ADAPT for Adolescents Adolescents

NCT04432571 | Completed

• 1 other identifier: 201910133
• Study Type: interventional
• Target: 880
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS

Keywords

Adolescents; Retention; Engagement in Care; Lost to follow-up; Kenya; Adaptive strategies; Sequentially randomized trial; Sequential Multiple Assignment Randomized Trial

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Compare survival between arms

  24 months

• Explore alternative outcome definitions: Mean visit adherence

  24 months

• Explore alternative outcome definitions: Medication possession ratio

  24 months

• Explore alternative outcome definitions: HIV RNA levels

  24 months

• Composite of time to return and time to viral resuppression

  24 months

Study Arms (6)

SOC-REC/SOC-OIC

ACTIVE COMPARATOR

Standard of care - routine education and counseling (SOC-REC)/SOC-Outreach and Intensified Counseling (OIC)

Behavioral: SOC-REC/SOC-OIC

SOC-REC/CCT

EXPERIMENTAL

SOC-REC/Conditional Cash Transfer (CCT)

Behavioral: SOC-REC/CCT

SOC-REC/IP-NAV

EXPERIMENTAL

SOC-REC/In-Person Peer Navigation (IP-NAV)

Behavioral: SOC-REC/IP-NAV

E-NAV/SOC-OIC

EXPERIMENTAL

Electronic Navigation/SOC-OIC

Behavioral: E-NAV/SOC-OIC

E-NAV/CCT

EXPERIMENTAL

E-Nav/Conditional cash transfer

Behavioral: E-NAV/CCT

E-NAV/IP-NAV

EXPERIMENTAL

E-Nav/In-Person Peer Navigation

Behavioral: E-Nav/IP-NAV

Interventions

SOC-REC/SOC-OIC BEHAVIORAL

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.

Also known as: Standard of care-routine education and counseling/Outreach and Intensified Counselling

SOC-REC/SOC-OIC

SOC-REC/CCT BEHAVIORAL

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).

Also known as: Standard of care-routine education and counseling/Conditional Cash Transfer

SOC-REC/CCT

SOC-REC/IP-NAV BEHAVIORAL

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.

Also known as: Standard of care-routine education and counseling/In-Person Peer Navigation

SOC-REC/IP-NAV

E-NAV/SOC-OIC BEHAVIORAL

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.

Also known as: Electronic-Navigation/SOC-Outreach and Intensified Counseling

E-NAV/SOC-OIC

E-NAV/CCT BEHAVIORAL

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).

Also known as: Electronic-Navigation/Conditional cash transfer

E-NAV/CCT

E-Nav/IP-NAV BEHAVIORAL

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

Also known as: Electronic-Navigation/In-Person Peer Navigation

E-NAV/IP-NAV

Eligibility Criteria

• Age: 14 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• HIV-infection, on or initiating ART,
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: collaborator
• Washington University School of Medicine: lead
• University of California, San Francisco: collaborator
• University of California, Berkeley: collaborator
• Kenya Medical Research Institute: collaborator

Study Sites (1)

Kenya Medical Research Institute

Kisumu, Kenya

Location

Related Publications (2)

• Ontuga GM, Mangale DI, Lewis-Kulzer J, Kwena ZA, Akama E, Adhiambo HF, Iguna S, Akinyi OB, Nyandieka E, Omondi E, Ochieng F, Owino OC, Goldin S, Anne BE, Geng E, Beres LK, Abuogi LL. "I feel like a guest on the other side": youth-identified challenges and solutions to transitioning from adolescent to adult HIV services in Western Kenya. AIDS Care. 2026 Feb 17:1-12. doi: 10.1080/09540121.2025.2591425. Online ahead of print.

  PMID: 41700479 DERIVED

• 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.

  PMID: 36813086 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Counseling

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 16, 2020
• Study Start: April 6, 2021
• Primary Completion: September 13, 2025
• Study Completion: December 31, 2025
• Last Updated: June 30, 2026

Record last verified: 2026-06

Locations

KE (1)