An interventional study of Point-of-care (POC) viral load (VL) testing plus refresher training and Standard of care central laboratory VL testing plus refresher training in HIV Infections, sponsored by Clinton Health Access Initiative Inc.. Completed at 20 sites in Zimbabwe. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-27.
Sponsored by Clinton Health Access Initiative Inc. · Not applicable, Interventional, and Diagnostic
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.
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:
Sites will be selected for inclusion in the study based on following criteria:
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
Intervention Cohort
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
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 POC VL testing in pregnant women, and a refresher training on Zimbabwe's guidelines will be provided at all facilities
Also known as: GeneXpert
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
Viral suppression at delivery
The proportion of enrolled PWLHIV on ART ≥ 6 months at their first ANC visit who are virally suppressed at delivery
Time frame: Within 2 weeks after delivery
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Through end of the study, approximately 1 year
Costing of POC VL
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
Time frame: Through end of the study, approximately 1 year
Acceptability of POC VL
The acceptability to healthcare workers of offering POC VL testing at the first ANC visit, based on a survey
Time frame: End of the study, approximately 1 year after study start
Plan to share: No
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Clinton Health Access Initiative Inc.