Trial Outcomes & Findings for Evaluating HITSystem 2.1 to Improve Viral Suppression in Kenya (NCT NCT04571684)

Last Updated: 2025-07-10

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

1639 participants

Primary outcome timeframe

7-15 months (PMTCT enrollment date through 6 months postpartum)

Results posted on

2025-07-10

Participant Flow

Unit of analysis: Sites

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	899 6	740 6
Overall Study COMPLETED	767 6	627 6
Overall Study NOT COMPLETED	132 0	113 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Arm (HITSystem 2.1) n=767 Participants 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.	Control Arm (Standard of Care) n=627 Participants Participants enrolled at control sites will receive standard of care PMTCT services, with no HITSystem 2.1 tracking or follow up.	Total n=1394 Participants Total of all reporting groups
Age, Continuous	30.6 years STANDARD_DEVIATION 5.8 • n=767 Participants	30.4 years STANDARD_DEVIATION 6.0 • n=627 Participants	30.5 years STANDARD_DEVIATION 5.9 • n=1394 Participants
Sex: Female, Male Female	767 Participants n=767 Participants	627 Participants n=627 Participants	1394 Participants n=1394 Participants
Sex: Female, Male Male	0 Participants n=767 Participants	0 Participants n=627 Participants	0 Participants n=1394 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Kenya	767 participants n=767 Participants	627 participants n=627 Participants	1394 participants n=1394 Participants
Gestational week at enrollment	19.1 weeks STANDARD_DEVIATION 7.8 • n=767 Participants	19.9 weeks STANDARD_DEVIATION 7.3 • n=627 Participants	19.5 weeks STANDARD_DEVIATION 7.6 • n=1394 Participants
Time of antiretroviral treatment (ART) initiation During current pregnancy	162 Participants n=767 Participants	145 Participants n=627 Participants	307 Participants n=1394 Participants
Time of antiretroviral treatment (ART) initiation <5 yrs prior to current pregnancy	331 Participants n=767 Participants	228 Participants n=627 Participants	559 Participants n=1394 Participants
Time of antiretroviral treatment (ART) initiation >5 years prior to current pregnancy	274 Participants n=767 Participants	232 Participants n=627 Participants	506 Participants n=1394 Participants
Time of antiretroviral treatment (ART) initiation Missing	0 Participants n=767 Participants	22 Participants n=627 Participants	22 Participants n=1394 Participants
Education level Less than secondary education	611 Participants n=767 Participants	508 Participants n=627 Participants	1119 Participants n=1394 Participants
Education level Completed secondary education	112 Participants n=767 Participants	74 Participants n=627 Participants	186 Participants n=1394 Participants
Education level Beyond secondary education	43 Participants n=767 Participants	41 Participants n=627 Participants	84 Participants n=1394 Participants
Education level Missing	1 Participants n=767 Participants	4 Participants n=627 Participants	5 Participants n=1394 Participants
HIV disclosure No one	90 Participants n=767 Participants	89 Participants n=627 Participants	179 Participants n=1394 Participants
HIV disclosure Anyone	676 Participants n=767 Participants	535 Participants n=627 Participants	1211 Participants n=1394 Participants
HIV disclosure Missing	1 Participants n=767 Participants	3 Participants n=627 Participants	4 Participants n=1394 Participants
Partner living situation No current partner	52 Participants n=767 Participants	58 Participants n=627 Participants	110 Participants n=1394 Participants
Partner living situation Live separate from partner	128 Participants n=767 Participants	104 Participants n=627 Participants	232 Participants n=1394 Participants
Partner living situation Live with current partner	581 Participants n=767 Participants	459 Participants n=627 Participants	1040 Participants n=1394 Participants
Partner living situation Missing	6 Participants n=767 Participants	6 Participants n=627 Participants	12 Participants n=1394 Participants
Past experience with prevention of mother to child transmission(PMTCT)/early infant diagnosis (EID) No	290 Participants n=767 Participants	272 Participants n=627 Participants	562 Participants n=1394 Participants
Past experience with prevention of mother to child transmission(PMTCT)/early infant diagnosis (EID) Yes	477 Participants n=767 Participants	355 Participants n=627 Participants	832 Participants n=1394 Participants
Household income <750 KSh	268 Participants n=767 Participants	224 Participants n=627 Participants	492 Participants n=1394 Participants
Household income >=750 KSH	336 Participants n=767 Participants	257 Participants n=627 Participants	593 Participants n=1394 Participants
Household income Missing	163 Participants n=767 Participants	146 Participants n=627 Participants	309 Participants n=1394 Participants

PRIMARY outcome

Timeframe: 7-15 months (PMTCT enrollment date through 6 months postpartum)

Outcome measures

Outcome measures
Measure	Intervention Arm (HITSystem 2.1) n=767 Participants 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.	Control Arm (Standard of Care) n=627 Participants Participants enrolled at control sites will receive standard of care PMTCT services, with no HITSystem 2.1 tracking or follow up.
Number of Participants Receiving Complete PMTCT	60 Participants	22 Participants

PRIMARY outcome

Timeframe: 1-9 months

Population: The overall number of participants analyzed include only those who had a documented viral load test at delivery.

