Clinical trial NCT04432571: ADAPT for Adolescents Adolescents
Official title: An Adaptive Strategy for Preventing and Treating Lapses of Retention in HIV Care for Adolescents
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HIV/AIDS
Keywords: Adolescents
Retention
Engagement in Care
Lost to follow-up
Kenya
Adaptive strategies
Sequentially randomized trial
Sequential Multiple Assignment Randomized Trial
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
name: University of California, San Francisco
name: University of California, Berkeley
name: Kenya Medical Research Institute
First posted: 2020-06-16
Enrollment: 880
Sex: ALL
Minimum age (years): 14
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Adolescents and young adults (AYA) with HIV face unique challenges to engagement in care and their ability to achieve optimal health outcomes. The investigators hypothesize that developmentally-tailored behavioral interventions will improve engagement in HIV care and viral suppression (per current MOH guidelines) among AYA with HIV in Kenya. This two stage study will initially randomize 880 AYA with HIV to either standard of care (SOC) or electronic navigation to prevent treatment lapse. Participants who have a lapse will be re-randomized to SOC, in-person peer navigation, or conditional cash transfers. Formative work will be conducted initially to tailor the interventions to AYA and then later to assess AYA perception, experience, and satisfaction with the interventions. We will evaluate the most effective and cost-effective intervention and sequence of interventions to inform HIV program managers, public policy makers, and other key stakeholders the best approaches to improve engagement of care of AYA with HIV.

Detailed description: While the global response to HIV has reached close to 20 million persons with life-saving antiretroviral therapy (ART) and saved upwards of 60 million life-years, progress has been uneven and adolescents and young adults (AYA) aged 14-24 years represent a key group left behind. Compared to adults, AYA with HIV face more numerous, more diverse and more intense barriers to adherence and retention. The investigators will utilize a SMART study design in two stages among 880 AYA with HIV in Kenya to improve retention and viral suppression per the current MOH guidelines. In stage 1 AYA will be randomized 1:1 to either (1) standard of care education or counseling vs. (2) electronic navigation. Participants who do well (no lapses in retention, medication pick up and viral suppression) will be maintained on these low-intensity interventions, whereas those who fail will be re-randomized a second time to one of three re-engagement interventions (stage 2): (1) standard of care tracing, (2) a conditional cash transfer and (3) in-person peer navigation. The primary outcomes include (1) for prevention: lapse in engagement or viral non-suppression following current MOH guidelines; (2) for re-engagement: viral suppression six months after re-randomization; and (3) across six strategies: sustained viral suppression and sustained engagement in care at two years. The investigators anticipate that enrolling 880 AYA will result in 99% power to detect a 15% difference in the primary outcome between intervention groups. The investigators believe this study will yield evidence specific to AYA with HIV, quantify the relative magnitude of different sequenced interventions, capture the costs, and have direct relevance for public health programming to end the AIDS epidemic through engaging adolescents and young adults with HIV.

Eligibility criteria: Inclusion Criteria:

* HIV-infection, on or initiating ART,
* 14-24 years of age,
* Living \> 6 months in Kisumu County, Kenya in previous year,
* Capable of informed consent (\> 18 years) or with a legal caregiver available for consent (14-\<18 years),
* Access to a cell phone,
* Ability to read or be read short message service (SMS) messages,
* Willingness to be contacted by clinic upon missed appointment,
* For AYA who report phone sharing must have disclosed to the person sharing the phone.
* Additionally, we will include AYA who are aware of their HIV status or whose caregivers agree to assisted disclosure.

Exclusion Criteria:

* AYA who participated in ADAPT-R,
* Those planning to move out of Kisumu County, those acutely ill and requiring hospitalization,
* Those who report sharing phones but have not disclosed to the person sharing the phone

Primary outcomes:
measure: Care engagement failure
timeFrame: 24 months
measure: Re-engagement
timeFrame: 24 months
measure: Sustained viral suppression and engagement in care
timeFrame: 24 months
Secondary outcomes:
measure: Compare survival between arms
timeFrame: 24 months
measure: Explore alternative outcome definitions: Mean visit adherence
timeFrame: 24 months
measure: Explore alternative outcome definitions: Medication possession ratio
timeFrame: 24 months
measure: Explore alternative outcome definitions: HIV RNA levels
timeFrame: 24 months
measure: Composite of time to return and time to viral resuppression
timeFrame: 24 months
measure: Cost effectiveness
timeFrame: 24 months
measure: Qualitative evaluation of how interventions work
timeFrame: 24 months
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Kenya Medical Research Institute
Study officials:
References: