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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH121245 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Kenya Medical Research Institute | OTHER |
| Children's Mercy Hospital Kansas City | OTHER |
| Global Health Innovations Foundation - Kenya | UNKNOWN |
| National Institute of Mental Health (NIMH) |
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The goal of this project is to rigorously evaluate the efficacy of HIV Infant Tracking System 2.1 (HITSystem, an eHealth intervention that uses short message service (SMS) texts to patients and algorithm-driven electronic alerts for providers) to increase retention in guideline-adherent prevention of mother-to-child transmission of HIV services (PMTCT) and to increase viral suppression and appropriate clinical action through the extended period of 6 months postpartum, compared to standard of care PMTCT services in a matched, cluster randomized controlled trial.
Despite progress in providing comprehensive prevention of mother-to-child transmission of HIV (PMTCT) services, significant gaps in the timely uptake and provision of guideline-adherent services and maternal retention in care remain. Such gaps create missed opportunities for preventing mother-to-child transmission and result in nearly 6,100 infants becoming infected with HIV each year in Kenya. Effective interventions that routinize the delivery of evidence-based PMTCT services and foster consistent patient engagement are essential to close the remaining gaps and eliminate mother-to-child transmission of HIV. Building off of a successful R34 grant to develop and pilot test the HITSystem 2.0, an eHealth intervention targeting PMTCT services, the overall goal of this proposal is to use a cluster randomized control design at 12 Kenyan government hospitals to evaluate a modified HITSystem 2.1 intervention. HITSystem 2.1 reflects the 2018 Kenyan PMTCT guidelines, including routine viral load monitoring and interventions to suppress maternal viral load. The investigators aim to evaluate the impact of HITSystem 2.1 to optimize the provision of guideline-adherent services and viral suppression through the antenatal, delivery, and early postpartum periods. Aim 1 of the proposed study will assess the efficacy of the HITSystem 2.1 to increase the proportion of mothers who receive complete PMTCT services (including appointment attendance, medication adherence support, viral load testing, hospital-based delivery, and infant testing per Kenyan National Guidelines) through 6 months postpartum. The investigators hypothesize that mothers receiving the HITSystem 2.1 intervention will have a significantly higher completion rate for guideline-adherence PMTCT services compared to mothers receiving standard of care PMTCT services. In Aim 1b, the investigators will evaluate HITSystem 2.1 implementation using the RE-AIM model to inform sustainable scale up. Aim 2 will assess the efficacy of HITSystem 2.1 to increase viral suppression (<1,000 copies/mL) among pregnant and postpartum women, including those who disengage from care. The investigators hypothesize that mothers at HITSystem 2.1 sites will have higher rates of viral suppression at delivery and 6 months postpartum. Aim 3 will evaluate the cost-effectiveness of the HITSystem 2.1. Driven by differences in PMTCT retention, viral suppression, and modeled estimates of pediatric HIV infections averted, the investigators hypothesize that the HITSystem 2.1 will be cost-effective, based on World Health Organization criteria. This proposal is aimed at improving the quality of PMTCT services in the health facility setting. If efficacious and cost-effective, HITSystem 2.1 holds strong promise for national dissemination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm (HITSystem 2.1) | Experimental | Participants enrolled at intervention sites will received HITSystem 2.1-supported PMTCT services through 6 months postpartum. Interventions received will include: text messages to patients to support medication adherence, appointment attendance, and hospital delivery and algorithm-driven alerts to notify providers when follow up services are missed. |
|
