Clinical trial NCT02338739: An Adaptive Strategy for Preventing and Treating Lapses of Retention in Adult HIV Care (AdaPT-R) in Nyanza, Kenya
Official title: An Adaptive Strategy for Preventing and Treating Lapses of Retention in Adult HIV Care (AdaPT-R)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: Retention
Lost to follow up
Adaptive strategies
Dynamic regime
Sequentially randomized trial
Sequential multiple assignment randomized trial
Engagement in care
Kenya
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: University of California, Berkeley
name: Kenya Medical Research Institute
name: University of Washington
name: National Institute of Mental Health (NIMH)
First posted: 2015-01-14
Enrollment: 1816
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Retention
timeFrame: Up to two years after enrollment
Secondary outcomes:
measure: Alive with suppressed HIV RNA level (<400 copies/ml)
timeFrame: Two years after study enrollment
measure: Time from second randomization to return to clinic after initial retention lapse
timeFrame: Up to two years after enrollment
measure: Mean visit adherence (% visits made)
timeFrame: Two years after study enrollment
measure: Retention
timeFrame: Two years after enrollment
measure: Fraction on-time pharmacy pick-ups for antiretroviral drugs
timeFrame: Two years after enrollment
measure: Cost effectiveness
timeFrame: After two years of enrollment
measure: Patient-reported barriers to engagement
timeFrame: At years one and two after study enrollment
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Kenya Medical Research Institute
state: Nyanza
Study officials:
affiliation: University of California, San Francisco
name: Elvin Geng, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Berkeley
name: Maya Petersen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: