HIV/AIDS
Conditions
Keywords
Medication adherence, Treatment adherence, HIV, Acceptance and Commitment Therapy, Retention
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALAcceptance-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.
BEHAVIORALEnhanced-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.
Sponsors
National Institute of Mental Health (NIMH)
Brown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. HIV+ 2. ≥18 years old 3. Entering HIV medical care services for the first time (that is, not transferring HIV care from another location) 4. Able to speak and read English at the level to be able to complete the study procedures 5. Have telephone access.
Exclusion criteria
1\. Cognitively impaired
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Meeting Retention in HIV Medical Care Guidelines at 52 Weeks | 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. |
| Number of Participants Who Met HIV Virologic Suppression | 52 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-Rating Scale Item (SRSI) - Antiretroviral Treatment Adherence | 52 weeks | 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. |
| Brief HIV Disclosure Scale (BHD) | 52 weeks | 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. |
| The Multidimensional Scale of Perceived Social Support (MSPSS) | 52 weeks | The MSPSS will be used to measure perceived social support. Scores range from 1-84, with higher scores indicating greater perceived social support. |
| HIV Stigma Scale (HSS) | 52 weeks | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred during routine intake at HIV clinics in Minneapolis, New Orleans, and Providence from December 2021 through March 2024.
Pre-assignment details
Randomization was stratified by active substance use and depression severity.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 16 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 1 |
| Overall Study | Lost to Follow-up | 5 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Enhanced-Treatment-as-Usual (ETAU) | Acceptance-Based Behavior Therapy (ABBT) |
|---|---|---|---|
| Addiction Severity Index | 6 Participants | 2 Participants | 4 Participants |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants | 16 Participants | 20 Participants |
| Age, Continuous | 32.2 years STANDARD_DEVIATION 11 | 32.8 years STANDARD_DEVIATION 13.5 | 31.6 years STANDARD_DEVIATION 8.4 |
| AUDIT-C | 3.8 units on a scale STANDARD_DEVIATION 2.9 | 3.8 units on a scale STANDARD_DEVIATION 3.1 | 3.7 units on a scale STANDARD_DEVIATION 2.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 3 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants | 13 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 19 Participants | 9 Participants | 10 Participants |
| Region of Enrollment United States | 36 Participants | 16 Participants | 20 Participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Male | 33 Participants | 14 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 20 | 1 / 16 |
| other Total, other adverse events | 0 / 20 | 0 / 16 |
| serious Total, serious adverse events | 0 / 20 | 0 / 16 |
Outcome results
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.
Time frame: 52 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Acceptance-Based Behavior Therapy (ABBT) | Number of Participants Meeting Retention in HIV Medical Care Guidelines at 52 Weeks | 20 Participants |
| Enhanced-Treatment-as-Usual (ETAU) | Number of Participants Meeting Retention in HIV Medical Care Guidelines at 52 Weeks | 16 Participants |
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.
Time frame: 52 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Acceptance-Based Behavior Therapy (ABBT) | Number of Participants Who Met HIV Virologic Suppression | 20 Participants |
| Enhanced-Treatment-as-Usual (ETAU) | Number of Participants Who Met HIV Virologic Suppression | 14 Participants |
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.
Time frame: 52 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acceptance-Based Behavior Therapy (ABBT) | Brief HIV Disclosure Scale (BHD) | 21.3 units on a scale | Standard Deviation 3.2 |
| Enhanced-Treatment-as-Usual (ETAU) | Brief HIV Disclosure Scale (BHD) | 22.1 units on a scale | Standard Deviation 4.2 |
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.
Time frame: 52 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acceptance-Based Behavior Therapy (ABBT) | HIV Stigma Scale (HSS) | 19.5 units on a scale | Standard Deviation 4.5 |
| Enhanced-Treatment-as-Usual (ETAU) | HIV Stigma Scale (HSS) | 21.1 units on a scale | Standard Deviation 5 |
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.
Time frame: 52 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acceptance-Based Behavior Therapy (ABBT) | Self-Rating Scale Item (SRSI) - Antiretroviral Treatment Adherence | 4.5 score on a scale | Standard Deviation 0.7 |
| Enhanced-Treatment-as-Usual (ETAU) | Self-Rating Scale Item (SRSI) - Antiretroviral Treatment Adherence | 4.6 score on a scale | Standard Deviation 0.7 |
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.
Time frame: 52 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acceptance-Based Behavior Therapy (ABBT) | The Multidimensional Scale of Perceived Social Support (MSPSS) | 5.8 units on a scale | Standard Deviation 0.7 |
| Enhanced-Treatment-as-Usual (ETAU) | The Multidimensional Scale of Perceived Social Support (MSPSS) | 5.3 units on a scale | Standard Deviation 0.9 |