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An Adaptive Strategy for Preventing and Treating Lapses of Retention in Adult HIV Care (AdaPT-R) in Nyanza, Kenya (AdaPT-R)

11. März 2021 aktualisiert von: University of California, San Francisco

An Adaptive Strategy for Preventing and Treating Lapses of Retention in Adult HIV Care (AdaPT-R)

Retaining HIV-infected patients in care is critical, but loss to follow-up after enrolment often reaches 20%-40% by two years, placing millions of patients at risk of poor outcomes. A strategy to optimize retention within resource constraints is urgently needed. Sequential adaptive strategies - a novel class of public health approaches - may offer a solution. A candidate sequential adaptive strategy would start with a less expensive intervention (e.g., SMS) in all patients and then apply a more costly and intensive one (e.g., navigator) only to patients who show early signs of poor retention. This study involves a sequential multiple assignment randomized trial to evaluate a family of such strategies. the investigators will randomize 1,800 adults newly initiating antiretroviral treatment (ART) at 4 HIV clinics in the Nyanza region of Kenya to (1) standard of care routine education and counselling (REC), (2) SMS text messages, or (3) transport vouchers. Patients with early signs of weakening retention (defined as the first time a patient is 14 days late for an appointment) will be re-randomized to (1) a single episode of outreach (standard of care), (2) SMS combined with vouchers, or (3) a peer navigator. Patients not successfully contacted by 28 days after missed visit (and not verified to have left the area or transferred to another clinic) will also be rerandomized to of one the same three re-engagement interventions. Individuals randomized at first stage to SMS or voucher that do not miss a visit by at least 14 days in the first 12 months of follow up will be re-randomized at 12 months to stop first stage intervention or continue with that same intervention to 24 months. The investigators primary objective is to assess the comparative effectiveness of sequenced intervention strategies to prevent initial lapses in retention and to treat those that occur. The investigators primary endpoint is fraction of time retained in care two years after enrolment. In addition, the investigators will assess the comparative effectiveness of first-stage strategies (REC, SMS, voucher) to prevent lapses in retention, and the comparative effectiveness of second stage strategies (outreach, SMS + voucher, navigator) to re-engage patients after initial lapse. This study will also compare outcomes among patients who continue versus discontinue the SMS and voucher interventions, including a small complementarity component utilizing qualitative methods to examine the voucher approach and the effects of discontinuing this approach after success among a subset of participants. At study conclusion the investigators output will be a menu of adaptive strategies for retention, accompanied by estimates of cost and effectiveness, which policy makers in different settings can use to advance the impact of HIV care and treatment programs in Africa.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

1816

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Kenia
    • Nyanza
      • Kisumu, Nyanza, Kenia
        • Kenya Medical Research Institute

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • HIV-infection
  • 18 years old
  • Planning to remain in the study area (Nyanza region) for the duration of the study, capable of informed consent
  • Newly initiating ART (within past 90 days)
  • Access to a cell phone
  • Ability to read or be read SMS messages
  • And willingness to be contacted by clinic upon missed appointment.

Exclusion Criteria:

