Health TrialsbyHealthPanel

Making ART Work Among Brazilian Youth

ConditionsHivAdherence, Medication
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-24
SponsorBrown University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Making ART WorkExperimental treatment 2 interventions
Group B: Standard of CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Retention rate

Time frame
6 months
2

Feasibility: mean number of intervention sessions attended

Session attendance (in intervention arm)

Time frame
3 months
3

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

CSQ-8

Time frame
3 months
4

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

Time frame
6 months

Secondary outcomes

1

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

verified via the SISCEL database

Time frame
6 months
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

verified using the SISCEL and SICLOM databases and medical records

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brown University

Lead sponsor

University of California, Los Angeles

Collaborator

Oswaldo Cruz Foundation

Collaborator

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov
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