- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Abuja, Nigeria
- FHI 360
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: SMART Connections
The intervention components include:
|
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.
|
Ingen inngripen: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
12-month retention in HIV services
Tidsramme: 12 months
|
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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Social support score
Tidsramme: 12 months
|
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.
|
12 months
|
Adherence to antiretroviral treatment
Tidsramme: 12 months
|
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.
|
12 months
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Lisa S Dulli, PhD, FHI 360 (Family Health International)
Publikasjoner og nyttige lenker
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
Nøkkelord
Ytterligere relevante MeSH-vilkår
- RNA-virusinfeksjoner
- Virussykdommer
- Infeksjoner
- Blodbårne infeksjoner
- Smittsomme sykdommer
- Seksuelt overførbare sykdommer, virale
- Seksuelt overførbare sykdommer
- Lentivirus infeksjoner
- Retroviridae-infeksjoner
- Immunologiske mangelsyndromer
- Sykdommer i immunsystemet
- Langsomme virussykdommer
- HIV-infeksjoner
- Ervervet immunsviktsyndrom
Andre studie-ID-numre
- 1151489
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
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 Humant immunsviktvirus
-
Columbia UniversityFullførtHIV (Human Immunodeficiency Virus)Forente stater
-
University of California, BerkeleyHealth for a Prosperous Nation; Tanzania Ministry of Health, Community... og andre samarbeidspartnereAktiv, ikke rekrutterendeHIV (Human Immunodeficiency Virus)Tanzania
-
Columbia UniversityNational Institute of Mental Health (NIMH); Ministry of Health and Social...FullførtHIV (Human Immunodeficiency Virus) | AIDS (ervervet immunsviktsyndrom)Tanzania
-
Columbia UniversityNational Institute of Allergy and Infectious Diseases (NIAID); New York... og andre samarbeidspartnereFullførtHIV (Human Immunodeficiency Virus)Swaziland
-
Columbia UniversityNational Institute of Nursing Research (NINR)FullførtHIV (Human Immunodeficiency Virus) | AIDS (ervervet immunsviktsyndrom)Forente stater
-
Columbia UniversityMinistry of Health, SwazilandFullført
-
University of California, BerkeleyNational Institute of Mental Health (NIMH); Ministry of Health, Tanzania; Management and Development for Health og andre samarbeidspartnereAktiv, ikke rekrutterende
-
University of California, BerkeleyNational Institute of Mental Health (NIMH); Ministry of Health, Tanzania; Management and Development for Health og andre samarbeidspartnereRekruttering
-
University of PennsylvaniaNational Institute of Mental Health (NIMH)FullførtSeksuelt overførbare sykdommer | HIV (Human Immunodeficiency Virus)Forente stater
-
University of California, Los AngelesAvsluttetHepatitt C | HIV (Human Immunodeficiency Virus)Forente stater
Kliniske studier på SMART Connections
-
The Policy & Research GroupMathematica Policy Research, Inc.; The Office of Adolescent Health, HHSFullført
-
University of OttawaTilbaketrukketForeldre-barn forholdCanada
-
University of OttawaRekrutteringForeldre-barn forholdCanada
-
Columbia UniversityEinhorn CollaborativeRekrutteringFor tidlig fødsel | Obstetrisk arbeid, prematurForente stater
-
University of Illinois at Urbana-ChampaignFullført
-
Columbia UniversityFullførtDelvis edentulismeForente stater
-
Medical University of South CarolinaBoston Scientific CorporationRekrutteringSubkutan ICD | Myopotensiell interferensForente stater
-
NYU Langone HealthFullført
-
Massachusetts General HospitalElizabeth Dole FoundationFullført
-
University of California, San FranciscoSan Francisco Veterans Affairs Medical CenterRekrutteringPosttraumatisk stresslidelseForente stater