- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03516318
Using Social Media to Improve ART Retention and Treatment Outcomes Among YLHIV in Nigeria (Y-SMART)
Using Social Media to Improve ART Retention and Treatment (SMART) Outcomes Among Youth Living With HIV (YLHIV) in Nigeria - The Youth SMART Study
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Abuja, Nigeria
- FHI 360
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- HIV positive and know their status
- Actively on ART for less than 12 months, including newly initiating patients
- Age 15 to 24 years
- Can demonstrate basic literacy necessary to participate in online chats
Exclusion Criteria:
- Unable to attend the initial intervention group meeting for treatment participants
- Currently enrolled in another research study related to HIV service retention or ART adherence
- Critically or severely ill requiring hospitalization or such that the individual is unable to provide informed consent at the time of study recruitment
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: SMART Connections
The intervention components include:
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SMART Connections: Trained facilitators will deliver key informational messages and moderate online group discussions.
The informational messages have been developed from key messages identified in each of the Positive Connections curriculum sessions.
Each SMART Connections group will consist of approximately 15 to 20 YLHIV.
Each online support group will begin with one in-person group meeting with the facilitator.
During this meeting, participants meet one another and the facilitators.
Facilitators will describe the intervention and set ground rules for participation.
Ground rules will be discussed and accepted by the group members, but at a minimum, group members will be advised not to talk about what is discussed in the online group with people outside of the group.
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Ingen indgriben: Control
All study participants, in both study arms, will receive standard services currently available to YLHIV in these facilities and communities.
The services currently include: routine clinical care for HIV treatment including laboratory testing (CD4, viral load tests); active case management by community volunteers with intensive adherence support during the first 4 weeks of ART; adherence support through phone calls and SMS (short messaging service) reminders; and enhanced adherence counseling for patients with unsuppressed viral loads.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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12-month retention in HIV services
Tidsramme: 12 months
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This main outcome is defined as the proportion of study participants retained in clinical HIV services and on treatment at 12 months after enrollment. We will abstract data from the clinic electronic medical record system on date of all visits, which are typically monthly, to ART services between enrollment and the end-line of this study. Retention is defined as having attended a scheduled HIV clinic visit within three months of the visit date. For our primary analysis, using a survival analysis approach, we will record the dates for all scheduled clinic visits for each participant, then follow the data up to three months from the date of the last visit attended. If a participant fails to return after a scheduled visit for more than three months, the date of the missed visit will be the date of loss to follow-up recorded, unless a death or transfer of service is documented. |
12 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Social support score
Tidsramme: 12 months
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To measure social support, we will use the Medical Outcomes Study - Social Support Survey (MOS-SSS).The MOS-SSS is a 19-item scale that covers the dimensions of emotional/informational (8 items), affectionate (3 items) and tangible (4 items) social support in addition to positive social interaction (3 items), and one additional item.
Each item is measured on a 4 point Likert-type scale.From the scale a total SS score is calculated by summing the items.
A transformed score can be calculated for total SS or each dimension by taking the raw score (total summed score), subtracting the number of items for the score and dividing by the total possible score for those items.
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12 months
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Adherence to antiretroviral treatment
Tidsramme: 12 months
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Proportion of participants who are adherent to ART will be measured through self-reported measures in the structured questionnaire of treatment adherence and challenges with taking medication as prescribed.
We will measure self-reported adherence using the AIDS Clinical Trials Group adherence measure (AACTG baseline: http://caps.ucsf.edu/uploads/tools/surveys/pdf/2098.4186.pdf).
We will also extract viral load cell data from patient medical records to triangulate self-reported adherence.
For this secondary outcome, a dichotomous variable will be created defined as adherent or not adherent (missed any doses of medication) in the prior 30 days.
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12 months
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Lisa S Dulli, PhD, FHI 360 (Family Health International)
Publikationer og nyttige links
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
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
- 1151489
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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Public Health EnglandAfsluttetHuman Papillomavirus VirusDet Forenede Kongerige
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Columbia UniversityNational Institute of Nursing Research (NINR)AfsluttetHIV (Human Immunodeficiency Virus) | AIDS (erhvervet immundefektsyndrom)Forenede Stater
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Columbia UniversityMinistry of Health, SwazilandAfsluttet
Kliniske forsøg med SMART Connections
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The Policy & Research GroupMathematica Policy Research, Inc.; The Office of Adolescent Health, HHSAfsluttet
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University of OttawaTrukket tilbageForældre-barn relationerCanada
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University of OttawaRekrutteringForældre-barn relationerCanada
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Columbia UniversityAfsluttetFor tidlig fødsel | Børns udviklingForenede Stater
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Columbia UniversityEinhorn CollaborativeRekrutteringFor tidlig fødsel | Obstetrisk arbejde, for tidligtForenede Stater
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University of Illinois at Urbana-ChampaignAfsluttetFysisk aktivitetForenede Stater
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Columbia UniversityAfsluttetDelvis EdentulismeForenede Stater
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Medical University of South CarolinaBoston Scientific CorporationRekrutteringSubkutan ICD | Myopotentiel interferensForenede Stater
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Massachusetts General HospitalElizabeth Dole FoundationAfsluttet
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Lawson Health Research InstituteIkke rekrutterer endnuPTSD | Post traumatisk stress syndromCanada