Pediatric HIV InfectionPARANCT03980119
Utilizing the HITSystem for Optimizing Paediatric ART Retention and Adherence in Western Nyanza Province, Kenya
A study testing HITSystem 3.0 in people with Pediatric HIV Infection, run by Global Health Innovations.
Trial summary
Overall, there are an estimated 98,000 children living with HIV in Kenya. Children who are initiated on ART in Kenya and other low resource settings face several challenges with ongoing care due to current limitations of paediatric HIV treatment services. Read more about this study
- Who is it for?
- Ages 1 day to 16 years
- Conditions the study is for
- Pediatric HIV Infection
- What is being tested?
- HITSystem 3.0
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,160 participants
- Where
- No sites listed yet
- Study dates
- Aug 2019to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 1 day to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Health facilities must meet the following criteria to be eligible for the trial:
- Level 3-5 and located in the Western Nyanza Province.
- Currently provide PMTCT, EID and paediatric ART programmes.
- Either government or private not-for-profit
- Agreement to participate, which will be granted by both Kisumu County minister of health, as well as the facility Director of Medical Operations (DMO).
Who cannot join
- Facilities that are classified as Level 1-2.
- Facilities that are participating in other research involving paediatric ART programmes.
- Private commercial facilities
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Utilizing the HITSystem 3.0 for Optimizing Paediatric ART Retention and Adherence in Western Nyanza Province, Kenya
Overall, there are an estimated 98,000 children living with HIV in Kenya. Children who are initiated on ART in Kenya and other low resource settings face several challenges with ongoing care due to current limitations of paediatric HIV treatment services. High quality paediatric HIV care requires routine monitoring of clinical and virologic status, support for ART adherence, and patient outreach to optimize retention in care.
The HIV Infant Tracking System (HITSystem) is a web-based, system-level intervention that has dramatically improved EID HIV-related outcomes in Kenya, Tanzania, and Malawi.
Read more
The objective of this study is to implement and evaluate the impact of HITSystem 3.0 on paediatric clinical outcomes, adherence, retention and viral suppression over 12 months among children in HIV care. Outcome measurements will be evaluated separately in children aged ≤2 years and in those aged 3-16 years.
Primary Outcomes
- The proportion of HIV infected children in each arm who are retained in HIV care at 12 months. Retention will be defined as regular engagement with HIV care, as measured by having attended the last three scheduled monthly appointments on time (see section 3.3 for further description).
- The proportion of HIV infected children who are virally suppressed (VL <50) at the end of the 12-month follow-up period.
The proposed trial design is an unblinded CRT with two arms: the HITSystem 3.0 Intervention vs. Standard of Care (SOC) as the control. The CRT will be implemented in 20 health facilities (10 intervention and 10 control) in Western Nyanza province in Kenya and will collect data from HIV-infected children aged ≤16 years. Outcomes will focus on ART retention, adherence and viral suppression.
Outcomes will be assessed among all HIV positive children aged ≤16 years attending the trial facilities for HIV care at the start of the trial, or who are diagnosed as HIV positive during the first 12 months of the trial. Follow-up data will be collected on each child for 12 months. Therefore, the total duration of the trial will be for 24 months.
All HIV-positive children and their caregivers attending health facilities randomised to the intervention arm will be monitored by the HITSystem 3.0.
The study will be conducted in Western Nyanza province, Kenya, which comprises six counties.
- Conditions
- Pediatric HIV Infection
- Being tested
- HITSystem 3.0
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HITSystem 3.0Other
The HITSystem 3.0 is a web-based intervention that aims to improve pediatric ART retention and adherence, and viral suppression. The HITSystem 3.0 is accessed online through a computer, using mobile broadband modems that respond to a cellular signal. The primary components include: (1) action alerts to complete time-sensitive interventions; (2) real time communication of HIV PCR results to hospitals to reduce turn-around time; (3) continuous follow-up for timely ART initiation among HIV-infected infants; (4) promotion of retention in EID care via SMS text messaging and/or patient tracing; and (5) an automated and individualized SMS text messaging component to communicate with mothers. The HITSystem has a unique dashboard that proactively monitors time-sensitive interventions along the EID cascade of care, alerting clinics, laboratories and mothers when an intervention has been missed.
| Study group | Role | What they receive |
|---|---|---|
| HITSystem 3.0 Intervention | Experimental | All HIV-positive children and their caregivers attending health facilities randomized to the HITSystem intervention arm will be monitored by the HITSystem. In the event that the child misses an appointment or a scheduled laboratory test, or the child's laboratory results suggest ART treatment failure, an automated SMS text message and alert will be generated in the HITSystem that will notify the child's health care provider. The child's caregiver will also receive a text message asking them to return to the clinic with the child. If the child is 16 years of age and considered an independent adolescent without a caregiver, the same process will be implemented, with the text messages being sent directly to the child. If the child's caregiver, or the independent adolescent, does not have a mobile phone, the health care provider will notify the community health worker (CHW) to trace the individual and visit them in their home. Receives: Other: HITSystem 3.0 |
| Control | No intervention | All HIV-positive children and their caregivers attending health facilities randomized to the Control arm will receive HIV/AIDS standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric ART Retention
The proportion of HIV infected children in each arm who are retained in HIV care at 12 months. Retention will be defined as regular engagement with HIV care, as measured by having attended the last three scheduled monthly appointments on time.
Measured: 12 months
Pediatric Viral Load Suppression
The proportion of HIV infected children who are virally suppressed (VL <50) at the end of the 12-month follow-up period.
Measured: 12 months
Secondary outcomes (3)
Missed ART
The proportion of HIV infected children who ever experienced a gap of >30 days without ART medication during the 12-month follow-up period.
Measured: 12 months
Medication Ratio >90%
The proportion of HIV-infected children with an ART medication possession ratio of ≥90% during the 12-month follow-up period
Measured: 12 months
Viral Load Testing
he proportion of HIV infected children who received viral load testing (per Kenya guidelines) at baseline, 6 months and 12 months
Measured: Baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study startAug 2019 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric HIV InfectionStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Global Health Innovations
- Sponsor type
- University, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, Kenya Medical Research Institute
- Responsible party
- Sponsor
- Investigators
- Brad Gautney, MPH, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03980119
- Sponsor's protocol ID
- HITSystem Peds Retention Kenya
- Acronym
- PARA
- Status last verified
- Jun 2019
- First submitted
- 4 Jun 2019
- Last updated
- 10 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD, all IPD that underlie results in a publication)
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing the HITSystem 3.0 for Optimizing Paediatric ART Retention and Adherence in Western Nyanza Province, Kenya
- ClinicalTrials.gov ID
- NCT03980119
- Acronym / sponsor ID
- PARA / HITSystem Peds Retention Kenya
- Conditions
- Pediatric HIV Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,160 participants (estimated)
- Lead sponsor
- Global Health InnovationsUniversity, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, Kenya Medical Research Institute
- Study start
- Aug 2019 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 10 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Overall, there are an estimated 98,000 children living with HIV in Kenya. Children who are initiated on ART in Kenya and other low resource settings face several challenges with ongoing care due to current limitations of paediatric HIV treatment services. High quality paediatric HIV care requires routine monitoring of clinical and virologic status, support for ART adherence, and patient outreach to optimize retention in care.
The HIV Infant Tracking System (HITSystem) is a web-based, system-level intervention that has dramatically improved EID HIV-related outcomes in Kenya, Tanzania, and Malawi.
The objective of this study is to implement and evaluate the impact of HITSystem 3.0 on paediatric clinical outcomes, adherence, retention and viral suppression over 12 months among children in HIV care. Outcome measurements will be evaluated separately in children aged ≤2 years and in those aged 3-16 years.
Primary Outcomes
- The proportion of HIV infected children in each arm who are retained in HIV care at 12 months. Retention will be defined as regular engagement with HIV care, as measured by having attended the last three scheduled monthly appointments on time (see section 3.3 for further description).
- The proportion of HIV infected children who are virally suppressed (VL <50) at the end of the 12-month follow-up period.
