Enhanced Virologic Monitoring for Pregnant and Postpartum Women With HIV
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About
The goal of this study is to learn about supporting pregnant and postpartum women living with HIV with treatment adherence. The investigators will conduct a pilot study of an intervention that includes peer counseling about viral load levels and rapid delivery of viral load results. The investigators will evaluate the feasibility of the intervention, and will assess whether it improves viral suppression 6 months following the intervention, compared to historical controls.
Full description
The investigators will examine the use of more frequent virologic monitoring with enhanced communication around low-level viremia as a strategy to identify and support pregnant and postpartum women at risk of virologic failure. Virologic monitoring itself can reinforce adherence in stable patients, and more frequent monitoring can detect potential adherence challenges early. Notably, low-level viremia is a strong predictor of subsequent virologic failure, and the lowest level associated with perinatal transmission is not known.
The pilot study will run for 6 months at 4 Ministry of Health facilities in Kisumu County, Kenya; 275 participants will be enrolled. Prior to the pilot study, 125 controls will be enrolled prospectively, and 150 controls will be abstracted from records from the prior year.
Enrollment
Sex
Volunteers
Inclusion criteria
- Women living with HIV
- On antiretroviral treatment
- Either pregnant in the 3rd trimester, OR, postpartum within 6 months of delivery
Exclusion criteria
- n/a
Trial design
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Interventional model
Masking
550 participants in 3 patient groups
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Central trial contact
Pamela Murnane, PhD
Data sourced from clinicaltrials.gov
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