Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

4. juni 2026 oppdatert av: Philip Kreniske, City University of New York, School of Public Health
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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

588

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: streamlined IPT-G with streamlined Suubi+Adherence
Streamlined IPT-G (6 weeks) one 90-min StrongMinds group counseling session per week & Suubi+Adherence (36 weeks)
Atferdsmessig: Streamlined Suubi+Adherence

Participants 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.
Atferdsmessig: Streamlined Interpersonal Psychotherapy Groups (IPT-G)
  • 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
Eksperimentell: streamlined IPT-G with SOC ART counseling
Streamlined IPT-G (6 weeks) as described above & Standard Of Care (SOC) ART counseling (8 weeks) individual 30-min counseling sessions once per week
Atferdsmessig: Streamlined Interpersonal Psychotherapy Groups (IPT-G)
  • 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
Ingen inngripen: SOC mental health counseling with SOC ART counseling.
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).

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Depressive symptomatology
Tidsramme: Baseline to 24 months post-intervention initiation
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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Viral Load
Tidsramme: Baseline to 12-months post intervention initiation
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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Anxiety
Tidsramme: Baseline to 24-months post intervention initiation
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.
Baseline to 24-months post intervention initiation
Adherence measurement
Tidsramme: Baseline to 24 months post-intervention initiation
The three-item Self-reported ART adherence measure used in prior Suubi studies
Baseline to 24 months post-intervention initiation
General functioning
Tidsramme: Baseline to 24 months post-intervention initiation
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

City University of New York, School of Public Health

Samarbeidspartnere

National Institute of Mental Health (NIMH)
New York University
Washington University Bursky School of Public Health

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. desember 2026

Primær fullføring (Antatt)

1. desember 2028

Studiet fullført (Antatt)

1. august 2030

Datoer for studieregistrering

Først innsendt

4. juni 2026

Først innsendt som oppfylte QC-kriteriene

4. juni 2026

Først lagt ut (Faktiske)

9. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • R01MH140406 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere