Making ART Work Among Brazilian Youth

Study Overview
=================
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.

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

Conditions
-----------------
Hiv, Adherence, Medication

Intervention / Treatment
-----------------
* Behavioral: Experimental: Making ART Work
* Behavioral: Standard of Care


Participation Criteria
=================
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, currently taking or prescribed ART for > 3 months, per chart review or National system (SICLOM) review self-report missing 2 or more doses of ART medications in any given week in the past month 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 24 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pilot randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Making ART Work<br>A culturally tailored, theoretically grounded social support intervention that includes receipt of daily text messages and provider-facilitated group adherence counseling (4 sessions) | Behavioral: Experimental: Making ART Work<br>* 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.<br>Behavioral: Standard of Care<br>* 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.<br>|
| Active Comparator: Standard of Care<br>Standard clinical care referrals and basic medication adherence education | Behavioral: Standard of Care<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma viral load - mean viral load as obtained through the SISCEL database (national registry) | verified via the SISCEL database | 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 | verified using the SISCEL and SICLOM databases and medical records | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, Brazil, sexual and gender minority, adolescents, Medication adherence