Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Engagement to Care South Africa (ICARE)

17. november 2017 opdateret af: University of California, San Francisco

Improving Engagement to HIV Prevention and Care in North West, South Africa

This study will evaluate the efficacy of two strategies for enhancing overall preventive behaviors, retention in HIV care, and adherence to medication for HIV positive individuals in South Africa: short message service (SMS) text messaging and peer navigation services.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Treatment-as-prevention represents a game changing potential to stem further HIV transmission by ensuring that infected individuals are tested, linked to care, retained in care, and adherent to their regimens. Little is known, however, about the most feasible and cost-effective means to promote overall engagement in care coupled with behavioral risk reduction for HIV positive individuals in South Africa. For this reason, the study proposes to first assess what engagement in care activities are underway in select clinics in the Bojanala Platinum District, North West Province, South Africa, and will then implement and evaluate the feasibility, acceptability, and potential efficacy of two strategies for enhancing overall preventive behaviors, retention in HIV care and adherence to medication. The first strategy will employ automated text message reminders to encourage patients to return for needed care, adhere to their antiretroviral therapy (ART) regimens, and practice safer sex and other risk reduction behaviors. This approach also includes designation of a retention, adherence, and prevention monitor to supervise the system. A second strategy builds on the first model, including the automated text message system, but also utilizes peer navigator-provider teams to serve as point people for care engagement. Peer navigators will work with providers to introduce patients to care and help them establish a care and prevention plan. They will also check in with patients to discuss and support resolution of challenges to engaging in care, adhering to drug regimens, and reducing transmission risk behavior.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

756

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Sydafrika
    • Northwest
      • Mabeskraal, Northwest, Sydafrika
        • Moses Kotane Sub-district clinics
      • Rustenburg, Northwest, Sydafrika
        • Rustenburg Sub-district clinics

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • HIV positive (diagnosed within the last 12 months prior to study/patient contact)
  • Has access to a mobile phone
  • Willing to receive and respond to text messages and calls from clinic and study staff (all arms)
  • Willing to communicate and meet with PN (PN arm)
  • Willing to meet with study staff for survey at study start, 6 months, and 12 months (all arms)
  • regard study clinic area as the regular clinic for accessing healthcare

Exclusion Criteria:

  • First tested positive over 12 months prior to recruitment
  • Under the age of 18
  • Unable to give informed consent
  • Unable to read basic English and with no one to read study sms to participant
  • Principally accesses care through a clinic not in the study
  • Planning to permanently move away from the area served by the clinic within next 6 months (following enrollment)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Standard of Care
Participants are administered baseline, 6 month, and 12 month questionnaires and provided with the study incentive (mobile phone airtime) only. This group will not receive any additional engagement to care intervention.
Aktiv komparator: SMS text message
Participants are administered baseline, 6 month, and 12 month questionnaires and provided with the study incentive (mobile phone airtime). In addition, they receive automated bi-weekly behavioral text messages aimed at improving health and reducing transmission risk and also automated bi-weekly "check-in" text messages that will trigger a phone call from clinic staff if the participant reports not being well.
Adfærdsmæssigt: SMS text message
bi-weekly behavioral messages and bi-weekly check-in messages
Aktiv komparator: SMS text message + Peer Navigation
Participants are administered baseline, 6 month, and 12 month questionnaires and provided with the study incentive (mobile phone airtime). In addition, they receive automated bi-weekly behavioral text messages aimed at improving health and reducing transmission risk and also bi-weekly contact from an HIV-positive peer who provides personalized support and with health or other service systems navigation assistance.
Adfærdsmæssigt: SMS text message + Peer Navigation
bi-weekly behavioral messages plus personalized peer navigation

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Linkage to Care - Participants Who Received Cluster of Differentiation 4 (CD4) T-cell Count Test Result Within 3 Months of Testing HIV-positive (Binary)
Tidsramme: 3 months
Participants who received CD4 count test result within 3 months of testing HIV-positive (binary)
3 months
Timely Antiretroviral Therapy (ART) Initiation (Participants Eligible for ART Who Initiate Treatment Within 3 Months of Diagnosis)
Tidsramme: 3 months
Participants eligible for ART who initiate treatment within 3 months of diagnosis
3 months
Retention in Care - ART Eligible (Participants Eligible for ART Who Initiated ART and Who Remain on Treatment)
Tidsramme: 12 months
Participants eligible for ART who initiated ART and who remain on treatment 12 months from enrollment. Retention in care at 12 months is defined as at least 4 clinical care visits with less than 4 months between each visit.
12 months
Retention in Care - Non-ART (Participants Who Return for Repeat CD4 Testing Within 12 Months of Diagnosis)
Tidsramme: 12 months
Participants who return for repeat CD4 testing within 12 months of diagnosis
12 months
Adherence to ART - Objective (Viral Load Test Results <400 Copies/mL)
Tidsramme: 12 months
Viral load test results <400 copies/mL (consistent with current and correct adherence to ART)
12 months
Adherence to ART - Subjective (Self-reported Ability to Take ART as Prescribed in Last Month)
Tidsramme: 12 months
Self-reported ability to take ART as prescribed in last month, assessed at 12 months from enrollment. Considered compliant if reported "very good" or "excellent" adherence.
12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of California, San Francisco

Samarbejdspartnere

University of Washington

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.

Generelle publikationer

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

1. oktober 2014

Primær færdiggørelse (Faktiske)

1. juni 2016

Studieafslutning (Faktiske)

1. juni 2016

Datoer for studieregistrering

Først indsendt

12. december 2014

Først indsendt, der opfyldte QC-kriterier

14. april 2015

Først opslået (Skøn)

15. april 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. august 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. november 2017

Sidst verificeret

1. november 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 12-10482
  • P0054377 (Andet bevillings-/finansieringsnummer: PHS Health Resources & Services Admin.)

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

Kliniske forsøg med SMS text message

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Morocco

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner