Trial · NCT04571684
Evaluating HITSystem 2.1 to Improve Viral Suppression in Kenya
NCT04571684, Not applicable, Completed, University of Kansas Medical Center; results first posted 2025-07-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluating HITSystem 2.1 to Improve Viral Suppression in Kenya. Trials, record NCT04571684. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04571684
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluating HITSystem 2.1 to Improve Viral Suppression in Kenya
- NCT number
- NCT04571684
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,639 participants, actual
- Lead sponsor
- University of Kansas Medical Center
- Conditions
- HIV, Pregnancy
- Interventions
- HITSystem 2.1
- First posted
- 2020-10-01
- Last updated
- 2025-07-10
- Results first posted
- 2025-07-10
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Receiving Complete PMTCT | 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. |
| Primary | Viral Suppression | 1-9 months | Number of clients with a suppressed viral load(\<1000 copies/mL) at delivery |
| Secondary | PMTCT Retention Duration (Weeks) | 7-15 months (PMTCT enrollment date through 6 months postpartum) | The number of weeks women were engaged in PMTCT services |
| Secondary | Antenatal Viral Load (VL) Test Coverage | 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). |
| Secondary | Postnatal Viral Load (VL) Test Coverage | Between delivery and 7 months postpartum | The number of women receiving postpartum viral load testing per the Kenyan national guidelines. |
| Secondary | Viral Load Test Utility | PMTCT enrollment date through 6 months postpartum | Number of detectable viral load results with clinical action per guidelines, such as: intensified adherence counseling and/or ARV regimen change |
| Secondary | Turnaround Time of Viral Load Sample Collection to Patient Notification | PMTCT enrollment date through 6 months postpartum | The median number of days from the date of VL sample collection to patient notification, among all viral load tests |
| Secondary | Antiretroviral Therapy (ART) Adherence | 7-15 months (PMTCT enrollment date through 6 months postpartum) | The number of participants with ART adherence \> 95% |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Receiving Complete PMTCT | 7-15 months (PMTCT enrollment date through 6 months postpartum) | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Viral Suppression | 1-9 months | The overall number of participants analyzed include only those who had a documented viral load test at delivery. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | PMTCT Retention Duration (Weeks) | 7-15 months (PMTCT enrollment date through 6 months postpartum) | weeks | MEAN | |
| SECONDARY | Antenatal Viral Load (VL) Test Coverage | Within one month of enrollment in PMTCT | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Postnatal Viral Load (VL) Test Coverage | Between delivery and 7 months postpartum | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Viral Load Test Utility | PMTCT enrollment date through 6 months postpartum | Viral load test utility was analyzed only among those participants with a detectable viral load result. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Turnaround Time of Viral Load Sample Collection to Patient Notification | PMTCT enrollment date through 6 months postpartum | Turnaround time was measured among all viral load samples taken in the antenatal and/or postpartum periods. | days | MEDIAN |
| SECONDARY | Antiretroviral Therapy (ART) Adherence | 7-15 months (PMTCT enrollment date through 6 months postpartum) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Receiving Complete PMTCT | Intervention Arm (HITSystem 2.1) | 60 | Participants | ||
| Number of Participants Receiving Complete PMTCT | Control Arm (Standard of Care) | 22 | Participants | ||
| Viral Suppression | Intervention Arm (HITSystem 2.1) | 655 | Participants | ||
| Viral Suppression | Control Arm (Standard of Care) | 535 | Participants | ||
| PMTCT Retention Duration (Weeks) | Intervention Arm (HITSystem 2.1) | 48.4 | Standard Deviation 9.6 | weeks | |
| PMTCT Retention Duration (Weeks) | Control Arm (Standard of Care) | 47.2 | Standard Deviation 8.1 | weeks | |
| Antenatal Viral Load (VL) Test Coverage | Intervention Arm (HITSystem 2.1) | 330 | Participants | ||
| Antenatal Viral Load (VL) Test Coverage | Control Arm (Standard of Care) | 137 | Participants | ||
| Postnatal Viral Load (VL) Test Coverage | Intervention Arm (HITSystem 2.1) | 518 | Participants | ||
| Postnatal Viral Load (VL) Test Coverage | Control Arm (Standard of Care) | 371 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Intervention Arm (HITSystem 2.1) | 899 | 6 |
| Overall Study | STARTED | Control Arm (Standard of Care) | 740 | 6 |
| Overall Study | COMPLETED | Intervention Arm (HITSystem 2.1) | 767 | 6 |
| Overall Study | COMPLETED | Control Arm (Standard of Care) | 627 | 6 |
| Overall Study | NOT COMPLETED | Intervention Arm (HITSystem 2.1) | 132 | 0 |
| Overall Study | NOT COMPLETED | Control Arm (Standard of Care) | 113 | 0 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Pregnancy Loss | Pregnancy, puerperium and perinatal conditions | Intervention Arm (HITSystem 2.1) | 41 | 899 | |
| serious | Pregnancy Loss | Pregnancy, puerperium and perinatal conditions | Control Arm (Standard of Care) | 41 | 740 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intervention Arm (HITSystem 2.1) | 14 | 899 |
| Total, all-cause mortality | Control Arm (Standard of Care) | 22 | 740 |
| Total, other adverse events | Intervention Arm (HITSystem 2.1) | 0 | 899 |
| Total, other adverse events | Control Arm (Standard of Care) | 0 | 740 |
| Total, serious adverse events | Intervention Arm (HITSystem 2.1) | 41 | 899 |
| Total, serious adverse events | Control Arm (Standard of Care) | 41 | 740 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01MH121245 | Evaluating the HITSystem to Improve PMTCT Retention and Maternal Viral Suppression in Kenya | KESSLER, SARAH FINOCCHARIO | UNIVERSITY OF KANSAS MEDICAL CENTER | NATIONAL INSTITUTE OF MENTAL HEALTH | 2020 to 2024 |
Source NIH RePORTER
Trial comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Intervention Arm (HITSystem 2.1) vs Control Arm (Standard of Care): Viral Suppression | Trial comparisons |
| Intervention Arm (HITSystem 2.1) vs Control Arm (Standard of Care): Antiretroviral Therapy (ART) Adherence | Trial comparisons |
| Intervention Arm (HITSystem 2.1) vs Control Arm (Standard of Care): Viral Load Test Utility | Trial comparisons |
| Intervention Arm (HITSystem 2.1) vs Control Arm (Standard of Care): Number of Participants Receiving Complete PMTCT | Trial comparisons |
| Intervention Arm (HITSystem 2.1) vs Control Arm (Standard of Care): Antenatal Viral Load (VL) Test Coverage | Trial comparisons |
| Intervention Arm (HITSystem 2.1) vs Control Arm (Standard of Care): Postnatal Viral Load (VL) Test Coverage | Trial comparisons |
| Intervention Arm (HITSystem 2.1) vs Control Arm (Standard of Care): deaths from any cause | Trial comparisons |
| Intervention Arm (HITSystem 2.1) vs Control Arm (Standard of Care): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04571684
GET https://conductscience.org/api/trials/v1/NCT04571684/registered