StressRISENCT07055360
A Trauma-Informed Intervention for the Newly HIV-Diagnosed
A study testing Resilience-Based Intervention for Stress Reduction and HIV-Related Efficacy (RISE) in people with Stress and HIV Care Loss to Followup, run by Temple University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Stress, HIV Care Loss to Followup, HIV Treatment Cascade
- What is being tested?
- Resilience-Based Intervention for Stress Reduction and HIV-Related Efficacy (RISE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 5 Jan 2026to 12 Sep 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
About this study
Official title: A Trauma-Informed Intervention for Sexual Minority Men Recently Diagnosed With HIV
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.
Read the 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.
- Conditions
- Stress, HIV Care Loss to Followup, HIV Treatment Cascade
- Being tested
- Resilience-Based Intervention for Stress Reduction and HIV-Related Efficacy (RISE), Waitlist control: Text messaging-reminder comparison condition
- Keywords
- resilience, trauma, intervention, mental health, HIV, HIV care, newly-diagnosed, mHealth, eHealth, stress
- Medical subject headings
- Wounds and Injuries, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resilience-Based Intervention for Stress Reduction and HIV-Related Efficacy (RISE)Behavioural
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.
Waitlist control: Text messaging-reminder comparison conditionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Waitlist control: Text messaging-reminder comparison condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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?"
Response options: Yes or No
Measured: 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?"
Response options: Yes or No
Measured: 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?"
Response options: Yes or No
Measured: Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up
Visual Analog Scale
Antiretroviral treatment adherence for HIV (percentage). Values: Range from 0% to 100%. Scoring: Higher scores indicate greater percentage of HIV medication dosages taken over the past 30 days.
Measured: Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up Post-Baseline
Berlin Social Support Scale
Berlin Social Support Scales. Values: Range from 52 (minimum) to 208 (maximum). Scoring: Higher scores indicate greater social support (e.g., greater perceived support, greater desire for support, greater receipt of support, etc.), although some items need to be reverse coded.
Measured: Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up Post-Baseline
Impact of Event Scale - Revised
Traumatic stress symptomology, specifically avoidance and intrusion. 8 items ranging from 0 (minimum) to 32 (maximum) for avoidance and intrusionm respectively.
Measured: Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up Post-Baseline
Center for Epidemiologic Studies - Depression Scale
Depressive symptomology. Values: 20 items, range from 0 (minimum) to 60 (maximum) Scoring: Greater scores = more severe depression during the past week; 4 items (4, 8, 12, 16) need to be reverse coded
Measured: Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up Post-Baseline
Beck Depression Inventory-II
Depressive symptomology. Values: 21 items, range from 0 (minimum) to 63 (maximum). Scoring: Greater scores = greater depressive symptom severity.
Measured: Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up Post-Baseline
Coping Self-Efficacy Scale
Participants' belief in ability to cope. Values: 26 items, range from 0 (minimum) to 260 (maximum). Scoring: Greater scores = greater coping self-efficacy.
Measured: Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up Post-Baseline
Illness Intrusiveness Ratings Scale
Extent to which the illness reduces or intrudes upon quality of life. Values: 13 items, range from 13 (minimum) to 91 (maximum). Scoring: Greater scores = greater illness intrusiveness.
Measured: Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up Post-Baseline
HIV Treatment Adherence Self-Efficacy Scale
Participants' confidence in ability to adhere to antiretroviral treatment for HIV.
Values: 12 items, range from 12 (minimum) to 120 (maximum). Scoring: Greater average scores = greater self-efficacy for treatment adherence in the past month.
Measured: Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up Post-Baseline
Demographics
Participants enter or select demographic characteristics with which they identify, such as age, ethnicity, years of formal education, and annual household income.
Measured: Baseline
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Substance use severity based on the use of specific substances (i.e., alcohol, cigarette/nicotine smoking, and other substance, including illicit substances) endorsed by the participant.
Values: For each drug, participants respond yes or no to any lifetime use. Subsequently, for each drug, participants complete six items with scores ranging from 0 to 3. Total scores rang from 0 (minimum) to 39 (maximum) for each drug the participant reports using.
Measured: Baseline
(Frequency of) Events (i.e., Barriers) in Care Screening Questionnaire
Frequency of events that act as barriers to engagement in HIV care. Values: 9 items, range from 0 (not at all) to 2 (a great deal). Scoring: Higher scores = greater frequency of events that act as barriers to care engagement
Measured: Baseline
Group-Based Medical Mistrust Scale
Extent of mistrust in the medical system and healthcare providers, in general, based on the participant's and participant communities' beliefs and experiences.
Values: 12 items, range from 12 (minimum) to 60 (maximum) Scoring: Greater scores = Greater levels of medical mistrust
Measured: Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up Post-Baseline
Internalized AIDS-Related Stigma Scale
Extent to which the participant living with HIV holds negative beliefs about HIV and AIDS.
Values: 6 items, range from 6 (minimum) to 30 (maximum). Scoring: Greater scores = greater degree of internalized stigma.
Measured: Throughout study completion: Baseline and 3-, 6-, and 9-Month Follow-Up Post-Baseline
Cultural Assessment of Risk for Suicide (CARS) Minority Stress Subscale
Extent of minority stress, or forms of enacted stigma as stressors, experience by the participant.
Values: 5 items in this subscale, range of 5 (minimum) to 30 (maximum). Scoring: Greater scores = greater minority stress; last item must be reverse coded.
Measured: Throughout study completion: Baseline and 3-, 6-, and 9-Month Follow-Up Post-Baseline
Everyday Discrimination Scale
Extent of everyday discrimination, from the extreme to the mundane, experienced by the participant.
Values: 9 items, range of 9 (minimum) to 54 (maximum). Scoring: Greater scores = more frequent perceived/experienced discrimination; has a follow-up question that allows participants to attribute experiences of discrimination to various aspects of identity.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start5 Jan 2026 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion12 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07055360
- Sponsor's protocol ID
- R34MH132561
- Other IDs
- 1R34MH132561-01
- Acronym
- RISE
- Status last verified
- Jun 2025
- First submitted
- 7 Apr 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No