A Trauma-Informed Intervention for the Newly HIV-Diagnosed (NCT07055360) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Trauma-Informed Intervention for the Newly HIV-Diagnosed
80 participantsStarted 2026-01-05
Plain-language 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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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).
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Client Satisfaction Questionnaire-8
Timeframe: Throughout study completion: 3-, 6- and 9-Month Follow-Up Post-Baseline