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

NCT05822206 | Completed

• 1 other identifier: 931482-1
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 2

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

Conditions

HIV/AIDS; Trauma

Keywords

MSM; HIV/AIDS; Trauma; Engagement in care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Davidson Trauma Scale

  1 week

• Viral Load

  baseline and 9 months

Study Arms (2)

Treatment

EXPERIMENTAL

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; Behavioral: Life Steps and Sexual Decision-Making

Control

OTHER

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

Interventions

CBT-TSC BEHAVIORAL

Cognitive Behavioral Therapy for Trauma and Self-Care

Treatment

Life Steps and Sexual Decision-Making BEHAVIORAL

Control; Treatment

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: To be eligible for the study, an individual needs to identify as male and have been assigned male at birth.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• The Fenway Institute: collaborator
• Toronto Metropolitan University: collaborator

Study Sites (2)

Fenway Community Health

Boston, Massachusetts, 02215, United States

Location

Ryerson University

Toronto, Ontario, M5B 1Y3, Canada

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Wounds and Injuries

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Conall O'Cleirigh, PhD

  Fenway Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Randomization is known to the study investigator, study clinician, project coordinator, and participant. The outcomes assessor is privy to randomization information.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Behavioral Medicine Program, Department of Psychiatry

Model Details: 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.

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: April 20, 2023
• Study Start: August 3, 2016
• Primary Completion: December 1, 2019
• Study Completion: March 1, 2020
• Last Updated: April 20, 2023

Record last verified: 2023-04

Locations

CA (1); US (1)