Clinical trial NCT06056037: Making ART Work Among Brazilian Youth
Official title: Making Universal, Free-of-charge Antiretroviral Therapy Work for Sexual and Gender Minority Youth in Brazil
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hiv
Adherence, Medication
Keywords: Brazil
sexual and gender minority
adolescents
HIV
Medication adherence
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: Oswaldo Cruz Foundation
name: National Institute of Mental Health (NIMH)
First posted: 2023-09-28
Enrollment: 72
Sex: MALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot randomized controlled trial
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility: number of participants who have at least one follow up visit
timeFrame: 6 months
measure: Feasibility: mean number of intervention sessions attended
timeFrame: 3 months
measure: Acceptability: mean score on the Client Satisfaction Questionnaire scale (CSQ-8)
timeFrame: 3 months
measure: Medication adherence - proportion of participants with presence of tenofovir in urine using a point-of-care lateral flow immunoassay (LFA) method
timeFrame: 6 months
measure: Medication adherence - proportion who have received all ART prescriptions over the course of follow up according to pharmacy dispensing records (SICLOM national registry)
timeFrame: 6 months
Secondary outcomes:
measure: Plasma viral load - mean viral load as obtained through the SISCEL database (national registry)
timeFrame: 6 months
measure: 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
timeFrame: 6 months
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Evandro Chagas National Institute of Infectious Diseases (INI) Oswaldo Cruz Foundation (FIOCRUZ)
Study officials:
affiliation: Brown University
name: Katie Biello, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: