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| ID | Type | Description | Link |
|---|---|---|---|
| 5R34MH122294 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Iowa | OTHER |
| Brown University | OTHER |
| University of Texas | OTHER |
| National Institute of Mental Health (NIMH) |
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Many people with HIV infection are not consistently engaged in outpatient HIV care, and avoidance, stigma and denial contribute to poor engagement in HIV care. This project will develop and pilot test a new intervention, "THRIVE," for hospitalized persons who are out of HIV care and endorse avoidance, to improve how well they stay in outpatient HIV care after discharge. If successfully developed, the intervention will undergo large scale testing in later studies and could improve the health of persons with HIV infection and help end the HIV epidemic in the United States.
Poor retention in HIV primary care results in lower rates of HIV viral suppression, higher rates of HIV transmission, and exacerbates racial and ethnic disparities in health outcomes, including survival. To date, there are no interventions that effectively relink and retain PWH in care when they are found outside the HIV clinic. Many persons with HIV infection (PWH) are hospitalized with life-threatening but preventable complications of inadequately treated HIV infection. They are among the most important patients to retain in care. Our previous research shows that among PWH who are out of care and hospitalized, avoidance coping, stigma, and mental health difficulties were nearly universal. Further, avoidance coping was a predictor of failure to re-engage in care after discharge. Acceptance and Commitment Therapy (ACT) is a transdiagnostic intervention with the capacity to address a range of psychosocial and behavior-related issues that PWH experience. ACT helps patients overcome avoidance, particularly avoidance of uncomfortable internal states and the situations that trigger such states, by promoting acceptance-based coping and re-engagement in meaningful and valued-life activities. Brief ACT interventions appear to be feasible, acceptable, and at least preliminarily, have efficacy. The investigators propose to develop, refine, and pilot a brief (4-5 contact hours) ACT intervention for hospitalized, out-of-care PWH. 'Targeting HIV Retention and Improved Viral load through Engagement' ('THRIVE') will aim to help patients overcome avoidance, a maladaptive coping strategy implicated in a range of problems, including depression, anxiety, substance abuse, and HIV-related self-stigma, all of which constitute barriers to care. Delivering THRIVE in the hospital with a phone booster session after discharge will increase therapy initiation and completion, the lack of which is often the greatest obstacle to effective delivery of mental health services for PWH. In Aim 1, a brief hospital-based transdiagnostic, individually delivered ACT intervention (THRIVE) tailored specifically for out-of-care hospitalized PWH will be developed. Input from a multi-disciplinary team of expert care providers and PHW will be utilized to create the therapist protocol and patient workbook. The investigators will then pilot THRIVE in 10 hospitalized out-of-care PWH who will provide qualitative feedback on the intervention. The feedback, along with input from patients and the multi-disciplinary team, will be used to refine THRIVE. In Aim 2, the investigators will conduct a pilot randomized clinical trial (RCT) of the refined THRIVE intervention (N=35) compared to treatment as usual (N=35). This pilot RCT will 1) evaluate feasibility and acceptability for a full-scale RCT; and 2) examine trends in outcomes of interest for the definitive RCT. The investigators will then be positioned to submit a separate grant to test the efficacy of THRIVE in a fully powered randomized trial. This work has the potential to decrease HIV morbidity and racial/ethnic disparities and contribute to ending the HIV epidemic in the United States, which are NIH priorities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| THRIVE | Experimental | 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. |
|
| Treatment as Usual | Other | Patients get usual care at the hospital. Service linkage workers (SLWs) meet with all hospitalized PWH and cover educational aspects of the care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THRIVE | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of Enrollment and Randomization: Eligible But Declined Participation | The number of eligible PWH who agree and decline to participate, and reasons for declining; | 6 months |
| Acceptability of Enrollment and Randomization: Completion Sessions | Completion of at least 3 out of 4 intervention sessions in the THRIVE group | 6 months |
| Acceptability of the Intervention: 6 Month Follow-up | The completion of participant 6-month follow-up assessments | 6 months |
| Acceptability of the Intervention | Mean duration of contact for participants who completed all four sessions | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Viral Load Improvement | Viral load less than 200 copies/mL at 180 days +/- 42 days of follow up | 6 months |
| Number of Patients Who Are Retained in HIV Care | Number of patients who complete at least 2 visits with an HIV clinician within 6 months, including 1 visit within 30 days of discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Internalized AIDS-Related Stigma Scale (IARSS) | The Internalized AIDS-Related Stigma Scale (IARSS) is a 6-item scale with scores that range between 0 and 6. There are 6 questions in the stigma scale. Each question answered "yes" counts as one point. A higher total sum suggests more internalized stigma, which is not beneficial. | 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lilian Dindo, Ph.D | Baylor College of Medicine | Principal Investigator |
| Thomas Giordano, M.D., M.P.H. | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ben Taub Hospital | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35628955 | Background | Dindo L, Moitra E, Roddy MK, Ratcliff C, Markham C, Giordano T. Development and Initial Feasibility of a Hospital-Based Acceptance and Commitment Therapy Intervention to Improve Retention in Care for Out-of-Care Persons with HIV: Lessons Learned from an Open Pilot Trial. J Clin Med. 2022 May 17;11(10):2827. doi: 10.3390/jcm11102827. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Acceptability of Enrollment and Randomization: Eligible But Declined Participation | The number of eligible PWH who agree and decline to participate, and reasons for declining; | Posted | Count of Participants | Participants | 6 months |
|
Enrollment through 6 months
We are only reporting all-cause mortality, serious adverse events, and other adverse events attributable to the study assessments or intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Giordano | Baylor College of Medicine | 7137988918 | tpg@bcm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | May 13, 2021 | Aug 7, 2025 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D009538 | Nicotine |
| D004522 | Educational Status |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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| NIH |
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|
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| Treatment as Usual | Other | Patients get usual care at the hospital. Service linkage workers (SLWs) meet with all hospitalized PWH and cover educational aspects of the care. |
|
| 6 months |
| Depression Anxiety and Stress Scale (DASS-21). |
The Depression Anxiety and Stress Scale (DASS-21) has 21 items. Each item is scored 1, 2, or 3. The score is calculated by adding each item's score, multiplied by 2. The range of scores for the total scale is between 0 and 126. Each subscale (depression, anxiety, and stress) has 7 items with a range of scores between 0 and 42. Higher scores suggest higher depression, anxiety, and stress, which are not beneficial. |
| 6 months |
| Alcohol Use Disorders Identification Test (AUDIT) | 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. | 6 months |
| The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) | 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. | 6 months |
| Coping With HIV/AIDS Scale: Coping and Social Support | The coping with HIV/AIDS positive coping scale scores range between 0 and 5. There are 5 questions in the positive coping subscale. Each question answered "often or a lot of the time" counts as one point. A higher total sum suggests more positive coping, which is beneficial. The coping with HIV/AIDS avoidance coping scale scores range between 0 and 9. There are 9 questions in the avoidance coping subscale. Each question answered "often or a lot of the time" counts as one point. A higher total sum suggests more avoidance coping, which is not beneficial. | 6 months |
| Coping With HIV/AIDS Scale | There are 2 questions in the seeking social support subscale. We report the number of participants who answer each question "often or a lot of the time". More responses "often or a lot of the time" suggests seeking more social support, which is beneficial. | 6 months |
| Client Satisfaction Questionnaire (CSQ) | The Client Satisfaction Questionnaire (CSQ) scale has 8 items. Each item is scored 1, 2, 3, or 4. The score is calculated by adding each item's score. The range of scores for the total scale is between 8 and 32. Higher scores represent greater satisfaction with the THRIVE intervention. | 2 weeks |
| Death before hospital discharge |
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| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Coping with HIV/AIDS Scale - Positive Coping | The coping with HIV/AIDS positive coping scale scores range between 0 and 5. There are 5 questions in the positive coping subscale. Each question answered "often or a lot of the time" counts as one point. A higher total sum suggests more positive coping, which is beneficial. | Median | Inter-Quartile Range | units on a scale |
|
| Coping with HIV/AIDS Scale - Avoidance Coping | The coping with HIV/AIDS avoidance coping scale scores range between 0 and 9. There are 9 questions in the avoidance coping subscale. Each question answered "often or a lot of the time" counts as one point. A higher total sum suggests more avoidance coping, which is not beneficial. | Median | Inter-Quartile Range | units on a scale |
|
| Coping with HIV/AIDS Scale - Seeking Social Support Subscale | There are 2 questions in the seeking social support subscale. We report the number of participants who answer each question "often or a lot of the time". More responses "often or a lot of the time" suggests seeking more social support, which is beneficial. | Count of Participants | Participants | No |
|
| Internalized AIDS-Related Stigma Scale (IARSS) | The Internalized AIDS-Related Stigma Scale (IARSS) is a 6-item scale with scores that range between 0 and 6. There are 6 questions in the stigma scale. Each question answered "yes" counts as one point. A higher total sum suggests more internalized stigma, which is not beneficial. | Median | Inter-Quartile Range | units on a scale |
|
| Depression Anxiety and Stress Scale (DASS-21) | The Depression Anxiety and Stress Scale (DASS-21) has 21 items. Each item is scored 1, 2, or 3. The score is calculated by adding each item's score, multiplied by 2. The range of scores for the total scale is between 0 and 126. Each subscale (depression, anxiety, and stress) has 7 items with a range of scores between 0 and 42. Higher scores suggest higher depression, anxiety, and stress, which are not beneficial. | Median | Inter-Quartile Range | units on a scale |
|
| AUDIT (Hazardous Alcohol Use) | Count of Participants | Participants |
|
| Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) | Count of Participants | Participants | No |
|
Patients get usual care at the hospital. Service linkage workers (SLWs) meet with all hospitalized PWH and cover educational aspects of the care.
