Making ART Work Among Brazilian Youth
Making Universal, Free-of-charge Antiretroviral Therapy Work for Sexual and Gender Minority Youth in Brazil
Brown University
72 participants
Oct 1, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- between 18 and 24 years of age
- assigned male sex at birth
- identify as a gay or bisexual man, or a transgender woman or another gender identity along the feminine spectrum
- self-report living with HIV, and verified by medical chart review,
- self-report currently taking or prescribed ART for \> 3 months
- self-report missing 2 or more doses of ART medications in any given week in the past month OR not virally suppressed (i.e., \>40 copies/mL in past 3 months; via national outpatient data \[SISCEL\] or plasma viral load testing)
- owns a cell phone or willing to use one as part of the study
Exclusion Criteria3
- unable to give informed consent due to cognitive limitation, severe mental/physical illness or intoxication
- unable to read and/or write to an extent that would limit their ability to comprehend the informed consent
- lived in the greater Rio de Janeiro area for \< 3 months or planning to move outside the area within the next year
Interventions
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.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06056037