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Completed

NCT Number: NCT05007717

Data-informed Stepped Care (DiSC) to Improve Adolescent HIV Outcomes (UH3)

The investigators will conduct a Phase III cluster randomized controlled trial (cRCT) to evaluate the effectiveness of the implementation of a data-informed stepped care (DiSC) intervention for HIV treatment management among adolescents living with HIV (ALHIV) in high-volume HIV clinics in Kenya. The DiSC intervention is comprised of a system to assign ALHIV to care based on their health needs and the different levels of care for each assignment group. The primary outcome will be ALHIV retention, and the secondary outcomes will include adherence, viral non-suppression, and receipt of differentiated care among ALHIV.

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Key information

Conditions

Adolescent Behavior Acquired Immunodeficiency Syndrome Behavior Blood-Borne Infections Communicable Diseases Genital Diseases HIV 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

10 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asumbi Health Centre, Homa Bay, Kenya

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About this study

UNAIDS '95-95-95' targets cannot be achieved without additional support for adolescents living with HIV (ALHIV) to increase retention in care and to support viral suppression. Risk prediction tools as well as a stepped care approach to care can support differentiation of ALHIV to different risk groups, and tailor care based on risk.

The investigators have conducted informative work with ALHIV, caregivers, healthcare workers (HCW) and policy makers, and has developed a clinical prediction tool to identify ALHIV at highest risk of not being retained in care and poor viral suppression that could be adapted to identify adolescents who may need more support in their care. Understanding how best to use the risk prediction tool as well as how to tailor services based on risk may ultimately result in more efficient HIV care services, as well as adequate support for ALHIV at highest risk of poor outcomes.

Building on that informative work, in this protocol, the investigators will conduct a Phase III cluster randomized controlled trial (cRCT) by implementing a data-informed stepped care (DiSC) intervention of ALHIV HIV treatment management in high-volume HIV clinics in Kenya.

The cRCT will be conducted at up to 24 HIV care and treatment facilities located in Kisumu, Homabay, Migori county in Western Kenya, in which approximately 2000 HIV positive adolescents and young adults ages 10-24 years enrolled in HIV care will be recruited in this study.

Clinics randomized to the DiSC intervention arm will use a data-driven system to assign ALHIV to different levels of care depending on their current and anticipated health care needs. The intervention will be delivered at the individual level by HCW providing routine care during routine HIV clinic visits. Clinics randomized to the control arm will continue with standard of care approaches for adolescent clinic visits (usually 1-3 monthly visits), regardless of health care needs and additional support as needed.

As secondary objectives, this study also aims to evaluate the effectiveness of the DiSC intervention on ALHIV cascade outcomes (adherence, viral non-suppression) and receiving differentiated HIV care based on health status evaluation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • HIV-positive
  • Enrolled in HIV care
  • Provision of informed consent
  • Willing and able to give informed consent

Exclusion criteria

  • Not able or willing to give informed consent

Treatment and study plan

Data-informed Stepped Care (DiSC)

Behavioral

The DiSC intervention is comprised of a data-driven system to assign adolescents to care based on their health needs and the different levels of care for each assignment group.

The trajectory of services moves from a relative position of ALHIV autonomy to more intensive service provision. Intervention steps start with 1) multi-month refills or community treatment delivery (differentiated care); 2) a standard of care level for those with medical needs such as pregnancy or opportunistic infections or patient choice; 3) patient reminders/tracking and counseling and referral services for mental health needs; 4) case management of unsuppressed individuals, including enhanced counseling and case conference problem-solving

Primary outcomes

  1. Proportion of Missed Visits

    Time frame: 12 months

    We will evaluate retention using a definition of missed visit and calculate the proportion of scheduled visits that are missed. Missed visits will be defined as a participant not seen within 30 days after each scheduled visit. Each scheduled visit will be classified as missed versus not missed.

Secondary outcomes

  1. Proportion of Viral Load Results Showing Viral Non-suppression

    Time frame: 12 months

    We will evaluate viral load test results and calculate the proportion of results that show non-suppression. Viral non-suppression will be defined as having HIV RNA viral loads (VL) >1,000 copies per milliliter. Each VL test result will be classified as VL suppressed vs. unsuppressed.

  2. Proportion of Visit Intervals With Good Adherence

    Time frame: 12 months

    We will evaluate adherence by calculating the number of pills dispensed divided by the number of days during an inter-visit interval. A proportion of adherence greater than 0.8 will be classified as good adherence. The level of adherence during the past inter-visit interval will be assessed at each visit.

  3. Incidence Rate of Loss to Follow-up

    Time frame: 12 months

    We will also analyze retention using loss to follow-up (LTFU). LTFU will be defined as a participant not seen within 30 days of a scheduled visit and not return to care within the 12-month study period. The incidence rate of LTFU is the ratio of the number of new cases of LTFU to the total time the study participants was at risk of LTFU. The denominator is the sum of the time each participant (person-year) was observed, totaled for all participants.

  4. Proportion of Visits Enrolled in Differentiated Care Services (Fast-track Visits)

    Time frame: 12 months

    We will calculate the proportion of visits enrolled in differentiated care using two definitions. The first is fast-track visit, which evaluates if participants are assigned to fast-track status during visits. Each visit will be assessed as enrolled in differentiated care (assigned to fast-track) or not.

  5. Proportion of Visits Enrolled in Differentiated Care Services (Multi-month Refills)

    Time frame: 12 months

    We will calculate the proportion of visits enrolled in differentiated care using two definitions. The second is multi-month prescription refills, which evaluates if participants are given multi-month refill intervals more than 3 months. Each visit will be assessed as enrolled in differentiated care (given multi-month refills) or not.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 16, 2021
Registry last updated
Nov 27, 2024

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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