An Adaptive Strategy for Preventing and Treating Lapses of Retention in Adult HIV Care (AdaPT-R) in Nyanza, Kenya
AdaPT-R
1 other identifier
interventional
1,816
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv
Started Mar 2015
Longer than P75 for not_applicable hiv
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 11, 2014
CompletedFirst Posted
Study publicly available on registry
January 14, 2015
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2020
CompletedMarch 16, 2021
March 1, 2021
5.7 years
December 11, 2014
March 11, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Retention
Fraction of time in care
Up to two years after enrollment
Secondary Outcomes (7)
Alive with suppressed HIV RNA level (<400 copies/ml)
Two years after study enrollment
Time from second randomization to return to clinic after initial retention lapse
Up to two years after enrollment
Mean visit adherence (% visits made)
Two years after study enrollment
Retention
Two years after enrollment
Fraction on-time pharmacy pick-ups for antiretroviral drugs
Two years after enrollment
- +2 more secondary outcomes
Study Arms (15)
REC; Outreach if Failure
ACTIVE COMPARATORREC; SMS + Voucher if Failure
ACTIVE COMPARATORREC; Navigator if Failure
ACTIVE COMPARATORSMS; Outreach if Failure
ACTIVE COMPARATORSMS; Outreach if Failure; Stop SMS if Success
ACTIVE COMPARATORSMS; SMS+Voucher if Failure
ACTIVE COMPARATORSMS; SMS+Voucher if Failure; Stop SMS if Success
ACTIVE COMPARATORSMS; Navigator if Failure
ACTIVE COMPARATORSMS; Navigator if Failure; Stop SMS if Success
ACTIVE COMPARATORVoucher; Outreach if Failure
ACTIVE COMPARATORVoucher; Outreach if Failure; Stop Voucher if Success
ACTIVE COMPARATORVoucher; SMS+Voucher if Failure
ACTIVE COMPARATORVoucher; SMS+Voucher if Failure; Stop Voucher if Success
ACTIVE COMPARATORVoucher; Navigator if Failure
ACTIVE COMPARATORVoucher; Navigator if Failure; Stop Voucher if Success
ACTIVE COMPARATORInterventions
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.
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 services, delivered per Kenya MOH Guidelines; followed by Peer Navigator (tailored outreach and support) for patients 14 days late for a scheduled visit
SMS text messages for patients; followed by SOC outreach for patients 14 days late for a scheduled visit
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 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 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 text messages for patents, followed by Peer Navigator (tailored outreach and support) for patients 14 days late for a scheduled visit
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
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
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
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
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
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
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
Eligibility Criteria
You may qualify if:
- HIV-infection
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, San Franciscolead
- University of California, Berkeleycollaborator
- Kenya Medical Research Institutecollaborator
- University of Washingtoncollaborator
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
Kenya Medical Research Institute
Kisumu, Nyanza, Kenya
Related Publications (1)
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.
PMID: 38143482DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elvin Geng, MD
University of California, San Francisco
- PRINCIPAL INVESTIGATOR
Maya Petersen, MD, PhD
University of California, Berkeley
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2014
First Posted
January 14, 2015
Study Start
March 1, 2015
Primary Completion
November 1, 2020
Study Completion
November 1, 2020
Last Updated
March 16, 2021
Record last verified: 2021-03