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| ID | Type | Description | Link |
|---|---|---|---|
| K01MH119910 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Kenya Medical Research Institute | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pilot | Experimental |
| |
| Controls - prospectively enrolled | No Intervention | ||
| Controls - abstracted from records | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced virologic monitoring | Behavioral | The pilot intervention will include the following components:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pamela Murnane, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lumumba Sub County Hospital | Kisumu | Kenya | ||||
| Nyakach County Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41432869 | Derived | 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. |
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There was no pre-assignment procedure
We enrolled 550 participants
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| ID | Title | Description |
|---|---|---|
| FG000 | Pilot | Enhanced virologic monitoring: The pilot intervention will include the following components:
|
| FG001 | Controls - Prospectively Enrolled | routine care |
| FG002 | Controls - Abstracted From Records | routine care |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pilot | Enhanced virologic monitoring: The pilot intervention will include the following components:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants | Posted | Count of Participants | Participants | 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) |
|
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)
We followed the clinicaltrials.gov definition of an adverse event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pilot | Enhanced virologic monitoring | 0 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pamela Murnane | University of California San Francisco | 4155021000 | pamela.murnane@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 27, 2023 | May 30, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 7, 2023 | Jul 1, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D014766 | Viremia |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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Pilot study participants will be compared to historical controls.
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|
| Nyakach |
| Kenya |
| Ahero County Hospital | Nyando | Kenya |
| Rabuor Sub county Hospital | Nyando | Kenya |
| BG001 | Controls - Prospectively Enrolled | routine care |
| BG002 | Controls - Abstracted From Records | routine care |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Viral load in prior 12 months | Values were collected from records only, no study participant interaction. (Suppression=good; non-suppression=not good; missing=unknown) | Count of Participants | Participants |
|
| OG002 | Controls - Abstracted From Records | routine care |
|
|
|
| 273 |
| 0 |
| 273 |
| 0 |
| 273 |
| EG001 | Controls - Prospectively Enrolled | routine care | 0 | 123 | 0 | 123 | 0 | 123 |
| EG002 | Controls - Abstracted From Records | routine care | 0 | 149 | 0 | 149 | 0 | 149 |
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D018805 | Sepsis |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |