Drug Use DisordersNCT03684252
Reducing Self-stigma in Persons With HIV and Drug Use Disorders in Primary Health Care Settings
A study testing CBT-based intervention and Treatment as Usual in people with Drug Use Disorders and HIV/AIDS, run by University of Puerto Rico at 1 site in Puerto Rico.
Trial summary
The investigators propose to lay the groundwork for a larger effectiveness clinical trial that will lead to the advancement of a novel evidence-based treatment for DUD and HIV among Spanish-speaking Latinos who suffer from self-stigma and have inadequate treatment adherence. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Drug Use Disorders, HIV/AIDS
- What is being tested?
- CBT-based intervention and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 sitePuerto Rico
- Study dates
- 9 Apr 2019to 31 Aug 2019
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Spanish speakers that comply with
- A drug use disorder based on the Spanish version of the short form of the WHO Composite International Diagnostic Interview (CIDI) that has been used widely in Puerto Rico;
- HIV clinical criteria;
- Moderate to higher levels of HIV felt self-stigma (>25);
- Using the clinic as the main source of medical care during the study; and
- Agreement to random assignment
Who cannot join
- DUD/HIV+ individuals who are not prescribed ART;
- An acute medical emergency (physical or psychiatric),
- Unable to provide informed consent
- Who are actively suicidal.
- Cognitive impairment or dementia based on a score of 24 or less on the Mini Mental State Examination
Trial locations and contacts
1 site in 1 country.
Puerto Rico1 site
University of Puerto Rico Medical Sciences Campus
San Juan, 00936
About this study
The investigators propose to lay the groundwork for a larger effectiveness clinical trial that will lead to the advancement of a novel evidence-based treatment for DUD and HIV among Spanish-speaking Latinos who suffer from self-stigma and have inadequate treatment adherence. This pilot project aims to: compare the outcomes of a culturally adapted CBT-based intervention to treatment as usual (TAU), in a randomized pilot trial of HIV+ individuals with a lifetime DUD.
Read the detailed description
This treatment model, new for Puerto Rico, should improve compliance with ART and health outcomes for Latino patients who have largely been excluded from efficacy and effectiveness studies, and thus have not benefited from these advances. The proposed research lays the groundwork to provide the benefits of theoretically grounded, culturally adapted, and evidence-based treatment to reduce self-stigma and increase drug and HIV treatment adherence among Puerto Ricans that may also apply to other Spanish-speaking patients.
The investigators work is guided by the Stage Model for Behavior Therapy that recognizes that the scientific study of behavior therapies involves a systematic developmental process that progresses from feasibility (Stage I) to efficacy (Stage II) to effectiveness (Stage III). The proposed research focuses on Stage Ib where the investigators propose to conduct a pilot randomized control trial to compare the outcomes between a novel CBT-based intervention and treatment as usual (TAU) among HIV/DUD+ Latinos reporting self-stigma who are receiving care in a primary care health setting. Assessments of self-stigma and HIV and drug treatment adherence for all participants will be collected pre-treatment and post-treatment. This model allows to lay the groundwork for a larger effectiveness clinical trial.
The investigators plan to enroll 16 patients who will be randomly assigned to the CBT (n=8) or to TAU (n=8). Sample size considers a 35% attrition rate as based in previous research experiences among similar population. Patients will be recruited in primary health care clinics in PR. Participants will be randomly assigned to (a) treatment as usual or (b) a Cognitive and Behavioral Therapy. This intervention is a theoretically-based efficacious treatment for self-stigma and related depression. It consists of weekly 60-minute sessions for 6-8 weeks; is flexible and can be modified to fit the needs of individual clients. The intervention is designed to help individuals to employ acceptance and values-directed behavior change strategies in order to increase psychological flexibility, a process that is at the core of behavioral health and retention in treatment.
Overall, analyses will allow generating an effect size that can be used to calculate the number of subjects needed for adequate power to detect significant differences between groups.
- Conditions
- Drug Use Disorders, HIV/AIDS
- Being tested
- CBT-based intervention, Treatment as Usual
- Keywords
- Self-stigma, Drug Use Disorders, HIV
- Medical subject headings
- Substance-Related Disorders, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-based interventionBehavioural
Cognitive Behavioral Therapy (CBT) that uses acceptance and mindfulness strategies, together with commitment and behavior change strategies.
Treatment as UsualOther
Participants' will receive treatment as usual.
