- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04481373
Targeting HIV Retention and Improved Viral Load Through Engagement ('THRIVE')
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77030
- Ben Taub Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Hospitalized at Ben Taub Hospital, Houston, TX;
- at least 18 years of age;
- able to speak English or Spanish;
- HIV infected;
- able to provide informed consent and participate in the study (patients who are temporarily unable to participate will be followed and approached for enrollment if and when they are cognitively and physically capable of consenting and participating);
- HIV VL>1000 c/mL;
- never in care or currently out of HIV care, defined as not meeting the 'visit constancy' measure (≥1 completed HIV primary care visit at Thomas Street Health Center (TSHC), Houston, TX, in each of the three 4-month intervals preceding admission); or ≥2 "no shows" to HIV primary care visits at TSHC in the last year.
- endorse one of two avoidance coping statements with the highest factor loadings on the Avoidant Coping Subscale from the Coping with HIV/AIDS scale
Exclusion Criteria:
- intending to use a source of HIV primary care other than TSHC after discharge, because their outcomes cannot be evaluated;
- in the opinion of the primary medical team caring for the patient, likely to be discharged to an institutional setting, die in the hospital or enter hospice;
- incarcerated or expected to be discharged to prison or jail;
- enrolled in another research study with prospective follow-up;
- pregnant, since pregnant women receive additional efforts to be linked and retained in care;
- admitted with acute psychosis which would preclude informed consent or meaningful participation with the intervention.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: THRIVE
Acceptance and Commitment Therapy plus Education about HIV A master's level mental health professional will provide the 4-5 hour intervention for out-of-care PWH during a hospitalization.
There are two important components to the intervention: Acceptance and Commitment Therapy (ACT) content, targeting avoidance with acceptance-based coping and active engagement in values-based living, and HIV education.
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The ACT components (3-3.5 hours) will focus on clarifying patient values and goals and identifying obstacles that may be getting in the way of living a rich life. Short-and long-term effects of avoidance will be discussed (e.g., avoidance reduces immediate contact with distressing experiences and provides short-term relief but leads to greater dysfunction in long run). Patients will be taught acceptance, mindfulness, and perspective taking to help patient cope with difficult emotions and thoughts that may interfere with living a values-driven life. Individuals will also be encouraged to examine the costs of stigmatization on their life (e.g. avoidance of medical care, sense of isolation). Education will include medical information about HIV, services available at the clinic, and health needs related to comorbidities. This content to be delivered in 30 minutes.
Other Names:
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Other: Treatment as Usual
Patients get usual care at the hospital.
Service linkage workers (SLWs) meet with all hospitalized PWH and cover educational aspects of the care.
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Patients get usual care at the hospital.
Service linkage workers (SLWs) meet with all hospitalized PWH and cover educational aspects of the care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability of enrollment and randomization
Time Frame: 6 months
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The number of eligible PWH who agree and decline to participate, and reasons for declining;
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6 months
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Acceptability of enrollment and randomization
Time Frame: 6 months
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The number of PWH who are not eligible to participate and the reasons for lack of eligibility.
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6 months
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Acceptability of the intervention
Time Frame: 6 months
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Intervention completion rate
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6 months
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Acceptability of the intervention
Time Frame: 6 months
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Retention of participants in follow-up assessments
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6 months
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Acceptability of the intervention
Time Frame: 6 months
|
Duration of contacts
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6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Viral Load Improvement
Time Frame: 6 months
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Change in Viral Load
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6 months
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Number of patients who are retained in HIV Care
Time Frame: 6 months
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Number of patients who complete at least 2 visits with an HIV clinician within 6 months
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6 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Internalized AIDS-Related Stigma Scale (IARSS)
Time Frame: 6 months
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This is a 6-item measure examines internalized stigma.
Response scores range from 0 (low stigma)-6 (high stigma) with higher scores representing higher levels of stigma.
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6 months
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Depression Anxiety and Stress Scale (DASS-21).
Time Frame: 6 months
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This is a 21-item measure.
The total score ranges from 0-120 with higher scores reflecting higher levels of distress including depression, anxiety, and stress.
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6 months
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Alcohol Use Disorders Identification Test (AUDIT)
Time Frame: 6 months
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This 3-item screener that identifies problem alcohol use for both men and women.
Participants respond on a 5-point scale.
Higher numbers represent more difficulty.
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6 months
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The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Time Frame: 6 months
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This measure asks about substance use of 7 categories of drugs in the previous 3 months and in a person's life time.
Participants respond YES or NO to each category of drugs.
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6 months
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Coping with HIV/AIDS scale
Time Frame: 6 months
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This is a 16 item measure that examines positive coping, avoidant coping, and social support.
Items are scores from 1-3 with higher scores reflecting greater positive coping, greater avoidant coping, and greater social support.
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6 months
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Client Satisfaction Questionnaire (CSQ)
Time Frame: 6 months
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This 8-item measure assesses patient satisfaction with services.
Scores range from 8-32 with higher scores representing greater satisfaction.
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6 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- Urogenital Diseases
- Genital Diseases
- Depression
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- H-47444
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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