NCT03986099

Brief Summary

A randomized, open label trial of two strategies for Virus Load Differentiated Care (VLDC) monitoring of virologic outcome in a rural community based treatment program in Zimbabwe.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
451

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 14, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2020

Completed
Last Updated

November 17, 2020

Status Verified

November 1, 2020

Enrollment Period

2.4 years

First QC Date

March 27, 2019

Last Update Submit

November 16, 2020

Conditions

ARTHIV I Infection

Keywords

Children and adolescentsHIV therapyVirologic suppressionZimbabweRuralGeneXpertPoint of careSAMBA

Outcome Measures

Primary Outcomes (1)

  • Viral load suppression

    Viral load suppression

    48 weeks

Secondary Outcomes (2)

  • Number of participants with confirmed virology failure who switched regimens

    96 weeks

  • Drug resistance mutations

    96 weeks

Study Arms (2)

Standard of care

NO INTERVENTION

SOC viral load

Near point of care

ACTIVE COMPARATOR

POC viral load

Diagnostic Test: Monitoring virus load

Interventions

Monitoring virus loadDIAGNOSTIC_TEST

Near point of care

Near point of care

Eligibility Criteria

Age2 Years - 26 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \- HIV positive children and adolescents on ART

You may not qualify if:

  • Unable to consent
  • Less than one year on ART

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chidamoyo Christian Hospital

Karoi, Mashonaland West, Zimbabwe

Location

Related Publications (2)

  • Kouamou V, Machekano R, Mapangisana T, Maposhere C, Mutetwa R, Manasa J, Shamu T, McCarty K, Munyati S, Mutsvangwa J, Bogoshi M, Israelski D, Katzenstein D. Clinic-based SAMBA-II vs centralized laboratory viral load assays among HIV-1 infected children, adolescents and young adults in rural Zimbabwe: A randomized controlled trial. PLoS One. 2023 Feb 14;18(2):e0281279. doi: 10.1371/journal.pone.0281279. eCollection 2023.

    PMID: 36787296DERIVED

  • Kouamou V, Machekano R, Mapangisana T, Maposhere C, Munyati S, Mutsvangwa J, Shamu T, McCarty K, Katzenstein D, Manasa J. Tenofovir, Lamivudine, and Dolutegravir Among Rural Adolescents in Zimbabwe: A Cautionary Tale. AIDS Res Hum Retroviruses. 2022 Oct;38(10):774-778. doi: 10.1089/AID.2021.0140. Epub 2022 Sep 7.

    PMID: 35959737DERIVED

Study Officials

  • Shungu Munyati, PhD

    Biomedical Research and Training Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single blind
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Patients assigned to either point of care (POC) or standard of care (SOC)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2019

First Posted

June 14, 2019

Study Start

February 1, 2018

Primary Completion

June 15, 2020

Study Completion

November 15, 2020

Last Updated

November 17, 2020

Record last verified: 2020-11

Locations

ZI(1)