Making ART Work Among Brazilian Youth
Making Universal, Free-of-charge Antiretroviral Therapy Work for Sexual and Gender Minority Youth in Brazil
2 other identifiers
interventional
72
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hiv
Started Oct 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2023
CompletedFirst Posted
Study publicly available on registry
September 28, 2023
CompletedStudy Start
First participant enrolled
October 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2026
CompletedSeptember 19, 2025
September 1, 2025
2.6 years
September 19, 2023
September 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Feasibility: number of participants who have at least one follow up visit
Retention rate
6 months
Feasibility: mean number of intervention sessions attended
Session attendance (in intervention arm)
3 months
Acceptability: mean score on the Client Satisfaction Questionnaire scale (CSQ-8)
CSQ-8
3 months
Medication adherence - proportion of participants with presence of tenofovir in urine using a point-of-care lateral flow immunoassay (LFA) method
Presence of tenofovir in urine using a point-of-care lateral flow immunoassay (LFA) method
6 months
Medication adherence - proportion who have received all ART prescriptions over the course of follow up according to pharmacy dispensing records (SICLOM national registry)
pharmacy dispensing records via the SICLOM database
6 months
Secondary Outcomes (2)
Plasma viral load - mean viral load as obtained through the SISCEL database (national registry)
6 months
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
6 months
Study Arms (2)
Making ART Work
EXPERIMENTALA culturally tailored, theoretically grounded social support intervention that includes receipt of daily text messages and provider-facilitated group adherence counseling (4 sessions)
Standard of Care
ACTIVE COMPARATORStandard clinical care referrals and basic medication adherence education
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brown Universitylead
- University of California, Los Angelescollaborator
- Oswaldo Cruz Foundationcollaborator
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
Evandro Chagas National Institute of Infectious Diseases (INI) Oswaldo Cruz Foundation (FIOCRUZ)
Rio de Janeiro, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katie Biello, PhD, MPH
Brown University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The PIs nor the individual conducting outcome assessments will know the status of the participants' randomization.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2023
First Posted
September 28, 2023
Study Start
October 1, 2023
Primary Completion
April 30, 2026
Study Completion
April 30, 2026
Last Updated
September 19, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Raw data for additional analysis will be available to outside individuals through contacting the MPIs at two different times. The first will be after all of the baseline data is collected. We will institute a concept plan process where internal study staff first have the availability to write primary papers or give presentations on particular topics. After this, if outside individuals wish to analyze data, we will welcome this collaboration. A similar process will happen for outcome data; however this will not be possible until the publication and release of the outcome paper(s). The PI will store the data indefinitely and allow access for pooled data analysis projects, or projects for outside individuals.
Raw data for additional analysis will be available to outside individuals through contacting the MPIs at two different times. The first will be after all of the baseline data is collected. We will institute a concept plan process where internal study staff first have the availability to write primary papers or give presentations on particular topics. After this, if outside individuals wish to analyze data, we will welcome this collaboration. A similar process will happen for outcome data; however this will not be possible until the publication and release of the outcome paper(s). The PI will store the data indefinitely and allow access for pooled data analysis projects, or projects for outside individuals. Information regarding the availability of data for analysis will be listed on the MPIs' web pages. Contact information for the PI will be listed in all manuscripts and publications as another means to access data.