Acquired Immunodeficiency SyndromeCLADENCT01791556
Clinic-based ART Diagnostic Evaluation
A study testing HIV-1 viral load testing in people with Acquired Immunodeficiency Syndrome and HIV Infection, run by Walter Reed Army Institute of Research (WRAIR) at 1 site in Kenya.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Immunodeficiency Syndrome, HIV Infection, RNA Virus Infections
- What is being tested?
- HIV-1 viral load testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 820 participants
- Where
- 1 siteKenya
- Study dates
- 26 Jan 2010to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Kenya1 site
Kenya Medical Research Institute/ Walter Reed Project HIV Program
Kericho
About this study
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.
Read the 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.
- Being tested
- HIV-1 viral load testing
- Keywords
- HIV, AIDS, Kenya, viral load, Antiretroviral therapy, randomized clinical trial, ART monitoring, treatment failure, HIV resistance
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV Infections, RNA Virus Infections, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV-1 viral load testingOther
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | 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 |
| HIV-1 viral load testing | Experimental | viral load in addition to clinical (World Health Organization staging) and immunological (CD4 count) monitoring every 6 months Receives: Other: HIV-1 viral load testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral failure
- 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.
- 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
Measured: 18 months on follow-up
Secondary outcomes (1)
Viral failures
- Combined clinical outcome as defined by 2 new World Health Organization stage III events or 1 new World Health Organization stage IV event.
- Death (as confirmed by medical records or death certificate).
- Hospitalization (for any illness).
- Opportunistic infections (onset after study entry).
- Adherence (routinely captured by clinics).
- Lost of follow-up (defined as missing 2 consecutive appointments and/or inability to have final study visit).
- HIV genotype resistance in all treatment failures and all viral failures at the final study visit.
- Feasibility of rolling out viral load monitoring in rural district-level ART clinics (based upon knowledge, attitudes, and performance indicators.)
- 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).
- Adherence to GCP (as a research study is incorporated in to ART clinics and based upon GCP indicators).
Measured: 18 months on follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study start26 Jan 2010
- Primary completion25 Mar 2011
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acquired Immunodeficiency SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 820 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Reed Army Institute of Research (WRAIR)
- Sponsor type
- US federal agency
- Collaborators
- US Military HIV Research Program, Kenya Medical Research Institute
- Responsible party
- Sponsor
- Investigators
- Fredrick Sawe, MBChB, MMED, Principal investigator, Kenya Medical Research Institute/ Walter Reed Project
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01791556
- Sponsor's protocol ID
- WRAIR# 1591
- Other IDs
- KEMRI SSC# 1717, RV 257
- Acronym
- CLADE
- Status last verified
- Dec 2023
- First submitted
- 11 Feb 2013
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Sawe FK, Obiero E, Yegon P, Langat RC, Aoko A, Tarus J, Kiptoo I, Langat RK, Maswai J, Bii M, Khamadi S, Shikuku KP, Close N, Sinei S, Shaffer DN. Kericho CLinic-based ART Diagnostic Evaluation (CLADE): design, accrual, and baseline characteristics of a randomized controlled trial conducted in predominately rural, district-level, HIV clinics of Kenya. PLoS One. 2015 Feb 23;10(2):e0116299. doi: 10.1371/journal.pone.0116299. eCollection 2015.
PubMed 25706652
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinic-based ART Diagnostic Evaluation
- ClinicalTrials.gov ID
- NCT01791556
- Acronym / sponsor ID
- CLADE / WRAIR# 1591
- Keywords
- HIV, AIDS, Kenya, viral load, Antiretroviral therapy, randomized clinical trial, ART monitoring, treatment failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 820 participants (actual)
- Lead sponsor
- Walter Reed Army Institute of Research (WRAIR)US federal agency
- Collaborators
- US Military HIV Research Program, Kenya Medical Research Institute
- Study start
- 26 Jan 2010 (actual)
- Primary completion
- 25 Mar 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 15 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –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 |
| HIV-1 viral load testing | Experimental | Other: HIV-1 viral load testingviral load in addition to clinical (World Health Organization staging) and immunological (CD4 count) monitoring every 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIV-1 viral load testing | Other | HIV-1 viral load testing |
Primary outcome
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
1 secondary outcome
Viral failures
Time frame: 18 months on follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Derived from this study: PubMed 25706652Sawe FK, Obiero E, Yegon P, Langat RC, Aoko A, Tarus J, Kiptoo I, Langat RK, Maswai J, Bii M, Khamadi S, Shikuku KP, Close N, Sinei S, Shaffer DN. Kericho CLinic-based ART Diagnostic Evaluation (CLADE): design, accrual, and baseline characteristics of a randomized controlled trial conducted in predominately rural, district-level, HIV clinics of Kenya. PLoS One. 2015 Feb 23;10(2):e0116299. doi: 10.1371/journal.pone.0116299. eCollection 2015.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fredrick Sawe, MBChB, MMED principal investigator
Kenya Medical Research Institute/ Walter Reed Project
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIV-1 viral load testing in people with Acquired Immunodeficiency Syndrome and HIV Infection, run by Walter Reed Army Institute of Research (WRAIR) at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral failure (time frame: 18 months on follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01791556, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.