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

January 25, 2021 updated by: Clinton Health Access Initiative Inc.

Impact of Point-of-Care (POC) Viral Load (VL) Testing on Ensuring Appropriate Management of Viremia During Pregnancy to Prevent Vertical Transmission: an Observational Difference-in-difference Cohort Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Twenty public health facilities that offer HIV care to pregnant women and maternity services will be included in the study with half offering VL testing at the first antenatal care visit using the centralized VL system (standard of care cluster) and the other half offering onsite POC VL (POC cluster). The primary end-point will be the proportion of enrolled pregnant women who are virally suppressed at the time of delivery. Positivity rate will be measured as a secondary outcome. Primary and secondary outcomes will be compared between study arms. As well, a baseline assessment in each facility will be included to enable a difference in difference analysis within clusters, in which viral suppression rates at delivery and other outcomes are compared before and after the intervention.

The primary research question to be addressed by this study is: Does the availability of POC VL testing during ANC increase the proportion of women who are virally suppressed at the time of delivery?

The primary objective is to demonstrate the impact of POC VL on ensuring viral suppression at the time of delivery (defined as a viral load < 1,000 cpm within 2 weeks of delivery) for pregnant women living with HIV (PWLHIV) who are on ART in order to avert vertical transmission.

In addition, this study will:

  • document the at-birth and 4-6 week EID positivity rate
  • document proportion of women who have undetectable VL at the time of delivery (defined as below the limit of detection (LOD) of the VL test)
  • document the baseline coverage of VL monitoring during the first ANC visit for WLHIV on ART ≥ 6 months
  • compare the timeliness of VL result receipt by clinics (HCW) and clients between facilities with POC VL and those using centralized testing
  • calculate the cost-effectiveness of POC VL for increasing the proportion of women who are virally suppressed at delivery

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1715

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Zimbabwe
      • Bulawayo, Zimbabwe
        • Luveve Clinic
      • Bulawayo, Zimbabwe
        • Mpilo Central Hospital
      • Bulawayo, Zimbabwe
        • Nkulumane Clinic
      • Bulawayo, Zimbabwe
        • Pelandaba Clinic
      • Bulawayo, Zimbabwe
        • United Bulawayo Hospital
      • Harare, Zimbabwe
        • Budiriro PolyClinic
      • Harare, Zimbabwe
        • Chitungwiza Central Hospital
      • Harare, Zimbabwe
        • Gleview
      • Harare, Zimbabwe
        • Hatcliffe PolyClinic
      • Harare, Zimbabwe
        • Highfield PolyClinic
      • Harare, Zimbabwe
        • Kambuzuma
      • Harare, Zimbabwe
        • Kuwadzana Polyclinic
      • Harare, Zimbabwe
        • Mabvuku Polyclinic
      • Harare, Zimbabwe
        • Mbare polyclinic
      • Harare, Zimbabwe
        • Rujeko
      • Harare, Zimbabwe
        • Rutsanana PolyClinic
      • Harare, Zimbabwe
        • Seke South Clinic
      • Harare, Zimbabwe
        • St. Mary's Clinic
      • Harare, Zimbabwe
        • Warren Park PolyClinic
      • Harare, Zimbabwe
        • Zengeza Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Sites will be selected for inclusion in the study based on following criteria:

  • Offer HIV testing and antiretroviral therapy (ART) services
  • Offer prevention of mother-to-child transmission (PMTCT) and maternity services
  • Offer Viral load monitoring either using POC or through referral
  • Availability of Second line ART
  • Located in 2 provinces in which VL testing labs are located
  • Have historic monthly ANC cohorts of ≥ 6 pregnant women living with HIV (PWLHIV) already on ART

Patient Inclusion Criteria:

Baseline Cohort:

All women living with HIV on ART ≥7 months who deliver at the study facilities during the enrollment period, who do not meet the study criteria for the intervention cohort, were on ART at ANC1 and are of the age of consent (≥ 18 years old) will be offered participation. Informed consent will be obtained to collect a study-specific blood sample to perform a VL test in the central lab at the time of delivery. 7 months has been selected to be comparable to women in the intervention cohort who may present for ANC1 at 4 weeks prior to delivery who are on ART ≥ 6 months.

