An Adaptive Strategy for Preventing and Treating Lapses of Retention in Adult HIV Care (AdaPT-R) in Nyanza, Kenya (AdaPT-R)
11 marca 2021 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
- Behawioralne: REC; Outreach if Failure
- Behawioralne: REC; SMS + Voucher if Failure
- Behawioralne: REC; Navigator if Failure
- Behawioralne: SMS; Outreach if Failure
- Behawioralne: SMS; Outreach if Failure; Stop SMS if Success
- Behawioralne: SMS; SMS+Voucher if Failure
- Behawioralne: SMS; SMS+Voucher if Failure; Stop SMS if Success
- Behawioralne: SMS; Navigator if Failure
- Behawioralne: SMS; Navigator if Failure; Stop SMS if Success
- Behawioralne: Voucher; Outreach if Failure
- Behawioralne: Voucher; Outreach if Failure; Stop Voucher if Success
- Behawioralne: Voucher; SMS+Voucher if Failure
- Behawioralne: Voucher; SMS+Voucher if Failure; Stop Voucher if Success
- Behawioralne: Voucher; Navigator if Failure
- Behawioralne: Voucher; Navigator if Failure; Stop Voucher if Success
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
1816
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
-
-
Nyanza
-
Kisumu, Nyanza, Kenia
- Kenya Medical Research Institute
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Badania usług zdrowotnych
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Aktywny 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.
|
|
Aktywny 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.
|
|
Aktywny 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
|
|
Aktywny komparator: SMS; Outreach if Failure
|
SMS text messages for patients; followed by SOC outreach for patients 14 days late for a scheduled visit
|
|
Aktywny 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
|
|
Aktywny 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.
|
|
Aktywny 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
|
|
Aktywny 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
|
|
Aktywny 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
|
|
Aktywny 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
|
|
Aktywny 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
|
|
Aktywny 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
|
|
Aktywny 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
|
|
Aktywny 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
|
|
Aktywny 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
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Retention
Ramy czasowe: Up to two years after enrollment
|
Fraction of time in care
|
Up to two years after enrollment
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Alive with suppressed HIV RNA level (<400 copies/ml)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: Two years after enrollment
|
Fraction of time in care
|
Two years after enrollment
|
|
Fraction on-time pharmacy pick-ups for antiretroviral drugs
Ramy czasowe: Two years after enrollment
|
Proportion of prescriptions filled and picked up by participants to prescriptions written
|
Two years after enrollment
|
|
Cost effectiveness
Ramy czasowe: 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
Ramy czasowe: At years one and two after study enrollment
|
Self-reported by questionnaire
|
At years one and two after study enrollment
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Współpracownicy
Śledczy
- Główny śledczy: Elvin Geng, MD, University of California, San Francisco
- Główny śledczy: Maya Petersen, MD, PhD, University of California, Berkeley
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 marca 2015
Zakończenie podstawowe (Rzeczywisty)
1 listopada 2020
Ukończenie studiów (Rzeczywisty)
1 listopada 2020
Daty rejestracji na studia
Pierwszy przesłany
11 grudnia 2014
Pierwszy przesłany, który spełnia kryteria kontroli jakości
9 stycznia 2015
Pierwszy wysłany (Oszacować)
14 stycznia 2015
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
16 marca 2021
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
11 marca 2021
Ostatnia weryfikacja
1 marca 2021
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- 1R01MH104123-01 (Grant/umowa NIH USA)
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
produkt wyprodukowany i wyeksportowany z USA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .