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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH119919 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The overall aim of this program of research is to test a newly developed intervention, Acceptance-Based Behavior Therapy (ABBT), to improve HIV patients' commitment to medical care.
The purpose of the proposed project is to establish the efficacy of ABBT and examine its mechanisms of action. To achieve the specific aims, the investigators will conduct a randomized clinical trial (n = 270), with two treatment arms: ABBT vs. an attention-matched HIV education control condition.
Drop-out rates from medical clinics in the first months following linkage to HIV care are as high as 50%, with 31-46% of patients dropping out after the first visit. People Living with HIV (PLWH) who are not consistently retained in care are at risk for: delayed antiretroviral treatment (ART) initiation, reduced ART adherence, unsuppressed viremia, and mortality. Moreover, poor retention means effective ART cannot be leveraged to prevent further HIV transmission. The objective of this study is to conduct a fully powered, randomized controlled trial (RCT) to assess the efficacy of a brief, 2-session acceptance-based behavioral therapy (ABBT) intervention to enhance retention in HIV care.
The aims of this proposal are: (1) To test, in a 2-arm RCT, the efficacy of the ABBT intervention on retention in care and virologic suppression (primary outcomes); and, ART adherence, disclosure of HIV status, perceived social support, HIV stigmatization (secondary outcomes), relative to an Enhanced-Treatment-as-Usual condition; and, (2) To examine the degree to which retention in HIV care and virologic suppression are mediated by (a) increased HIV acceptance (and decreased HIV experiential avoidance) and (b) increased willingness to disclose HIV status. The sample will consist of 270 HIV patients who are new to care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acceptance-Based Behavior Therapy (ABBT) | Experimental | The 2-session ABBT will be delivered in person at session 1 and by telephone at session 2. |
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| Enhanced-Treatment-as-Usual (ETAU) | Placebo Comparator | In addition to receiving treatment-as-usual at the clinic, ETAU participants will receive a 2-session program of HIV education. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acceptance-Based Behavior Therapy (ABBT) | Behavioral | Acceptance-Based Behavior Therapy (ABBT) In the first session, the interventionist will introduce the concept of acceptance and its possible benefits in the context of life values and participant-identified barriers to retention in care. Interventionists will help participants identify potential challenges to acceptance, including disclosure concerns. At the second session, participants will practice acceptance-based coping skills and a behavioral plan will be developed to target barriers identified in the first session. These discussions will help the participant clarify how best to align their values with decisions on how to manage their HIV. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Meeting Retention in HIV Medical Care Guidelines at 52 Weeks | Objective data from participants' electronic health records will be obtained to examine how many medical appointments they attended in the past year at their HIV treatment clinic. Participants will be deemed as sufficiently retained if they attend at least 3 medical visits during this period. | 52 weeks |
| Number of Participants Who Met HIV Virologic Suppression | Objective data from participants' electronic health records will be obtained to examine their viral load, which is a blood-based measure of the amount of HIV viruses in the person's body. If participants are not currently retained in medical care and blood sample results are not available in their electronic health record, they will submit 1-3ml of blood at each assessment through the study's research phlebotomist. A viral load that measures as "undetectable" (i.e., fewer than 200 copies of HIV per millilitre of blood) will represent virologic suppression, which is a positive indication of HIV health. | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Self-Rating Scale Item (SRSI) - Antiretroviral Treatment Adherence | Self-report data of participants' HIV antiretroviral treatment adherence will be obtained with the SRSI. Scores range from 0 to 5, which correspond to "very poor" to "excellent" medication adherence. | 52 weeks |
| Brief HIV Disclosure Scale (BHD) |
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Inclusion Criteria:
Exclusion Criteria:
1. Cognitively impaired
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| Name | Affiliation | Role |
|---|---|---|
| Ethan Moitra, Ph.D. | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brown University | Providence | Rhode Island | 02912 | United States |
The investigators will share data via the Research Data Center at the CDC's National Center for Health Statistics (NCHS).
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Data will be shared upon the completion of the study and after summary data are published in a peer-reviewed journal. Consistent with NIMH guidelines, there will be no specific time limit regarding how long IPD are available.
