HIV InfectionsNCT04048629
Impact of Point-of-care (POC) Viral Load (VL) Testing During Pregnancy in Zimbabwe
A study testing Point-of-care (POC) viral load (VL) testing plus refresher training in people with HIV Infections, run by Clinton Health Access Initiative Inc. at 20 sites in Zimbabwe.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV Infections
- What is being tested?
- Point-of-care (POC) viral load (VL) testing plus refresher training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,715 participants
- Where
- 20 sitesZimbabwe
- Study dates
- 5 Aug 2019to 31 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Zimbabwe20 sites
Luveve Clinic
Bulawayo
Mpilo Central Hospital
Bulawayo
Nkulumane Clinic
Bulawayo
Pelandaba Clinic
Bulawayo
United Bulawayo Hospital
Bulawayo
Budiriro PolyClinic
Harare
Chitungwiza Central Hospital
Harare
Gleview
Harare
Hatcliffe PolyClinic
Harare
Highfield PolyClinic
Harare
Kambuzuma
Harare
Kuwadzana PolyClinic
Harare
Mabvuku PolyClinic
Harare
Mbare PolyClinic
Harare
Rujeko
Harare
Rutsanana PolyClinic
Harare
Seke South Clinic
Harare
St. Mary's Clinic
Harare
Warren Park PolyClinic
Harare
Zengeza Clinic
Harare
About this study
Official title: 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.
Read the 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
- Conditions
- HIV Infections
- Being tested
- Point-of-care (POC) viral load (VL) testing plus refresher training, Standard of care central laboratory VL testing plus refresher training
- Keywords
- Zimbabwe, HIV, Viral load, Point-of-care, GeneXpert
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-care (POC) viral load (VL) testing plus refresher trainingDevice
Also called GeneXpert
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
Standard of care central laboratory VL testing plus refresher trainingOther
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
| Study group | Role | What they receive |
|---|---|---|
| Point-of-care (POC) | Experimental | 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. Receives: Device: Point-of-care (POC) viral load (VL) testing plus refresher training |
| Standard of care (SOC) | Active comparator | 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. Receives: Other: Standard of care central laboratory VL testing plus refresher training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral suppression at delivery
The proportion of enrolled PWLHIV on ART ≥ 6 months at their first ANC visit who are virally suppressed at delivery
Measured: Within 2 weeks after delivery
Secondary outcomes (4)
Viral suppression at delivery among those with an unsuppressed viral load at first antenatal care visit
The proportion of enrolled PWLHIV identified as having unsuppressed VL at first ANC who suppress at delivery
Measured: Within 2 weeks after delivery
Infant HIV infection
The proportion of infants who test HIV positive at birth and/or 4-6 weeks using an early infant diagnosis (EID) test
Measured: Within 6 weeks of birth
Turnaround time to VL results available at facility
The time between VL sample collection and result receipt by health care provider
Measured: Through end of the study, approximately 1 year
Turnaround time to VL results available to patient
The time between VL sample collection and result receipt by pregnant woman living with HIV
Measured: Through end of the study, approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start5 Aug 2019
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study is an observational cohort study with a baseline assessment, which will be used to conduct a difference in difference (DiD) analysis. The study design allows for assessment in more than one cross-section: 1) intervention clusters will be compared with control and 2) post-intervention clusters will be compared with an earlier baseline condition in control and intervention arms. The intervention (POC compared to centralized VL) is being offered at the facility level, as viral load testing is an intervention that is carried out on a clinic level, rather than at an individual patient level. The study is intended to investigate the effect of offering on-site POC VL testing on the proportion of enrolled PWLHIV who are virally suppressed at the time of delivery.
- Masking
- None (open label)
- Enrolment
- 1,715 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinton Health Access Initiative Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health and Child Welfare, Zimbabwe
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04048629
- Sponsor's protocol ID
- POC VL during pregnancy
- Status last verified
- Jan 2021
- First submitted
- 2 Aug 2019
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04048629
- Acronym / sponsor ID
- POC VL during pregnancy
- Conditions
- HIV Infections
- Keywords
- Zimbabwe, HIV, Viral load, Point-of-care, GeneXpert
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,715 participants (actual)
- Lead sponsor
- Clinton Health Access Initiative Inc.University, hospital or other
- Collaborators
- Ministry of Health and Child Welfare, Zimbabwe
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 7 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is an observational cohort study with a baseline assessment, which will be used to conduct a difference in difference (DiD) analysis. The study design allows for assessment in more than one cross-section: 1) intervention clusters will be compared with control and 2) post-intervention clusters will be compared with an earlier baseline condition in control and intervention arms. The intervention (POC compared to centralized VL) is being offered at the facility level, as viral load testing is an intervention that is carried out on a clinic level, rather than at an individual patient level. The study is intended to investigate the effect of offering on-site POC VL testing on the proportion of enrolled PWLHIV who are virally suppressed at the time of delivery.
| Arm | Type | Receives |
|---|---|---|
| Point-of-care (POC) | Experimental | Device: Point-of-care (POC) viral load (VL) testing plus refresher trainingAll 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. |
| Standard of care (SOC) | Active comparator | Other: Standard of care central laboratory VL testing plus refresher trainingAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point-of-care (POC) viral load (VL) testing plus refresher trainingAlso: GeneXpertVL 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 | Device | Point-of-care (POC) |
| Standard of care central laboratory VL testing plus refresher trainingVL 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 | Other | Standard of care (SOC) |
Primary outcome
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
4 secondary outcomes
Viral suppression at delivery among those with an unsuppressed viral load at first antenatal care visit
Time frame: Within 2 weeks after delivery
Infant HIV infection
Time frame: Within 6 weeks of birth
Turnaround time to VL results available at facility
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Point-of-care (POC) viral load (VL) testing plus refresher training in people with HIV Infections, run by Clinton Health Access Initiative Inc. at 20 sites in Zimbabwe.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Zimbabwe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral suppression at delivery (time frame: Within 2 weeks after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.