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Gruppebaseret intervention for at forbedre mental sundhed og tilslutning blandt unge, der lever med hiv i lave ressourcer

IMPAACT 2016 - Evaluering af en gruppebaseret intervention for at forbedre mental sundhed og antiretroviral terapi (ART) overholdelse blandt unge, der lever med hiv i miljøer med lav ressource

IMPAACT 2016 er en multi-site, to-arm, individuelt randomiseret, kontrolleret undersøgelse for at evaluere, om en Indigenous Leader Outreach Model (ILOM) af traume-informeret kognitiv adfærdsterapi (TI-CBT) leveret af Indigenous Youth Leaders (IYL) er forbundet med forbedrede mentale sundhedsresultater og ART-tilslutning blandt unge, der lever med HIV i ressourcebegrænsede omgivelser. Interventionen tilpasses den lokale kontekst gennem forudgående gennemførelse af fokusgrupper og pilottest.

Studieoversigt

Detaljeret beskrivelse

IMPAACT 2016 er en multi-site, to-arm, individuelt randomiseret, kontrolleret undersøgelse for at evaluere, om en Indigenous Leader Outreach Model (ILOM) af traume-informeret kognitiv adfærdsterapi (TI-CBT) leveret af Indigenous Youth Leaders (IYL) er forbundet med forbedrede mentale sundhedsresultater og ART-tilslutning blandt unge, der lever med HIV i ressourcebegrænsede omgivelser. For at tilpasse interventionen til den lokale kontekst, vil forsøget blive forudgået af en tilpasning af TI-CBT-interventionen på hvert sted ved hjælp af "ADAPT-ITT"-modellen, som inkluderer fokusgrupper og pilottests. I den randomiserede undersøgelse vil unge individuelt blive randomiseret til enten TI-CBT Intervention Arm eller Discussion Control Arm. Deltagerne vil mødes som en gruppe inden for deres randomiserede arm og modtage flere gruppesessioner inden for en otte ugers periode. Hver gruppe vil inkludere et gennemsnit på otte unge for i alt 192-256 unge i det randomiserede forsøg (96-128 unge pr. arm). TI-CBT og diskussionskontrolgrupper i hver arm vil være blandet køn, medmindre det er bestemt nødvendigt at have enkeltkønsgrupper under fokusgruppen. Pårørende (hvis de er tilgængelige og med unges tilladelse) vil blive tilknyttet den samme studiearm som deres unge. Pårørende mødes som en gruppe til to pårørende-specifikke sessioner på to separate uger og adskilt fra deres ungdomsgruppesessioner. Unge og pårørende vil gennemføre et opfølgningsbesøg umiddelbart efter deres sidste gruppesession og to yderligere opfølgningsbesøg efter seks og 12 måneder. Unge og pårørende vil også modtage en to-timers booster-gruppesession i overensstemmelse med deres tildelte studiearm umiddelbart efter de seks måneder lange evalueringer. Booster-sessionerne har til formål at forbedre behandlingseffekter og øge bæredygtighed. Når alle deltagere har gennemført deres seks måneders evalueringer, vil data fra disse evalueringer blive analyseret for at bestemme de kortsigtede effekter af interventionen. Yderligere analyser for at vurdere de langsigtede effekter af interventionen, herunder effekterne af booster-gruppesessionen, vil blive udført efter afslutningen af ​​opfølgningen.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

484

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Gaborone, Botswana
        • Gaborone Prevention/Treatment Trials CRS 12701
      • Molepolole, Botswana
        • Molepolole Prevention/Treatment Trials CRS 12702
      • Blantyre, Malawi
        • College of Medicine CRS 30301
      • Lilongwe, Malawi
        • University of North Carolina Lilongwe CRS 12001
      • Soweto, Sydafrika
        • Soweto IMPAACT CRS 8052
      • Chitungwiza, Zimbabwe
        • St. Mary's CRS 30303
      • Harare, Zimbabwe
        • Harare Family Care CRS 31890
      • Harare, Zimbabwe
        • Seke North CRS 30306

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

15 år til 19 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier - For ungdomsdeltagere:

  • Ved screening, 15-19 år.
  • Hvis de er myndige til at give uafhængigt informeret samtykke som bestemt af webstedets standarddriftsprocedurer (SOP'er) og i overensstemmelse med webstedets IRB/EC-politikker og -procedurer: potentiel ungdomsdeltager er villig og i stand til at give skriftligt informeret samtykke til undersøgelsesdeltagelse.
  • Hvis du ikke er myndig til at give uafhængigt informeret samtykke: Forælder eller værge er villig og i stand til at give skriftligt informeret samtykke til studiedeltagelse, og potentiel ungdomsdeltager er villig og i stand til at give skriftligt informeret samtykke til studiedeltagelse.
  • Bekræftet HIV-infektion baseret på dokumenteret test af to prøver indsamlet på forskellige tidspunkter som dokumenteret i journaler eller ved bekræftende test.
  • Ved screening, opmærksom på hans eller hendes hiv-infektion, som bekræftet af journalforsker eller udpeget.
  • Har ved screening fået ordineret ART i minimum 24 uger før screening baseret på journaldokumentation.
  • Ved screening opfylder mindst én af følgende indikatorer for moderat til svær mental sundhed symptomologi:

    • Patient Health Questionnaire-9 (PHQ-9) score ≥ 10
    • Generel angstlidelse-7 (GAD-7) score ≥ 10
    • UCLA Post-Traumatic Stress Disorder-Reaction Index (UCLA PTSD-RI) score > 35

Inklusionskriterier - for plejepersonale:

  • Plejegiver, defineret som en biologisk forælder, juridisk værge eller person, der yder følelsesmæssig, psykologisk og/eller informativ pleje til en ungdom, der deltager i det randomiserede forsøg, som identificeret af den unge, og for hvem den unge har givet skriftlig tilladelse til at deltage i undersøgelsen.
  • Myndig til at give uafhængigt samtykke og villig og i stand til at give skriftligt informeret samtykke til studiedeltagelse.

Eksklusionskriterier - For ungdomsdeltagere:

  • Ved indrejse, deltagelse i en undersøgelse, der leverer en mental sundhed eller ART adherence intervention.
  • Har tidligere deltaget i en IMPAACT 2016 fokusgruppe eller pilottest
  • Enhver anden tilstand, ugunstig social situation eller kognitiv svækkelse, der efter stedets undersøgelsesleders mening ville udelukke informeret samtykke og informeret samtykke, gøre undersøgelsesdeltagelse usikker, komplicere fortolkning af undersøgelsesresultatdata eller på anden måde forstyrre opnåelsen af ​​undersøgelsens mål.

Eksklusionskriterier - For plejepersonale-deltagere:

Har tidligere deltaget i en IMPAACT 2016 fokusgruppe eller pilottest.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Youth TI-CBT Intervention Arm
For youth, the TI-CBT intervention arm consisted of six 2-hour TI-CBT group sessions led by Indigenous Youth Leaders (IYL) during weeks 1 to 8 and one 2-hour booster group session at 6-months. The TI-CBT Intervention was delivered in a group format. The TI-CBT Intervention arm had 15 groups with an average of 8.5 youth per group (range 6-11).
For youth, each TI-CBT group session was led by IYL. TI-CBT teaches techniques and ways to manage distress through psychosocial health education, cognitive restructuring, and "mastery of trauma", which refers to the process by which survivors of psychological trauma work through the traumatic experience in a meaningful way, and are able to move on with life. TI-CBT addresses both the trauma of learning one has HIV and the trauma associated with managing a chronic and stigmatized illness. The intervention highlights links between HIV and traditional gender roles, gender inequities, and gender-based violence. Finally, the relaxation training teaches youth strategies to relax and these are integrated at the beginning and end of each session. TI-CBT Youth Intervention Manuals were distributed to sites for translation, backtranslation, and cultural adaptation in preparation for the Randomized Trial.
Aktiv komparator: Youth Discussion Control Arm
For youth, the Discussion Control arm consisted of six 2-hour discussion group sessions led by IYL during weeks 1 to 8 and one 2-hour booster discussion group session at 6 months. The Discussion Control was delivered in a group format. The Discussion Control arm had 15 groups with an average of 8.4 youth per group (range 5-10).
For youth, each discussion group session was led by IYL. Discussion topics were selected by youth in the group. Discussion Control sessions took place at a separate time from TI-CBT Intervention sessions to minimize contamination. Youth and caregiver group sessions were also held separately.
Eksperimentel: Caregiver TI-CBT Intervention Arm
For caregivers, the TI-CBT Intervention arm consisted of two 2-hour TI-CBT group sessions on two separate weeks within 8 weeks of their youth's first group session and one 2-hour booster group session at 6-months led by adult study staff. The TI-CBT Intervention was delivered in group format. The TI-CBT Intervention arm had 15 groups with an average of 7.7 caregivers per group (range 5-10).
For caregivers, each TI-CBT group session was led by adult study staff. TI-CBT teaches techniques and ways to manage distress through psychosocial health education, cognitive restructuring, and "mastery of trauma", which refers to the process by which survivors of psychological trauma work through the traumatic experience in a meaningful way, and are able to move on with life. TI-CBT addresses both the trauma of learning one has HIV and the trauma associated with managing a chronic and stigmatized illness. The intervention highlights links between HIV and traditional gender roles, gender inequities, and gender-based violence. Finally, the relaxation training teaches strategies to relax and these are integrated at the beginning and end of each session. TI-CBT Caregiver Intervention Manuals were distributed to sites for translation, backtranslation, and cultural adaptation in preparation for the Randomized Trial.
Aktiv komparator: Caregivers Discussion Control Arm
For caregivers, the Discussion Control arm consisted of: two 2-hour discussion group sessions on two separate weeks within 8 weeks of their youth's first group session and one 2-hour booster discussion group session at 6 months led by adult study staff. The Discussion Control intervention was delivered in a group format. The Discussion Control arm had 15 groups with an average of 7.6 caregivers per group (range 3-10).
For caregivers, each discussion group session was led by adult study staff. Discussion topics were selected by caregivers in the group. Discussion Control sessions took place at a separate time from TI-CBT Intervention sessions to minimize contamination. Youth and caregiver group sessions were also held separately.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Group-level Mean General Anxiety Disorder-7 (GAD-7) at 6 Months
Tidsramme: at 6 months
Average (standard deviation) of the group-level mean General Anxiety Disorder-7 (GAD-7) score within arm. The GAD-7 features 7 items assessing frequency of anxiety symptoms over the past 2 weeks on a scale from 0="Not at all" to 3="Nearly every day". Responses to the 7 items are summed to obtain a GAD-7 score ranging from 0 (least) to 21 (most severe symptoms). A score of 10 or more points indicates moderate to severe anxiety symptoms.
at 6 months
Group-level Mean UCLA Post-Traumatic Stress Disorder-Reaction Index (UCLA-PTSD-RI) at 6 Months
Tidsramme: at 6 months
Average (standard deviation) of the group-level mean UCLA Post Traumatic Stress Disorder-Reaction Index (PTSD-RI) score within arm. The UCLA PTSD-RI assesses DSM-IV criteria for PTSD in youth. If prior trauma is endorsed, assessment asks whether 31 PTSD symptoms have occurred within the past month on a scale from 0="None" to 4="Most of the time". A scoring algorithm is applied to the 31 items to calculate a score ranging from 0 (least) to 80 (most severe symptoms). A score of 35 or more indicates moderate to severe PTSD symptoms. If no trauma is endorsed, no score is calculated.
at 6 months
Group-level Mean Composite Mental Health Measure at 6 Months
Tidsramme: at 6 months
Average (standard deviation) of the group-level mean Composite score within arm. Composite scores are a study-specific measure of combined mental health symptoms. A participant's PHQ-9, GAD-7, and UCLA PTSD-RI scores at the given timepoint are each standardized according to baseline to get Z scores. The 3 Z scores are summed to obtain a Composite score. Composite scores are not Z scores themselves and can range from -Inf to +Inf, with greater scores reflecting more severe symptoms overall. Composite scores of 0 at baseline represent average symptom levels overall, but otherwise do not have a meaningful central value.
at 6 months
Group-level Mean Patient Health Questionnaire-9 (PHQ-9) at 6 Months
Tidsramme: at 6 months
Average (standard deviation) of the group-level mean Patient Health Questionnaire-9 (PHQ-9) score within arm. The PHQ-9 features 9 items assessing the frequency of depression symptoms over the past 2 weeks on a scale from 0="Not at all" to 3="Nearly every day". Responses to the 9 items are summed to obtain a PHQ-9 score ranging from 0 (least) to 27 (most severe symptoms). A score of 10 or more points indicates moderate to severe depression symptoms.
at 6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Group-level Mean General Anxiety Disorder-7 (GAD-7) at IPL (Immediately Post-Last Group Session)
Tidsramme: After initial treatment completion (initial treatment lasted an average of 6 weeks)
Average (standard deviation) of the group-level mean General Anxiety Disorder-7 (GAD-7) score within arm. The GAD-7 features 7 items assessing frequency of anxiety symptoms over the past 2 weeks on a scale from 0="Not at all" to 3="Nearly every day". Responses to the 7 items are summed to obtain a GAD-7 score ranging from 0 (least) to 21 (most severe symptoms). A score of 10 or more points indicates moderate to severe anxiety symptoms.
After initial treatment completion (initial treatment lasted an average of 6 weeks)
Group-level Mean Patient Health Questionnaire-9 (PHQ-9) at IPL (Immediately Post Last Group Session)
Tidsramme: After initial treatment completion (initial treatment lasted an average of 6 weeks)
Average (standard deviation) of the group-level mean Patient Health Questionnaire-9 (PHQ-9) score within arm. The PHQ-9 features 9 items assessing the frequency of depression symptoms over the past 2 weeks on a scale from 0="Not at all" to 3="Nearly every day". Responses to the 9 items are summed to obtain a PHQ-9 score ranging from 0 (least) to 27 (most severe symptoms). A score of 10 or more points indicates moderate to severe depression symptoms.
After initial treatment completion (initial treatment lasted an average of 6 weeks)
Group-level Mean UCLA Post-Traumatic Stress Disorder-Reaction Index (UCLA PTSD-RI) at IPL (Immediately Post-Last Group Session)
Tidsramme: After initial treatment completion (initial treatment lasted an average of 6 weeks)
Average (standard deviation) of the group-level mean UCLA Post Traumatic Stress Disorder-Reaction Index (PTSD-RI) score within arm. The UCLA PTSD-RI assesses DSM-IV criteria for PTSD in youth. If prior trauma is endorsed, assessment asks whether 31 PTSD symptoms have occurred within the past month on a scale from 0="None" to 4="Most of the time". A scoring algorithm is applied to the 31 items to calculate a score ranging from 0 (least) to 80 (most severe symptoms). A score of 35 or more indicates moderate to severe PTSD symptoms. If no trauma is endorsed, no score is calculated.
After initial treatment completion (initial treatment lasted an average of 6 weeks)
Group-level Mean Composite Mental Health Measure at IPL (Immediately Post-Last Group Session)
Tidsramme: After initial treatment completion (initial treatment lasted an average of 6 weeks)
Average (standard deviation) of the group-level mean Composite score within arm. Composite scores are a study-specific measure of combined mental health symptoms. A participant's PHQ-9, GAD-7, and UCLA PTSD-RI scores at the given timepoint are each standardized according to baseline to get Z scores. The 3 Z scores are summed to obtain a Composite score. Composite scores are not Z scores themselves and can range from -Inf to +Inf, with greater scores reflecting more severe symptoms overall. Composite scores of 0 at baseline represent average symptom levels overall, but otherwise do not have a meaningful central value.
After initial treatment completion (initial treatment lasted an average of 6 weeks)
Group-level Mean ART Adherence at 6 Months
Tidsramme: at 6 months
Average (standard deviation) of the group-level mean antiretroviral therapy (ART) adherence score within arm. The Wilson 3-Item Adherence Scale assessed self-reported ART adherence. Within the past 30 days, the 3 items correspond to missed daily doses (0-30), adherence to medication instructions ("Very poor" to "Excellent"), and frequency of perfect use ("Never" to "Always"). Responses on the three items are transformed linearly to scores between 0 and 100 points and averaged to obtain a single score. Scores range from 0 (worst) possible adherence to 100 (best possible adherence).
at 6 months
Viral Load at 6 Months
Tidsramme: at 6 months
HIV-1 RNA
at 6 months
Group-level Mean ART Adherence at IPL (Immediately Post-Last Group Session).
Tidsramme: After initial treatment completion (initial treatment lasted an average of 6 weeks).
Self-report - Wilson 3-item scale (range 0-100, higher=better)
After initial treatment completion (initial treatment lasted an average of 6 weeks).
Viral Load at IPL (Immediately Post-Last Group Session)
Tidsramme: After initial treatment completion (initial treatment lasted an average of 6 weeks)
HIV-1 RNA
After initial treatment completion (initial treatment lasted an average of 6 weeks)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

