An interventional study of Enhanced virologic monitoring in HIV Infections, Viremia and Pregnancy Related, sponsored by University of California, San Francisco. Completed at 4 sites in Kenya. Open to female participants. Per ClinicalTrials.gov, last updated 2025-08-14.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Supportive care
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.
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.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's enrollment of 550 is above the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Enhanced virologic monitoring
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)).
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.
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)
We enrolled 550 participants
| Milestone | Pilot | Controls - Prospectively Enrolled | Controls - Abstracted From Records |
|---|---|---|---|
| Started | 275 | 125 | 150 |
| Completed | 273 | 123 | 149 |
| Not completed | 2 | 2 | 1 |
| Withdrew: Duplicate enrollment | 2 | 2 | 1 |
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.
| Participants | Pilot | Controls - Prospectively Enrolled | Controls - Abstracted From Records |
|---|---|---|---|
| Plasma HIV RNA >50 Copies/mL | 34 | 13 | 15 |
Collected over 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). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pilot | 0/273 (0%) | 0/273 (0%) | 0/273 (0%) |
| Controls - Prospectively Enrolled | 0/123 (0%) | 0/123 (0%) | 0/123 (0%) |
| Controls - Abstracted From Records | 0/149 (0%) | 0/149 (0%) | 0/149 (0%) |
| Age, Continuous(years) | Pilot | Controls - Prospectively Enrolled | Controls - Abstracted From Records | Total |
|---|---|---|---|---|
| Median | 30 (25 to 34) | 30 (27 to 34) | 31 (27 to 36) | 30 (26 to 35) |
| Sex: Female, Male(Participants) | Pilot | Controls - Prospectively Enrolled | Controls - Abstracted From Records | Total |
|---|---|---|---|---|
| Female | 273 | 123 | 149 | 545 |
| Male | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Pilot | Controls - Prospectively Enrolled | Controls - Abstracted From Records | Total |
|---|---|---|---|---|
| Black African | 273 | 123 | 149 | 545 |
| Region of Enrollment(participants) | Pilot | Controls - Prospectively Enrolled | Controls - Abstracted From Records | Total |
|---|---|---|---|---|
| Kenya | 273 | 123 | 149 | 545 |
| Viral load in prior 12 months(Participants) | Pilot | Controls - Prospectively Enrolled | Controls - Abstracted From Records | Total |
|---|---|---|---|---|
| Suppressed viral load (per clinical records) | 175 | 82 | 94 | 351 |
| Not suppressed viral load (per clinical records) | 47 | 21 | 18 | 86 |
| No record (missing) | 51 | 20 | 37 | 108 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2023 to primary completion in Jun 2024, 13 months.
Results were first posted in Aug 2025, 1 year 1 month after primary completion.
Of 393 non-industry interventional studies with no phase under HIV Infections, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 45. This study's 13 months is below that.
Counting every sponsor, half of 402 studies reached it within 28 months; a quarter within 16 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of California, San Francisco →