An Adaptive Strategy for Preventing and Treating Lapses of Retention in Adult HIV Care (AdaPT-R) in Nyanza, Kenya (AdaPT-R)
11. marts 2021 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
- Adfærdsmæssigt: REC; Outreach if Failure
- Adfærdsmæssigt: REC; SMS + Voucher if Failure
- Adfærdsmæssigt: REC; Navigator if Failure
- Adfærdsmæssigt: SMS; Outreach if Failure
- Adfærdsmæssigt: SMS; Outreach if Failure; Stop SMS if Success
- Adfærdsmæssigt: SMS; SMS+Voucher if Failure
- Adfærdsmæssigt: SMS; SMS+Voucher if Failure; Stop SMS if Success
- Adfærdsmæssigt: SMS; Navigator if Failure
- Adfærdsmæssigt: SMS; Navigator if Failure; Stop SMS if Success
- Adfærdsmæssigt: Voucher; Outreach if Failure
- Adfærdsmæssigt: Voucher; Outreach if Failure; Stop Voucher if Success
- Adfærdsmæssigt: Voucher; SMS+Voucher if Failure
- Adfærdsmæssigt: Voucher; SMS+Voucher if Failure; Stop Voucher if Success
- Adfærdsmæssigt: Voucher; Navigator if Failure
- Adfærdsmæssigt: Voucher; Navigator if Failure; Stop Voucher if Success
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
1816
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Nyanza
-
Kisumu, Nyanza, Kenya
- Kenya Medical Research Institute
-
-
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-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.
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 |
|---|---|
|
Aktiv komparator: 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.
|
|
Aktiv komparator: 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.
|
|
Aktiv komparator: 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
|
|
Aktiv komparator: SMS; Outreach if Failure
|
SMS text messages for patients; followed by SOC outreach for patients 14 days late for a scheduled visit
|
|
Aktiv komparator: 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
|
|
Aktiv komparator: 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.
|
|
Aktiv komparator: 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
|
|
Aktiv komparator: 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
|
|
Aktiv komparator: 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
|
|
Aktiv komparator: 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
|
|
Aktiv komparator: 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
|
|
Aktiv komparator: 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
|
|
Aktiv komparator: 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
|
|
Aktiv komparator: 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
|
|
Aktiv komparator: 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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Retention
Tidsramme: Up to two years after enrollment
|
Fraction of time in care
|
Up to two years after enrollment
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Alive with suppressed HIV RNA level (<400 copies/ml)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: Two years after enrollment
|
Fraction of time in care
|
Two years after enrollment
|
|
Fraction on-time pharmacy pick-ups for antiretroviral drugs
Tidsramme: Two years after enrollment
|
Proportion of prescriptions filled and picked up by participants to prescriptions written
|
Two years after enrollment
|
|
Cost effectiveness
Tidsramme: 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
Tidsramme: At years one and two after study enrollment
|
Self-reported by questionnaire
|
At years one and two after study enrollment
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Elvin Geng, MD, University of California, San Francisco
- Ledende efterforsker: Maya Petersen, MD, PhD, University of California, Berkeley
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. marts 2015
Primær færdiggørelse (Faktiske)
1. november 2020
Studieafslutning (Faktiske)
1. november 2020
Datoer for studieregistrering
Først indsendt
11. december 2014
Først indsendt, der opfyldte QC-kriterier
9. januar 2015
Først opslået (Skøn)
14. januar 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. marts 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. marts 2021
Sidst verificeret
1. marts 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 1R01MH104123-01 (U.S. NIH-bevilling/kontrakt)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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