Request to access the data will be evaluated by the PI to ensure that they meet reasonable standards of scientific integrity.
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Randomization was stratified by active substance use and depression severity.
Recruitment occurred during routine intake at HIV clinics in Minneapolis, New Orleans, and Providence from December 2021 through March 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Acceptance-Based Behavior Therapy (ABBT) | The 2-session ABBT will be delivered in person at session 1 and by telephone at session 2. Acceptance-Based Behavior Therapy (ABBT): Acceptance-Based Behavior Therapy (ABBT) In the first session, the interventionist will introduce the concept of acceptance and its possible benefits in the context of life values and participant-identified barriers to retention in care. Interventionists will help participants identify potential challenges to acceptance, including disclosure concerns. At the second session, participants will practice acceptance-based coping skills and a behavioral plan will be developed to target barriers identified in the first session. These discussions will help the participant clarify how best to align their values with decisions on how to manage their HIV. |
| FG001 | Enhanced-Treatment-as-Usual (ETAU) | In addition to receiving treatment-as-usual at the clinic, ETAU participants will receive a 2-session program of HIV education. Enhanced-Treatment-as-Usual (ETAU): ETAU will consist of two brief sessions lead by study interventionists, performed at the same times and by same methods as ABBT. Topics of education include safe sex practices, review of treatment options, and review of HIV-related indices of health. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Acceptance-Based Behavior Therapy (ABBT) | The 2-session ABBT will be delivered in person at session 1 and by telephone at session 2. Acceptance-Based Behavior Therapy (ABBT): Acceptance-Based Behavior Therapy (ABBT) In the first session, the interventionist will introduce the concept of acceptance and its possible benefits in the context of life values and participant-identified barriers to retention in care. Interventionists will help participants identify potential challenges to acceptance, including disclosure concerns. At the second session, participants will practice acceptance-based coping skills and a behavioral plan will be developed to target barriers identified in the first session. These discussions will help the participant clarify how best to align their values with decisions on how to manage their HIV. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Participants Meeting Retention in HIV Medical Care Guidelines at 52 Weeks | Objective data from participants' electronic health records will be obtained to examine how many medical appointments they attended in the past year at their HIV treatment clinic. Participants will be deemed as sufficiently retained if they attend at least 3 medical visits during this period. | Posted | Count of Participants | Participants | 52 weeks |
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Duration of the study, which was 4 years.
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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 | Acceptance-Based Behavior Therapy (ABBT) | The 2-session ABBT will be delivered in person at session 1 and by telephone at session 2. Acceptance-Based Behavior Therapy (ABBT): Acceptance-Based Behavior Therapy (ABBT) In the first session, the interventionist will introduce the concept of acceptance and its possible benefits in the context of life values and participant-identified barriers to retention in care. Interventionists will help participants identify potential challenges to acceptance, including disclosure concerns. At the second session, participants will practice acceptance-based coping skills and a behavioral plan will be developed to target barriers identified in the first session. These discussions will help the participant clarify how best to align their values with decisions on how to manage their HIV. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ethan Moitra, Associate Professor of Psychiatry and Human Behavior | Brown University | 401-444-1949 | ethan_moitra@brown.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 30, 2021 | Sep 3, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 23, 2019 | Sep 3, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 13, 2022 | Sep 3, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D055118 | Medication Adherence |
| D000074822 | Treatment Adherence and Compliance |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| Enhanced-Treatment-as-Usual (ETAU) | Behavioral | ETAU will consist of two brief sessions lead by study interventionists, performed at the same times and by same methods as ABBT. Topics of education include safe sex practices, review of treatment options, and review of HIV-related indices of health. |
|
The BHD HIV disclosure scale will be used to assess for willingness to make informed disclosure and for actual disclosure of HIV status. Scores range from 8-32, with higher scores indicating increased willingness to disclose. |
| 52 weeks |
| The Multidimensional Scale of Perceived Social Support (MSPSS) | The MSPSS will be used to measure perceived social support. Scores range from 1-84, with higher scores indicating greater perceived social support. | 52 weeks |
| HIV Stigma Scale (HSS) | The HSS will be used to measure self-reported experiences, fear, and perception of stigmatization due to being HIV+. Scores range from 6-24, with lower scores indicating less fear or concern about stigmatization. | 52 weeks |
| Withdrawal by Subject |
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| BG001 | Enhanced-Treatment-as-Usual (ETAU) | In addition to receiving treatment-as-usual at the clinic, ETAU participants will receive a 2-session program of HIV education. Enhanced-Treatment-as-Usual (ETAU): ETAU will consist of two brief sessions lead by study interventionists, performed at the same times and by same methods as ABBT. Topics of education include safe sex practices, review of treatment options, and review of HIV-related indices of health. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Addiction Severity Index | Number of participants endorsing current (past month) non-prescribed substance use (opioids and/or stimulants). | Count of Participants | Participants |
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| AUDIT-C | Alcohol Use Disorders Identification Test - Concise (AUDIT-C) is a brief 3-item screener for hazardous alcohol use. A total score is calculated by summing the items, with a possible range of 0-12, with higher scores representing more hazardous alcohol use (worse outcome). | Mean | Standard Deviation | units on a scale |
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| OG001 | Enhanced-Treatment-as-Usual (ETAU) | In addition to receiving treatment-as-usual at the clinic, ETAU participants will receive a 2-session program of HIV education. Enhanced-Treatment-as-Usual (ETAU): ETAU will consist of two brief sessions lead by study interventionists, performed at the same times and by same methods as ABBT. Topics of education include safe sex practices, review of treatment options, and review of HIV-related indices of health. |
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| Primary | Number of Participants Who Met HIV Virologic Suppression | Objective data from participants' electronic health records will be obtained to examine their viral load, which is a blood-based measure of the amount of HIV viruses in the person's body. If participants are not currently retained in medical care and blood sample results are not available in their electronic health record, they will submit 1-3ml of blood at each assessment through the study's research phlebotomist. A viral load that measures as "undetectable" (i.e., fewer than 200 copies of HIV per millilitre of blood) will represent virologic suppression, which is a positive indication of HIV health. | Posted | Count of Participants | Participants | 52 weeks |
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| Secondary | Self-Rating Scale Item (SRSI) - Antiretroviral Treatment Adherence | Self-report data of participants' HIV antiretroviral treatment adherence will be obtained with the SRSI. Scores range from 0 to 5, which correspond to "very poor" to "excellent" medication adherence. | Posted | Mean | Standard Deviation | score on a scale | 52 weeks |
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| Secondary | Brief HIV Disclosure Scale (BHD) | The BHD HIV disclosure scale will be used to assess for willingness to make informed disclosure and for actual disclosure of HIV status. Scores range from 8-32, with higher scores indicating increased willingness to disclose. | Posted | Mean | Standard Deviation | units on a scale | 52 weeks |
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| Secondary | The Multidimensional Scale of Perceived Social Support (MSPSS) | The MSPSS will be used to measure perceived social support. Scores range from 1-84, with higher scores indicating greater perceived social support. | Posted | Mean | Standard Deviation | units on a scale | 52 weeks |
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| Secondary | HIV Stigma Scale (HSS) | The HSS will be used to measure self-reported experiences, fear, and perception of stigmatization due to being HIV+. Scores range from 6-24, with lower scores indicating less fear or concern about stigmatization. | Posted | Mean | Standard Deviation | units on a scale | 52 weeks |
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| 1 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Enhanced-Treatment-as-Usual (ETAU) | In addition to receiving treatment-as-usual at the clinic, ETAU participants will receive a 2-session program of HIV education. Enhanced-Treatment-as-Usual (ETAU): ETAU will consist of two brief sessions lead by study interventionists, performed at the same times and by same methods as ABBT. Topics of education include safe sex practices, review of treatment options, and review of HIV-related indices of health. | 1 | 16 | 0 | 16 | 0 | 16 |
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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 |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D015438 | Health Behavior |
| D001519 | Behavior |