Reducing Self-stigma in Persons With HIV and Drug Use Disorders in Primary Health Care Settings

HIV/AIDS Clinical Trial

Official title: Reducing Self-stigma in Persons With HIV and Drug Use Disorders in Primary Health Care Settings

Status Completed

Clinical 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. 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Disease
• Drug Use Disorders
• HIV/AIDS
• Substance-Related Disorders

• NCT number: NCT03684252
• Study type: Interventional
• Source: University of Puerto Rico
• Status: Completed
• Phase: N/A
• Start date: April 9, 2019
• Completion date: August 31, 2019