NCT03249493

Brief Summary

As of today, HIV-infected patients followed in decentralized area have little or even no access to viral load monitoring because laboratories able to perform this biological measurement are only in large cities, and because plasma transfer to these laboratories is complex and very costly. Blood sampling using dried blood spots (DBS) could overcome these difficulties. The goal of this operational research is to document the feasibility of DBS use in decentralised area to monitor viral load, to evaluate the virological response on ART, and to compare the virological response between injecting drug users (IDU) and the other patients, as IDU represent a large proportion of HIV-infected patients who may have a lower access/adherence to care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
584

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2017

Typical duration for all trials

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

First Submitted

Initial submission to the registry

August 7, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 15, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

August 15, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

May 20, 2022

Status Verified

March 1, 2021

Enrollment Period

3 years

First QC Date

August 7, 2017

Last Update Submit

May 16, 2022

Conditions

HIV/AIDSDried Blood SpotViral Load

Keywords

Decentralised Area

Outcome Measures

Primary Outcomes (1)

  • Virological success at 24 months of ART

    Patients with a VL \<1000 copies/mL at 24 months of ART

    24 months (+/- 1 month) after ART initiation

Secondary Outcomes (15)

  • Outcomes related to DBS transfer

    through study completion, an average of 2 years

  • Outcomes related to quality of DBS samples

    through study completion, an average of 2 years

  • Outcomes related to delay concerning the return of viral load result

    through study completion, an average of 2 years

  • Outcomes related to ability of DBS to provide viral load result

    through study completion, an average of 2 years

  • Outcomes related to ability of DBS to provide HIV drug resistance result

    through study completion, an average of 2 years

  • +10 more secondary outcomes

Study Arms (2)

HIV Injection drug users

Blood sample on DBS. Blood sample for HIV Viral Load measurements and HIV Drug Resistance at baseline, 6, 12 and 24 months of follow up after ART initiation using Dried Blood Spot

Other: Blood sample on DBS

HIV Non injection drug users

Blood sample on DBS. Blood sample for HIV Viral Load measurements and HIV Drug Resistance at baseline, 6, 12 and 24 months of follow up after ART initiation using Dried Blood Spot

Other: Blood sample on DBS

Interventions

Blood sample on DBSOTHER

We will take 5 mL of whole blood at ART initiation, 6, 12 and 24 months of follow up after ART initiation. Blood will be transferred on DBS cards. HIV Viral Load measurements will be done and HIV Drug Resistance measurements will be performed in case of 2 consecutive VL results \> 1000 cp/mL

HIV Injection drug usersHIV Non injection drug users

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The key population for this research project is HIV-positive patients who initiate ART followed in 24 out-patient clinics (OPCs) located in decentralised areas in two provinces, where laboratories facilities are not easily accessible and where VL monitoring is extremely scarce.

You may qualify if:

  • confirmed HIV-1 infection,
  • age at enrolment ≥18 years,
  • ART naïve (women exposed through PMTCT are eligible),
  • consent to participate.

You may not qualify if:

  • negative for HIV,
  • age at enrolment \<18 years,
  • ART experienced (excepted PMTCT),
  • not consenting to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yen Bai medical center

Yên Bái, Vietnam

Location

Related Publications (5)

  • Taieb F, Tran Hong T, Ho HT, Nguyen Thanh B, Pham Phuong T, Viet Ta D, Le Thi Hong N, Ba Pham H, Nguyen LTH, Nguyen HT, Nguyen TT, Tuaillon E, Delaporte E, Le Thi H, Tran Thi Bich H, Nguyen TA, Madec Y. First field evaluation of the optimized CE marked Abbott protocol for HIV RNA testing on dried blood spot in a routine clinical setting in Vietnam. PLoS One. 2018 Feb 9;13(2):e0191920. doi: 10.1371/journal.pone.0191920. eCollection 2018.

    PMID: 29425216BACKGROUND

  • Taieb F, Tram TH, Ho HT, Pham VA, Nguyen L, Pham BH, Tong LA, Tuaillon E, Delaporte E, Nguyen AT, Bui DD, Do N, Madec Y. Evaluation of Two Techniques for Viral Load Monitoring Using Dried Blood Spot in Routine Practice in Vietnam (French National Agency for AIDS and Hepatitis Research 12338). Open Forum Infect Dis. 2016 Jul 7;3(3):ofw142. doi: 10.1093/ofid/ofw142. eCollection 2016 Sep.

    PMID: 27704001BACKGROUND

  • Nguyen TA, Tran TH, Nguyen BT, Pham TTP, Hong Le NT, Ta DV, Phan HTT, Nguyen LH, Ait-Ahmed M, Ho HT, Taieb F, Madec Y; MOVIDA 2 study group. Feasibility of dried blood spots for HIV viral load monitoring in decentralized area in North Vietnam in a test-and-treat era, the MOVIDA project. PLoS One. 2020 Apr 9;15(4):e0230968. doi: 10.1371/journal.pone.0230968. eCollection 2020.

    PMID: 32271796RESULT

  • Araujo Chaveron L, Pham TTP, Nguyen BT, Tran TH, Le NTH, Pham TH, Ngo KP, Tong HT, Phan HTT, Ait-Ahmed M, Nguyen TA, Taieb F, Madec Y; MOVIDA 2 study group. Injecting drug use increases the risk of death in HIV patients on antiretroviral therapy in Vietnam. AIDS Care. 2024 May;36(5):631-640. doi: 10.1080/09540121.2023.2224549. Epub 2023 Jun 20.

    PMID: 37339000DERIVED

  • Lefrancois LH, Nguyen BT, Pham TTP, Le NTH, Dao HTT, Tran TH, Ngo KP, Tong HT, Phan HTT, Ait-Ahmed M, Pham TH, Nguyen TA, Taieb F, Madec Y; MOVIDA 2 study group. Assessment of HIV viral load monitoring in remote settings in Vietnam - comparing people who inject drugs to the other patients. PLoS One. 2023 Feb 21;18(2):e0281857. doi: 10.1371/journal.pone.0281857. eCollection 2023.

    PMID: 36802388DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood samples on Dried Blood spot cards

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Fabien TAIEB, MD

    Institut Pasteur

    PRINCIPAL INVESTIGATOR

  • Yoann Madec, PhD

    Institut Pasteur

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2017

First Posted

August 15, 2017

Study Start

August 15, 2017

Primary Completion

August 1, 2020

Study Completion

September 1, 2020

Last Updated

May 20, 2022

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Non applicable

Locations

VN(1)