Human Immunodeficiency VirusAPPROACHNCT02696681
Addressing Psychosocial Comorbidities in HIV Treatment and Prevention
A study testing Cognitive Behavioral Therapy in people with Human Immunodeficiency Virus and Depression, run by University of Miami at 1 site in United States.
Trial summary
Project AProaCH is an open pilot trial of a cognitive behavioral therapy (CBT) for individuals with HIV with various psychological comorbidities, which the investigators call "syndemics". Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Human Immunodeficiency Virus, Depression, Mental Health
- What is being tested?
- Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 18 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV+ individuals
- Uncontrolled virus (plasma HIV RNA concentrations that reach detectable limits) or being diagnosed with a sexually transmitted infection (STI) (gonorrhea, chlamydia, syphilis, trichomoniasis (female only)) currently or within the past 3 months.
Who cannot join
- Unable or unwilling to provide informed consent
- 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 himself or others as a result of study participation,
- Under the age of 18 or over the age of 65,
- Current CBT for a psychiatric disorder, or a course of CBT in the past year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Addressing Psychosocial Comorbidities in HIV Treatment and Prevention: Phase 2
Project AProaCH is an open pilot trial of a cognitive behavioral therapy (CBT) for individuals with HIV with various psychological comorbidities, which the investigators call "syndemics". Syndemics are co-occurring psychosocial problems that interact with each other and with health behavior such as HIV sexual transmission risk behavior and adherence to self care.
- Conditions
- Human Immunodeficiency Virus, Depression, Mental Health
- Being tested
- Cognitive Behavioral Therapy
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Depression, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
Integrating CBT for mental health and substance issues concern with CBT for health behavior change
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Integrating CBT for any substance use or mental health problems with CBT for adherence/self-care Receives: Behavioral: Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder status as defined by the number of participants who change from a detectable to suppressed (undetectable) HIV viral load
Attaining viral suppression
Measured: 4 months assessment
Responder status as defined by the number of participants who change from a detectable to suppressed (undetectable) HIV viral load
Attaining viral suppression
Measured: 8 month assessment
Secondary outcomes (1)
Adherence to antiretroviral therapy via real time monitoring
Adherence to ART will be measured using a real time monitoring devices that tracks when a pill box is opened and closed.
Measured: Changes over time from baseline to 8 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2016 (estimated)
- Study startMar 2016
- Primary completion18 Sep 2018
- Study completion18 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), 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
- NCT02696681
- Sponsor's protocol ID
- 20150383
- Other IDs
- 1K24MH094214-01, 9K24DA040489-07
- Acronym
- APPROACH
- Status last verified
- Aug 2019
- First submitted
- 18 Feb 2016
- Last updated
- 6 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Safren SA, Harkness A, Lee JS, Rogers BG, Mendez NA, Magidson JF, Blashill AJ, Bainter S, Rodriguez A, Ironson G. Addressing Syndemics and Self-care in Individuals with Uncontrolled HIV: An Open Trial of a Transdiagnostic Treatment. AIDS Behav. 2020 Nov;24(11):3264-3278. doi: 10.1007/s10461-020-02900-7.
PubMed 32410049
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Psychosocial Comorbidities in HIV Treatment and Prevention: Phase 2
- ClinicalTrials.gov ID
- NCT02696681
- Acronym / sponsor ID
- APPROACH / 20150383
- Conditions
- Human Immunodeficiency Virus, Depression, Mental Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), National Institute on Drug Abuse (NIDA)
- Study start
- Mar 2016 (actual)
- Primary completion
- 18 Sep 2018 (actual)
- Study completion
- 18 Sep 2018 (actual)
- First posted
- 2 Mar 2016 (estimated)
- 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.
Project AProaCH is an open pilot trial of a cognitive behavioral therapy (CBT) for individuals with HIV with various psychological comorbidities, which the investigators call "syndemics". Syndemics are co-occurring psychosocial problems that interact with each other and with health behavior such as HIV sexual transmission risk behavior and adherence to self care.
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 | Experimental | Behavioral: Cognitive Behavioral TherapyIntegrating CBT for any substance use or mental health problems with CBT for adherence/self-care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- HIV+ individuals
- Uncontrolled virus (plasma HIV RNA concentrations that reach detectable limits) or being diagnosed with a sexually transmitted infection (STI) (gonorrhea, chlamydia, syphilis, trichomoniasis (female only)) currently or within the past 3 months.
Key exclusion criteria (5 listed)
- Unable or unwilling to provide informed consent
- 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 himself or others as a result of study participation,
- Under the age of 18 or over the age of 65,
- Current CBT for a psychiatric disorder, or 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 |
|---|---|---|
| Cognitive Behavioral TherapyIntegrating CBT for mental health and substance issues concern with CBT for health behavior change | Behavioural | Cognitive Behavioral Therapy |
Primary outcome
Responder status as defined by the number of participants who change from a detectable to suppressed (undetectable) HIV viral load
Time frame: 4 months assessment
Attaining viral suppression
Responder status as defined by the number of participants who change from a detectable to suppressed (undetectable) HIV viral load
Time frame: 8 month assessment
Attaining viral suppression
1 secondary outcome
Adherence to antiretroviral therapy via real time monitoring
Time frame: Changes over time from baseline to 8 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
- Derived from this study: PubMed 32410049Safren SA, Harkness A, Lee JS, Rogers BG, Mendez NA, Magidson JF, Blashill AJ, Bainter S, Rodriguez A, Ironson G. Addressing Syndemics and Self-care in Individuals with Uncontrolled HIV: An Open Trial of a Transdiagnostic Treatment. AIDS Behav. 2020 Nov;24(11):3264-3278. doi: 10.1007/s10461-020-02900-7.
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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.
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 Cognitive Behavioral Therapy in people with Human Immunodeficiency Virus and Depression, 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 2 inclusion and 5 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 6 Aug 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Responder status as defined by the number of participants who change from a detectable to suppressed (undetectable) HIV viral load (time frame: 4 months assessment). 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 NCT02696681, 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 6 Aug 2019.