ADAPT for Adolescents Adolescents (A4A)

An Adaptive Strategy for Preventing and Treating Lapses of Retention in HIV Care for Adolescents

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.

Study Overview

• Status: Active, not recruiting
• Conditions: HIV/AIDS
• Intervention / Treatment: Behavioral: SOC-REC/SOC-OIC; Behavioral: SOC-REC/CCT; Behavioral: SOC-REC/IP-NAV; Behavioral: E-NAV/SOC-OIC; Behavioral: E-NAV/CCT; Behavioral: E-Nav/IP-NAV

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.

• Study Type: Interventional
• Enrollment (Actual): 880
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Kisumu, Kenya
    • Kenya Medical Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SOC-REC/SOC-OIC; Standard of care - routine education and counseling (SOC-REC)/SOC-Outreach and Intensified Counseling (OIC)	Behavioral: SOC-REC/SOC-OIC; Standard of care - routine education and counseling (SOC-REC)/SOC-Outreach and Intensified Counseling (OIC). SOC-REC is a stage 1 intervention to prevent lapses in HIV engagement through routine care. If an adolescent (1) misses an appointment >14 days, or (2) who have unsuppressed HIV RNA as per current MOH viral load threshold or (3) clinically documented non-adherence after >3 months of treatment he/she is re-randomized to a stage 2 intervention. SOC-OIC is a stage 2 intervention to treat lapses in HIV engagement through routine care which may include tracing and counseling to return to the clinic.; Other Names: Standard of care-routine education and counseling/Outreach and Intensified Counselling
Experimental: SOC-REC/CCT; SOC-REC/Conditional Cash Transfer (CCT)	Behavioral: SOC-REC/CCT; SOC-REC/Conditional Cash Transfer (CCT). SOC-REC is a stage 1 intervention to prevent lapses in HIV engagement through routine care. If an adolescent (1) misses an appointment >14 days, or (2) who have unsuppressed HIV RNA as per current MOH viral load threshold or (3) clinically documented non-adherence after >3 months of treatment he/she is re-randomized to a stage 2 intervention. CCT is a stage 2 intervention to treat lapses in HIV engagement by providing a small cash incentive for on-time clinic attendance and/or viral load suppression (following per current MOH guidelines).; Other Names: Standard of care-routine education and counseling/Conditional Cash Transfer
Experimental: SOC-REC/IP-NAV; SOC-REC/In-Person Peer Navigation (IP-NAV)	Behavioral: SOC-REC/IP-NAV; SOC-REC/In-Person Peer Navigation (IP-NAV). SOC-REC is a stage 1 intervention (routine care) to prevent lapses in HIV engagement. If an adolescent (1) misses an appointment >14 days, or (2) who have unsuppressed HIV RNA as per current MOH viral load threshold or (3) clinically documented non-adherence after >3 months of treatment he/she is re-randomized to a stage 2 intervention. IP-NAV is a stage 2 intervention to treat lapses in HIV engagement. Trained peer navigators will develop rapport with the participants and provide psychosocial support, case management, and assess retention and adherence barriers in a systematic manner and work with the participant to develop social support and clear, feasible plans to address barriers. The peer navigator will meet with the participant at least monthly, and no more than weekly, until HIV care engagement is demonstrated.; Other Names: Standard of care-routine education and counseling/In-Person Peer Navigation
Experimental: E-NAV/SOC-OIC; Electronic Navigation/SOC-OIC	Behavioral: E-NAV/SOC-OIC; E-Nav is a stage 1 intervention to prevent lapses in HIV engagement. Trained e-peer navigators will develop rapport and provide support through phone calls and/or patient preferred social media platforms. They will meet once in person and then weekly electronically for 8 weeks, and then monthly. If an adolescent (1) misses an appointment >14 days, or (2) who have unsuppressed HIV RNA as per current MOH viral load threshold or (3) clinically documented non-adherence after >3 months of treatment he/she is re-randomized to a stage 2 intervention. SOC-OIC is a stage 2 intervention to treat lapses in HIV engagement through routine care which may include tracing and counseling to return to the clinic.; Other Names: Electronic-Navigation/SOC-Outreach and Intensified Counseling
Experimental: E-NAV/CCT; E-Nav/Conditional cash transfer	Behavioral: E-NAV/CCT; E-Nav is a stage 1 intervention to prevent lapses in HIV engagement. Trained e-peer navigators will develop rapport and provide support through phone calls and/or patient preferred social media platforms. They will meet once in person and then weekly electronically for 8 weeks, and then monthly. If an adolescent (1) misses an appointment >14 days, or (2) who have unsuppressed HIV RNA as per current MOH viral load threshold or (3) clinically documented non-adherence after >3 months of treatment he/she is re-randomized to a stage 2 intervention. CCT is a stage 2 intervention to treat lapses in HIV engagement by providing a small cash incentive for on-time clinic attendance and/or viral load suppression (following current MOH guidelines).; Other Names: Electronic-Navigation/Conditional cash transfer
Experimental: E-NAV/IP-NAV; E-Nav/In-Person Peer Navigation	Behavioral: E-Nav/IP-NAV; E-Nav is a stage 1 intervention to prevent lapses in HIV engagement. Trained e-peer navigators will develop rapport and provide support through phone calls and/or patient preferred social media platforms. They will meet once in person and then weekly electronically for 8 weeks, and then monthly. If an adolescent (1) misses an appointment >14 days, or (2) has unsuppressed HIV RNA as per current MOH viral load threshold or (3) clinically documented non-adherence after >3 months of treatment he/she is re-randomized to a stage 2 intervention. IP-NAV is a stage 2 intervention to treat lapses in HIV engagement by providing in person navigation and counseling to a cash incentive for on-time clinic attendance and/or viral load suppression (MOH guidelines). Trained peer navigators will provide psychosocial support, case management, assess retention and adherence barriers in a systematic manner and work with the participant to develop social support and clear, feasible plans to address barriers; Other Names: Electronic-Navigation/In-Person Peer Navigation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Care engagement failure	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.	24 months
Re-engagement	Viral suppression (per current MOH guidelines) six months after re-randomization	24 months
Sustained viral suppression and engagement in care	Sustained viral suppression (per current MOH guidelines) and sustained engagement in care at 24 months	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare survival between arms	Use log rank test to compare survival curves between arms	24 months
Explore alternative outcome definitions: Mean visit adherence	mean number of scheduled clinic visits attended	24 months
Explore alternative outcome definitions: Medication possession ratio	Proportion of scheduled pharmacy/medication visits attended	24 months
Composite of time to return and time to viral resuppression	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	24 months
Cost effectiveness	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.	24 months
Qualitative evaluation of how interventions work	Qualitative methods will be used to identify major themes to understand how interventions worked (or did not work).	24 months
Explore alternative outcome definitions: HIV RNA levels	Viral suppression threshold (following current MOH guidelines)	24 months

