Making ART Work Among Brazilian Youth

NCT06056037 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2025-09-19

No results posted yet for this study

Summary

This study seeks to develop and pilot test a theory-based, integrated technology and counseling intervention to improve ART adherence among sexual and gender minority (SGM) young people living with HIV (ages 18-24) in Rio de Janeiro, Brazil. The intervention aims to improve social support, self-efficacy for taking ART, and teach skills for problem-solving barriers to promote better adherence.

Conditions

  • Hiv
  • Adherence, Medication

Interventions

BEHAVIORAL

Experimental: Making ART Work

A culturally tailored, theoretically grounded provider-facilitated group-based social support intervention (4 sessions) that emphasizes a collective approach to ART adherence and includes establishing a common understanding of ART, identifying potential barriers to ART adherence with a focus on social and structural barriers (e.g., stigma, relationship influences, family support, economic stressors), developing practical strategies to increase self-esteem and self-efficacy to enhance ART adherence, and generating and maintaining peer norms and support for ART adherence within one's social group. These sessions will include SGM youth-specific video vignettes that address the social/contextual realities faced by SGM YLWH in Brazil. Lastly, the intervention includes daily SMS text messaging that serve as both reminders and cognitive cues to take medication as prescribed.

BEHAVIORAL

Standard of Care

Prior to randomization, all participants will meet briefly with a counselor to assess current needs for standard HIV primary care and referrals to social and/or health (including mental health) services. If participants do not have a primary HIV care provider, they will be linked to a provider at INI-Fiocruz or their preferred clinic, where they can access free HIV care through the no-cost universal access program of the Brazilian Public Health System. Additionally, the counselor will provide necessary referrals as needed, e.g., for social, general health and/or mental health services. Additionally, in order to provide a baseline level of standardized adherence information, all participants will receive a brief adherence educational session, which consists of a review of medications and recommended dosing, adherence expectations, toxicity expectations, and medication misperceptions.

Sponsors & Collaborators

  • University of California, Los Angeles

    collaborator OTHER
  • Oswaldo Cruz Foundation

    collaborator OTHER
  • National Institute of Mental Health (NIMH)

    collaborator NIH
  • Brown University

    lead OTHER

Principal Investigators

  • Katie Biello, PhD, MPH · Brown University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
24 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2026-04-30
Completion
2026-04-30

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06056037 on ClinicalTrials.gov