NCT03553693

Brief Summary

The RAPID-VL study will take place in 20 HIV care health facilities in Southwestern Uganda. The study will test the hypothesis that a multi-component intervention package that targets barriers to efficient and timely HIV viral load (VL) testing will improve test ordering, speed up result turnaround times, and improve the quality of VL results counseling to patients. Phase 1 of the study will consist of a 1-year retrospective medical record review in all participating health facilities. In Phase 2 the intervention will be introduced in 10 randomly chosen health facilities, while the remaining 10 sites will continue with standard VL testing and counseling operations. The study will measure the speed and efficiency of VL testing, experiences of patients and clinicians with the intervention, and the cost of the intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,443

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Jul 2018

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

May 18, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 12, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

July 16, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2020

Completed
Last Updated

March 30, 2021

Status Verified

January 1, 2020

Enrollment Period

2.3 years

First QC Date

May 18, 2018

Last Update Submit

March 25, 2021

Conditions

HIV

Keywords

HIVViral LoadCounselingCosts and Costs AnalysisPoint-Of-Care Systems

Outcome Measures

Primary Outcomes (2)

  • Successful VL ordering

    Proportion of patients who had a VL ordered when indicated by country guidelines

    1 year

  • VL turnaround time

    Mean turnaround time in days from VL ordering to delivery of results to patient

    1 year

Secondary Outcomes (5)

  • VL suppression 12 months after the start of Phase 2 of trial

    12 months after the start of Phase 2 of trial

  • Viral re-suppression after positive VL

    1 year

  • Number of patients changed from 1st line to 2nd line ART

    1 year

  • CPHL integration process

    12 months after the start of Phase 2 of trial

  • VL results in CPHL database

    12 months after the start of Phase 2 of trial

Study Arms (2)

Intervention Clinics

EXPERIMENTAL

RAPID-VL study intervention testing and counseling package, which includes near point-of-care viral load (VL) testing at local testing hubs, structured VL counseling, forms to track VL ordering and testing, with feedback and performance evaluations at regular intervals.

Other: RAPID-VL study intervention

Control Clinics

NO INTERVENTION

Standard of care VL testing and counseling procedures consistent with country guidelines.

Interventions

RAPID-VL study interventionOTHER

* Viral load (VL) ordering flowsheet with periodic health facility performance feedback * Rapid near-point-of-care VL testing and telephone delivery of results * Structured VL counseling package

Intervention Clinics

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Phase 1, Intervention and Control Clinics:
  • "High risk" subgroups of patients (n=10 each per clinic, total of 40 per clinic): registered for care, with a clinic visit within a year of the Phase 1 start date, plus the following:
  • Phase 2, Intervention Clinics:
  • "High risk" subgroups of patients (n=10 each per clinic, total of 40 per clinic): registered for care, with a clinic visit within a year of the Phase 2 start date; able to consent for study participation; plus the following:
  • Phase 2, Control Clinics:
  • "High risk" subgroups of patients (n=10 each per clinic, total of 40 per clinic): registered for care, with a clinic visit within a year of the Phase 1 start date; able to provide consent; plus the following:

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southwestern Uganda

Mbarara, Uganda

Location

Related Publications (6)

  • Working Group on Modelling of Antiretroviral Therapy Monitoring Strategies in Sub-Saharan Africa; Phillips A, Shroufi A, Vojnov L, Cohn J, Roberts T, Ellman T, Bonner K, Rousseau C, Garnett G, Cambiano V, Nakagawa F, Ford D, Bansi-Matharu L, Miners A, Lundgren JD, Eaton JW, Parkes-Ratanshi R, Katz Z, Maman D, Ford N, Vitoria M, Doherty M, Dowdy D, Nichols B, Murtagh M, Wareham M, Palamountain KM, Chakanyuka Musanhu C, Stevens W, Katzenstein D, Ciaranello A, Barnabas R, Braithwaite RS, Bendavid E, Nathoo KJ, van de Vijver D, Wilson DP, Holmes C, Bershteyn A, Walker S, Raizes E, Jani I, Nelson LJ, Peeling R, Terris-Prestholt F, Murungu J, Mutasa-Apollo T, Hallett TB, Revill P. Sustainable HIV treatment in Africa through viral-load-informed differentiated care. Nature. 2015 Dec 3;528(7580):S68-76. doi: 10.1038/nature16046.

    PMID: 26633768BACKGROUND

  • Rutstein SE, Golin CE, Wheeler SB, Kamwendo D, Hosseinipour MC, Weinberger M, Miller WC, Biddle AK, Soko A, Mkandawire M, Mwenda R, Sarr A, Gupta S, Mataya R. On the front line of HIV virological monitoring: barriers and facilitators from a provider perspective in resource-limited settings. AIDS Care. 2016;28(1):1-10. doi: 10.1080/09540121.2015.1058896. Epub 2015 Aug 17.

    PMID: 26278724BACKGROUND

  • Roberts T, Cohn J, Bonner K, Hargreaves S. Scale-up of Routine Viral Load Testing in Resource-Poor Settings: Current and Future Implementation Challenges. Clin Infect Dis. 2016 Apr 15;62(8):1043-8. doi: 10.1093/cid/ciw001. Epub 2016 Jan 6.

    PMID: 26743094BACKGROUND

  • Shafiee H, Wang S, Inci F, Toy M, Henrich TJ, Kuritzkes DR, Demirci U. Emerging technologies for point-of-care management of HIV infection. Annu Rev Med. 2015;66:387-405. doi: 10.1146/annurev-med-092112-143017. Epub 2014 Nov 12.

    PMID: 25423597BACKGROUND

  • Ouattara EN, Robine M, Eholie SP, MacLean RL, Moh R, Losina E, Gabillard D, Paltiel AD, Danel C, Walensky RP, Anglaret X, Freedberg KA. Laboratory Monitoring of Antiretroviral Therapy for HIV Infection: Cost-Effectiveness and Budget Impact of Current and Novel Strategies. Clin Infect Dis. 2016 Jun 1;62(11):1454-1462. doi: 10.1093/cid/ciw117. Epub 2016 Mar 1.

    PMID: 26936666BACKGROUND

  • Marseille E, Giganti MJ, Mwango A, Chisembele-Taylor A, Mulenga L, Over M, Kahn JG, Stringer JS. Taking ART to scale: determinants of the cost and cost-effectiveness of antiretroviral therapy in 45 clinical sites in Zambia. PLoS One. 2012;7(12):e51993. doi: 10.1371/journal.pone.0051993. Epub 2012 Dec 20.

    PMID: 23284843BACKGROUND

Study Officials

  • Vivek Jain, MD, MAS

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Moses R Kamya, MBChB, MMed

    Makerere University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Comparative effectiveness cluster-randomized trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2018

First Posted

June 12, 2018

Study Start

July 16, 2018

Primary Completion

November 16, 2020

Study Completion

November 16, 2020

Last Updated

March 30, 2021

Record last verified: 2020-01

Locations

UG(1)