  • Plans to move out of Nyanza region or acutely ill and requiring hospitalization.
  • Hospitalized patients who later recover will be eligible for enrolment at the first post-hospitalization clinic visit during which eligibility criteria are met.
  • No access to a cell phone.
  • Involvement in studies with the potential to influence retention behaviors.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: REC; Outreach if Failure
Verhalten: REC; Outreach if Failure
Routine education and counseling (REC) services, delivered per Kenya Ministry of Health Guidelines; followed by standard of care (SOC) outreach to encourage return to clinic for patients 14 days late for a scheduled visit in year 1.
Aktiver Komparator: REC; SMS + Voucher if Failure
Verhalten: REC; SMS + Voucher if Failure
Routine education and counseling services, delivered per Kenya Ministry of Health (MOH) Guidelines; followed by SMS text messages for patients and reimbursement at a fixed amount (KSH 400) for transport to the clinic for patients 14 days late for a scheduled visit in year 1.
Aktiver Komparator: REC; Navigator if Failure
Verhalten: REC; Navigator if Failure
REC services, delivered per Kenya MOH Guidelines; followed by Peer Navigator (tailored outreach and support) for patients 14 days late for a scheduled visit
Aktiver Komparator: SMS; Outreach if Failure
Verhalten: SMS; Outreach if Failure
SMS text messages for patients; followed by SOC outreach for patients 14 days late for a scheduled visit
Aktiver Komparator: SMS; Outreach if Failure; Stop SMS if Success
Verhalten: SMS; Outreach if Failure; Stop SMS if Success
SMS text messages for patients, followed by SOC outreach for patients 14 days late for a scheduled visit, and discontinuation of SMS text messages if never 14 days late
Aktiver Komparator: SMS; SMS+Voucher if Failure
Verhalten: SMS; SMS+Voucher if Failure
SMS text messages for patients, followed by reimbursement at a fixed amount (KSH 400) for transport to the clinic for patients 14 days late for a scheduled visit in year 1.
Aktiver Komparator: SMS; SMS+Voucher if Failure; Stop SMS if Success
Verhalten: SMS; SMS+Voucher if Failure; Stop SMS if Success
SMS text messages for patients, followed by reimbursement at a fixed amount (KSH 400) for transport to the clinic for patients 14 days late for a scheduled visit in year 1, and discontinuation of SMS text messages if never 14 days late
Aktiver Komparator: SMS; Navigator if Failure
Verhalten: SMS; Navigator if Failure
SMS text messages for patents, followed by Peer Navigator (tailored outreach and support) for patients 14 days late for a scheduled visit
Aktiver Komparator: SMS; Navigator if Failure; Stop SMS if Success
Verhalten: SMS; Navigator if Failure; Stop SMS if Success
SMS text messages for patents, followed by Peer Navigator (tailored outreach and support) for patients 14 days late for a scheduled visit, and discontinuation of SMS text messages if never 14 days late
Aktiver Komparator: Voucher; Outreach if Failure
Verhalten: Voucher; Outreach if Failure
Reimbursement at a fixed amount (KSH 400) for transport to the clinic for patients, followed by SOC outreach for patients 14 days late for a scheduled visit
Aktiver Komparator: Voucher; Outreach if Failure; Stop Voucher if Success
Verhalten: Voucher; Outreach if Failure; Stop Voucher if Success
Reimbursement at a fixed amount (KSH 400) for transport to the clinic for patients, followed by SOC outreach for patients 14 days late for a scheduled visit, and discontinuation of voucher for patients if never 14 days late
Aktiver Komparator: Voucher; SMS+Voucher if Failure
Verhalten: Voucher; SMS+Voucher if Failure
Reimbursement at a fixed amount (KSH 400) for transport to the clinic for patients, followed by SMS text message and reimbursement (KSH 400) for transport to the clinic for patients 14 days late for a scheduled visit
Aktiver Komparator: Voucher; SMS+Voucher if Failure; Stop Voucher if Success
Verhalten: Voucher; SMS+Voucher if Failure; Stop Voucher if Success
Reimbursement at a fixed amount (KSH 400) for transport to the clinic for patients, followed by SMS text message and reimbursement (KSH 400) for transport to the clinic for patients 14 days late for a scheduled visit, and discontinuation of voucher for patients if never 14 days late
Aktiver Komparator: Voucher; Navigator if Failure
Verhalten: Voucher; Navigator if Failure
Reimbursement at a fixed amount (KSH 400) for transport to the clinic for patients, followed by Peer Navigator (tailored outreach and support) for patients 14 days late for a scheduled visit
Aktiver Komparator: Voucher; Navigator if Failure; Stop Voucher if Success
Verhalten: Voucher; Navigator if Failure; Stop Voucher if Success
Reimbursement at a fixed amount (KSH 400) for transport to the clinic for patients, followed by Peer Navigator (tailored outreach and support) for patients 14 days late for a scheduled visit, and discontinuation of voucher for patients if never 14 days late

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Retention
Zeitfenster: Up to two years after enrollment
Fraction of time in care
Up to two years after enrollment

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Alive with suppressed HIV RNA level (<400 copies/ml)
Zeitfenster: Two years after study enrollment
Number of subjects alive with suppressed HIV RNA levels (<400 copies/ml)
Two years after study enrollment
Time from second randomization to return to clinic after initial retention lapse
Zeitfenster: Up to two years after enrollment
Time from second randomization to re-engagement; re-engagement is defined as first visit back to clinic
Up to two years after enrollment
Mean visit adherence (% visits made)
Zeitfenster: Two years after study enrollment
Proportion of kept scheduled appointments (range=0-100%), with kept visits being those attended by the patient and with the denominator excluding canceled visits
Two years after study enrollment
Retention
Zeitfenster: Two years after enrollment
Fraction of time in care
Two years after enrollment
Fraction on-time pharmacy pick-ups for antiretroviral drugs
Zeitfenster: Two years after enrollment
Proportion of prescriptions filled and picked up by participants to prescriptions written
Two years after enrollment
Cost effectiveness
Zeitfenster: After two years of enrollment
Cost per failure (virological failure (HIV RNA>=400 copies/ml) or death averted
After two years of enrollment
Patient-reported barriers to engagement
Zeitfenster: At years one and two after study enrollment
Self-reported by questionnaire
At years one and two after study enrollment

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of California, San Francisco

Mitarbeiter

National Institute of Mental Health (NIMH)
University of California, Berkeley
University of Washington
Kenya Medical Research Institute

Ermittler

  • Hauptermittler: Elvin Geng, MD, University of California, San Francisco
  • Hauptermittler: Maya Petersen, MD, PhD, University of California, Berkeley

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. März 2015

Primärer Abschluss (Tatsächlich)

1. November 2020

Studienabschluss (Tatsächlich)

1. November 2020

Studienanmeldedaten

Zuerst eingereicht

11. Dezember 2014

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

9. Januar 2015

Zuerst gepostet (Schätzen)

14. Januar 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. März 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

11. März 2021

Zuletzt verifiziert

1. März 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • 1R01MH104123-01 (US NIH Stipendium/Vertrag)

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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