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

NCT ID: NCT02338739

Last Updated: 2021-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1816 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2020-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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REC; Outreach if Failure

Group Type ACTIVE_COMPARATOR

REC; Outreach if Failure

Intervention Type BEHAVIORAL

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.

REC; SMS + Voucher if Failure

Group Type ACTIVE_COMPARATOR

REC; SMS + Voucher if Failure

Intervention Type BEHAVIORAL

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.

REC; Navigator if Failure

Group Type ACTIVE_COMPARATOR

REC; Navigator if Failure

Intervention Type BEHAVIORAL

REC services, delivered per Kenya MOH Guidelines; followed by Peer Navigator (tailored outreach and support) for patients 14 days late for a scheduled visit

SMS; Outreach if Failure

Group Type ACTIVE_COMPARATOR

SMS; Outreach if Failure

Intervention Type BEHAVIORAL

SMS text messages for patients; followed by SOC outreach for patients 14 days late for a scheduled visit

SMS; Outreach if Failure; Stop SMS if Success

Group Type ACTIVE_COMPARATOR

SMS; Outreach if Failure; Stop SMS if Success

Intervention Type BEHAVIORAL

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

SMS; SMS+Voucher if Failure

Group Type ACTIVE_COMPARATOR

SMS; SMS+Voucher if Failure

Intervention Type BEHAVIORAL

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.

SMS; SMS+Voucher if Failure; Stop SMS if Success

Group Type ACTIVE_COMPARATOR

SMS; SMS+Voucher if Failure; Stop SMS if Success

Intervention Type BEHAVIORAL

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

SMS; Navigator if Failure

Group Type ACTIVE_COMPARATOR

SMS; Navigator if Failure

Intervention Type BEHAVIORAL

SMS text messages for patents, followed by Peer Navigator (tailored outreach and support) for patients 14 days late for a scheduled visit

SMS; Navigator if Failure; Stop SMS if Success

Group Type ACTIVE_COMPARATOR

SMS; Navigator if Failure; Stop SMS if Success

Intervention Type BEHAVIORAL

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

Voucher; Outreach if Failure

Group Type ACTIVE_COMPARATOR

Voucher; Outreach if Failure

Intervention Type BEHAVIORAL

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

Voucher; Outreach if Failure; Stop Voucher if Success

Group Type ACTIVE_COMPARATOR

Voucher; Outreach if Failure; Stop Voucher if Success

Intervention Type BEHAVIORAL

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

Voucher; SMS+Voucher if Failure

Group Type ACTIVE_COMPARATOR

Voucher; SMS+Voucher if Failure

Intervention Type BEHAVIORAL

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

Voucher; SMS+Voucher if Failure; Stop Voucher if Success

Group Type ACTIVE_COMPARATOR

Voucher; SMS+Voucher if Failure; Stop Voucher if Success

Intervention Type BEHAVIORAL

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

Voucher; Navigator if Failure

Group Type ACTIVE_COMPARATOR

Voucher; Navigator if Failure

Intervention Type BEHAVIORAL

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

Voucher; Navigator if Failure; Stop Voucher if Success

Group Type ACTIVE_COMPARATOR

Voucher; Navigator if Failure; Stop Voucher if Success

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

SMS; Outreach if Failure

SMS text messages for patients; followed by SOC outreach for patients 14 days late for a scheduled visit

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Berkeley

OTHER

Sponsor Role collaborator

Kenya Medical Research Institute

OTHER

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elvin Geng, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Maya Petersen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Berkeley

Locations

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Kenya Medical Research Institute

Kisumu, Nyanza, Kenya

Site Status

Countries

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Kenya

References

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Geng EH, Odeny TA, Montoya LM, Iguna S, Kulzer JL, Adhiambo HF, Eshun-Wilson I, Akama E, Nyandieka E, Guze MA, Shade S, Packel L, Fox B, Camlin C, Thirumurthy H, Lyons C, Bukusi EA, Petersen ML. Adaptive Strategies for Retention in Care among Persons Living with HIV. NEJM Evid. 2023 Apr;2(4):10.1056/evidoa2200076. doi: 10.1056/evidoa2200076. Epub 2023 Mar 28.

Reference Type DERIVED
PMID: 38143482 (View on PubMed)

Other Identifiers

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1R01MH104123-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R01MH104123-01

Identifier Type: NIH

Identifier Source: org_study_id

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