Clinical trial NCT05822206: Trauma Informed Intervention to Support Engagement in HIV Care Among MSM (THRIVE+)
Official title: Development of a Trauma Informed Intervention to Support Adaptive Engagement in Care Among MSM Living With HIV: Project THRIVE+
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Trauma
Keywords: MSM
HIV/AIDS
Trauma
Engagement in care
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: The Fenway Institute
name: Toronto Metropolitan University
First posted: 2023-04-20
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized into one of two conditions: treatment (Cognitive Behavioral Therapy for Trauma and Self-Care; CBT-TSC) or control. The CBT-TSC condition consists of 10 therapy sessions and 3 follow-up visits. The control condition consists of 2 therapy sessions and 3 follow-up visits. The first two therapy sessions, which are received by all participants regardless of condition, employ LifeSteps and sexual decision making techniques. The remaining eight therapy sessions, which only those in the CBT-TSC condition receive, address thoughts and behaviors associated with trauma distress and poor engagement in HIV care.
Primary purpose: TREATMENT

Brief summary: This purpose of this project is to specify and provide an initial test of a 10 session, individual-based cognitive therapy intervention to address symptoms of PTSD and poor engagement in HIV care among men who have sex with men (MSM) with trauma histories

Detailed description: The proposed intervention will incorporate the most current approaches to mediating trauma responses and stressors related to experiences of HIV stigma and homonegativity with cognitive-processing therapy, an empirically validated, cognitive-behavioral intervention for reducing negative consequences of traumatic stress. This intervention intends to improve uptake of HIV care in the prevention, engagement, and care cascade while also addressing the mental health needs of HIV-positive persons in a program of research that leads to outcomes in the short-term. If found to be efficacious, this intervention can also be scalable across clinical settings.

The study will be implemented at The Fenway Institute at Fenway Health (TFI) and at Ryerson University, Toronto, Canada and Drs. O'Cleirigh and Hart will assume the responsibility of coordinating the study across sites.

Randomization will be to the 10 session intervention or to two medication adherence/engagement in care sessions.

Eligibility criteria: Inclusion Criteria:

* HIV-infected
* is a man who has sex with men
* has a history of trauma and is experiencing trauma-related distress (as operationalized by a score of \>/= 20 on the Davidson Trauma Scale)
* is sub-optimally engaged in HIV care (as operationalized by missing 1 or more HIV care appointments in the past 12 months, having a detectable viral load at most recent testing, or having poor adherence - \</=80% - to HIV medications)

Exclusion Criteria:

* has a significant mental health diagnosis that requires immediate treatment (e.g., acute major depression; panic disorder; any psychotic disorder)
* unable to complete the informed consent process (e.g., substantial cognitive impairment, inadequate English language skills).

Primary outcomes:
measure: ACTG Adherence Interview
timeFrame: up to 4 times over 9 months
Secondary outcomes:
measure: Davidson Trauma Scale
timeFrame: 1 week
measure: Viral Load
timeFrame: baseline and 9 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Fenway Community Health
state: Massachusetts
city: Toronto
country: Canada
facility: Ryerson University
state: Ontario
Study officials:
affiliation: Fenway Health
name: Conall O'Cleirigh, PhD
role: PRINCIPAL_INVESTIGATOR
References: