Sexually Transmitted Infection (STI) Prevention, Stress Disorders, Post-Traumatic
Conditions
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
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.
Interventions
BEHAVIORALCognitive Processing Therapy
We propose a conceptual model for the relationship between PTSD, substance use, & sexual risk behaviour wherein using substances to avoid posttraumatic cognitions & affect leads to risky sexual behaviour through impaired safer sex negotiation. These mechanisms are consistent with the theory underlying CPT. Behaviourally, substance use (and potentially risky sexual behaviour) is negatively reinforced through avoiding unwanted negative affect. Cognitively, PTSD-based predictions may generate unrealistic risk appraisals that contribute to sexual risk. CPT addresses these specified pathways by a) identifying how trauma leads to maladaptive beliefs about the self, others, & the future, b) cognitive interventions to address these beliefs, & c) an overall trauma-focused orientation that addresses cognitive, affective & behavioural avoidance, using cognitive restructuring to lead to more realistic/adaptive beliefs, less cognitive/affective avoidance, & more goal-directed approach behaviours.
Sponsors
Toronto Metropolitan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Condomless anal sex (CAS) with casual partners, based on response at 6 months. | 3-months following final treatment session | Participants will indicate frequency of CAS and number of casual sex partners, defined as partners of less than a 6-month duration for 1) insertive and receptive anal sex and vaginal or frontal sex both with and without a condom, in the past 3 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-Report Measures - PTSD | baseline, post-intervention (an average of 16-18 weeks after baseline), 3-month follow-up | PTSD. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) is a well-validated measure of PTSD severity. The Impact of Events - Revised scale will also be used to evaluate our mediator of avoidance of negative cognitions and affect and provide additional data on participants' trauma. |
| Self-Report Measures - Sexual behavior | baseline, post-intervention (an average of 16-18 weeks after baseline), 3-month follow-up | Self-report: Frequency and number of sexual partners |
| Change in Clinical diagnosis and Severity of Mental Health Symptoms | baseline, post-intervention (an average of 16-18 weeks after baseline), 3-month follow-up | The Structured Clinical Interview for DSM-5 Disorders (SCID-5) will be used to determine whether participants meet diagnostic criteria for PTSD disorder or any other psychological disorder. A subset of 20% of randomly selected baseline assessments will be reviewed by a second diagnostician for reliability. |
| PTSD Measures | baseline, post-intervention (an average of 16-18 weeks after baseline), 3-month follow-up | PTSD Scale-5 (CAPS-5). The CAPS-5 will be our primary measure of PTSD. The CAPS-5 includes a lifetime trauma checklist and questions about stressor exposure, which will be used to ensure that participants meet the DSM-5 criterion of traumatic stressor criteria exposure that is required for diagnosis. The CAPS-5 yields a continuous measure of PTSD severity, as well as diagnostic status. The psychometric properties of the CAPS-5 have been well-established. |
| Self-Report Measures - Substance Use. | baseline, post-intervention (an average of 16-18 weeks after baseline), 3-month follow-up | To assess substance use and dependence problems, we will use the well validated and highly reliable World Health Organization Alcohol, Smoking and Substance Involvement Screening Test (WHO-ASSIST). |
| Qualitative Exit Interview | post-intervention (an average of 16-18 weeks after baseline) | This is a structured interview that guides the participant through primary open-ended questions concerning their experience of the intervention. These questions are designed to solicit information of the acceptability of the intervention and the participant's satisfaction with intervention. A sample question is Do you have any concerns about the program or recommendations for improvement? The interview takes approximately 30 minutes to complete. |
| Cumulative incidence of bacterial STIs and incidence of HIV and viral hepatitis | baseline, post-intervention (an average of 16-18 weeks after baseline), 3-month follow-up | Laboratory specimens will be collected via blood tests, and throat and rectal swabs. We will also ask for self-report of HIV/STI incidence in the last 6 months. |
Countries
Canada
Contacts
Primary ContactJane Cao, BA
Backup ContactTrevor A Hart, Ph.D, CPsych
Outcome results
None listed