  • Dow DE, Libous J, Ponatshego PL, Masheto G, Mvalo T, Payesa C, Buckley J, Stranix-Chibanda L, Nematadzira T, Vhembo T, Ace A, Warshaw M, Townley E, Lee S, Allison S, Donenberg G and the IMPAACT 2016 Team. High levels of mental distress among youth with HIV in Southern Africa: A description of enrollment into IMPAACT 2016, a randomized controlled trial of a peer-led, group-based mental health intervention. Presented at IAS, Kigali, Rwanda, 15 July 2025.
  • Libous J, Jeffrey R, George K, Montañez N, Warshaw M, Shakes Raesi M, Ponatshego PL, Maliwichi L, Vhembo T, Mutasa T, Bere CT, Galvin L, Townley E, Varechtchouk O, Dow D, Donenberg G, and the IMPAACT 2016 Team. IMPAACT 2016: The ADAPT-ITT Framework Leveraging Youth and Supporter Voices in the Adaptation of a Trauma-Informed Cognitive Behavioral Therapy Group-Based Intervention for Youth Living with HIV and Mental Health Distress. Presented at Fast Track Cities, Paris, France, 13-15 October 2024.
  • Vhemo T, Mhembere T, Mbengeranwa T, Bere TC, Mutasa T, Katsande R, Gumbo J, Mudzonga N, Nematadzira T, Maturure SJ, Mandima PF, Maonera S, Stranix-Chibanda L. High Prevalence of Common Mental Health Disorders Amongst Adolescents With HIV in Zimbabwe: IMPAACT 2016; Presented at International Workshop on Pediatrics & HIV, Munich, Germany, 19-20 July 2024.
  • Libous JL, Montañez N, Donenberg G, Kapetanovic S, Dow D. IMPAACT 2016: Operationalizing the ADAPT-ITT Model to drive local adaptation of an intervention to improve mental health and medication adherence in youth living with HIV. Presented at Society for Clinical Research Associates 29th Annual Conference, Virtual, 23-26 September 2020.
  • Warshaw M, Dow D, Kapetanovic S, Libous J, Reding C, Montañez , Donenberg G. IMPAACT 2016: Interdisciplinary Collaboration at Multiple Levels. Society for Clinical Trials 41st Annual Meeting, Baltimore, MD (Virtual), 2020.
  • Libous JL, Montanez NA, Dow DE, Kapetanovic S, Buckley J, Kakhu TJ, Kamthunzi P, Maliwichi LA, Vhembo T, Chawana TD, Nematadzira T, Donenberg GR. IMPAACT 2016: Operationalizing HIV Intervention Adaptations to Inform the Science and Outcomes of Implementation. Front Reprod Health. 2021 May 28;3:662912. doi: 10.3389/frph.2021.662912. eCollection 2021.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

