- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04024488
Gruppebasert intervensjon for å forbedre mental helse og etterlevelse blant unge som lever med hiv i miljøer med lite ressurser
IMPAACT 2016 - Evaluering av en gruppebasert intervensjon for å forbedre mental helse og etterlevelse av antiretroviral terapi (ART) blant ungdommer som lever med hiv i lavressursmessige omgivelser
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Gaborone, Botswana
- Gaborone Prevention/Treatment Trials CRS 12701
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Molepolole, Botswana
- Molepolole Prevention/Treatment Trials CRS 12702
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Blantyre, Malawi
- College of Medicine CRS 30301
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Lilongwe, Malawi
- University of North Carolina Lilongwe CRS 12001
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Soweto, Sør-Afrika
- Soweto IMPAACT CRS 8052
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Chitungwiza, Zimbabwe
- St. Mary's CRS 30303
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Harare, Zimbabwe
- Harare Family Care CRS 31890
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Harare, Zimbabwe
- Seke North CRS 30306
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Beskrivelse
Inkluderingskriterier – for ungdomsdeltakere:
- Ved visning, 15-19 år.
- Hvis du er myndig for å gi uavhengig informert samtykke som bestemt av nettstedets standard driftsprosedyrer (SOPs) og i samsvar med nettstedets IRB/EC-retningslinjer og prosedyrer: potensielle ungdomsdeltakere er villig og i stand til å gi skriftlig informert samtykke for studiedeltakelse.
- Hvis du ikke er myndig for å gi uavhengig informert samtykke: Foreldre eller foresatte er villig og i stand til å gi skriftlig informert samtykke for studiedeltakelse og potensiell ungdomsdeltaker er villig og i stand til å gi skriftlig informert samtykke for studiedeltakelse.
- Bekreftet HIV-infeksjon basert på dokumentert testing av to prøver tatt på ulike tidspunkt som dokumentert i medisinske journaler eller ved bekreftende testing.
- Ved screening, klar over hans eller hennes HIV-infeksjon, som bekreftet av etterforsker eller utpekt.
- Har ved screening blitt foreskrevet ART i minimum 24 uker før screening basert på journaldokumentasjon.
Ved screening oppfyller minst én av følgende indikatorer for moderat til alvorlig psykisk helsesymptom:
- Patient Health Questionnaire-9 (PHQ-9) score ≥ 10
- Generell angstlidelse-7 (GAD-7) score ≥ 10
- UCLA Post-Traumatic Stress Disorder-Reaction Index (UCLA PTSD-RI) score > 35
Inkluderingskriterier – for omsorgspersoner:
- Omsorgsperson, definert som en biologisk forelder, juridisk verge eller person som gir emosjonell, psykologisk og/eller informasjonshjelp til en ungdom som deltar i den randomiserte rettssaken, som identifisert av ungdommen, og som ungdommen har gitt skriftlig tillatelse til å delta for. i studiet.
- Myndig til å gi selvstendig samtykke og villig og i stand til å gi skriftlig informert samtykke for studiedeltakelse.
Ekskluderingskriterier - For ungdomsdeltakere:
- Ved innreise deltar du i en studie som gir en intervensjon for mental helse eller ART-overholdelse.
- Har tidligere deltatt i en IMPAACT 2016 Focus Group eller Pilot Test
- Enhver annen tilstand, ugunstig sosial situasjon eller kognitiv svekkelse som etter stedsundersøkerens oppfatning vil utelukke informert samtykke og informert samtykke, gjøre studiedeltakelse utrygg, komplisere tolkning av studieresultatdata eller på annen måte forstyrre å nå studiemålene.
Ekskluderingskriterier – for omsorgspersoner:
Har tidligere deltatt i en IMPAACT 2016 Focus Group eller Pilot Test.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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).
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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.
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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).
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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.
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Eksperimentell: 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).
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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.
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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).
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Group-level Mean General Anxiety Disorder-7 (GAD-7) at 6 Months
Tidsramme: at 6 months
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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.
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at 6 months
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Group-level Mean UCLA Post-Traumatic Stress Disorder-Reaction Index (UCLA-PTSD-RI) at 6 Months
Tidsramme: at 6 months
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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.
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at 6 months
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Group-level Mean Composite Mental Health Measure at 6 Months
Tidsramme: at 6 months
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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.