The proposed trial design is an unblinded CRT with two arms: the HITSystem 3.0 Intervention vs. Standard of Care (SOC) as the control. The CRT will be implemented in 20 health facilities (10 intervention and 10 control) in Western Nyanza province in Kenya and will collect data from HIV-infected children aged ≤16 years. Outcomes will focus on ART retention, adherence and viral suppression.
Outcomes will be assessed among all HIV positive children aged ≤16 years attending the trial facilities for HIV care at the start of the trial, or who are diagnosed as HIV positive during the first 12 months of the trial. Follow-up data will be collected on each child for 12 months. Therefore, the total duration of the trial will be for 24 months.
All HIV-positive children and their caregivers attending health facilities randomised to the intervention arm will be monitored by the HITSystem 3.0.
The study will be conducted in Western Nyanza province, Kenya, which comprises six counties.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HITSystem 3.0 Intervention | Experimental | Other: HITSystem 3.0All HIV-positive children and their caregivers attending health facilities randomized to the HITSystem intervention arm will be monitored by the HITSystem. In the event that the child misses an appointment or a scheduled laboratory test, or the child's laboratory results suggest ART treatment failure, an automated SMS text message and alert will be generated in the HITSystem that will notify the child's health care provider. The child's caregiver will also receive a text message asking them to return to the clinic with the child. If the child is 16 years of age and considered an independent adolescent without a caregiver, the same process will be implemented, with the text messages being sent directly to the child. If the child's caregiver, or the independent adolescent, does not have a mobile phone, the health care provider will notify the community health worker (CHW) to trace the individual and visit them in their home. |
| Control | No intervention | –All HIV-positive children and their caregivers attending health facilities randomized to the Control arm will receive HIV/AIDS standard of care. |
Who may qualify
- Ages
- 1 day to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Level 3-5 and located in the Western Nyanza Province.
- Currently provide PMTCT, EID and paediatric ART programmes.
- Either government or private not-for-profit
- Agreement to participate, which will be granted by both Kisumu County minister of health, as well as the facility Director of Medical Operations (DMO).
Key exclusion criteria (3 listed)
- Facilities that are classified as Level 1-2.
- Facilities that are participating in other research involving paediatric ART programmes.
- Private commercial facilities
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 3.0The HITSystem 3.0 is a web-based intervention that aims to improve pediatric ART retention and adherence, and viral suppression. The HITSystem 3.0 is accessed online through a computer, using mobile broadband modems that respond to a cellular signal. The primary components include: (1) action alerts to complete time-sensitive interventions; (2) real time communication of HIV PCR results to hospitals to reduce turn-around time; (3) continuous follow-up for timely ART initiation among HIV-infected infants; (4) promotion of retention in EID care via SMS text messaging and/or patient tracing; and (5) an automated and individualized SMS text messaging component to communicate with mothers. The HITSystem has a unique dashboard that proactively monitors time-sensitive interventions along the EID cascade of care, alerting clinics, laboratories and mothers when an intervention has been missed. | Other | HITSystem 3.0 Intervention |
Primary outcome
Pediatric ART Retention
Time frame: 12 months
The proportion of HIV infected children in each arm who are retained in HIV care at 12 months. Retention will be defined as regular engagement with HIV care, as measured by having attended the last three scheduled monthly appointments on time.
Pediatric Viral Load Suppression
Time frame: 12 months
The proportion of HIV infected children who are virally suppressed (VL <50) at the end of the 12-month follow-up period.
3 secondary outcomes
Missed ART
Time frame: 12 months
Medication Ratio >90%
Time frame: 12 months
Viral Load Testing
Time frame: Baseline, 6 months, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2019.
- Individual participant dataSharing planned: Yes. All collected IPD, all IPD that underlie results in a publication)
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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.
Brad Gautney, MPH principal investigator
London School of Hygiene and Tropical Medicine
Questions about this trial
What is this clinical trial studying?
A study testing HITSystem 3.0 in people with Pediatric HIV Infection, run by Global Health Innovations.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 10 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brad Gautney, MPH (913-706-3120, brad.gautney@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric ART Retention (time frame: 12 months). 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?
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 Jun 2019.