Clinic-based ART Diagnostic Evaluation (CLADE)

December 14, 2023 updated by: Walter Reed Army Institute of Research (WRAIR)
The study is funded through the Office of the Global AIDS Coordinator (OGAC #KE-07-0044). The purpose of this study is two-fold. The first purpose is to see if routine monitoring of the level of HIV virus in the blood (viral load) every six months is superior to monitoring by standard clinical evaluations and or immune status (CD4 count) with intermittent viral load monitoring in adults receiving antiretroviral therapy (ART). The second purpose is to understand the cost implications and possible benefits of routine HIV viral load monitoring.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Kenya Ministry of Health (MoH) guidelines for antiretroviral therapy (ART) and manual for ART providers recommend targeted viral load monitoring in ART management. While only limited use of viral load monitoring exist due to limitations in technical and financial resources, the feasibility and cost-effectiveness of viral load monitoring has not been prospectively studied in ART roll-out at the clinic level.

"Clinic-based ART Diagnostic Evaluation" (CLADE) is an unblinded, randomized (1:1), prospective, observational, cohort public health evaluation (PHE) aimed at evaluating the superiority and cost-effectiveness of two recommended Ministry of Health ART diagnostic evaluation approaches at the clinic level in adult treatment naive patients beginning Ministry of Health approved first-line ART: "routine care", the most common approach to ART roll-out where clinical (World Health Organization) staging and immunological (CD4) monitoring are the primary baseline and follow-up evaluations and targeted viral load monitoring; and "viral load care", where routine viral loads are included with clinical and immunological evaluations.

In this study we plan to enroll 820 adult participants starting ART, 410 people will be enrolled in each of the public health evaluation arms. Arm A/ "routine care" will receive MoH standard of care monitoring consisting of baseline CD4 and WHO staging every 6 months, or as clinically indicated, with CD4 and WHO staging criteria guiding care and treatment in addition to routine clinical evaluations. In addition, MoH criteria for targeted viral load monitoring will be used. Arm B/ "viral load guided care" will receive MoH standard of care as in Arm A but also have routine viral load monitoring at baseline and every 6 months, or as clinically indicated, to guide care and treatment. Each arm will receive Kenya Ministry of Health first-line ART. Participants meeting MoH criteria for treatment failure will being second-line ART.

Study Type

Interventional

Enrollment (Actual)

820

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
      • Kericho, Kenya
        • Kenya Medical Research Institute/ Walter Reed Project HIV Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female > 18 years of age at the time of consent.
  • Identified by clinic staff as intending to start ART at the next clinic visit
  • Provision of informed consent in either Kiswahili, Luo or English

Exclusion Criteria:

  • Any reason (medical, physical location of home relative to clinic, or other) existing that the ART team feel will prohibit the volunteer from coming for routine ART clinic visits.
  • Any reason (medical, social, or other) existing that the ART team or study team feel may present a risk to the participant that outweighs the benefit of participating in the study.
  • Pregnancy (confirmed or suspected) at time of enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of Care
clinical (World Health Organization staging) and immunological (CD4 count) monitoring every 6 months with confirmatory or targeted viral load monitoring based upon Kenya Ministry of Health and World Health Organization guidelines
Experimental: HIV-1 viral load testing
viral load in addition to clinical (World Health Organization staging) and immunological (CD4 count) monitoring every 6 months
Other: HIV-1 viral load testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Viral failure
Time Frame: 18 months on follow-up
  1. The study primary endpoint is viral failure at the 18 month follow-up visit as defined by VL>1000 copies/mL by the viral load platform approved by the Kenya Medical Research Institute/ Walter Reed Project Clinical Research Center laboratory under the College of American Pathologist and related external quality assurance programs.
  2. Relative cost-effectiveness of routine viral load monitoring in addition to CD4 count and clinical monitoring compared to CD4 and clinical alone in clinic-based ART management
18 months on follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Viral failures
Time Frame: 18 months on follow-up
  1. Combined clinical outcome as defined by 2 new World Health Organization stage III events or 1 new World Health Organization stage IV event.
  2. Death (as confirmed by medical records or death certificate).
  3. Hospitalization (for any illness).
  4. Opportunistic infections (onset after study entry).
  5. Adherence (routinely captured by clinics).
  6. Lost of follow-up (defined as missing 2 consecutive appointments and/or inability to have final study visit).
  7. HIV genotype resistance in all treatment failures and all viral failures at the final study visit.
  8. Feasibility of rolling out viral load monitoring in rural district-level ART clinics (based upon knowledge, attitudes, and performance indicators.)
  9. Cost of viral load monitoring (in addition to CD4 count and clinical care monitoring as actual costs collected during 18 months of follow-up on ART).
  10. Adherence to GCP (as a research study is incorporated in to ART clinics and based upon GCP indicators).
18 months on follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Walter Reed Army Institute of Research (WRAIR)

Collaborators

US Military HIV Research Program
Kenya Medical Research Institute

Investigators

  • Principal Investigator: Fredrick Sawe, MBChB, MMED, Kenya Medical Research Institute/ Walter Reed Project

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2010

Primary Completion (Actual)

March 25, 2011

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

February 11, 2013

First Submitted That Met QC Criteria

February 11, 2013

First Posted (Estimated)

February 15, 2013

Study Record Updates

Last Update Posted (Estimated)

December 15, 2023

Last Update Submitted That Met QC Criteria

December 14, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WRAIR# 1591
  • KEMRI SSC# 1717 (Other Identifier: Kenya Medical Research Institute)
  • RV 257 (Other Identifier: US Military HIV Research Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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