Enhanced Virologic Monitoring for Pregnant and Postpartum Women With HIV

Not Applicable

Completed

• Conditions: HIV Infections; Viremia; Pregnancy Related
• Interventions: Behavioral: Enhanced virologic monitoring

• Registration Number: NCT05845619
• Lead Sponsor: University of California, San Francisco

Brief 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.

Study Timeline

• Study First Submitted: 2023-04-25
• Study First Submitted QC: 2023-04-25
• Study First Posted: 2023-05-06
• Study Start: 2023-05-08
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 550

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pilot	Enhanced virologic monitoring	-

Primary Outcome Measures

Name	Time	Method
Virologic suppression	Within 6 months after study engagement (i.e., after pilot study participation; after the enrollment visit for prospectively enrolled controls; after the date of eligibility for controls from records)	Plasma HIV RNA \<50 copies/mL. Data will be collected from clinical records. If \>1 viral load is collected during the time frame below, the first will be used.

Trial Locations

Locations (4)

Lumumba Sub County Hospital; 🇰🇪 Kisumu, Kenya

Ahero County Hospital; 🇰🇪 Nyando, Kenya

Nyakach County Hospital; 🇰🇪 Nyakach, Kenya

Rabuor Sub county Hospital; 🇰🇪 Nyando, Kenya