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A Trauma-Informed Intervention for the Newly HIV-Diagnosed

ConditionsStressHIV Care Loss to FollowupHIV Treatment Cascade
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorTemple University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Resilience-Based Intervention for Stress Reduction and HIV-Related Efficacy (RISE)Experimental treatment 1 intervention
Group B: Waitlist Control: Text messaging-reminder comparison conditionActive comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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

Time frame
Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up Post-Baseline
2

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

Response options: Yes or No

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

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

Response options: Yes or No

Time frame
Throughout study completion: Baseline and 3-, 6- and 9-Month Follow-Up
4

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.

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Temple University

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: