CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 550 enrolled
Drug / intervention
Enhanced virologic monitoringbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05845619
NCT05845619N/ACompleted

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

University of California, San Francisco·interventional·Posted May 6, 2023·Updated Aug 14, 2025

In Brief

A clinical study evaluating Enhanced virologic monitoring for HIV Infections and 2 related conditions. Completed, enrolled 550 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesKenya

Timeline

N/ACompletedFinished
202420252026
First PostedMay 6, 2023
Enrollment StartMay 8, 2023
Primary CompletionJun 30, 2024
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 3.2 years ago

Interventions

Enhanced virologic monitoringbehavioral

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)).