- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04024488
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
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
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, Sydafrika
- 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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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
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
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 |
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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).
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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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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).
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Studiestol: Dorothy Dow, MD, MSc, Duke University
Publikationer og nyttige links
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
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
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)?
IPD-planbeskrivelse
IPD-delingstidsramme
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
Studerer et amerikansk FDA-reguleret enhedsprodukt
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
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Federal University of São PauloGilead SciencesAfsluttet
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Thomas Aagaard RasmussenAarhus University Hospital; The Alfred; Germans Trias i Pujol Hospital; Walter...Rekruttering
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Fundación HuéspedViiV HealthcareIkke rekrutterer endnuHIV-1-infektionArgentina, Brasilien
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Fundación HuéspedMSD Pharmaceuticals LLC; Fundacion IDEAAIkke rekrutterer endnu
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Henan Genuine Biotech Co., Ltd.Rekruttering
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University of North Carolina, Chapel HillIkke rekrutterer endnuHIV-1-infektionForenede Stater
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Craig Cohen, MD, MPHNational Institute of Allergy and Infectious Diseases (NIAID); Duke University og andre samarbejdspartnereRekruttering
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Fondazione Policlinico Universitario Agostino Gemelli...Ikke rekrutterer endnu
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BioNTech SERekrutteringHIV -1 infektionTyskland, Forenede Stater
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TaiMed Biologics Inc.Aktiv, ikke rekrutterendeHIV -1 infektionForenede Stater
Kliniske forsøg med Youth TI-CBT Intervention Arm
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Brown UniversityNational Institute of Mental Health (NIMH)Aktiv, ikke rekrutterende
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University of California, Los AngelesUniversity of Chicago; Children's Hospital Los Angeles; Cook County Health...Afsluttet
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Boston CollegeUniversity of Georgia; Innovations for Poverty Action; Caritas Freetown; German...AfsluttetPsykisk lidelse | Psykisk svækkelse | Psykosocialt problemSierra Leone
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VA Office of Research and DevelopmentAfsluttet
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Ohio State UniversityNational Institute on Drug Abuse (NIDA)AfsluttetHypotetisk cannabis -købForenede Stater
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Duke UniversityNational Institute of Mental Health (NIMH); National Institute for Medical... og andre samarbejdspartnereAktiv, ikke rekrutterendeOverholdelse, Medicin | HIV-1-infektion | Psykisk sundhedsproblemTanzania
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Pakistan Institute of Living and LearningAktiv, ikke rekrutterendeAutismespektrumforstyrrelse | SelvskadePakistan
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McMaster UniversityAfsluttetInflammatoriske tarmsygdomme | Juvenil idiopatisk arthritisCanada
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Jonsson Comprehensive Cancer CenterAmerican Cancer Society, Inc.AfsluttetKolorektal cancerForenede Stater
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Massachusetts General HospitalAfsluttetAkut koronarsyndromForenede Stater