Streamlined Treatment and Evidence-based Adolescent Counseling and Medication Support (STREAMS)

N/ANot Yet RecruitingNCT07637058

City University of New York, School of Public Health588 enrolled

Overview

Combination interventions to address mental health and adherence to HIV care in low- and middle-income countries (LMICs), are crucial to achieving the UNAIDS 95-95-95 targets as one in four adolescents living with HIV (ALWHIV) experience poor mental health and this contributes to suboptimal medication adherence and lack of viral suppression. Yet few evidence-based mental health and adherence interventions have been evaluated in sub-Saharan Africa (SSA), the region where the majority of the 1.7 million ALWHIV reside. STREAMS will determine if our streamlined combination intervention approach to mental health screening, provision of evidence-based interpersonal psychotherapy groups (IPT-G), and evidence-based family strengthening, and medication counseling is feasible and efficacious for ALWHIV in Uganda.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

588

Conditions

Depression in Adolescence

Interventions

Streamlined Interpersonal Psychotherapy Groups (IPT-G)BEHAVIORAL

* Participants in the IPT-G intervention arms will attend: * Six weekly group counseling sessions, * Conducted in groups of approximately 6-10 adolescents, * Facilitated by trained StrongMinds counselors. The sessions will focus on: * Emotional wellbeing * Relationships * Coping with stress * Grief and loss * Social support * Problem-solving skills

Eligibility

Sex: ALLMin age: 15 YearsMax age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Living with HIV with confirmation by medical report and aware of their status * Living within a family (defined broadly, not necessarily with biological parents); - - Between the ages of 15 to 19 years * Prescribed ART * Score a 10 or greater on the PHQ-9 Exclusion Criteria: * an inability to understand study procedures and participant rights as assessed during informed consent/assent process with the adolescent or caregiver.

Outcomes

Primary Outcomes

Depressive symptomatology

PHQ-9, a standardized 9-item self-report instrument used to assess depression, is used. Participants rate the frequency of their symptoms over the past 2 weeks. Items are rated on a 4-point scale, ranging from 0 (not at all) to 3 (nearly every day), and scale scores range from 0 to 27. PHQ-9 scores of 5 to 9 represent minimal to mild depression and 10 to 20 represent moderate to severe depression. A score ≥10 has a sensitivity of 88% and a specificity of 88% for major depression.

Time frame: Baseline to 24 months post-intervention initiation

Secondary Outcomes

Viral Load

Viral Load (VL) Suppression (Biological assay) will be assessed through blood draws. In accordance with in-country cutoffs, VL will be dichotomized between undetectable (\< 200 copies/ml) and detectable (≥ 200 copies/ml) levels.

Time frame: Baseline to 12-months post intervention initiation