 30973745 | Derived | Batchelder AW, Choi K, Dale SK, Pierre-Louis C, Sweek EW, Ironson G, Safren SA, O'Cleirigh C. Effects of syndemic psychiatric diagnoses on health indicators in men who have sex with men. Health Psychol. 2019 Jun;38(6):509-517. doi: 10.1037/hea0000724. Epub 2019 Apr 11. |
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| Supportive Psychotherapy | Behavioral | Eight weekly sessions |
|
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| Sexual Risk Reduction Intervention | Behavioral | Two weekly sessions. |
|
| Boston |
| Massachusetts |
| 02114-2919 |
| United States |
| The Fenway Institute | Boston | Massachusetts | 02215 | United States |
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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