Number of clients with a suppressed viral load(\<1000 copies/mL) at delivery

Outcome measures

Outcome measures
Measure	Intervention Arm (HITSystem 2.1) n=703 Participants 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.	Control Arm (Standard of Care) n=581 Participants Participants enrolled at control sites will receive standard of care PMTCT services, with no HITSystem 2.1 tracking or follow up.
Viral Suppression	655 Participants	535 Participants

SECONDARY outcome

Timeframe: 7-15 months (PMTCT enrollment date through 6 months postpartum)

The number of weeks women were engaged in PMTCT services

Outcome measures

Outcome measures
Measure	Intervention Arm (HITSystem 2.1) n=767 Participants 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.	Control Arm (Standard of Care) n=627 Participants Participants enrolled at control sites will receive standard of care PMTCT services, with no HITSystem 2.1 tracking or follow up.
PMTCT Retention Duration (Weeks)	48.4 weeks Standard Deviation 9.6	47.2 weeks Standard Deviation 8.1

SECONDARY outcome

Timeframe: Within one month of enrollment in PMTCT

The number of women receiving viral load testing upon enrolling in prevention of mother to child transmission of HIV services (PMTCT).

Outcome measures

Outcome measures
Measure	Intervention Arm (HITSystem 2.1) n=767 Participants 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.	Control Arm (Standard of Care) n=627 Participants Participants enrolled at control sites will receive standard of care PMTCT services, with no HITSystem 2.1 tracking or follow up.
Antenatal Viral Load (VL) Test Coverage	330 Participants	137 Participants

SECONDARY outcome

Timeframe: Between delivery and 7 months postpartum

The number of women receiving postpartum viral load testing per the Kenyan national guidelines.

Outcome measures

Outcome measures
Measure	Intervention Arm (HITSystem 2.1) n=767 Participants 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.	Control Arm (Standard of Care) n=627 Participants Participants enrolled at control sites will receive standard of care PMTCT services, with no HITSystem 2.1 tracking or follow up.
Postnatal Viral Load (VL) Test Coverage	518 Participants	371 Participants

SECONDARY outcome

Timeframe: PMTCT enrollment date through 6 months postpartum

Population: Viral load test utility was analyzed only among those participants with a detectable viral load result.

Number of detectable viral load results with clinical action per guidelines, such as: intensified adherence counseling and/or ARV regimen change

Outcome measures

Outcome measures
Measure	Intervention Arm (HITSystem 2.1) n=35 Participants 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.	Control Arm (Standard of Care) n=29 Participants Participants enrolled at control sites will receive standard of care PMTCT services, with no HITSystem 2.1 tracking or follow up.
Viral Load Test Utility	28 Participants	18 Participants

SECONDARY outcome

Timeframe: PMTCT enrollment date through 6 months postpartum

Population: Turnaround time was measured among all viral load samples taken in the antenatal and/or postpartum periods.

The median number of days from the date of VL sample collection to patient notification, among all viral load tests

Outcome measures

Outcome measures
Measure	Intervention Arm (HITSystem 2.1) n=767 Participants 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.	Control Arm (Standard of Care) n=627 Participants Participants enrolled at control sites will receive standard of care PMTCT services, with no HITSystem 2.1 tracking or follow up.
Turnaround Time of Viral Load Sample Collection to Patient Notification	35 days Interval 21.0 to 56.5	35 days Interval 23.0 to 48.3

SECONDARY outcome

Timeframe: 7-15 months (PMTCT enrollment date through 6 months postpartum)

The number of participants with ART adherence \> 95%

Outcome measures

Outcome measures
Measure	Intervention Arm (HITSystem 2.1) n=767 Participants 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.	Control Arm (Standard of Care) n=627 Participants Participants enrolled at control sites will receive standard of care PMTCT services, with no HITSystem 2.1 tracking or follow up.
Antiretroviral Therapy (ART) Adherence	466 Participants	200 Participants

Adverse Events

Intervention Arm (HITSystem 2.1)

Serious events: 41 serious events

Other events: 0 other events

Deaths: 14 deaths

Control Arm (Standard of Care)

Serious events: 41 serious events

Other events: 0 other events

Deaths: 22 deaths

Serious adverse events

Serious adverse events
Measure	Intervention Arm (HITSystem 2.1) n=899 participants at risk 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.	Control Arm (Standard of Care) n=740 participants at risk Participants enrolled at control sites will receive standard of care PMTCT services, with no HITSystem 2.1 tracking or follow up.
Pregnancy, puerperium and perinatal conditions Pregnancy Loss	4.6% 41/899 • We collected information on adverse events from the time of participant enrollment through 6 months postpartum, up to a total of 15 months.	5.5% 41/740 • We collected information on adverse events from the time of participant enrollment through 6 months postpartum, up to a total of 15 months.

Other adverse events

Adverse event data not reported

Additional Information

Principal Investigator

University of Kansas Medical Center

Phone: 913-945-7709

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place