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NOT YET RECRUITING
NCT07055360
NA

A Trauma-Informed Intervention for the Newly HIV-Diagnosed

Sponsor: Temple University

View on ClinicalTrials.gov

Summary

The current approach to HIV prevention emphasizes: (1) achieving viral suppression among HIV+ people in order to reduce HIV transmissibility, particularly for disproportionately affected groups such as Black sexual minority men (BSMM), by increasing retention in HIV care, and (2) addressing comorbidities and complications, which include mental health concerns such as trauma symptomology and severe acute stress reactivity. Despite the disproportionate impact of both HIV and traumatic stress on BSMM and the adverse effects of stress on engagement in HIV care, BSMM remain grossly underserved with respect to mental health. To address these gaps, the proposed study will develop an intervention that will: (1) provide a brief, resilience-oriented, trauma-informed intervention that combines online sessions and highly tailored text-messaging to reduce participant burden and motivate clients between sessions, (2) provide preliminary treatment for HIV+ BSMM's unaddressed mental health needs, and (3) be embedded early in the HIV continuum of care immediately after diagnosis to facilitate linkage to and retention in HIV care.

Official title: A Trauma-Informed Intervention for Sexual Minority Men Recently Diagnosed With HIV

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-01-05

Completion Date

2026-09-12

Last Updated

2025-07-08

Healthy Volunteers

No

Interventions

BEHAVIORAL

Resilience-Based Intervention for Stress Reduction and HIV-Related Efficacy (RISE)

RISE is based on Cognitive-Behavior Therapy (CBT) and the Information-Motivation-Behavioral Skills (IMB) Model. RISE will consist of six, weekly sessions, followed by a booster session in week 8, including resilience-building and health-promoting activities of RISE. Sessions will emphasize the participants' strengths, including positive thoughts, beliefs, and behaviors that work for the client and existing assets and supports in the participant's life. Tailored, health-promotion text messages will be sent weekly after each session.

BEHAVIORAL

Waitlist control: Text messaging-reminder comparison condition

This control condition will involve reminder text messages for adherence to HIV treatment and engaging in HIV care. As this condition is a waitlist control, participants in this condition will ultimately receive the RISE intervention.