Medication AdherenceSynk2bNCT05352061
Addressing Psychosocial Comorbidities in HIV Treatment and Prevention 2b
A study testing CBT for Syndemics and Adherence Factors in people with Medication Adherence and Mental Health Issue, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to learn about ways to better support people living with HIV with their HIV treatment and cope with mental health challenges and/or substance use concerns. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Adherence, Mental Health Issue
- What is being tested?
- CBT for Syndemics and Adherence Factors
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2022to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age: 18 years or older
- HIV positive
- Evidence of uncontrolled virus (e.g., > 20 copies/ml) within the past 12 months as verified by medical record
- Group 1: (Men who have sex with men (MSM) who have used stimulants within the past 4 months (approximately 10 participants))OR Group 2: transgender women (approximately 10 participants) OR Group 3: Emerging adults between the ages of 18 and 26 (inclusive; approximately 10 participants)
Who cannot join
- Unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at the time of interview
- Active untreated, unstable, major mental illness (i.e., untreated psychosis or mania) that would interfere with study participation
- Opinion of the PI that the participant would be at risk for harm to self or others
- Currently receiving CBT for a psychiatric disorder, or received a course of CBT in the past year.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Addressing Psychosocial Comorbidities in HIV Treatment and Prevention: Phase 2b
The purpose of this study is to learn about ways to better support people living with HIV with their HIV treatment and cope with mental health challenges and/or substance use concerns.
- Conditions
- Medication Adherence, Mental Health Issue
- Being tested
- CBT for Syndemics and Adherence Factors
- Keywords
- HIV Medication Adherence, Mental Health
- Medical subject headings
- Medication Adherence, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT for Syndemics and Adherence FactorsBehavioural
Each hour-long session is conducted via zoom or in person with a study clinician. Sessions focus on HIV medication adherence, coping with life stressors, and managing other challenging situations (e.g., possible traumatic experiences, drug and alcohol use and sexual behavior) that may affect mental or HIV-related health.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy (CBT) for Syndemic and Adherence Factors Group | Experimental | Participants in this group will receive the CBT for Syndemics and Adherence Factors intervention for a total of 14 sessions over 4 months. Receives: Behavioral: CBT for Syndemics and Adherence Factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who completes the follow up assessment
Feasibility will be reported as the percentage of participants who completes the study follow up assessment.
Measured: 8 months
Secondary outcomes (3)
ART Medication Adherence
Antiretroviral Therapy (ART) adherence will be reported as the percentage of participants who reports taking > 80% of their ART from baseline up to follow up visit.
Measured: Up to 8 months
Percentage of participants with undetectable viral load
As assessed via serum blood samples.
Measured: Up to 8 months
Percentage of participants with improvement in syndemic, behavioral health outcomes
Participants with a 2-point reduction in their Diagnostic Interview for Anxiety, Mood and Obsessive Compulsive Disorder (OCD) Related Neuropsychiatric Disorders (DIAMOND) scores from baseline will be reported as having improvement in behavioral health outcome. DIAMOND has a total score ranging from 1-7 with the higher score indicating greater severity.
Measured: Up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start15 Aug 2022
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Steven Safren, University of Miami
- Investigators
- Steven A Safren, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05352061
- Sponsor's protocol ID
- 20210836
- Other IDs
- 9K24DA040489
- Acronym
- Synk2b
- Status last verified
- Jun 2026
- First submitted
- 22 Apr 2022
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Psychosocial Comorbidities in HIV Treatment and Prevention: Phase 2b
- ClinicalTrials.gov ID
- NCT05352061
- Acronym / sponsor ID
- Synk2b / 20210836
- Conditions
- Medication Adherence, Mental Health Issue
- Keywords
- HIV Medication Adherence, Mental Health
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn about ways to better support people living with HIV with their HIV treatment and cope with mental health challenges and/or substance use concerns.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy (CBT) for Syndemic and Adherence Factors Group | Experimental | Behavioral: CBT for Syndemics and Adherence FactorsParticipants in this group will receive the CBT for Syndemics and Adherence Factors intervention for a total of 14 sessions over 4 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 18 years or older
- HIV positive
- Evidence of uncontrolled virus (e.g., > 20 copies/ml) within the past 12 months as verified by medical record
- Group 1: (Men who have sex with men (MSM) who have used stimulants within the past 4 months (approximately 10 participants))OR Group 2: transgender women (approximately 10 participants) OR Group 3: Emerging adults between the ages of 18 and 26 (inclusive; approximately 10 participants)
Key exclusion criteria (4 listed)
- Unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at the time of interview
- Active untreated, unstable, major mental illness (i.e., untreated psychosis or mania) that would interfere with study participation
- Opinion of the PI that the participant would be at risk for harm to self or others
- Currently receiving CBT for a psychiatric disorder, or received a course of CBT in the past year.
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 |
|---|---|---|
| CBT for Syndemics and Adherence FactorsEach hour-long session is conducted via zoom or in person with a study clinician. Sessions focus on HIV medication adherence, coping with life stressors, and managing other challenging situations (e.g., possible traumatic experiences, drug and alcohol use and sexual behavior) that may affect mental or HIV-related health. | Behavioural | Cognitive Behavioral Therapy (CBT) for Syndemic and Adherence Factors Group |
Primary outcome
Percentage of participants who completes the follow up assessment
Time frame: 8 months
Feasibility will be reported as the percentage of participants who completes the study follow up assessment.
3 secondary outcomes
ART Medication Adherence
Time frame: Up to 8 months
Percentage of participants with undetectable viral load
Time frame: Up to 8 months
Percentage of participants with improvement in syndemic, behavioral health outcomes
Time frame: Up to 8 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Steven A Safren, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT for Syndemics and Adherence Factors in people with Medication Adherence and Mental Health Issue, run by University of Miami 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 4 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 26 Jun 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Percentage of participants who completes the follow up assessment (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2026.