Enhanced Virologic Monitoring for Pregnant and Postpartum Women With HIV

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Inflammation Lentivirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Related RNA Virus Infections Retroviridae Infections Sepsis Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Systemic Inflammatory Response Syndrome Urogenital Diseases Viremia Virus Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Lumumba Sub County Hospital, Kisumu, Kenya

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Women living with HIV
On antiretroviral treatment
Either pregnant in the 3rd trimester, OR, postpartum within 6 months of delivery

Exclusion criteria

Treatment and study plan

Enhanced virologic monitoring

Behavioral

The pilot intervention will include the following components:

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.
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.
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)).

Primary outcomes

Plasma HIV RNA >50 Copies/mL

Time frame: 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 only, no participant interaction. If >1 viral load is collected during the time frame below, the first will be used.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

Kenya Medical Research Institute
National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: May 6, 2023
Registry last updated: Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed