NCT07055360Not yet recruiting
A Trauma-Informed Intervention for the Newly HIV-Diagnosed
A Trauma-Informed Intervention for Sexual Minority Men Recently Diagnosed With HIV
Source: ClinicalTrials.gov · Last updated 8 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 7 Apr 2025
- Start date
- 5 Jan 2026
- Primary completion date
- 31 Aug 2026
- Lead sponsor
- Temple University
- Diseases
- HIV
- NCT number
- NCT07055360
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 5 Jan 2026 to the primary completion date, 31 Aug 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Demonstrating cognitive impairment or acute psychosis
Other
- Reporting unvailability to participate in the Baseline Assessment, the RISE intervention, and 3-, 6, and 9-Month Follow-Up Assessments
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.