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Treatment as usual Receives: Other: Treatment as Usual |
| Intervention | Experimental | CBT-based intervention Receives: Behavioral: CBT-based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substance Abuse Self-stigma Scale (change is being assessed)
Psychometrically sound and culturally adapted, this is a 40-item scale that contains four sub-scales that measures self-devaluation, fear of enacted stigma, stigma avoidance, and values disengagement due to self stigma. Internal consistency coefficients for the sub-scales ranged from .82 to .88. Study participants will need to endorse at least three items from the self-devaluation sub-scale to be considered as presenting self-stigma (this will be used as an inclusion criteria). Item endorsement will be analyzed as a count, per sub-scale. The greater number of items endorsed per sub-scale, will be indicative of a higher level of self-stigma as manifested by the sub-scale construct.
Measured: Change from baseline/pre-treatment at any point from last intervention (for both groups) to up to 2 weeks after
Secondary outcomes (3)
HIV Felt-stigma Scale (change is being assessed)
The scale measures felt and enacted stigma constructs among persons living with HIV (PLWHIV). Developed for Spanish-speaking populations, this is a 17-item, self-administered multi-dimensional measure for felt and enacted stigma in PLWHIV, using a 4-point Likert scale and that is culturally-sensitive. Exhibits adequate alpha and Pearson correlation coefficients (0.91 and 0.68, respectively) and convergent validity. The scale has four dimensions which scores will be summed to obtain a total scale score. The total scale score is indicative of the level of HIV-related felt stigma experienced by a person. Scale ranges are interpreted as follows: 0-15 no stigma; 16-24 mild; 25-35 moderate; and > 35 severe. For this study, a total score of > 25 is required for enrollment.
Measured: Change from baseline/pre-treatment at any point from last intervention (for both groups) to up to 2 weeks after
Depressive symptoms (change is being assessed)
To assess depressive symptoms, the study will use The Patient Health Questionnaire, depression module: Is a 8 item validated measure. The Spanish version showed a sensitivity of 77% and a specificity of 100% when compared to the Structured Clinical Interview for DSM mood module. The higher the score obtained on the scale, the greater the manifestation of depressive symptoms.
Measured: Change from baseline/pre-treatment at any point from last intervention (for both groups) to up to 2 weeks after
Adherence to Combination Therapy Questionnaire (change is being assessed)
The research team have completed translation, back-translation, and agreements with an expert/bilingual panel of the Single-Item Self-Rating Adherence Scale (SRSI). This is a single item scale that has been use successfully among the health sector.
Measured: Change from baseline/pre-treatment at any point from last intervention (for both groups) to up to 2 weeks after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start9 Apr 2019
- Primary completion25 Jun 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Use DisordersStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Puerto Rico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Coralee Perez-Pedrogo, University of Puerto Rico
- Investigators
- Coralee Perez-Pedrogo, PhD, Principal investigator, University of Puerto Rico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03684252
- Sponsor's protocol ID
- A3890118
- Status last verified
- Oct 2019
- First submitted
- 14 Sep 2018
- Last updated
- 2 Oct 2019
- 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 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Self-stigma in Persons With HIV and Drug Use Disorders in Primary Health Care Settings
- ClinicalTrials.gov ID
- NCT03684252
- Acronym / sponsor ID
- A3890118
- Conditions
- Drug Use Disorders, HIV/AIDS
- Keywords
- Self-stigma, Drug Use Disorders, HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of Puerto RicoUniversity, hospital or other
- Study start
- 9 Apr 2019 (actual)
- Primary completion
- 25 Jun 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 25 Sep 2018 (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 investigators propose to lay the groundwork for a larger effectiveness clinical trial that will lead to the advancement of a novel evidence-based treatment for DUD and HIV among Spanish-speaking Latinos who suffer from self-stigma and have inadequate treatment adherence. This pilot project aims to: compare the outcomes of a culturally adapted CBT-based intervention to treatment as usual (TAU), in a randomized pilot trial of HIV+ individuals with a lifetime DUD.
Detailed description
This treatment model, new for Puerto Rico, should improve compliance with ART and health outcomes for Latino patients who have largely been excluded from efficacy and effectiveness studies, and thus have not benefited from these advances. The proposed research lays the groundwork to provide the benefits of theoretically grounded, culturally adapted, and evidence-based treatment to reduce self-stigma and increase drug and HIV treatment adherence among Puerto Ricans that may also apply to other Spanish-speaking patients.
