HIV/AIDSNCT04201288
Brief Acceptance-Based Retention Intervention for Newly Diagnosed HIV Patients
A study testing Acceptance-Based Behavior Therapy (ABBT) and Enhanced-Treatment-as-Usual (ETAU) in people with HIV/AIDS, run by Brown University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Acceptance-Based Behavior Therapy (ABBT) and Enhanced-Treatment-as-Usual (ETAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2020to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV+
- ≥18 years old
- Entering HIV medical care services for the first time (that is, not transferring HIV care from another location)
- Able to speak and read English at the level to be able to complete the study procedures
- Have telephone access.
Who cannot join
- 1. Cognitively impaired
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- HIV/AIDS
- Being tested
- Acceptance-Based Behavior Therapy (ABBT), Enhanced-Treatment-as-Usual (ETAU)
- Keywords
- Medication adherence, Treatment adherence, HIV, Acceptance and Commitment Therapy, Retention
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Medication Adherence, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance-Based Behavior Therapy (ABBT)Behavioural
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.
Enhanced-Treatment-as-Usual (ETAU)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Acceptance-Based Behavior Therapy (ABBT) | Experimental | The 2-session ABBT will be delivered in person at session 1 and by telephone at session 2. Receives: Behavioral: Acceptance-Based Behavior Therapy (ABBT) |
| 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. Receives: Behavioral: Enhanced-Treatment-as-Usual (ETAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 52 weeks
Secondary outcomes (4)
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.
Measured: 52 weeks
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.
Measured: 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.
Measured: 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.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start21 Dec 2020
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Ethan Moitra, Ph.D., Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04201288
- Sponsor's protocol ID
- 1908002504
- Other IDs
- R01MH119919
- Status last verified
- Sep 2025
- First submitted
- 12 Dec 2019
- Last updated
- 14 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will share data via the Research Data Center at the CDC's National Center for Health Statistics (NCHS).
Publications
Moitra E, Herman DS, Busch AM, Molina PE, Ferguson TF, Baker JV, Stein MD. A pilot randomized controlled trial of acceptance-based behavior therapy to address treatment engagement outcomes and disclosure among new-to-care patients with HIV. AIDS Care. 2026 Sep 10:1-12. doi: 10.1080/09540121.2026.2728926. Online ahead of print.
PubMed 42723344
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Acceptance-Based Retention Intervention for Newly Diagnosed HIV Patients
- ClinicalTrials.gov ID
- NCT04201288
- Acronym / sponsor ID
- 1908002504
- Conditions
- HIV/AIDS
- Keywords
- Medication adherence, Treatment adherence, HIV, Acceptance and Commitment Therapy, Retention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 21 Dec 2020 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 17 Dec 2019 (actual)
- Results
- Posted 14 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acceptance-Based Behavior Therapy (ABBT) | Experimental | Behavioral: Acceptance-Based Behavior Therapy (ABBT)The 2-session ABBT will be delivered in person at session 1 and by telephone at session 2. |
| Enhanced-Treatment-as-Usual (ETAU) | Placebo comparator | Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- HIV+
- ≥18 years old
- Entering HIV medical care services for the first time (that is, not transferring HIV care from another location)
- Able to speak and read English at the level to be able to complete the study procedures
- Have telephone access.
Key exclusion criteria (1 listed)
- 1. Cognitively impaired
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Acceptance-Based Behavior Therapy (ABBT) |
| 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. | Behavioural | Enhanced-Treatment-as-Usual (ETAU) |
Primary outcome
Number of Participants Meeting Retention in HIV Medical Care Guidelines at 52 Weeks
Time frame: 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
Time frame: 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.
4 secondary outcomes
Self-Rating Scale Item (SRSI) - Antiretroviral Treatment Adherence
Time frame: 52 weeks
Brief HIV Disclosure Scale (BHD)
Time frame: 52 weeks
The Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: 52 weeks
HIV Stigma Scale (HSS)
Time frame: 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42723344Moitra E, Herman DS, Busch AM, Molina PE, Ferguson TF, Baker JV, Stein MD. A pilot randomized controlled trial of acceptance-based behavior therapy to address treatment engagement outcomes and disclosure among new-to-care patients with HIV. AIDS Care. 2026 Sep 10:1-12. doi: 10.1080/09540121.2026.2728926. Online ahead of print.
- Individual participant dataSharing planned: Yes. The investigators will share data via the Research Data Center at the CDC's National Center for Health Statistics (NCHS).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ethan Moitra, Ph.D. principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance-Based Behavior Therapy (ABBT) and Enhanced-Treatment-as-Usual (ETAU) in people with HIV/AIDS, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Meeting Retention in HIV Medical Care Guidelines at 52 Weeks (time frame: 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04201288, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2025.