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

Study Overview
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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.

Official Title
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An Adaptive Strategy for Preventing and Treating Lapses of Retention in Adult HIV Care (AdaPT-R)

Conditions
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HIV

Intervention / Treatment
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* Behavioral: REC; Outreach if Failure
* Behavioral: REC; SMS + Voucher if Failure
* Behavioral: REC; Navigator if Failure
* Behavioral: SMS; Outreach if Failure
* Behavioral: SMS; Outreach if Failure; Stop SMS if Success
* Behavioral: SMS; SMS+Voucher if Failure
* Behavioral: SMS; SMS+Voucher if Failure; Stop SMS if Success
* Behavioral: SMS; Navigator if Failure
* Behavioral: SMS; Navigator if Failure; Stop SMS if Success
* Behavioral: Voucher; Outreach if Failure
* Behavioral: Voucher; Outreach if Failure; Stop Voucher if Success
* Behavioral: Voucher; SMS+Voucher if Failure
* Behavioral: Voucher; SMS+Voucher if Failure; Stop Voucher if Success
* Behavioral: Voucher; Navigator if Failure
* Behavioral: Voucher; Navigator if Failure; Stop Voucher if Success


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: REC; Outreach if Failure<br> | Behavioral: REC; Outreach if Failure<br>* 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.<br>|
| Active Comparator: REC; SMS + Voucher if Failure<br> | Behavioral: REC; SMS + Voucher if Failure<br>* 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.<br>|
| Active Comparator: REC; Navigator if Failure<br> | Behavioral: REC; Navigator if Failure<br>* REC services, delivered per Kenya MOH Guidelines; followed by Peer Navigator (tailored outreach and support) for patients 14 days late for a scheduled visit<br>|
| Active Comparator: SMS; Outreach if Failure<br> | Behavioral: SMS; Outreach if Failure<br>* SMS text messages for patients; followed by SOC outreach for patients 14 days late for a scheduled visit<br>|
| Active Comparator: SMS; Outreach if Failure; Stop SMS if Success<br> | Behavioral: SMS; Outreach if Failure; Stop SMS if Success<br>* 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<br>|
| Active Comparator: SMS; SMS+Voucher if Failure<br> | Behavioral: SMS; SMS+Voucher if Failure<br>* 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.<br>|
| Active Comparator: SMS; SMS+Voucher if Failure; Stop SMS if Success<br> | Behavioral: SMS; SMS+Voucher if Failure; Stop SMS if Success<br>* 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<br>|
| Active Comparator: SMS; Navigator if Failure<br> | Behavioral: SMS; Navigator if Failure<br>* SMS text messages for patents, followed by Peer Navigator (tailored outreach and support) for patients 14 days late for a scheduled visit<br>|
| Active Comparator: SMS; Navigator if Failure; Stop SMS if Success<br> | Behavioral: SMS; Navigator if Failure; Stop SMS if Success<br>* 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<br>|
| Active Comparator: Voucher; Outreach if Failure<br> | Behavioral: Voucher; Outreach if Failure<br>* 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<br>|
| Active Comparator: Voucher; Outreach if Failure; Stop Voucher if Success<br> | Behavioral: Voucher; Outreach if Failure; Stop Voucher if Success<br>* 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<br>|
| Active Comparator: Voucher; SMS+Voucher if Failure<br> | Behavioral: Voucher; SMS+Voucher if Failure<br>* 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<br>|
| Active Comparator: Voucher; SMS+Voucher if Failure; Stop Voucher if Success<br> | Behavioral: Voucher; SMS+Voucher if Failure; Stop Voucher if Success<br>* 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<br>|
| Active Comparator: Voucher; Navigator if Failure<br> | Behavioral: Voucher; Navigator if Failure<br>* 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<br>|
| Active Comparator: Voucher; Navigator if Failure; Stop Voucher if Success<br> | Behavioral: Voucher; Navigator if Failure; Stop Voucher if Success<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention | Fraction of time in care | Up to two years after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alive with suppressed HIV RNA level (<400 copies/ml) | 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 | 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) | 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 | Fraction of time in care | Two years after enrollment | 
| Fraction on-time pharmacy pick-ups for antiretroviral drugs | Proportion of prescriptions filled and picked up by participants to prescriptions written | Two years after enrollment | 
| Cost effectiveness | Cost per failure (virological failure (HIV RNA>=400 copies/ml) or death averted | After two years of enrollment | 
| Patient-reported barriers to engagement | Self-reported by questionnaire | At years one and two after study enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sequential multiple assignment randomized trial, Retention, Lost to follow up, Adaptive strategies, Dynamic regime, Sequentially randomized trial, Engagement in care, Kenya