NCT05845619

Enhanced Virologic Monitoring for Pregnant and Postpartum Women With HIV

Implementing a Risk Score to Facilitate Enhanced Adherence Support for Pregnant and Postpartum Women at Risk of Viremia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 550 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• HIV Infections
• Viremia
• Pregnancy Related

Interventions

Type	Name	Description
BEHAVIORAL	Enhanced virologic monitoring	The pilot intervention will include the following components: 1. More frequent viral load collection: Participants who enroll in the first 3 months of the pilot study period will be eligible for a 3-month follow-up visit and will have viral load assessed again at that time. 2. Rapid return of viral load results: Mentor mothers (peer counselors) will be trained to return viral load results to patients. Viral loads will will be processed with GeneXpert point of care technology. 3. Enhanced viral load counseling: Mentor mothers will reinforce adherence with all patients with undetectable levels via scripted messaging to reward and encourage healthy behavior. For those with any detectable levels, mentor mothers will be trained to provide targeted counseling with scripted messaging according to viral load level (undetectable, low-level viremia (50-1000), high viral load (\>1000)).

Timeline

• Start date: 2023-05-08
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2023-05-06
• Last updated: 2025-08-14
• Results posted: 2025-08-14

Locations

4 sites across 1 country: Kenya