Enhanced Virologic Monitoring for Pregnant and Postpartum Women With HIV

Sponsor
University of California, San Francisco
Study ID
NCT05845619
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Enhanced virologic monitoring — BEHAVIORAL
    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)).

Study Details

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.

Key Dates

Start date
May 8, 2023
Status verified
Jul 2025
Primary completion
Jun 30, 2024
Completion
Jun 30, 2024

Study Design

Enrollment
550 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Pilot
  • No Intervention: Controls - prospectively enrolled
  • No Intervention: Controls - abstracted from records

Primary Outcome Measure

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) ]

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