Enhanced Virologic Monitoring for Pregnant and Postpartum Women With HIV

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05845619
• Other study ID #: K01MH119910
• Secondary ID: K01MH119910
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 8, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2024
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 550
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections
• Pregnancy Related
• Viremia

Intervention

Behavioral:
• Enhanced virologic monitoring
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)).

Locations

Country	Name	City	State
Kenya	Lumumba Sub County Hospital	Kisumu
Kenya	Nyakach County Hospital	Nyakach
Kenya	Ahero County Hospital	Nyando
Kenya	Rabuor Sub county Hospital	Nyando

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	Kenya Medical Research Institute, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Virologic suppression	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.	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)