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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH140406 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| New York University | OTHER |
| Washington University Bursky School of Public Health | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| streamlined IPT-G with streamlined Suubi+Adherence | Experimental | Streamlined IPT-G (6 weeks) one 90-min StrongMinds group counseling session per week & Suubi+Adherence (36 weeks) |
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| streamlined IPT-G with SOC ART counseling | Experimental | Streamlined IPT-G (6 weeks) as described above & Standard Of Care (SOC) ART counseling (8 weeks) individual 30-min counseling sessions once per week |
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| SOC mental health counseling with SOC ART counseling. | No Intervention | Receive treatment per Uganda national guidelines Standard Of Care (SOC) Mental Health Counseling (6-weeks) delivered by HIV clinic staff in 60-min sessions once per week and SOC ART counseling (8-weeks). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Streamlined Suubi+Adherence | Behavioral | Participants in this intervention arm will receive:
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 24 months post-intervention initiation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 12-months post intervention initiation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philip Kreniske, PhD | Contact | (646) 364-9600 | philip.kreniske@sph.cuny.edu |
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| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| D003863 | Depression |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
| D001526 | Behavioral Symptoms |
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Participants and care providers will know which intervention is being given but will not know about the interventions given in the other 2 arms of the study.
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| Streamlined Interpersonal Psychotherapy Groups (IPT-G) | Behavioral |
The sessions will focus on:
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| Baseline to 24-months post intervention initiation |
| Adherence measurement | The three-item Self-reported ART adherence measure used in prior Suubi studies | Baseline to 24 months post-intervention initiation |
| 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 | Baseline to 24 months post-intervention initiation |