Engagement to Care South Africa (ICARE)
17 november 2017 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
756
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Northwest
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Mabeskraal, Northwest, Sydafrika
- Moses Kotane Sub-district clinics
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Rustenburg, Northwest, Sydafrika
- Rustenburg Sub-district clinics
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: 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.
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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.
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bi-weekly behavioral messages and bi-weekly check-in messages
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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.
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bi-weekly behavioral messages plus personalized peer navigation
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Linkage to Care - Participants Who Received Cluster of Differentiation 4 (CD4) T-cell Count Test Result Within 3 Months of Testing HIV-positive (Binary)
Tidsram: 3 months
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Participants who received CD4 count test result within 3 months of testing HIV-positive (binary)
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3 months
|
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Timely Antiretroviral Therapy (ART) Initiation (Participants Eligible for ART Who Initiate Treatment Within 3 Months of Diagnosis)
Tidsram: 3 months
|
Participants eligible for ART who initiate treatment within 3 months of diagnosis
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3 months
|
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Retention in Care - ART Eligible (Participants Eligible for ART Who Initiated ART and Who Remain on Treatment)
Tidsram: 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.
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12 months
|
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Retention in Care - Non-ART (Participants Who Return for Repeat CD4 Testing Within 12 Months of Diagnosis)
Tidsram: 12 months
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Participants who return for repeat CD4 testing within 12 months of diagnosis
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12 months
|
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Adherence to ART - Objective (Viral Load Test Results <400 Copies/mL)
Tidsram: 12 months
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Viral load test results <400 copies/mL (consistent with current and correct adherence to ART)
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12 months
|
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Adherence to ART - Subjective (Self-reported Ability to Take ART as Prescribed in Last Month)
Tidsram: 12 months
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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.
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12 months
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.
- Steward WT, Agnew E, de Kadt J, Ratlhagana MJ, Sumitani J, Gilmore HJ, Grignon J, Shade SB, Tumbo J, Barnhart S, Lippman SA. Impact of SMS and peer navigation on retention in HIV care among adults in South Africa: results of a three-arm cluster randomized controlled trial. J Int AIDS Soc. 2021 Aug;24(8):e25774. doi: 10.1002/jia2.25774.
- Lippman SA, Shade SB, Sumitani J, DeKadt J, Gilvydis JM, Ratlhagana MJ, Grignon J, Tumbo J, Gilmore H, Agnew E, Saberi P, Barnhart S, Steward WT. Evaluation of short message service and peer navigation to improve engagement in HIV care in South Africa: study protocol for a three-arm cluster randomized controlled trial. Trials. 2016 Feb 6;17:68. doi: 10.1186/s13063-016-1190-y.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 oktober 2014
Primärt slutförande (Faktisk)
1 juni 2016
Avslutad studie (Faktisk)
1 juni 2016
Studieregistreringsdatum
Först inskickad
12 december 2014
Först inskickad som uppfyllde QC-kriterierna
14 april 2015
Första postat (Uppskatta)
15 april 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
20 augusti 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 november 2017
Senast verifierad
1 november 2017
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 12-10482
- P0054377 (Annat bidrag/finansieringsnummer: PHS Health Resources & Services Admin.)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .