Evaluating HITSystem 2.1 to Improve Viral Suppression in Kenya (NCT04571684) | Clinical Trial Compass
CompletedNot Applicable
Evaluating HITSystem 2.1 to Improve Viral Suppression in Kenya
Kenya1,639 participantsStarted 2020-10-05
Plain-language 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 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.
Who can participate
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants Receiving Complete PMTCT
Timeframe: 7-15 months (PMTCT enrollment date through 6 months postpartum)