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NCT Number: NCT06056037

Making ART Work Among Brazilian Youth

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.

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Key information

Age range

18 year–24 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Evandro Chagas National Institute of Infectious Diseases (INI) Oswaldo Cruz Foundation (FIOCRUZ)

Rio de Janeiro, Brazil

Location status: Recruiting

Location contact

Beatriz Grinsztejn, MD, PhD

CONTACT

Emilia Jalil, MD, PhD

CONTACT

About this study

Background. Sexual and gender minority (SGM) youth account for the largest number of incident HIV infections in Brazil. Although HIV can be managed with ongoing antiretroviral therapy (ART), exceptionally high levels of adherence are required. Brazil has implemented a comprehensive HIV treatment program with broad access to ART, but this program does not specifically address barriers to optimal ART adherence, particularly for SGM youth who experience many challenges taking their medication as prescribed. Overview. This application seeks to develop and pilot test a theory-based, integrated technology and counseling intervention to improve ART adherence among HIV infected SGM youth (ages 15-24) 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. To inform the content, structure, and format of the proposed intervention, the MPIs recently conducted focus groups with SGM youth (N = 18) and key informant interviews (N = 7) with medical providers and staff at local HIV service organizations working closely with SGM youth in Rio de Janeiro. Across focus groups and key informant interviews there was universal agreement that an intervention should capitalize on and enhance social support structures among SGM youth, and address their specific concerns, especially as related to the individual (e.g., ART side effects, mood, substance use), social (e.g., HIV/SGM stigma), and structural (e.g., clinic hours, transportation challenges) barriers that they regularly face. Theoretical Model. The intervention is guided by Social Cognitive and Social Support Theories and is grounded in the social and contextual realities of SGM youth living with HIV in Brazil. Specifically, social support is emphasized and informational, problem-solving and cognitive-behavioral "steps" are addressed over 4-group adherence counseling sessions, which include short video vignettes that seek to normalize adherence challenges. In addition, daily tailored SMS text messages are delivered as part of the intervention to facilitate social-cognitive cues to take medications as prescribed. Research Plan. Phase 1: Refine and enhance participant acceptability of the intervention and resolve any issues with intervention delivery/implementation; this will be achieved by convening and obtaining feedback from our youth community advisory board throughout this phase and subsequent phases; and by conducting an open-phase pilot with up to 12 SGM youth, with post-intervention exit interviews, as well as obtaining feedback from our youth community advisory board throughout this and subsequent phases. Phase 2: Examine, in a pilot randomized controlled trial, the feasibility, acceptability and potential impact of the proposed intervention among approximately 72 SGM youth who will be equally randomized to the intervention or a standard of care control condition with standard of care. The outcomes are improved ART adherence, retention in care and viral load suppression. Study assessments will be conducted at baseline, 3- and 6-months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Experimental: Making ART Work

Behavioral

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.

Standard of Care

Behavioral

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.

Primary outcomes

  1. Feasibility: number of participants who have at least one follow up visit

    Time frame: 6 months

    Retention rate

  2. Feasibility: mean number of intervention sessions attended

    Time frame: 3 months

    Session attendance (in intervention arm)

  3. Acceptability: mean score on the Client Satisfaction Questionnaire scale (CSQ-8)

    Time frame: 3 months

    CSQ-8

  4. Medication adherence - proportion of participants with presence of tenofovir in urine using a point-of-care lateral flow immunoassay (LFA) method

    Time frame: 6 months

    Presence of tenofovir in urine using a point-of-care lateral flow immunoassay (LFA) method

  5. Medication adherence - proportion who have received all ART prescriptions over the course of follow up according to pharmacy dispensing records (SICLOM national registry)

    Time frame: 6 months

    pharmacy dispensing records via the SICLOM database

Secondary outcomes

  1. Plasma viral load - mean viral load as obtained through the SISCEL database (national registry)

    Time frame: 6 months

    verified via the SISCEL database

  2. Retention in HIV care: proportion who have been in continuous care according to 1) at least 1 or more routine HIV visits, 3 months apart or more, (2) receiving 1 or more CD4 tests; and (3) receiving 1 or more viral load tests

    Time frame: 6 months

    verified using the SISCEL and SICLOM databases and medical records

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Olson, MBA

CONTACT

[email protected]

Katie Biello, PhD, MPH

CONTACT

[email protected]

4018634082

Sponsors and collaborators

Lead sponsor

Brown University

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • Oswaldo Cruz Foundation
  • University of California, Los Angeles

Registry information

Official study title

Making Universal, Free-of-charge Antiretroviral Therapy Work for Sexual and Gender Minority Youth in Brazil

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 28, 2023
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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