Clinical trial NCT06463431: Cognitive Processing Therapy to Treat PTSD and Sexually Transmitted Infections Among Men Who Have Sex With Men
Official title: A Trial for An Integrated Cognitive Behavioural Therapy to Treat PTSD and Sexually Transmitted Infections Among Gay, Bisexual, and Other Men Who Have Sex With Men
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Sexually Transmitted Infection (STI) Prevention
Keywords: Cognitive Processing Therapy
men who have sex with men
gay bisexual queer men
gay men
post traumatic stress disorder
Cognitive Behavioral Therapy
sexually transmitted blood borne infections
sexual risk
prevention
Lead sponsor: Toronto Metropolitan University
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 56
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Gay, bisexual, queer, and other men who have sex with men (GBM) continue to bear a disproportionate burden of the sexually transmitted and blood-borne infections (STBBI), largely attributable to efficient transmission during condomless anal sex (CAS; Baggaley et al., 2010). In 2022, GBM accounted for 38.1% of new HIV diagnoses in Canada (Public Health Agency of Canada, 2023). Incidence of syphilis, chlamydia and gonorrhea have risen among men who have sex with men (MSM), especially among HIV+ GBM living in Canadian urban centres, including Toronto and Quebec (Public Health Agency of Canada, 2022). Post-traumatic stress disorder prevalence is also higher among GBM than among heterosexual men (Roberts et al., 2010). Post-traumatic stress disorder (PTSD) is a risk factor for CAS and related STBBI among GBM (O'Cleirigh, 2019). Despite the strong association between PTSD and STBBI risk among GBM, no studies have examined the efficacy of PTSD treatment on STBBI risk among GBM. PTSD may also increase substance use in sexual situations, another risk factor for STBBIs among GBQM (Semple et al., 2011; Elkington et al., 2010). Substance use tends to follow PTSD because alcohol and other substances are often used to self-medicate trauma symptoms (as an avoidant coping strategy) in interpersonal situations (Tan et al., 2021). Alcohol and substance use in sexual situations are consistent risk factors for CAS among Canadian GBQM (Lambert et al., 2011), and are associated with higher HIV incidence. Due to consistent data linking substance use to STBBI risk, it has been suggested that incorporating alcohol and substance use treatment into sexual risk reduction counselling (Koblin et al., 2006; Parsons et al., 2005; Shoptaw \& Frosch, 2000) may increase the efficacy of STBBI prevention efforts for GBQM. PTSD is highly treatable via cognitive-behavioural therapies, including by Cognitive Processing Therapy (CPT; Benight \& Bandura, 2004; Monson \& Shnaider, 2014; Watkins et al., 2018).

The present study will provide preliminary feasibility and acceptability data for a novel and innovative STI/HIV prevention intervention for GBQM. This intervention builds upon empirically supported treatments for PTSD, including PTSD-related substance use, by adding risk reduction counselling to reduce sexually transmitted infections (STI) and HIV sexual risk behaviour. The present study will provide trial data for a novel and innovative STBBI prevention psychotherapy for GBM that could be administered by mental health providers across Canada. The intervention will consist of 14 90-minute sessions of an integrated cognitive-behavioural approach using CPT to treat PTSD and to reduce STBBI risks among GBQM. The primary outcome will be condomless anal sex with casual partners. The secondary outcomes will be PTSD prevalence, trauma symptoms, problematic substance use, sexual risk, and PTSD-related avoidance of negative thoughts and feelings.

This psychotherapy intervention will build upon empirically supported interventions to reduce HIV risk.


Eligibility criteria: Inclusion Criteria:

* Live in Ontario or Quebec (able to travel to Toronto Metropolitan University or CLSC de Cote-des-Neiges, respectively)
* Identify as a man
* Are over 18 years of age
* Have had anal sex without a condom with a person assigned male at birth in the past 3 months
* Have experienced symptoms consistent with a diagnosis of PTSD
* Are able to read, speak, and understand English

Exclusion Criteria:

* if a 14-session protocol is deemed inappropriate for their treatment needs (e.g., psychotic or bipolar disorders not well-managed by medications)
* if either our assessors or therapists identify that a participant's ability to respond to study measures is compromised by mental or physical disabilities or inability to speak and understand English