| Control Arm (Standard of care) | No Intervention | Participants enrolled at control sites will receive standard of care PMTCT services, with no HITSystem 2.1 tracking or follow up. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HITSystem 2.1 | Other | HITSystem 2.1 is an intervention that tracks HIV+ pregnant women and their infants to improve the completeness and efficiency of PMTCT services. Key intervention features include: (1) SMS messages sent to enrolled women and mothers to support essential PMTCT services, (2) automated, algorithm-driven alerts for providers when per-guidelines PMTCT services are missed, and (3) automatic enrollment of infants into early infant diagnosis (EID) and linkage with maternal PMTCT file at documentation of infant birth to improve the continuum of care for HIV+ mothers and HIV-exposed infants. The HITSystem 2.1 intervention aims to facilitate complete PMTCT retention and viral load (VL) monitoring with prompt clinical action (adherence support, antiretroviral therapy (ART) regimen change) in the antenatal, delivery, and 6-month postpartum periods to increase viral suppression during windows critical for HIV prevention. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Receiving Complete PMTCT | documented receipt of all of the following: maternal ART initiation, antenatal appointment attendance, facility delivery, EID linkage by 7 weeks of age, maternal viral load testing and clinical action per national guidelines through 6 months postpartum (Table 6). Participants who receive all indicated services per guidelines will be coded as 1 or 'yes'. Participants missing > 1 service will be coded as 0 or incomplete PMTCT services. | 7-15 months (PMTCT enrollment date through 6 months postpartum) |
| Viral Suppression | Number of clients with a suppressed viral load(<1000 copies/mL) at delivery | 1-9 months |
| Measure | Description | Time Frame |
|---|---|---|
| PMTCT Retention Duration (Weeks) | The number of weeks women were engaged in PMTCT services | 7-15 months (PMTCT enrollment date through 6 months postpartum) |
| Antenatal Viral Load (VL) Test Coverage |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Finocchario-Kessler, PhD, MPH | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mariakani Subcounty Hospital | Mariakani | Kilifi County | Kenya | |||
| Mtwapa Subcounty Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38195390 | Derived | Wexler C, Maloba M, Mokua S, Babu S, Maosa N, Staggs V, Goggin K, Acharya H, Hurley EA, Finocchario-Kessler S. Assessing COVID-related concerns and their impact on antenatal and delivery care among pregnant women living with HIV in Kenya: a brief report. BMC Pregnancy Childbirth. 2024 Jan 9;24(1):46. doi: 10.1186/s12884-023-06216-x. | |
| 35881649 | Derived | Mokua S, Maloba M, Wexler C, Goggin K, Staggs V, Mabachi N, Maosa N, Babu S, Hurley E, Finocchario-Kessler S. Evaluating the efficacy of the HITSystem 2.1 to improve PMTCT retention and maternal viral suppression in Kenya: Study protocol of a cluster-randomized trial. PLoS One. 2022 Jul 26;17(7):e0263988. doi: 10.1371/journal.pone.0263988. eCollection 2022. |
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The investigators will make data collected for aims 1 & 2 available only upon request from users who can show proof of human subject's training and only under a data-sharing agreement that provides for: (1) use of the data only for research purposes, (2) exclusion of any identifying or potentially identifying information in shared analyses, publications, reports, etc., (3) appropriate storage and securing of the data to prevent authorized persons from accessing it, (4) a commitment to destroy or return the data after analyses are completed.
Data from aim 3 includes costing data for PMTCT services. These data will be shared openly at the dissemination meetings planned at the end of the study, which will include county and national health personnel. Furthermore, these data will be placed in a readily accessible public database.
After participant follow up is complete, data is cleaned, and the final data set is locked
Upon request from users who can show proof of human subject's training and only under a data-sharing agreement
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Arm (HITSystem 2.1) | Participants enrolled at intervention sites will received HITSystem 2.1-supported PMTCT services through 6 months postpartum. Interventions received will include: text messages to patients to support medication adherence, appointment attendance, and hospital delivery and algorithm-driven alerts to notify providers when follow up services are missed. HITSystem 2.1: HITSystem 2.1 is an intervention that tracks HIV+ pregnant women and their infants to improve the completeness and efficiency of PMTCT services. Key intervention features include: (1) SMS messages sent to enrolled women and mothers to support essential PMTCT services, (2) automated, algorithm-driven alerts for providers when per-guidelines PMTCT services are missed, and (3) automatic enrollment of infants into early infant diagnosis (EID) and linkage with maternal PMTCT file at documentation of infant birth to improve the continuum of care for HIV+ mothers and HIV-exposed infants. The HITSystem 2.1 intervention aims to facilitate complete PMTCT retention and viral load (VL) monitoring with prompt clinical action (adherence support, antiretroviral therapy (ART) regimen change) in the antenatal, delivery, and 6-month postpartum periods to increase viral suppression during windows critical for HIV prevention. |
