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

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05822206

Collaborator

The Fenway Institute (Other), Ryerson University (Other)

Enrollment

Locations

Arms

42.9

Actual Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
HIV/AIDS Trauma	Behavioral: CBT-TSC Behavioral: Life Steps and Sexual Decision-Making	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

Single (Outcomes Assessor)

Masking Description:

Randomization is known to the study investigator, study clinician, project coordinator, and participant. The outcomes assessor is privy to randomization information.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 3, 2016

Actual Primary Completion Date :

Dec 1, 2019

Actual Study Completion Date :

Mar 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Participants in the Treatment arm receive 2 therapy sessions on LifeSteps and sexual decision-making, as well at 8 sessions of Cognitive Behavioral Therapy for Trauma and Self-Care (CBT-TSC). Participants then participate in 3-, 6-, and 9-month follow-up assessments.	Behavioral: CBT-TSC Cognitive Behavioral Therapy for Trauma and Self-Care Behavioral: Life Steps and Sexual Decision-Making
Other: Control Participants in the Control arm receive 2 therapy sessions on LifeSteps and sexual decision-making. Participants then participate in 3-, 6-, and 9-month follow-up assessments.	Behavioral: Life Steps and Sexual Decision-Making

Arm

Intervention/Treatment

Experimental: Treatment

Participants in the Treatment arm receive 2 therapy sessions on LifeSteps and sexual decision-making, as well at 8 sessions of Cognitive Behavioral Therapy for Trauma and Self-Care (CBT-TSC). Participants then participate in 3-, 6-, and 9-month follow-up assessments.

Behavioral: CBT-TSC

Cognitive Behavioral Therapy for Trauma and Self-Care

Behavioral: Life Steps and Sexual Decision-Making

Other: Control

Participants in the Control arm receive 2 therapy sessions on LifeSteps and sexual decision-making. Participants then participate in 3-, 6-, and 9-month follow-up assessments.

Behavioral: Life Steps and Sexual Decision-Making

Outcome Measures

Primary Outcome Measures

ACTG Adherence Interview [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 Outcome Measures

Davidson Trauma Scale [1 week]
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.
Viral Load [baseline and 9 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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).