|
|
| Primary | Acceptability of Enrollment and Randomization: Completion Sessions | Completion of at least 3 out of 4 intervention sessions in the THRIVE group | 80% of THRIVE participants received at least 3 of 4 sessions. Participants randomized to the Treatment as Usual arm were not analyzed and did not receive the intervention (sessions). | Posted | Count of Participants | Participants | 6 months |
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|
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| Primary | Acceptability of the Intervention: 6 Month Follow-up | The completion of participant 6-month follow-up assessments | Posted | Count of Participants | Participants | 6 months |
|
|
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| Primary | Acceptability of the Intervention | Mean duration of contact for participants who completed all four sessions | Treatment as usual participants did not get any intervention. | Posted | Number | minutes | 6 months |
|
|
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| Secondary | Viral Load Improvement | Viral load less than 200 copies/mL at 180 days +/- 42 days of follow up | Posted | Count of Participants | Participants | 6 months |
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|
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| Secondary | Number of Patients Who Are Retained in HIV Care | Number of patients who complete at least 2 visits with an HIV clinician within 6 months, including 1 visit within 30 days of discharge | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Other Pre-specified | Internalized AIDS-Related Stigma Scale (IARSS) | The Internalized AIDS-Related Stigma Scale (IARSS) is a 6-item scale with scores that range between 0 and 6. There are 6 questions in the stigma scale. Each question answered "yes" counts as one point. A higher total sum suggests more internalized stigma, which is not beneficial. | Posted | Median | Inter-Quartile Range | units on a scale | 6 months |
|
|
|
| Other Pre-specified | Depression Anxiety and Stress Scale (DASS-21). | The Depression Anxiety and Stress Scale (DASS-21) has 21 items. Each item is scored 1, 2, or 3. The score is calculated by adding each item's score, multiplied by 2. The range of scores for the total scale is between 0 and 126. Each subscale (depression, anxiety, and stress) has 7 items with a range of scores between 0 and 42. Higher scores suggest higher depression, anxiety, and stress, which are not beneficial. | Posted | Median | Inter-Quartile Range | units on a scale | 6 months |
|
|
|
| Other Pre-specified | Alcohol Use Disorders Identification Test (AUDIT) | 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. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Other Pre-specified | The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) | 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. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Other Pre-specified | Coping With HIV/AIDS Scale: Coping and Social Support | The coping with HIV/AIDS positive coping scale scores range between 0 and 5. There are 5 questions in the positive coping subscale. Each question answered "often or a lot of the time" counts as one point. A higher total sum suggests more positive coping, which is beneficial. The coping with HIV/AIDS avoidance coping scale scores range between 0 and 9. There are 9 questions in the avoidance coping subscale. Each question answered "often or a lot of the time" counts as one point. A higher total sum suggests more avoidance coping, which is not beneficial. | Posted | Median | Inter-Quartile Range | Medan, ICR | 6 months |
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|
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| Other Pre-specified | Coping With HIV/AIDS Scale | There are 2 questions in the seeking social support subscale. We report the number of participants who answer each question "often or a lot of the time". More responses "often or a lot of the time" suggests seeking more social support, which is beneficial. | Posted | Count of Participants | Participants | 6 months |
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|
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| Other Pre-specified | Client Satisfaction Questionnaire (CSQ) | The Client Satisfaction Questionnaire (CSQ) scale has 8 items. Each item is scored 1, 2, 3, or 4. The score is calculated by adding each item's score. The range of scores for the total scale is between 8 and 32. Higher scores represent greater satisfaction with the THRIVE intervention. | CSQ was only measured in the THRIVE arm. | Posted | Median | Inter-Quartile Range | units on a scale | 2 weeks |
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|
|
| 2 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | 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. | 1 | 35 | 0 | 35 | 0 | 35 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| DASS-21 Stress |
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| DASS-21 Anxiety |
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| Ever Used Cannabis/Cocaine/Amphetamine/Inhalants/Sedatives |
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| Used in past 3 months Tobacco products |
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| Used in past 3 months Alcoholic beverages |
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| Used in past 3 months Cannabis/Cocaine/Amphetamine/Inhalants/Sedatives |
|