Point-of-care Viral Load Testing Among HIV-infected Adolescents in Haiti

NCT03288246 | Completed

• 1 other identifier: 1708018474
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed as an individual randomized trial among 150 HIV-infected adolescents aged 10-24 years who have been on ART for \>6 months and will be randomized in a 1:1 fashion to one of two arms: 1) the intervention arm (POC) will receive a POC VL test with adherence counseling informed by the VL result the same day as testing vs. 2) the standard-of-care arm (SOC) will receive a standard laboratory-based test with adherence counseling informed by the VL result 1 month later. The study tests an intervention, POC VL testing, which reduces the time between sample collection and participant receipt of results, thus decreasing the number of steps in the HIV treatment cascade. This intervention was developed to addresses health systems-based barriers which delay clinic, laboratory, and data management processes for VL monitoring for HIV-infected adolescents. Our results will contribute to research on whether POC VL testing is a feasible testing method which could be incorporated into health systems in similar resource-limited settings and whether it can improve outcomes among HIV-infected adolescents.

Conditions

HIV

Keywords

adolescent; HIV; point-of-care; viral load

Outcome Measures

Primary Outcomes (1)

• The number of steps in the HIV care cascade involved with viral load testing.

  The number of steps within the HIV care cascade involved with viral load testing will be measured comparing standard laboratory-based testing to POC testing.

  1 day of clinic visit

Secondary Outcomes (2)

• The proportion of participants who demonstrate comprehension of the correlation between ART adherence and viral level

  1 month

• The proportion of participants who achieve or sustain a viral level <1000 cells/ml

  6 months

Study Arms (2)

Standard-of-care

NO INTERVENTION

Participants in the standard-of-care arm will receive a standard laboratory-based viral load test at baseline, 3, and 6 months.

Point-of-care

EXPERIMENTAL

Participants in the point-of-care arm will receive a point-of-care viral load test at baseline, 3, and 6 months.

Diagnostic Test: point-of-care viral load test

Interventions

point-of-care viral load test DIAGNOSTIC_TEST

A point-of-care viral load test returns viral load test results within 90 minutes.

Point-of-care

Eligibility Criteria

• Age: 10 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Aged 10-24 years
• HIV-infected
• On ART for \> 6 months
• Permanent residence in Port-au-Prince
• Able to provide informed consent/assent

You may not qualify if:

• Requires urgent VL test the day of enrollment/randomization
• Requires ART regimen change
• Currently pregnant
• Co-infected with tuberculosis
• Severe co-morbidities including cognitive impairment, bipolar disorder, psychosis, or current need for inpatient psychiatric hospitalization

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic: collaborator

Study Sites (1)

GHESKIO

Port-au-Prince, Haiti

Location

Related Publications (2)

• Reif LK, Belizaire ME, Rouzier V, Seo G, Severe P, Bajo Joseph JM, Joseph B, Apollon S, Pape JW, McNairy ML, Elul B, Fitzgerald DW, Arpadi SM, Abrams EJ, Kuhn L. Point-of-care viral load testing among adolescents and young adults living with HIV in Haiti: a randomized control trial. AIDS Care. 2022 Apr;34(4):409-420. doi: 10.1080/09540121.2021.1981816. Epub 2021 Oct 6.

  PMID: 34612092 DERIVED

• Reif LK, Belizaire ME, Seo G, Rouzier V, Severe P, Joseph JM, Joseph B, Apollon S, Abrams EJ, Arpadi SM, Elul B, Pape JW, McNairy ML, Fitzgerald DW, Kuhn L. Point-of-care viral load testing among adolescents and youth living with HIV in Haiti: a protocol for a randomised trial to evaluate implementation and effect. BMJ Open. 2020 Aug 31;10(8):e036147. doi: 10.1136/bmjopen-2019-036147.

  PMID: 32868354 DERIVED

Study Officials

• Daniel Fitzgerald, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 13, 2017
• First Posted: September 20, 2017
• Study Start: May 3, 2018
• Primary Completion: January 30, 2020
• Study Completion: January 30, 2020
• Last Updated: July 29, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share

Locations

HA (1)