A Trauma-Informed Intervention for the Newly HIV-Diagnosed

NCT07055360 | Not Yet Recruiting

• 2 other identifiers: R34MH1325611R34MH132561-01
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Stress; HIV Care Loss to Followup; HIV Treatment Cascade

Keywords

resilience; trauma; intervention; mental health; HIV; HIV care; newly-diagnosed; mHealth; eHealth; stress

Outcome Measures

Primary Outcomes (1)

• Client Satisfaction Questionnaire-8

  Acceptability, specifically participant satisfaction. Values: Range from 8 to 32. Scoring: Higher scores indicate greater percentage of HIV medication dosages taken over the past 30 days.

  Throughout study completion: 3-, 6- and 9-Month Follow-Up Post-Baseline

Secondary Outcomes (18)

• Question (Yes/No; Attended HIV care appointment in past 3 months): "Have [the participant] attended an HIV care appointment with a HIV care, primary care, or similarly care provider in the past 3 months?"

  Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up Post-Baseline

• Question (Yes/No; Initiated antiretroviral treatment): "Have [the participant] begun taking medication prescribed to treat HIV?"

  Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up Post-Baseline

• Question (Yes/No; Have future appointment scheduled): "Do [the participant] have a future HIV care appointment scheduled?"

  Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up

• Visual Analog Scale

  Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up Post-Baseline

• Berlin Social Support Scale

  Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up Post-Baseline

Study Arms (2)

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

EXPERIMENTAL

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

Waitlist Control: Text messaging-reminder comparison condition

ACTIVE COMPARATOR

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

Behavioral: Waitlist control: Text messaging-reminder comparison condition

Interventions

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

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.

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

Waitlist control: Text messaging-reminder comparison condition BEHAVIORAL

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.

Waitlist Control: Text messaging-reminder comparison condition

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with HIV within the past 3 months
• Self-identification as Black or African American
• Aged 18-39 years
• Elevated traumatic stress as indicated by scores above clinical cutoffs on either of the following subscales of the Impact of Event Scale--Revised: Intrusion (score of 5 or greater) and Avoidance (score of 7 or greater)
• Owning a phone with short-message service or messaging
• Access to a device with a screen, a web browser, and adequate internet speed for videoconferencing (e.g., smartphone, computer).

You may not qualify if:

• Demonstrating cognitive impairment or acute psychosis
• Reporting unvailability to participate in the Baseline Assessment, the RISE intervention, and 3-, 6, and 9-Month Follow-Up Assessments

Sponsors & Collaborators

• Temple University: lead
• National Institute of Mental Health (NIMH): collaborator

MeSH Terms

Conditions

Wounds and Injuries; Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: July 8, 2025
• Study Start: January 5, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): September 12, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-06