Clinical trial NCT03684252: Reducing Self-stigma in Persons With HIV and Drug Use Disorders in Primary Health Care Settings
Official title: Reducing Self-stigma in Persons With HIV and Drug Use Disorders in Primary Health Care Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Use Disorders
HIV/AIDS
Keywords: Self-stigma
Drug Use Disorders
HIV
Lead sponsor: University of Puerto Rico
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 17
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Substance Abuse Self-stigma Scale (change is being assessed)
timeFrame: Change from baseline/pre-treatment at any point from last intervention (for both groups) to up to 2 weeks after
Secondary outcomes:
measure: HIV Felt-stigma Scale (change is being assessed)
timeFrame: Change from baseline/pre-treatment at any point from last intervention (for both groups) to up to 2 weeks after
measure: Depressive symptoms (change is being assessed)
timeFrame: Change from baseline/pre-treatment at any point from last intervention (for both groups) to up to 2 weeks after
measure: Adherence to Combination Therapy Questionnaire (change is being assessed)
timeFrame: Change from baseline/pre-treatment at any point from last intervention (for both groups) to up to 2 weeks after
Other outcomes:
Locations:
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico Medical Sciences Campus
Study officials:
affiliation: University of Puerto Rico
name: Coralee Perez-Pedrogo, PhD
role: PRINCIPAL_INVESTIGATOR
References: