Trauma Informed Intervention to Support Engagement in HIV Care Among MSM (THRIVE+)

Trauma Clinical Trial

— THRIVE+  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05822206
• Other study ID #: 931482-1
• Status: Completed
• Phase: N/A
• Start date: August 3, 2016
• Est. completion date: March 2020

Study information

• Verified date: April 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS
• Trauma
• Wounds and Injuries

Intervention

Behavioral:
• CBT-TSC
Cognitive Behavioral Therapy for Trauma and Self-Care
• Life Steps and Sexual Decision-Making

Locations

Country	Name	City	State
Canada	Ryerson University	Toronto	Ontario
United States	Fenway Community Health	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Ryerson University, The Fenway Institute

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ACTG Adherence Interview	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).	up to 4 times over 9 months
Secondary	Davidson Trauma Scale	The Davidson Trauma Scale measures the frequency and severity of PTSD symptoms in the past week, and is conducted at each study visit (baseline, weekly visits, and all follow-up visits). Each item on the 17-item scale is scored 0-4 on frequency (0 = not at all; 4 = every day) and severity (0 = not at all distressing; 4 = extremely distressing), yielding a total between 0 and 136.	1 week
Secondary	Viral Load	Most recent viral load is collected from each participant at baseline (first study visit) and at 9 month follow-up (final study visit) through medical record abstraction.	baseline and 9 months