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Completed

NCT Number: NCT04432571

ADAPT for Adolescents 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.

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

14 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kenya Medical Research Institute

Kisumu, Kenya

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Standard of care-routine education and counseling/Outreach and Intensified Counselling

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).

Other names: Standard of care-routine education and counseling/Conditional Cash Transfer

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.

Other names: Standard of care-routine education and counseling/In-Person Peer Navigation

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.

Other names: Electronic-Navigation/SOC-Outreach and Intensified Counseling

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).

Other names: Electronic-Navigation/Conditional cash transfer

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

Other names: Electronic-Navigation/In-Person Peer Navigation

Primary outcomes

  1. Care engagement failure

    Time frame: 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.

  2. Re-engagement

    Time frame: 24 months

    Viral suppression (per current MOH guidelines) six months after re-randomization

  3. Sustained viral suppression and engagement in care

    Time frame: 24 months

    Sustained viral suppression (per current MOH guidelines) and sustained engagement in care at 24 months

Secondary outcomes

  1. Compare survival between arms

    Time frame: 24 months

    Use log rank test to compare survival curves between arms

  2. Explore alternative outcome definitions: Mean visit adherence

    Time frame: 24 months

    mean number of scheduled clinic visits attended

  3. Explore alternative outcome definitions: Medication possession ratio

    Time frame: 24 months

    Proportion of scheduled pharmacy/medication visits attended

  4. Explore alternative outcome definitions: HIV RNA levels

    Time frame: 24 months

    Viral suppression threshold (following current MOH guidelines)

  5. Composite of time to return and time to viral resuppression

    Time frame: 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

  6. Cost effectiveness

    Time frame: 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.

  7. Qualitative evaluation of how interventions work

    Time frame: 24 months

    Qualitative methods will be used to identify major themes to understand how interventions worked (or did not work).

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Kenya Medical Research Institute
  • University of California, Berkeley
  • University of California, San Francisco
  • University of Colorado, Denver

Registry information

Official study title

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

Acronym: A4A

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jun 16, 2020
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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