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

NCT03288246 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2020-07-29

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

point-of-care viral load test

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

Sponsors & Collaborators

  • Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic

    collaborator OTHER

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Daniel Fitzgerald, MD · Weill Medical College of Cornell University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
24 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-03
Primary Completion
2020-01-30
Completion
2020-01-30

Countries

  • Haiti

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03288246 on ClinicalTrials.gov