NCT04517825

Brief Summary

This is a two-phase study designed to assess measures of feasibility, sustainability, acceptability, penetration, and fidelity before and after implementation of a rapid molecular HIV-1 viral load testing infrastructure at a level III health center in rural western Uganda. The central hypothesis is that implementation of PoC HIV-1 testing without accompanying modifications to clinic triage and flow, laboratory processes, and existing protocols guiding adherence counseling and regimen change, will not result in significant improvement in clinical outcomes in PLWH.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
242

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

July 31, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

August 8, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 18, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

May 23, 2022

Status Verified

May 1, 2022

Enrollment Period

11 months

First QC Date

July 31, 2020

Last Update Submit

May 20, 2022

Conditions

HIV-1-infection

Keywords

viral loadCD4

Outcome Measures

Primary Outcomes (2)

  • Number of Tests Performed Successfully Each Clinic Day

    HIV viral load tests performed at peripheral health center

    Each clinic day for up to six months

  • Number of Tests Performed Successfully each Month

    HIV viral load tests performed at peripheral health center

    Each month for up to six months

Secondary Outcomes (6)

  • Proportion of Eligible Patients Electing to Stay to Receive Results

    Each clinic day for up to six months

  • Proportion of Eligible Patients Electing to Stay to Receive Results

    Each month for up to six months

  • Mean Time Clients Spend in Clinic

    Each clinic day for up to 9 months

  • Provider Perception of Workload

    Pre- and post-intervention (approximately 6 months apart)

  • Mean and median time-to-result

    Up to 90 days after blood draw, after which considered not returned

  • +1 more secondary outcomes

Study Arms (1)

Target Population

HIV positive individuals attending Bugoye ART clinic

Diagnostic Test: Cepheid Xpert HIV-1 Viral Load Assay

Interventions

Cepheid Xpert HIV-1 Viral Load AssayDIAGNOSTIC_TEST

Rapid, on-site molecular HIV-1 viral load testing used in accordance with cleared/approved labeling

Target Population

Eligibility Criteria

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

Adult patients aged 18 years or older receiving care at the Bugoye Health Center Antiretroviral therapy clinic

You may qualify if:

  • Adult patients aged 18 years or older receiving care at the Bugoye Health Center Antiretroviral therapy clinic

You may not qualify if:

  • Patients unwilling or unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bugoye Level III Health Centre

Bugoye, Kasese, Uganda

Location

Mbarara University of Science and Technology (MUST)

Mbarara, PO Box 1410, Uganda

Location

Related Publications (1)

  • Boyce RM, Ndizeye R, Ngelese H, Baguma E, Shem B, Rubinstein RJ, Rockwell E, Lotspeich SC, Shook-Sa BE, Ntaro M, Nyehangane D, Wohl DA, Siedner MJ, Mulogo EM. It takes more than a machine: A pilot feasibility study of point-of-care HIV-1 viral load testing at a lower-level health center in rural western Uganda. PLOS Glob Public Health. 2023 Mar 27;3(3):e0001678. doi: 10.1371/journal.pgph.0001678. eCollection 2023.

    PMID: 36972208DERIVED

Study Officials

  • Ross M Boyce, MD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 31, 2020

First Posted

August 18, 2020

Study Start

August 8, 2020

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

May 23, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Shared Documents
STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
Time Frame
Beginning 9 to 36 months following publication
Access Criteria
An investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Locations

UG(2)