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at 6 months
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Group-level Mean Patient Health Questionnaire-9 (PHQ-9) at 6 Months
Tidsramme: at 6 months
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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.
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at 6 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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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)
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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.
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After initial treatment completion (initial treatment lasted an average of 6 weeks)
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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)
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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.
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After initial treatment completion (initial treatment lasted an average of 6 weeks)
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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)
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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.
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After initial treatment completion (initial treatment lasted an average of 6 weeks)
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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)
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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.
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After initial treatment completion (initial treatment lasted an average of 6 weeks)
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Group-level Mean ART Adherence at 6 Months
Tidsramme: at 6 months
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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).
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at 6 months
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Viral Load at 6 Months
Tidsramme: at 6 months
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HIV-1 RNA
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at 6 months
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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).
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Self-report - Wilson 3-item scale (range 0-100, higher=better)
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After initial treatment completion (initial treatment lasted an average of 6 weeks).
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Viral Load at IPL (Immediately Post-Last Group Session)
Tidsramme: After initial treatment completion (initial treatment lasted an average of 6 weeks)
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HIV-1 RNA
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After initial treatment completion (initial treatment lasted an average of 6 weeks)
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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Studiestol: Dorothy Dow, MD, MSc, Duke University
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IMPAACT 2016
- DAIDS ID #38506 (Annen identifikator: DAIDS/NIAID/NIH)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
Data vil bli delt med forskere som gir et metodisk forsvarlig forslag til bruk av dataene som er godkjent av IMPAACT Network.
Typer analyser: Spesielt for typene analyser som trengs for å oppnå målene i forslaget godkjent av IMPAACT-nettverket.
Mekanisme: Forskere kan sende inn en forespørsel om tilgang til data ved å bruke IMPAACT "Data Request"-skjemaet på: https://www.impaactnetwork.org/resources/study-proposals.htm. Forskere av godkjente forslag må signere en IMPAACT-databruksavtale før de mottar dataene.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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. .
Kliniske studier på HIV-1-infeksjon
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Federal University of São PauloGilead SciencesFullført
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Thomas Aagaard RasmussenAarhus University Hospital; The Alfred; Germans Trias i Pujol Hospital; Walter...Rekruttering
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Fundación HuéspedViiV HealthcareHar ikke rekruttert ennåHIV-1-infeksjonArgentina, Brasil
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Fundación HuéspedMSD Pharmaceuticals LLC; Fundacion IDEAAHar ikke rekruttert ennå
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Henan Genuine Biotech Co., Ltd.Rekruttering
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University of North Carolina, Chapel HillHar ikke rekruttert ennå
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Craig Cohen, MD, MPHNational Institute of Allergy and Infectious Diseases (NIAID); Duke University og andre samarbeidspartnereRekruttering
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Fondazione Policlinico Universitario Agostino Gemelli...Har ikke rekruttert ennå
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BioNTech SERekrutteringHIV -1 infeksjonTyskland, Forente stater
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TaiMed Biologics Inc.Aktiv, ikke rekrutterendeHIV -1 infeksjonForente stater
Kliniske studier på Youth TI-CBT Intervention Arm
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Brown UniversityNational Institute of Mental Health (NIMH)Aktiv, ikke rekrutterende
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Boston CollegeUniversity of Georgia; Innovations for Poverty Action; Caritas Freetown; German...FullførtPsykisk helselidelse | Psykisk helsesvikt | Psykososialt problemSierra Leone
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McMaster UniversityFullførtInflammatoriske tarmsykdommer | Juvenil idiopatisk artrittCanada
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St. Louis UniversityEpharmix, Inc.AvsluttetKort tarm syndromForente stater
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RANDUniversity of Southern California; University of Massachusetts, Boston; APLA...AvsluttetUtnyttelse av helsevesenet | Diskriminering, sosialtForente stater
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RANDBienestar Human Services, Inc.Avsluttet
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UConn HealthNational Heart, Lung, and Blood Institute (NHLBI)Fullført
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University of MinnesotaNational Institute on Deafness and Other Communication Disorders (NIDCD)FullførtDysfoni | Stemmeforstyrrelser | Funksjonell dysfoniForente stater
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Superior UniversityAktiv, ikke rekrutterendeMedfødt Talipes EquinovarusPakistan
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Menoufia UniversityMansoura UniversityHar ikke rekruttert ennå