Clinic-based ART Diagnostic Evaluation

NCT01791556 | Completed DMC

• 3 other identifiers: WRAIR# 1591KEMRI SSC# 1717RV 257
• Study Type: interventional
• Target: 820
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Acquired Immunodeficiency Syndrome; HIV Infection; RNA Virus Infections; Virus Diseases

Keywords

HIV; AIDS; Kenya; viral load; Antiretroviral therapy; randomized clinical trial; ART monitoring; treatment failure; HIV resistance

Outcome Measures

Primary Outcomes (1)

• Viral failure

  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 Outcomes (1)

• Viral failures

  18 months on follow-up

Study Arms (2)

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

Other: HIV-1 viral load testing

Interventions

HIV-1 viral load testing OTHER

HIV-1 viral load testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Walter Reed Army Institute of Research (WRAIR): lead
• US Military HIV Research Program: collaborator
• Kenya Medical Research Institute: collaborator

Study Sites (1)

Kenya Medical Research Institute/ Walter Reed Project HIV Program

Kericho, Kenya

Location

Related Publications (1)

• 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.

  PMID: 25706652 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; HIV Infections; RNA Virus Infections; Virus Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Fredrick Sawe, MBChB, MMED

  Kenya Medical Research Institute/ Walter Reed Project

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 11, 2013
• First Posted: February 15, 2013
• Study Start: January 26, 2010
• Primary Completion: March 25, 2011
• Study Completion: August 1, 2012
• Last Updated: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)