6. april 2024

Primær færdiggørelse (Faktiske)

27. marts 2025

Studieafslutning (Faktiske)

5. juni 2025

Datoer for studieregistrering

Først indsendt

2. juli 2019

Først indsendt, der opfyldte QC-kriterier

16. juli 2019

Først opslået (Faktiske)

18. juli 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. maj 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IMPAACT 2016
  • DAIDS ID #38506 (Anden identifikator: DAIDS/NIAID/NIH)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Individuelle deltagerdata, der ligger til grund, resulterer i offentliggørelsen efter afidentifikation.

IPD-delingstidsramme

Begyndende tre måneder efter offentliggørelsen og tilgængelig i hele finansieringsperioden for International Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT) Network af NIH.

IPD-delingsadgangskriterier

Data vil blive delt med forskere, som giver et metodisk forsvarligt forslag til brug af data, som er godkendt af IMPAACT-netværket.

Typer af analyser: Specifikt for de typer analyser, der er nødvendige for at nå målene i forslaget godkendt af IMPAACT-netværket.

Mekanisme: Forskere kan indsende en anmodning om adgang til data ved hjælp af IMPAACT "Data Request"-formularen på: https://www.impaactnetwork.org/resources/study-proposals.htm. Forskere af godkendte forslag skal underskrive en IMPAACT-databrugsaftale, før de modtager dataene.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med HIV-1-infektion

Kliniske forsøg med Youth TI-CBT Intervention Arm

Abonner