| FG001 | Control Arm (Standard of Care) | Participants enrolled at control sites will receive standard of care PMTCT services, with no HITSystem 2.1 tracking or follow up. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Arm (HITSystem 2.1) | Participants enrolled at intervention sites will received HITSystem 2.1-supported PMTCT services through 6 months postpartum. Interventions received will include: text messages to patients to support medication adherence, appointment attendance, and hospital delivery and algorithm-driven alerts to notify providers when follow up services are missed. HITSystem 2.1: HITSystem 2.1 is an intervention that tracks HIV+ pregnant women and their infants to improve the completeness and efficiency of PMTCT services. Key intervention features include: (1) SMS messages sent to enrolled women and mothers to support essential PMTCT services, (2) automated, algorithm-driven alerts for providers when per-guidelines PMTCT services are missed, and (3) automatic enrollment of infants into early infant diagnosis (EID) and linkage with maternal PMTCT file at documentation of infant birth to improve the continuum of care for HIV+ mothers and HIV-exposed infants. The HITSystem 2.1 intervention aims to facilitate complete PMTCT retention and viral load (VL) monitoring with prompt clinical action (adherence support, antiretroviral therapy (ART) regimen change) in the antenatal, delivery, and 6-month postpartum periods to increase viral suppression during windows critical for HIV prevention. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants Receiving Complete PMTCT | documented receipt of all of the following: maternal ART initiation, antenatal appointment attendance, facility delivery, EID linkage by 7 weeks of age, maternal viral load testing and clinical action per national guidelines through 6 months postpartum (Table 6). Participants who receive all indicated services per guidelines will be coded as 1 or 'yes'. Participants missing > 1 service will be coded as 0 or incomplete PMTCT services. | Posted | Count of Participants | Participants | 7-15 months (PMTCT enrollment date through 6 months postpartum) |
|
We collected information on adverse events from the time of participant enrollment through 6 months postpartum, up to a total of 15 months.
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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 | Intervention Arm (HITSystem 2.1) | Participants enrolled at intervention sites will received HITSystem 2.1-supported PMTCT services through 6 months postpartum. Interventions received will include: text messages to patients to support medication adherence, appointment attendance, and hospital delivery and algorithm-driven alerts to notify providers when follow up services are missed. HITSystem 2.1: HITSystem 2.1 is an intervention that tracks HIV+ pregnant women and their infants to improve the completeness and efficiency of PMTCT services. Key intervention features include: (1) SMS messages sent to enrolled women and mothers to support essential PMTCT services, (2) automated, algorithm-driven alerts for providers when per-guidelines PMTCT services are missed, and (3) automatic enrollment of infants into early infant diagnosis (EID) and linkage with maternal PMTCT file at documentation of infant birth to improve the continuum of care for HIV+ mothers and HIV-exposed infants. The HITSystem 2.1 intervention aims to facilitate complete PMTCT retention and viral load (VL) monitoring with prompt clinical action (adherence support, antiretroviral therapy (ART) regimen change) in the antenatal, delivery, and 6-month postpartum periods to increase viral suppression during windows critical for HIV prevention. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pregnancy Loss | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | University of Kansas Medical Center | 913-945-7709 | skessler2@kumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Oct 3, 2020 | May 7, 2025 | Prot_SAP_ICF_000.pdf |
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| NIH |
Matched, cluster randomized controlled design
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|
The number of women receiving viral load testing upon enrolling in prevention of mother to child transmission of HIV services (PMTCT).
| Within one month of enrollment in PMTCT |
| Postnatal Viral Load (VL) Test Coverage | The number of women receiving postpartum viral load testing per the Kenyan national guidelines. | Between delivery and 7 months postpartum |
| Viral Load Test Utility | Number of detectable viral load results with clinical action per guidelines, such as: intensified adherence counseling and/or ARV regimen change | PMTCT enrollment date through 6 months postpartum |
| Turnaround Time of Viral Load Sample Collection to Patient Notification | The median number of days from the date of VL sample collection to patient notification, among all viral load tests | PMTCT enrollment date through 6 months postpartum |
| Antiretroviral Therapy (ART) Adherence | The number of participants with ART adherence > 95% | 7-15 months (PMTCT enrollment date through 6 months postpartum) |
| Mtwapa |
| Kilifi County |
| Kenya |
| Vipingo Subcounty Hospital | Vipingo | Kilifi County | Kenya |
| Likoni Subcounty Hospital | Likoni | Mombasa County | Kenya |
| Ambira Subcounty Hospital | Ambira | Siaya County | Kenya |
| Bondo Subcounty Hospital | Bondo | Siaya County | Kenya |
| Malanga Subcounty Hospital | Malanga | Siaya County | Kenya |
| Sigomere Health Center | Sigomere | Siaya County | Kenya |
| Ukwala Subcounty Hospital | Ukwala | Siaya County | Kenya |
| Yala Subcounty Hospital | Yala | Siaya County | Kenya |
| Akala Subcounty Hospital | Siaya | Kenya |
| Siaya County Hospital | Siaya | Kenya |
| BG001 | Control Arm (Standard of Care) | Participants enrolled at control sites will receive standard of care PMTCT services, with no HITSystem 2.1 tracking or follow up. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Gestational week at enrollment | Mean | Standard Deviation | weeks |
|
| Time of antiretroviral treatment (ART) initiation | Count of Participants | Participants |
|
| Education level | Count of Participants | Participants |
|
| HIV disclosure | Count of Participants | Participants |
|
| Partner living situation | Count of Participants | Participants |
|
| Past experience with prevention of mother to child transmission(PMTCT)/early infant diagnosis (EID) | Count of Participants | Participants |
|
| Household income | Count of Participants | Participants |
|
| OG001 | Control Arm (Standard of Care) | Participants enrolled at control sites will receive standard of care PMTCT services, with no HITSystem 2.1 tracking or follow up. |
|
|
| Primary | Viral Suppression | Number of clients with a suppressed viral load(<1000 copies/mL) at delivery | The overall number of participants analyzed include only those who had a documented viral load test at delivery. | Posted | Count of Participants | Participants | 1-9 months |
|
|
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| Secondary | PMTCT Retention Duration (Weeks) | The number of weeks women were engaged in PMTCT services | Posted | Mean | Standard Deviation | weeks | 7-15 months (PMTCT enrollment date through 6 months postpartum) |
|
|
|
| Secondary | Antenatal Viral Load (VL) Test Coverage | The number of women receiving viral load testing upon enrolling in prevention of mother to child transmission of HIV services (PMTCT). | Posted | Count of Participants | Participants | Within one month of enrollment in PMTCT |
|
|
|
| Secondary | Postnatal Viral Load (VL) Test Coverage | The number of women receiving postpartum viral load testing per the Kenyan national guidelines. | Posted | Count of Participants | Participants | Between delivery and 7 months postpartum |
|
|
|
| Secondary | Viral Load Test Utility | Number of detectable viral load results with clinical action per guidelines, such as: intensified adherence counseling and/or ARV regimen change | Viral load test utility was analyzed only among those participants with a detectable viral load result. | Posted | Count of Participants | Participants | PMTCT enrollment date through 6 months postpartum |
|
|
|
| Secondary | Turnaround Time of Viral Load Sample Collection to Patient Notification | The median number of days from the date of VL sample collection to patient notification, among all viral load tests | Turnaround time was measured among all viral load samples taken in the antenatal and/or postpartum periods. | Posted | Median | Inter-Quartile Range | days | PMTCT enrollment date through 6 months postpartum |
|
|
|
| Secondary | Antiretroviral Therapy (ART) Adherence | The number of participants with ART adherence > 95% | Posted | Count of Participants | Participants | 7-15 months (PMTCT enrollment date through 6 months postpartum) |
|
|
|
| 14 |
| 899 |
| 41 |
| 899 |
| 0 |
| 899 |
| EG001 | Control Arm (Standard of Care) | Participants enrolled at control sites will receive standard of care PMTCT services, with no HITSystem 2.1 tracking or follow up. | 22 | 740 | 41 | 740 | 0 | 740 |
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| >5 years prior to current pregnancy |
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| Missing |
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| Beyond secondary education |
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| Missing |
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| Missing |
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| Live with current partner |
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| Missing |
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| Missing |
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