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Clinical Trials/NCT05822206
NCT05822206
Completed
Not Applicable

Development of a Trauma Informed Intervention to Support Adaptive Engagement in Care Among MSM Living With HIV: Project THRIVE+

Massachusetts General Hospital2 sites in 2 countries40 target enrollmentAugust 3, 2016
ConditionsHIV/AIDSTrauma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV/AIDS
Sponsor
Massachusetts General Hospital
Enrollment
40
Locations
2
Primary Endpoint
ACTG Adherence Interview
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 3, 2016
End Date
March 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Conall O'Cleirigh

Director of Behavioral Medicine Program, Department of Psychiatry

Massachusetts General Hospital

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).

Outcomes

Primary Outcomes

ACTG Adherence Interview

Time Frame: up to 4 times over 9 months

HIV medication adherence is collected at all major time points (baseline, 3 month follow-up, 6 month follow-up, and 9 month follow-up) via self-report, using the AIDS Clinical Trials Group Adherence Interview. Participants are asked to give the number of doses they take of each of their HIV medications per day, and to note how many doses were missed at 4 time time points (yesterday, day before yesterday, 3 days ago, in the past 2 weeks).

Secondary Outcomes

  • Viral Load(baseline and 9 months)
  • Davidson Trauma Scale(1 week)

Study Sites (2)

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