Primary outcomes:
measure: Condomless anal sex (CAS) with casual partners, based on response at 6 months.
timeFrame: 3-months following final treatment session
Secondary outcomes:
measure: PTSD Measures
timeFrame: baseline, post-intervention (an average of 16-18 weeks after baseline), 3-month follow-up
measure: Self-Report Measures - PTSD
timeFrame: baseline, post-intervention (an average of 16-18 weeks after baseline), 3-month follow-up
measure: Self-Report Measures - Sexual behavior
timeFrame: baseline, post-intervention (an average of 16-18 weeks after baseline), 3-month follow-up
measure: Change in Clinical diagnosis and Severity of Mental Health Symptoms
timeFrame: baseline, post-intervention (an average of 16-18 weeks after baseline), 3-month follow-up
measure: Cumulative incidence of bacterial STIs and incidence of HIV and viral hepatitis
timeFrame: baseline, post-intervention (an average of 16-18 weeks after baseline), 3-month follow-up
measure: Self-Report Measures - Substance Use.
timeFrame: baseline, post-intervention (an average of 16-18 weeks after baseline), 3-month follow-up
measure: Qualitative Exit Interview
timeFrame: post-intervention (an average of 16-18 weeks after baseline)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Metropolitan University
state: Ontario
city: Montreal
country: Canada
facility: McGill University
state: Quebec
Study officials:
References:
citation: Shoptaw S, Frosch D. Substance abuse treatment as HIV prevention for men who have sex with men. AIDS Behav. 2000;4(2):193-203.
citation: Parsons JT, Kutnick AH, Halkitis PN, Punzalan JC, Carbonari JP. Sexual risk behaviors and substance use among alcohol abusing HIV-positive men who have sex with men. J Psychoactive Drugs. 2005 Mar;37(1):27-36. doi: 10.1080/02791072.2005.10399746.
citation: Koblin BA, Husnik MJ, Colfax G, Huang Y, Madison M, Mayer K, Barresi PJ, Coates TJ, Chesney MA, Buchbinder S. Risk factors for HIV infection among men who have sex with men. AIDS. 2006 Mar 21;20(5):731-9. doi: 10.1097/01.aids.0000216374.61442.55.
citation: Lambert G, Cox J, Hottes TS, Tremblay C, Frigault LR, Alary M, Otis J, Remis RS; M-Track Study Group. Correlates of unprotected anal sex at last sexual episode: analysis from a surveillance study of men who have sex with men in Montreal. AIDS Behav. 2011 Apr;15(3):584-95. doi: 10.1007/s10461-009-9605-3.
citation: Tan RKJ, Phua K, Tan A, Gan DCJ, Ho LPP, Ong EJ, See MY. Exploring the role of trauma in underpinning sexualised drug use ('chemsex') among gay, bisexual and other men who have sex with men in Singapore. Int J Drug Policy. 2021 Nov;97:103333. doi: 10.1016/j.drugpo.2021.103333. Epub 2021 Jun 24.
citation: Elkington KS, Bauermeister JA, Zimmerman MA. Psychological distress, substance use, and HIV/STI risk behaviors among youth. J Youth Adolesc. 2010 May;39(5):514-27. doi: 10.1007/s10964-010-9524-7. Epub 2010 Mar 14.
citation: Semple SJ, Strathdee SA, Zians J, McQuaid JR, Patterson TL. Drug assertiveness and sexual risk-taking behavior in a sample of HIV-positive, methamphetamine-using men who have sex with men. J Subst Abuse Treat. 2011 Oct;41(3):265-72. doi: 10.1016/j.jsat.2011.03.006. Epub 2011 May 8.
citation: Benight CC, Bandura A. Social cognitive theory of posttraumatic recovery: the role of perceived self-efficacy. Behav Res Ther. 2004 Oct;42(10):1129-48. doi: 10.1016/j.brat.2003.08.008.
citation: Roberts AL, Austin SB, Corliss HL, Vandermorris AK, Koenen KC. Pervasive trauma exposure among US sexual orientation minority adults and risk of posttraumatic stress disorder. Am J Public Health. 2010 Dec;100(12):2433-41. doi: 10.2105/AJPH.2009.168971. Epub 2010 Apr 15.
citation: O'Cleirigh C, Safren SA, Taylor SW, Goshe BM, Bedoya CA, Marquez SM, Boroughs MS, Shipherd JC. Cognitive Behavioral Therapy for Trauma and Self-Care (CBT-TSC) in Men Who have Sex with Men with a History of Childhood Sexual Abuse: A Randomized Controlled Trial. AIDS Behav. 2019 Sep;23(9):2421-2431. doi: 10.1007/s10461-019-02482-z.
citation: Baggaley RF, White RG, Boily MC. Infectiousness of HIV-infected homosexual men in the era of highly active antiretroviral therapy. AIDS. 2010 Sep 24;24(15):2418-20. doi: 10.1097/QAD.0b013e32833dbdfd. No abstract available.