HIV/AIDS Clinical Trial
Official title:
Reducing Self-stigma in Persons With HIV and Drug Use Disorders in Primary Health Care Settings
NCT number | NCT03684252 |
Other study ID # | A3890118 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 9, 2019 |
Est. completion date | August 31, 2019 |
Verified date | October 2019 |
Source | University of Puerto Rico |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 17 |
Est. completion date | August 31, 2019 |
Est. primary completion date | June 25, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility |
Inclusion Criteria: 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Puerto Rico | University of Puerto Rico Medical Sciences Campus | San Juan |
Lead Sponsor | Collaborator |
---|---|
University of Puerto Rico |
Puerto Rico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Change from baseline/pre-treatment at any point from last intervention (for both groups) to up to 2 weeks after | |
Secondary | 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. | Change from baseline/pre-treatment at any point from last intervention (for both groups) to up to 2 weeks after | |
Secondary | 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. | Change from baseline/pre-treatment at any point from last intervention (for both groups) to up to 2 weeks after | |
Secondary | 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. | Change from baseline/pre-treatment at any point from last intervention (for both groups) to up to 2 weeks after |
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