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Impact of Point-of-care (POC) Viral Load (VL) Testing During Pregnancy in Zimbabwe

NCT04048629 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1715

Last updated 2021-01-27

No results posted yet for this study

Summary

The Ministry of Health and Child Care (MOHCC) in collaboration with Clinton Health Access Initiative (CHAI) will conduct an observational cohort study to determine the impact and cost-effectiveness of POC VL testing for pregnant women. It is hypothesized that POC VL testing will enable an increased proportion of pregnant women to be virally suppressed at delivery, which will avert vertical transmission.

Conditions

  • HIV Infections

Interventions

DEVICE

Point-of-care (POC) viral load (VL) testing plus refresher training

VL testing at the first antenatal care visit will occur using POC VL testing in pregnant women, and a refresher training on Zimbabwe's guidelines will be provided at all facilities

OTHER

Standard of care central laboratory VL testing plus refresher training

VL testing at the first antenatal care visit will occur using central laboratory VL testing in pregnant women, and a refresher training on Zimbabwe's guidelines will be provided at all facilities

Sponsors & Collaborators

  • Ministry of Health and Child Welfare, Zimbabwe

    collaborator OTHER

  • Clinton Health Access Initiative Inc.

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-05
Primary Completion
2020-08-31
Completion
2020-08-31

Countries

  • Zimbabwe

Study Locations

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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 NCT04048629 on ClinicalTrials.gov