A Trauma-Informed Intervention for the Newly HIV-Diagnosed
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Resilience-Based Intervention for Stress Reduction and HIV-Related Efficacy (RISE), Waitlist control: Text messaging-reminder comparison condition.
- Who it may be relevant to
- Registry conditions: Stress, HIV Care Loss to Followup, HIV Treatment Cascade. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Trauma-Informed Intervention for Sexual Minority Men Recently Diagnosed With HIV
Overview
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.
Detailed description
Compared to the general population in the United States, people living with HIV (PLWH) show high rates of trauma- and stress-related disorders and severe acute stress reactivity to events that are, diagnostically, not considered traumatic. Trauma is highly correlated with depression, a robust predictor of antiretroviral treatment (ART) non-adherence. Additionally, reporting a high number of recent stressful events is associated with ART non-adherence. Despite Black sexual minority men (BSMM), particularly those under age 40, being disproportionately affect by HIV and trauma and less likely to be linked to HIV care after diagnosis, BSMM remain grossly underserved with respect to mental health. Further, although interventions exist that address trauma for PWLH, few HIV-related interventions emphasize the traumatic stress cycle and acute stress reactivity immediately following an HIV diagnosis. To address the need for early mental health intervention immediately after HIV diagnosis, in general, as well as the under-addressed mental-health needs of HIV+ BSMM (+BSMM), in particular, the investigators will develop and pilot-test a resilience-focused, trauma-informed intervention called, Resilience- Based Intervention for Stress Reduction and HIV-Related Efficacy (RISE). RISE will be based on approaches and techniques of Cognitive-Behavior Therapy (CBT) and the framework of Resilience Theory. It will address trauma- and stress-related symptomology and acute stress reactivity within three months of an HIV diagnosis to facilitate linkage to HIV care. The brief RISE will include six online sessions, a booster session, and text messaging. Innovative commercial marketing techniques will be used to develop highly targeted messages to supplement the CBT- and resilience-based approach of RISE. First, Aim 1 will involve formative research to assess +BSSM's needs, preferences, and perceptions regarding mental health and engagement in HIV care via in-depth interviews with +BSMM and service providers. Next, Aim 2 will include development of the RISE intervention manual and digital health infrastructure. Tailored text messages and health-promotion materials will be developed via in-depth interview-derived quantitative surveys with 50 +BSMM. The Aim will also include an iterative process of intervention development, including focus groups with +BSMM and service providers, respectively, and intervention theatre tests with 6 +BSMM. Finally, Aim 3 will consist of a randomized, controlled pilot trial for feasibility (e.g., recruitment and enrollment rates, fidelity), acceptability (i.e., feedback interview, satisfaction questionnaire), and preliminary efficacy (i.e., increased HIV care engagement, including attending an HIV care appointment, antiretroviral treatment ART initiation, and ART adherence primary outcome; reduced trauma symptoms, including intrusive experiences, avoidance, and hyperarousal secondary outcome) with 40 +BSMM diagnosed within the past three months. Participants will be assessed at baseline, post-intervention, and 6- and 9-month follow-ups post-baseline. The investigators will develop and maintain a community advisory board for consultation throughout the study.
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 wi - 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.
Primary outcome measures
- Client Satisfaction Questionnaire-8 [Time frame: Throughout study completion: 3-, 6- and 9-Month Follow-Up Post-Baseline]
Secondary outcome measures (12)
- 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?" [Time frame: 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?" [Time frame: 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?" [Time frame: Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up]
- Visual Analog Scale [Time frame: Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up Post-Baseline]
- Berlin Social Support Scale [Time frame: Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up Post-Baseline]
- Impact of Event Scale - Revised [Time frame: Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up Post-Baseline]
- Center for Epidemiologic Studies - Depression Scale [Time frame: Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up Post-Baseline]
- Beck Depression Inventory-II [Time frame: Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up Post-Baseline]
- Coping Self-Efficacy Scale [Time frame: Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up Post-Baseline]
- Illness Intrusiveness Ratings Scale [Time frame: Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up Post-Baseline]
- HIV Treatment Adherence Self-Efficacy Scale [Time frame: Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up Post-Baseline]
- Demographics [Time frame: Baseline]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07055360 · R34MH132561 · 1R34MH132561-01