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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 marzo 2021 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

1816

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: REC; Outreach if Failure
Comportamentale: 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.
Comparatore attivo: REC; SMS + Voucher if Failure
Comportamentale: 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.
Comparatore attivo: REC; Navigator if Failure
Comportamentale: 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
Comparatore attivo: SMS; Outreach if Failure
Comportamentale: SMS; Outreach if Failure
SMS text messages for patients; followed by SOC outreach for patients 14 days late for a scheduled visit
Comparatore attivo: SMS; Outreach if Failure; Stop SMS if Success
Comportamentale: 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
Comparatore attivo: SMS; SMS+Voucher if Failure
Comportamentale: 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.
Comparatore attivo: SMS; SMS+Voucher if Failure; Stop SMS if Success
Comportamentale: 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
Comparatore attivo: SMS; Navigator if Failure
Comportamentale: 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
Comparatore attivo: SMS; Navigator if Failure; Stop SMS if Success
Comportamentale: 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
Comparatore attivo: Voucher; Outreach if Failure
Comportamentale: 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
Comparatore attivo: Voucher; Outreach if Failure; Stop Voucher if Success
Comportamentale: 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
Comparatore attivo: Voucher; SMS+Voucher if Failure
Comportamentale: 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
Comparatore attivo: Voucher; SMS+Voucher if Failure; Stop Voucher if Success
Comportamentale: 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
Comparatore attivo: Voucher; Navigator if Failure
Comportamentale: 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
Comparatore attivo: Voucher; Navigator if Failure; Stop Voucher if Success
Comportamentale: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Retention
Lasso di tempo: Up to two years after enrollment
Fraction of time in care
Up to two years after enrollment

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Alive with suppressed HIV RNA level (<400 copies/ml)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: Two years after enrollment
Fraction of time in care
Two years after enrollment
Fraction on-time pharmacy pick-ups for antiretroviral drugs
Lasso di tempo: Two years after enrollment
Proportion of prescriptions filled and picked up by participants to prescriptions written
Two years after enrollment
Cost effectiveness
Lasso di tempo: 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
Lasso di tempo: At years one and two after study enrollment
Self-reported by questionnaire
At years one and two after study enrollment

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of California, San Francisco

Collaboratori

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

Investigatori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 marzo 2015

Completamento primario (Effettivo)

1 novembre 2020

Completamento dello studio (Effettivo)

1 novembre 2020

Date di iscrizione allo studio

Primo inviato

11 dicembre 2014

Primo inviato che soddisfa i criteri di controllo qualità

9 gennaio 2015

Primo Inserito (Stima)

14 gennaio 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 marzo 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 marzo 2021

Ultimo verificato

1 marzo 2021

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • 1R01MH104123-01 (Sovvenzione/contratto NIH degli Stati Uniti)

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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