HIVNCT04571684
Evaluating HITSystem 2.1 to Improve Viral Suppression in Kenya
A study testing HITSystem 2.1 in people with HIV and Pregnancy, run by University of Kansas Medical Center at 12 sites in Kenya.
Trial summary
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… Read more about this study
- Who is it for?
- Any age, women only
- What is being tested?
- HITSystem 2.1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,639 participants
- Where
- 12 sitesKenya
- Study dates
- 5 Oct 2020to 1 Apr 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
- Pregnant women living with HIV who present for care at one of the study hospitals by 36 weeks gestation and provide written informed consent are eligible for enrollment in the study.
Who cannot join
- Pregnant women living with HIV will be excluded from study participation if she has any condition (including drug abuse, alcohol abuse, or psychiatric disorder) that study or hospital staff feel precludes her from providing informed consent.
- Women who transfer care from one study site to another during their PMTCT services will be ineligible for enrollment at their new facility.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Kenya12 sites
Ambira Subcounty Hospital
Ambira, Siaya County
Bondo Subcounty Hospital
Bondo, Siaya County
Likoni Subcounty Hospital
Likoni, Mombasa County
Malanga Subcounty Hospital
Malanga, Siaya County
Mariakani Subcounty Hospital
Mariakani, Kilifi County
Mtwapa Subcounty Hospital
Mtwapa, Kilifi County
Akala Subcounty Hospital
Siaya
Siaya County Hospital
Siaya
Sigomere Health Center
Sigomere, Siaya County
Ukwala Subcounty Hospital
Ukwala, Siaya County
Vipingo Subcounty Hospital
Vipingo, Kilifi County
Yala Subcounty Hospital
Yala, Siaya County
About this study
Official title: Evaluating the HITSystem to Improve PMTCT Retention and Maternal Viral Suppression in Kenya
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.
Read the detailed description
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.
- Being tested
- HITSystem 2.1
- Keywords
- Prevention of mother-to-child transmission (PMTCT) services, maternal viral load monitoring, early infant diagnosis (EID), Kenya, perinatal HIV transmission
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HITSystem 2.1Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: HITSystem 2.1 |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 1-9 months
Secondary outcomes (6)
PMTCT Retention Duration (Weeks)
The number of weeks women were engaged in PMTCT services
Measured: 7-15 months (PMTCT enrollment date through 6 months postpartum)
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).
Measured: 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.
Measured: 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
Measured: 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
Measured: PMTCT enrollment date through 6 months postpartum
Antiretroviral Therapy (ART) Adherence
The number of participants with ART adherence > 95%
Measured: 7-15 months (PMTCT enrollment date through 6 months postpartum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start5 Oct 2020
- Primary completion1 Mar 2024
- Study completion1 Apr 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 (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Matched, cluster randomized controlled design
- Masking
- None (open label)
- Enrolment
- 1,639 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Kenya Medical Research Institute, Children's Mercy Hospital Kansas City, Global Health Innovations Foundation - Kenya, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Sarah Finocchario-Kessler, PhD, MPH, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04571684
- Sponsor's protocol ID
- R01MH121245
- Other IDs
- R01MH121245
- Status last verified
- Jun 2025
- First submitted
- 22 Sep 2020
- Last updated
- 10 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 38195390Mokua 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.
PubMed 35881649
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the HITSystem to Improve PMTCT Retention and Maternal Viral Suppression in Kenya
- ClinicalTrials.gov ID
- NCT04571684
- Acronym / sponsor ID
- R01MH121245
- Keywords
- Prevention of mother-to-child transmission (PMTCT) services, maternal viral load monitoring, early infant diagnosis (EID), Kenya, perinatal HIV transmission
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,639 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- Kenya Medical Research Institute, Children's Mercy Hospital Kansas City, Global Health Innovations Foundation - Kenya, National Institute of Mental Health (NIMH)
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 1 Oct 2020 (actual)
- Results
- Posted 10 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Matched, cluster randomized controlled design
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm (HITSystem 2.1) | Experimental | Other: HITSystem 2.1Participants 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant women living with HIV who present for care at one of the study hospitals by 36 weeks gestation and provide written informed consent are eligible for enrollment in the study.
Key exclusion criteria (2 listed)
- Pregnant women living with HIV will be excluded from study participation if she has any condition (including drug abuse, alcohol abuse, or psychiatric disorder) that study or hospital staff feel precludes her from providing informed consent.
- Women who transfer care from one study site to another during their PMTCT services will be ineligible for enrollment at their new facility.
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 |
|---|---|---|
| HITSystem 2.1HITSystem 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. | Other | Intervention Arm (HITSystem 2.1) |
Primary outcome
Number of Participants Receiving Complete PMTCT
Time frame: 7-15 months (PMTCT enrollment date through 6 months postpartum)
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.
Viral Suppression
Time frame: 1-9 months
Number of clients with a suppressed viral load(<1000 copies/mL) at delivery
6 secondary outcomes
PMTCT Retention Duration (Weeks)
Time frame: 7-15 months (PMTCT enrollment date through 6 months postpartum)
Antenatal Viral Load (VL) Test Coverage
Time frame: Within one month of enrollment in PMTCT
Postnatal Viral Load (VL) Test Coverage
Time frame: Between delivery and 7 months postpartum
Viral Load Test Utility
Time frame: PMTCT enrollment date through 6 months postpartum
Turnaround Time of Viral Load Sample Collection to Patient Notification
Time frame: PMTCT enrollment date through 6 months postpartum
Antiretroviral Therapy (ART) Adherence
Time frame: 7-15 months (PMTCT enrollment date through 6 months postpartum)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38195390Wexler 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.
- Derived from this study: PubMed 35881649Mokua 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.
- Individual participant dataSharing planned: Yes. 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.
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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.
Sarah Finocchario-Kessler, PhD, MPH principal investigator
University of Kansas Medical Center
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HITSystem 2.1 in people with HIV and Pregnancy, run by University of Kansas Medical Center at 12 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 1 inclusion and 2 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 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 10 Jul 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?
Number of Participants Receiving Complete PMTCT (time frame: 7-15 months (PMTCT enrollment date through 6 months postpartum)). The study lists 2 primary outcomes in all. 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 NCT04571684, which also lists 2 linked publications.
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 10 Jul 2025.