Enhanced Virologic Monitoring for Pregnant and Postpartum Women With HIV

NCT05845619 | Completed Results

• 1 other identifier: K01MH119910
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 4

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.

Conditions

HIV Infections; Viremia; Pregnancy Related

Outcome Measures

Primary Outcomes (1)

• Plasma HIV RNA >50 Copies/mL

  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.

  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)

Study Arms (3)

Pilot

EXPERIMENTAL

Behavioral: Enhanced virologic monitoring

Controls - prospectively enrolled

NO INTERVENTION

Controls - abstracted from records

NO INTERVENTION

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)).

Pilot

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• n/a

Sponsors & Collaborators

• University of California, San Francisco: lead
• Kenya Medical Research Institute: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (4)

Lumumba Sub County Hospital

Kisumu, Kenya

Location

Nyakach County Hospital

Nyakach, Kenya

Location

Ahero County Hospital

Nyando, Kenya

Location

Rabuor Sub county Hospital

Nyando, Kenya

Location

Related Publications (1)

• Murnane PM, Ouma S, Onyango R, Mukand N, Thapar I, Odhiambo F, Kabami J, Bukusi EA, Cohen CR, Ayieko J. Engaging Mentor Mothers in Rapid Return of Viral Load Results to Pregnant and Postpartum Women Living with HIV: An Implementation Pilot Study. AIDS Behav. 2025 Dec 23. doi: 10.1007/s10461-025-04987-2. Online ahead of print.

  PMID: 41432869 DERIVED

MeSH Terms

Conditions

HIV Infections; Viremia

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

This was a pilot study, and therefore not powered to detect statistically significant differences between intervention and control. Additionally, participants were not randomized and may have different baseline risks for subsequent viremia.

Results Point of Contact

• Title: Pamela Murnane
• Organization: University of California San Francisco

pamela.murnane@ucsf.edu

4155021000

Study Officials

• Pamela Murnane, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot study participants will be compared to historical controls.

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 6, 2023
• Study Start: May 8, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: August 14, 2025
• Results First Posted: August 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

KE (4)