About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
an inability to understand study procedures and participant rights as assessed during informed consent/assent process with the adolescent or caregiver.
Trial design
Parallel
Treatments tested in this trial
Streamlined Suubi+Adherence
BehavioralParticipants in this intervention arm will receive: * Financial literacy training * Youth savings accounts The intervention aims to strengthen economic stability and support long-term treatment adherence and psychosocial well-being.
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
Treatment groups
Trial 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.
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.
Other outcomes
Anxiety
The GAD-7 is a standardized instrument that asks participants to rate their symptoms over the past two weeks on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). Overall scores for the GAD-7 range from 0 to 21. At a cut-point of 10 (indicative of clinically significant symptoms), the sensitivity and specificity of the scale equals 89% and 82% respectively. The GAD-7 has a Cronbach's of .92, indicating good internal consistency with an intra-class correlation of .83, indicating good procedural validity.
Adherence measurement
The three-item Self-reported ART adherence measure used in prior Suubi studies
General functioning
Children's Global Assessment Scale (CGAS)136, an adaptation of the Global Assessment Scale for adults, young people scored between 1 to 100, with 10 categories. Participants with CGAS score of 1-10 needs constant supervision, with scores of 91-100 means superior functioning. CGAS can be a useful measure of overall severity of disturbance. It was found to have moderate to good reliability between raters and across time, as measured by intraclass correlation
Locations
Sponsors and contacts
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City University of New York, School of Public Health
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
New York University
Collaborator
Washington University Bursky School of Public Health
Collaborator
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