HIVNCT01305629
Intervention Targeting Substance Using Older Adults With HIV
A study testing Spiritual Self-Schema Therapy in people with HIV and Medication Adherence, run by Hunter College of City University of New York at 1 site in United States.
Trial summary
The proposed study uses a randomized controlled experimental design to evaluate the efficacy of a brief intervention using spiritual self schema (3S+) counseling to simultaneously target HIV health outcomes, and substance use among alcohol and/or drug dependent HIV positive older adults (age 50+), relative to an… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- HIV, Medication Adherence, Substance Dependence
- What is being tested?
- Spiritual Self-Schema Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Jun 2016
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV+ (provide HIV medication bottle with name on it)
- Age 50 or older (provide picture ID with DOB at baseline)
- Report current alcohol/drug dependence (AUDIT score of 8 or DAST-10 score of 4 on screener; C-DIS at baseline)
- On a prescribed HAART medication regimen and reports sub-optimal adherence (self-report missed at least 3 days in last 30 at 1 pill/day that is 90%)
- Communicate with staff and complete a survey in English or Spanish (English only for the pilot)
Who cannot join
- Current intravenous drug use (self-report at screener and baseline)
- Currently in a methadone drug treatment program (screener self-report)
- Unstable, serious psychiatric symptoms (SCID-Psych at baseline)
- Currently suicidal/homicidal (SCID-Psych at baseline)
- Gross cognitive impairment (Mini-Mental at baseline)
- Current enrollment in alcohol/drug treatment or HIV study (screener self-report)
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for HIV/AIDS Educational Studies and Training of Hunter College, CUNY
New York, New York, 10018
About this study
The proposed study uses a randomized controlled experimental design to evaluate the efficacy of a brief intervention using spiritual self schema (3S+) counseling to simultaneously target HIV health outcomes, and substance use among alcohol and/or drug dependent HIV positive older adults (age 50+), relative to an attention control condition. Participants will be randomly assigned to receive either: (1) 12 sessions of 3S+ counseling, adapted for the present study to target both non-injection drug use, drinking, and HIV health; or (2) 12 sessions of education about HIV health and the associated with alcohol and drug use that will serve as an attention-control.
- Conditions
- HIV, Medication Adherence, Substance Dependence
- Being tested
- Spiritual Self-Schema Therapy
- Keywords
- HIV, Medication Adherence, Substance Use, Older adults, Treatment
- Medical subject headings
- Medication Adherence, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spiritual Self-Schema TherapyBehavioural
The Spiritual Self Schema therapy (3S+) intervention will consist of a series of 12 one hour-long sessions delivered individually to participants over a four-month period. The 3S+ approach combines cognitive and behavioral therapy techniques with elements of non-theistic Buddhist philosophy to increase motivation for treatment adherence, alcohol and/or substance use reduction or abstinence and the prevention or reduction of HIV risk behaviors. 3S+ draws from self-regulation theory, self-schema theory, and self-discrepancy theory to assist participants in defining and perceiving their addict self, when their addict self is active, and its resulting negative affect state. 3S+ remediates the "addict" schema by proposing the construction of an alternate and competing schema: the "spiritual self." This spiritual self schema is compatible with HIV self-care, alcohol and drug use reduction or abstinence, adherence to treatment, and a compassionate life.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Condition | Experimental | Twelve sessions of spiritual self schema counseling, adapted to target target medication adherence and substance use. Receives: Behavioral: Spiritual Self-Schema Therapy |
| Education Condition | Active comparator | Eight sessions of education with content designed to mirror the information covered in the intervention condition. Receives: Behavioral: Spiritual Self-Schema Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to HIV medication
Participants in the intervention condition will report greater reductions in viral load, and greater increases in CD4 counts and self-reported adherence than those in the education comparison at the end of the intervention period (4 months). Those in the intervention condition will also maintain greater reductions in viral load, and greater increases in CD4 counts and self-reported adherence than those in the education comparison condition at the three follow-up assessments (4, 8, and 12 months).
Measured: every four months over the course of a year
Substance use
Participants in the intervention condition will report greater reductions in self-reported days of substance use and severity of dependence than those in the education comparison at at the end of the intervention period (4 months). Those in the intervention condition will also maintain greater reductions in self-reported days of substance use than those in the education comparison condition at the three follow-up assessments (4, 8, and 12 months).
Measured: every four months over the course of a year
Secondary outcomes (2)
Mental Health/Quality of Life
Participants in the intervention condition will report greater increases in mental health measures (e.g, depression, anxiety) and quality of life measures (e.g., life satisfaction, loneliness, perceived stress).
Measured: every four months over the course of a year
Sexual Risk
Participants in the intervention condition will report greater reductions in high-risk sexual behavior compared to participants in the educational comparison condition.
Measured: every four months over the course of a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2011 (estimated)
- Study startJun 2011
- Primary completionAug 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hunter College of City University of New York
- Sponsor type
- University, hospital or other
- Collaborators
- Fordham University
- Responsible party
- Principal investigator, Jeffrey T. Parsons, Hunter College of City University of New York
- Investigators
- Jeffrey T. Parsons, Ph.D., Principal investigator, Hunter College, CUNY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01305629
- Sponsor's protocol ID
- R01DA029567-01
- Status last verified
- Oct 2016
- First submitted
- 28 Feb 2011
- Last updated
- 10 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Targeting Substance Using Older Adults With HIV
- ClinicalTrials.gov ID
- NCT01305629
- Acronym / sponsor ID
- R01DA029567-01
- Conditions
- HIV, Medication Adherence, Substance Dependence
- Keywords
- HIV, Medication Adherence, Substance Use, Older adults, Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hunter College of City University of New YorkUniversity, hospital or other
- Collaborators
- Fordham University
- Study start
- Jun 2011
- Primary completion
- Aug 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 1 Mar 2011 (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.
The proposed study uses a randomized controlled experimental design to evaluate the efficacy of a brief intervention using spiritual self schema (3S+) counseling to simultaneously target HIV health outcomes, and substance use among alcohol and/or drug dependent HIV positive older adults (age 50+), relative to an attention control condition. Participants will be randomly assigned to receive either: (1) 12 sessions of 3S+ counseling, adapted for the present study to target both non-injection drug use, drinking, and HIV health; or (2) 12 sessions of education about HIV health and the associated with alcohol and drug use that will serve as an attention-control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Condition | Experimental | Behavioral: Spiritual Self-Schema TherapyTwelve sessions of spiritual self schema counseling, adapted to target target medication adherence and substance use. |
| Education Condition | Active comparator | Behavioral: Spiritual Self-Schema TherapyEight sessions of education with content designed to mirror the information covered in the intervention condition. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- HIV+ (provide HIV medication bottle with name on it)
- Age 50 or older (provide picture ID with DOB at baseline)
- Report current alcohol/drug dependence (AUDIT score of 8 or DAST-10 score of 4 on screener; C-DIS at baseline)
- On a prescribed HAART medication regimen and reports sub-optimal adherence (self-report missed at least 3 days in last 30 at 1 pill/day that is 90%)
- Communicate with staff and complete a survey in English or Spanish (English only for the pilot)
Key exclusion criteria (6 listed)
- Current intravenous drug use (self-report at screener and baseline)
- Currently in a methadone drug treatment program (screener self-report)
- Unstable, serious psychiatric symptoms (SCID-Psych at baseline)
- Currently suicidal/homicidal (SCID-Psych at baseline)
- Gross cognitive impairment (Mini-Mental at baseline)
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 |
|---|---|---|
| Spiritual Self-Schema TherapyThe Spiritual Self Schema therapy (3S+) intervention will consist of a series of 12 one hour-long sessions delivered individually to participants over a four-month period. The 3S+ approach combines cognitive and behavioral therapy techniques with elements of non-theistic Buddhist philosophy to increase motivation for treatment adherence, alcohol and/or substance use reduction or abstinence and the prevention or reduction of HIV risk behaviors. 3S+ draws from self-regulation theory, self-schema theory, and self-discrepancy theory to assist participants in defining and perceiving their addict self, when their addict self is active, and its resulting negative affect state. 3S+ remediates the "addict" schema by proposing the construction of an alternate and competing schema: the "spiritual self." This spiritual self schema is compatible with HIV self-care, alcohol and drug use reduction or abstinence, adherence to treatment, and a compassionate life. | Behavioural | Education Condition, Intervention Condition |
Primary outcome
Adherence to HIV medication
Time frame: every four months over the course of a year
Participants in the intervention condition will report greater reductions in viral load, and greater increases in CD4 counts and self-reported adherence than those in the education comparison at the end of the intervention period (4 months). Those in the intervention condition will also maintain greater reductions in viral load, and greater increases in CD4 counts and self-reported adherence than those in the education comparison condition at the three follow-up assessments (4, 8, and 12 months).
Substance use
Time frame: every four months over the course of a year
Participants in the intervention condition will report greater reductions in self-reported days of substance use and severity of dependence than those in the education comparison at at the end of the intervention period (4 months). Those in the intervention condition will also maintain greater reductions in self-reported days of substance use than those in the education comparison condition at the three follow-up assessments (4, 8, and 12 months).
2 secondary outcomes
Mental Health/Quality of Life
Time frame: every four months over the course of a year
Sexual Risk
Time frame: every four months over the course of a year
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 10 Oct 2016.
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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.
Jeffrey T. Parsons, Ph.D. principal investigator
Hunter College, CUNY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spiritual Self-Schema Therapy in people with HIV and Medication Adherence, run by Hunter College of City University of New York 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 6 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 10 Oct 2016. 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?
Adherence to HIV medication (time frame: every four months over the course of a year). 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?
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 10 Oct 2016.