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: University of Colorado, Denver; University of California, Berkeley; University of California, San Francisco; Kenya Medical Research Institute

Publications and helpful links

General Publications

• Abuogi LL, Kulzer JL, Akama E, Odeny TA, Eshun-Wilson I, Petersen M, Shade SB, Montoya LM, Beres LK, Iguna S, Adhiambo HF, Osoro J, Opondo I, Sang N, Kwena Z, Bukusi EA, Geng EH. Adapt for Adolescents: Protocol for a sequential multiple assignment randomized trial to improve retention and viral suppression among adolescents and young adults living with HIV in Kenya. Contemp Clin Trials. 2023 Apr;127:107123. doi: 10.1016/j.cct.2023.107123. Epub 2023 Feb 20.

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2021
• Primary Completion (Actual): September 13, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 4, 2020
• First Submitted That Met QC Criteria: June 12, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Estimated): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Adolescents; Kenya; Retention; Engagement in Care; Lost to follow-up; Adaptive strategies; Sequentially randomized trial; Sequential Multiple Assignment Randomized Trial
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Health Services; Health Care Facilities Workforce and Services; Community Health Services; Behavioral Disciplines and Activities; Mental Health Services; Counseling
• Other Study ID Numbers: 201910133

Plan for Individual participant data (IPD)

• IPD Plan Description: There is no plan to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No