The investigators work is guided by the Stage Model for Behavior Therapy that recognizes that the scientific study of behavior therapies involves a systematic developmental process that progresses from feasibility (Stage I) to efficacy (Stage II) to effectiveness (Stage III). The proposed research focuses on Stage Ib where the investigators propose to conduct a pilot randomized control trial to compare the outcomes between a novel CBT-based intervention and treatment as usual (TAU) among HIV/DUD+ Latinos reporting self-stigma who are receiving care in a primary care health setting. Assessments of self-stigma and HIV and drug treatment adherence for all participants will be collected pre-treatment and post-treatment. This model allows to lay the groundwork for a larger effectiveness clinical trial.
The investigators plan to enroll 16 patients who will be randomly assigned to the CBT (n=8) or to TAU (n=8). Sample size considers a 35% attrition rate as based in previous research experiences among similar population. Patients will be recruited in primary health care clinics in PR. Participants will be randomly assigned to (a) treatment as usual or (b) a Cognitive and Behavioral Therapy. This intervention is a theoretically-based efficacious treatment for self-stigma and related depression. It consists of weekly 60-minute sessions for 6-8 weeks; is flexible and can be modified to fit the needs of individual clients. The intervention is designed to help individuals to employ acceptance and values-directed behavior change strategies in order to increase psychological flexibility, a process that is at the core of behavioral health and retention in treatment.
Overall, analyses will allow generating an effect size that can be used to calculate the number of subjects needed for adequate power to detect significant differences between groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: Treatment as UsualTreatment as usual |
| Intervention | Experimental | Behavioral: CBT-based interventionCBT-based intervention |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Spanish speakers that comply with
- A drug use disorder based on the Spanish version of the short form of the WHO Composite International Diagnostic Interview (CIDI) that has been used widely in Puerto Rico;
- HIV clinical criteria;
- Moderate to higher levels of HIV felt self-stigma (>25);
- Using the clinic as the main source of medical care during the study; and
Key exclusion criteria (5 listed)
- DUD/HIV+ individuals who are not prescribed ART;
- An acute medical emergency (physical or psychiatric),
- Unable to provide informed consent
- Who are actively suicidal.
- Cognitive impairment or dementia based on a score of 24 or less on the Mini Mental State Examination
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-based interventionCognitive Behavioral Therapy (CBT) that uses acceptance and mindfulness strategies, together with commitment and behavior change strategies. | Behavioural | Intervention |
| Treatment as UsualParticipants' will receive treatment as usual. | Other | Control |
Primary outcome
Substance Abuse Self-stigma Scale (change is being assessed)
Time frame: Change from baseline/pre-treatment at any point from last intervention (for both groups) to up to 2 weeks after
Psychometrically sound and culturally adapted, this is a 40-item scale that contains four sub-scales that measures self-devaluation, fear of enacted stigma, stigma avoidance, and values disengagement due to self stigma. Internal consistency coefficients for the sub-scales ranged from .82 to .88. Study participants will need to endorse at least three items from the self-devaluation sub-scale to be considered as presenting self-stigma (this will be used as an inclusion criteria). Item endorsement will be analyzed as a count, per sub-scale. The greater number of items endorsed per sub-scale, will be indicative of a higher level of self-stigma as manifested by the sub-scale construct.
3 secondary outcomes
HIV Felt-stigma Scale (change is being assessed)
Time frame: Change from baseline/pre-treatment at any point from last intervention (for both groups) to up to 2 weeks after
Depressive symptoms (change is being assessed)
Time frame: Change from baseline/pre-treatment at any point from last intervention (for both groups) to up to 2 weeks after
Adherence to Combination Therapy Questionnaire (change is being assessed)
Time frame: Change from baseline/pre-treatment at any point from last intervention (for both groups) to up to 2 weeks after
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 2 Oct 2019.
- 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. This study is not recruiting at the moment.
Coralee Perez-Pedrogo, PhD principal investigator
University of Puerto Rico
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-based intervention and Treatment as Usual in people with Drug Use Disorders and HIV/AIDS, run by University of Puerto Rico at 1 site in Puerto Rico.
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 6 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 2 Oct 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 Puerto Rico. 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?
Substance Abuse Self-stigma Scale (change is being assessed) (time frame: Change from baseline/pre-treatment at any point from last intervention (for both groups) to up to 2 weeks after). 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 2 Oct 2019.