ADAPT for Adolescents Adolescents

Not Applicable

Active, not recruiting

• Conditions: HIV/AIDS
• Interventions: Behavioral: SOC-REC/CCT; Behavioral: SOC-REC/IP-NAV; Behavioral: SOC-REC/SOC-OIC; Behavioral: E-NAV/CCT; Behavioral: E-NAV/SOC-OIC; Behavioral: E-Nav/IP-NAV

• Registration Number: NCT04432571
• Lead Sponsor: Washington University School of Medicine

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-06-04
• Study First Submitted QC: 2020-06-12
• Study First Posted: 2020-06-16
• Study Start: 2021-04-06
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-13
• Last Update Posted: 2024-06-17
• Primary Completion: 2024-09-13
• Study Completion: 2024-09-13

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 880

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SOC-REC/CCT	SOC-REC/CCT	SOC-REC/Conditional Cash Transfer (CCT)
SOC-REC/IP-NAV	SOC-REC/IP-NAV	SOC-REC/In-Person Peer Navigation (IP-NAV)
SOC-REC/SOC-OIC	SOC-REC/SOC-OIC	Standard of care - routine education and counseling (SOC-REC)/SOC-Outreach and Intensified Counseling (OIC)
E-NAV/CCT	E-NAV/CCT	E-Nav/Conditional cash transfer
E-NAV/SOC-OIC	E-NAV/SOC-OIC	Electronic Navigation/SOC-OIC
E-NAV/IP-NAV	E-Nav/IP-NAV	E-Nav/In-Person Peer Navigation

Primary Outcome Measures

Name	Time	Method
Care engagement failure	24 months	Experiencing any of the following three events within the first year of follow-up: lapse in retention (defined as 14 days late for a scheduled visit) or unsuppressed HIV RNA following current MOH guidelines during routine monitoring, or death.
Re-engagement	24 months	Viral suppression (per current MOH guidelines) six months after re-randomization
Sustained viral suppression and engagement in care	24 months	Sustained viral suppression (per current MOH guidelines) and sustained engagement in care at 24 months

Secondary Outcome Measures

Name	Time	Method
Explore alternative outcome definitions: Medication possession ratio	24 months	Proportion of scheduled pharmacy/medication visits attended
Qualitative evaluation of how interventions work	24 months	Qualitative methods will be used to identify major themes to understand how interventions worked (or did not work).
Explore alternative outcome definitions: HIV RNA levels	24 months	Viral suppression threshold (following current MOH guidelines)
Cost effectiveness	24 months	We will compute unit cost for intervention activity and use information on activities for each participant to compute intervention cost per participant for each intervention strategy.
Compare survival between arms	24 months	Use log rank test to compare survival curves between arms
Composite of time to return and time to viral resuppression	24 months	Composite of time to return for the subset of patients failing Stage 1 treatments through missed visits, and time to viral resuppression for those who failed through an elevated viral load
Explore alternative outcome definitions: Mean visit adherence	24 months	mean number of scheduled clinic visits attended

Trial Locations

Locations (1)

Kenya Medical Research Institute; 🇰🇪 Kisumu, Kenya