NCT04048629

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,715 (actual)
• Sponsor: Clinton Health Access Initiative Inc. · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-08-05
• Primary completion: 2020-08-31
• Completion: 2020-08-31
• First posted: 2019-08-07
• Last updated: 2021-01-27

Locations

20 sites across 1 country: Zimbabwe