HIV InfectionsNCT05845619

Enhanced Virologic Monitoring for Pregnant and Postpartum Women With HIV

A study testing Enhanced virologic monitoring in people with HIV Infections and Viremia, run by University of California, San Francisco at 4 sites in Kenya.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age, women only
Conditions the study is for: HIV Infections, Viremia, Pregnancy Related
What is being tested?: Enhanced virologic monitoring
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 550 participants
Where: 4 sitesKenya
Study dates: 8 May 2023to 30 Jun 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
Women only
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

Trial locations and contacts

4 sites in 1 country.

Kenya4 sites

Lumumba Sub County Hospital
Kisumu
Nyakach County Hospital
Nyakach
Ahero County Hospital
Nyando
Rabuor Sub county Hospital
Nyando

Other trials in Kenya

About this study

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

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.

Read the detailed 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.

Conditions: HIV Infections, Viremia, Pregnancy Related
Being tested: Enhanced virologic monitoring
Medical subject headings: HIV Infections, Viremia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Enhanced virologic monitoringBehavioural
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 groups in NCT05845619
Study group	Role	What they receive
Pilot	Experimental	Not described Receives: Behavioral: Enhanced virologic monitoring
Controls - prospectively enrolled	No intervention	Not described
Controls - abstracted from records	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 May 202330 Jun 2024

First posted6 May 2023
Study start8 May 2023
Primary completion30 Jun 2024
Study completion30 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
More trials run by University of California, San FranciscoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Pilot study participants will be compared to historical controls.
Masking: None (open label)
Enrolment: 550 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05845619
Sponsor's protocol ID: K01MH119910
Other IDs: K01MH119910
Status last verified: Jul 2025
First submitted: 25 Apr 2023
Last updated: 14 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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. 2026 May;30(5):1589-1598. doi: 10.1007/s10461-025-04987-2. Epub 2025 Dec 23.
PubMed 41432869

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Implementing a Risk Score to Facilitate Enhanced Adherence Support for Pregnant and Postpartum Women at Risk of Viremia
ClinicalTrials.gov ID: NCT05845619
Acronym / sponsor ID: K01MH119910
Conditions: HIV Infections, Viremia, Pregnancy Related
Study type: Interventional
Recruitment status: Completed
Enrolment: 550 participants (actual)
Lead sponsor: University of California, San FranciscoUniversity, hospital or other
Collaborators: Kenya Medical Research Institute, National Institute of Mental Health (NIMH)
Study start: 8 May 2023 (actual)
Primary completion: 30 Jun 2024 (actual)
Study completion: 30 Jun 2024 (actual)
First posted: 6 May 2023 (actual)
Results: Posted 14 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: Pilot study participants will be compared to historical controls.

Arm	Type	Receives
Pilot	Experimental	Behavioral: Enhanced virologic monitoring
Controls - prospectively enrolled	No intervention	–
Controls - abstracted from records	No intervention	–

Who may qualify

Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (1 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Enhanced virologic monitoringThe 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)).	Behavioural	Pilot

Primary outcome

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.

Results and safety

Results posted to the registry on 14 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pilot	275	273
Controls - Prospectively Enrolled	125	123
Controls - Abstracted From Records	150	149

Primary outcome: 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). Count of participants. Unit: Participants

Measure	Pilot n = 273	Controls - Prospectively Enrolled n = 123	Controls - Abstracted From Records n = 149
Value	34	13	15

Pilot vs Controls - Prospectively Enrolled: Odds Ratio (OR): 1.21 (95% CI 0.83 to 1.76), p = 0.33, Regression, Logistic
Pilot vs Controls - Abstracted From Records: Odds Ratio (OR): 1.25 (95% CI 0.73 to 2.14), p = 0.41, Regression, Logistic

Population analysed: All participants

Adverse events

Time frame: Prospectively enrolled controls had only one cross sectional visit. Among 273 pilot participants, 124 had only a baseline cross sectional visit and 149 had both a baseline visit and a 3 month follow up visit. (this was a 6-month pilot implementation study at the facilities, and thus only those enrolled during the first 3 months reached the period in which a 3 month follow- up was possible). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pilot	0 of 273 (0%)	0 of 273 (0%)	0 of 273
Controls - Prospectively Enrolled	0 of 123 (0%)	0 of 123 (0%)	0 of 123
Controls - Abstracted From Records	0 of 149 (0%)	0 of 149 (0%)	0 of 149

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41432869Murnane 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. 2026 May;30(5):1589-1598. doi: 10.1007/s10461-025-04987-2. Epub 2025 Dec 23.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pamela Murnane, PhD principal investigator

University of California, San Francisco

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Enhanced virologic monitoring in people with HIV Infections and Viremia, run by University of California, San Francisco at 4 sites in Kenya.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05845619, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.