NCT04571684Completed
Evaluating HITSystem 2.1 to Improve Viral Suppression in Kenya
Evaluating the HITSystem to Improve PMTCT Retention and Maternal Viral Suppression in Kenya
Source: ClinicalTrials.gov · Last updated 10 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 1639 (actual)
- First submitted
- 22 Sept 2020
- Start date
- 5 Oct 2020
- Primary completion date
- 1 Mar 2024
- Lead sponsor
- University of Kansas Medical Center
- Diseases
- HIV
- NCT number
- NCT04571684
What you commit to
- Study type: Interventional
- Participants enrolled: 1639
- From 5 Oct 2020 to the primary completion date, 1 Mar 2024
- 12 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Women who transfer care from one study site to another during their PMTCT services will be ineligible for enrollment at their new facility.
Who the study is looking for
- 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.
Sex: Female · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ambira Subcounty Hospital Coordinator of this site? Confirm its status | Ambira | Kenya | Unknown status |
| Bondo Subcounty Hospital Coordinator of this site? Confirm its status | Bondo | Kenya | Unknown status |
| Likoni Subcounty Hospital Coordinator of this site? Confirm its status | Likoni | Kenya | Unknown status |
| Malanga Subcounty Hospital Coordinator of this site? Confirm its status | Malanga | Kenya | Unknown status |
| Mariakani Subcounty Hospital Coordinator of this site? Confirm its status | Mariakani | Kenya | Unknown status |
| Mtwapa Subcounty Hospital Coordinator of this site? Confirm its status | Mtwapa | Kenya | Unknown status |
| Siaya County Hospital Coordinator of this site? Confirm its status | Siaya | Kenya | Unknown status |
| Akala Subcounty Hospital Coordinator of this site? Confirm its status | Siaya | Kenya | Unknown status |
| Sigomere Health Center Coordinator of this site? Confirm its status | Sigomere | Kenya | Unknown status |
| Ukwala Subcounty Hospital Coordinator of this site? Confirm its status | Ukwala | Kenya | Unknown status |
| Vipingo Subcounty Hospital Coordinator of this site? Confirm its status | Vipingo | Kenya | Unknown status |
| Yala Subcounty Hospital Coordinator of this site? Confirm its status | Yala | Kenya | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.