HIV/AIDS Clinical Trial
Official title:
Reducing Self-stigma in Persons With HIV and Drug Use Disorders in Primary Health Care Settings
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.
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.
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