Intervention Cohort:

Pregnant women who are known to be living with HIV and on ART for ≥ 6 months and attend the study facilities for ANC services and have an anticipated due date ≥ 4 weeks, will be offered participation in the study. It is expected that a woman who is on ART < 6 months may not yet have achieved viral suppression (using current NNRTI-containing regimens) and therefore conducting a VL at this time is not currently standard. According to Zimbabwe guidelines and consistent with normative guidance from the World Health Organization (WHO), any infant born to a woman living with HIV who is on ART for less than 4 weeks is considered at high risk of HIV transmission. Therefore, for this study the first ANC visit must be ≥ 4 weeks prior to delivery. Women must be at least the age of adult consent (≥ 18 years old) in Zimbabwe. If consent is obtained, a sample will be collected at ANC1 for VL testing.

Patient Exclusion Criteria:

Baseline Cohort

  • PWLHIV not on ART at ANC1 or on ART < 7 months at time of delivery
  • Women who have enrolled in or are eligible for the intervention cohort
  • Women who are not HIV positive
  • Pregnant women who are newly diagnosed as HIV positive during pregnancy
  • Women who cannot or do not provide informed consent

Intervention Cohort

  • Pregnant women who are newly diagnosed as HIV positive during pregnancy
  • PWLHIV not on ART or on ART < 6 months at their first ANC visit
  • Women who are not HIV positive
  • Women who cannot or do not provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Point-of-care (POC)
All facilities will receive a refresher training on Zimbabwe's 2018 Guidelines. At POC facilities, at the first antenatal visit (ANC1), all women enrolled in the intervention cohort will have a blood sample collected for VL which will be tested onsite using an existing POC device. If a woman is virally unsuppressed (VL ≥1000 cpm), she will be given adherence counseling and, if necessary, a treatment regimen switch/infant prophylaxis per national guidelines.
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 Names:
  • GeneXpert
Active Comparator: Standard of care (SOC)
All facilities will receive a refresher training on Zimbabwe's 2018 Guidelines. At SOC facilities, at ANC1, all women enrolled in the intervention cohort will have a blood sample collected for VL which will be sent to centralized labs for testing. If a woman is virally unsuppressed (VL ≥1000 cpm), she will be given adherence counseling and, if necessary, a treatment regimen switch/infant prophylaxis per national guidelines.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Viral suppression at delivery
Time Frame: Within 2 weeks after delivery
The proportion of enrolled PWLHIV on ART ≥ 6 months at their first ANC visit who are virally suppressed at delivery
Within 2 weeks after delivery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Viral suppression at delivery among those with an unsuppressed viral load at first antenatal care visit
Time Frame: Within 2 weeks after delivery
The proportion of enrolled PWLHIV identified as having unsuppressed VL at first ANC who suppress at delivery
Within 2 weeks after delivery
Infant HIV infection
Time Frame: Within 6 weeks of birth
The proportion of infants who test HIV positive at birth and/or 4-6 weeks using an early infant diagnosis (EID) test
Within 6 weeks of birth
Turnaround time to VL results available at facility
Time Frame: Through end of the study, approximately 1 year
The time between VL sample collection and result receipt by health care provider
Through end of the study, approximately 1 year
Turnaround time to VL results available to patient
Time Frame: Through end of the study, approximately 1 year
The time between VL sample collection and result receipt by pregnant woman living with HIV
Through end of the study, approximately 1 year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Costing of POC VL
Time Frame: Through end of the study, approximately 1 year
The commodity costs of VL testing at ANC1 on the POC platform will be calculated ($USD per patient) and compared to the commodity costs of VL testing using the central laboratory given any differences in the primary and secondary endpoints by group
Through end of the study, approximately 1 year
Acceptability of POC VL
Time Frame: End of the study, approximately 1 year after study start
The acceptability to healthcare workers of offering POC VL testing at the first ANC visit, based on a survey
End of the study, approximately 1 year after study start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Clinton Health Access Initiative Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministry of Health and Child Welfare, Zimbabwe

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 5, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 2, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • POC VL during pregnancy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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