- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03152006
Adolescent Coordinated Transition Nigerian HIV+ Youth (ACT)
14. oktober 2017 opdateret af: Echezona Ezeanolue, University of Nevada, Las Vegas
Adolescent Coordinated Transition (ACT) to Improve Health Outcomes Among Nigerian HIV+ Youth
The purpose of this study is to evaluate the comparative effectiveness of a comprehensive, coordinated transition protocol which includes an early introduction to the adult provider, an integrated case management team and a peer-facilitated organized support group on retention in care, viral suppression and psychosocial wellbeing among adolescents living with HIV.
Studieoversigt
Detaljeret beskrivelse
Using a two-arm cluster randomized design, our proposed study will evaluate the comparative effectiveness of ACT, a coordinated protocol for transitioning adolescents living with HIV (ALHIV) from pediatric to adult care (Intervention Group; IG) versus the usual abrupt transfer to adult care (Control group; CG) on rates of retention in care and viral suppression, and differences in perceived psychosocial wellbeing.
Twelve health facilities, two in each of the six geopolitical zones of Nigeria will be pair-matched and randomly assigned to either IG (N=6 health facilities) or CG (N=6 health facilities).
A total of 216 ALHIV will be enrolled in the study over a 36-month period.
The primary outcome will be the difference in the rate of retention between the groups.
Secondary outcomes will be difference in the rate of viral suppression and the difference in perceived psychosocial wellbeing.
Additionally, the investigators will conduct mediation/moderation analysis to examine the role of intermediate variables such as transition readiness, perceived mental health, social support, health locus of control, self-esteem and sexual risk behavior self-efficacy on the primary outcomes.
Implementation factors will be assessed using the hybrid 2 model.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
216
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Abuja, Nigeria
- Rekruttering
- Center for Integrated Health Program
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Kontakt:
- Bolanle Oyeledu, MD
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Abuja, Nigeria
- Rekruttering
- Centre for Clinical Care and Research
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Kontakt:
- Ayodotun Olutola, MD
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Abuja, Nigeria
- Rekruttering
- Family Health International
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Kontakt:
- Hadiza Khamofu, MD
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Lagos, Nigeria
- Rekruttering
- AIDS Prevention Initiative Nigeria
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Kontakt:
- Prosper Okonkwo
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FCT
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Abuja, FCT, Nigeria
- Rekruttering
- Institute of Human Virology
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Kontakt:
- Nadia Sam-Agudu
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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
13 år til 17 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Documented HIV infection
- Aware of HIV diagnosis
- Currently on ART
Exclusion Criteria:
- Medically unstable
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: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Ingen indgriben: Control
The control arm does not receive the ACT intervention.
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Eksperimentel: ACT Intervention
Intervention activities include the three components of the ACT intervention: (1) alternating pediatric and adult clinic visits in the 12 month pre-transfer period (2) peer facilitated organized support group during the 24-month graduated transition period and (3) patient advocate and case management team to coordinate transfer process.
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Coordinated, graduated transition which includes an early introduction to the adult clinician during the PAPA pre-transfer period, a peer-facilitated organized support group aimed at improving transition readiness and addressing critical psychosocial skills including self-efficacy and locus of control and a case management team including a patient advocate who coordinates the transfer between pediatric and adult care teams.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Retention in care in care 6 months post-transfer
Tidsramme: 6 months
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Proportion of participants who had at least 1 clinical visit to an HIV provider within the 6 months post-transfer
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6 months
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Retention in care 12 months post-transfer
Tidsramme: 12 months
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Proportion of participants who had at least 2 clinical visits to an HIV provider separated by 6 months within the 1 year period post-transfer
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12 months
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Retention in care 24 months post-transfer
Tidsramme: 24 months
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Proportion of participants who had at least 2 clinical visits to an HIV provider separated by 6 months within a 1 year period during the second year post-transfer
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24 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Viral Suppression
Tidsramme: Enrollment, baseline (12 months), 24 and 36 months
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Proportion of participants with undetectable viral load
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Enrollment, baseline (12 months), 24 and 36 months
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Mental Health and Wellbeing
Tidsramme: Enrollment, baseline (12 months), 24 and 36 months
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Mental health continuum-short form Questionnaire
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Enrollment, baseline (12 months), 24 and 36 months
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Health Locus of Control
Tidsramme: Enrollment, baseline (12 months), 24 and 36 months
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Health Locus of control / Self-esteem Questionnaire
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Enrollment, baseline (12 months), 24 and 36 months
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Social Support
Tidsramme: Enrollment, baseline (12 months), 24 and 36 months
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Functional Social Support Questionnaire
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Enrollment, baseline (12 months), 24 and 36 months
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Sexual Risk Behavior
Tidsramme: Enrollment, baseline (12 months), 24 and 36 months
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Sexual Risk Beliefs and Behavior Self Efficacy Questionnaire
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Enrollment, baseline (12 months), 24 and 36 months
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Transition Readiness
Tidsramme: Enrollment, baseline (12 months), 24 and 36 months
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Transition Readiness Assessment Questionnaire
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Enrollment, baseline (12 months), 24 and 36 months
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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.
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)
28. juni 2017
Primær færdiggørelse (Forventet)
30. maj 2020
Studieafslutning (Forventet)
30. juni 2021
Datoer for studieregistrering
Først indsendt
9. maj 2017
Først indsendt, der opfyldte QC-kriterier
11. maj 2017
Først opslået (Faktiske)
12. maj 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. oktober 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. oktober 2017
Sidst verificeret
1. oktober 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- RNA-virusinfektioner
- Virussygdomme
- Infektioner
- Blodbårne infektioner
- Overførbare sygdomme
- Seksuelt overførte sygdomme, virale
- Seksuelt overførte sygdomme
- Lentivirus infektioner
- Retroviridae infektioner
- Immunologiske mangelsyndromer
- Sygdomme i immunsystemet
- Langsomme virussygdomme
- HIV-infektioner
- Erhvervet immundefektsyndrom
Andre undersøgelses-id-numre
- 990070-4
- R01HD089871 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ingen
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
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Ingen
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