Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-30 @ 12:02 PM
Study NCT ID:
NCT02072603
Status:
COMPLETED
Last Update Posted:
2020-07-13
First Post:
2014-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the HITSystem to Improve Early Infant Diagnosis Outcomes in Kenya
Sponsor:
Sarah Kessler, PhD, MPH
Organization:
Study Overview
Official Title:
Evaluation of the HITSystem to Improve Early Infant Diagnosis Outcomes in Kenya
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the effectiveness of the HITSystem in maximizing early infant diagnosis (EID) service utilization for HIV-exposed infants and early antiretroviral therapy (ART) initiation for infants diagnosed with HIV.
Detailed Description:
The current EID system is hampered by significant structural barriers that contribute to late and sporadic testing of HIV-exposed infants, lost or delayed test results from the laboratory, and the absence of a reliable system to notify mothers of test results or the need to return to the hospital.
Consequently, in Kenya only about one-third of HIV-exposed infants receive complete EID care through 18 months of age, and less than 20% of diagnosed HIV+ infants are initiated on life saving ART.
To maximize both the benefits and efficiencies of EID efforts, the investigators have developed a system strengthening intervention called the HIV Infant Tracking System (HITSystem©). The HITSystem intervention is an online, automated intervention designed to overcome current EID barriers by providing efficient prospective tracking of HIV- exposed infants and triggering electronic action 'alerts' for both EID providers and lab technicians when time sensitive interventions are overdue for specific infants. A built-in text messaging system sends text messages to mothers' cell phones when test results are ready or follow up visits are needed. The ultimate goals of the HITSystem are to maximize (a) EID service utilization for HIV-exposed infants (retention until 18 months) and (b) early ART initiation for infants diagnosed HIV+, by facilitating collaboration and accountability between key stakeholders (hospitals, laboratories and mothers) to improve EID outcomes.
Our pilot data from two hospitals in Kenya (one urban, one peri-urban) demonstrate the acceptability and feasibility of implementing this intervention. Using a pre-post intervention design the investigators compared EID outcomes from n=330 mother-infant pairs assessed by retrospective chart review during the 12 months prior to the initiation of the intervention to n=460 mother-infant pairs enrolled in the HITSystem intervention over the course of several months (9 and 6 months, respectively). Pilot data indicate a 3 fold increase in EID retention (31% vs. 97%, p\<0.001), and more than doubled infant ART initiation rates (44% vs. 95%, p\<0.001).14 These data have resulted in great interest and support from the Kenya Ministry of Health for this study, the findings of which will influence national EID dissemination decisions.
To more rigorously evaluate the impact of the HITSystem intervention on EID care in a low-resource country and implications for the feasibility of scaling up this intervention, the investigators will use a cluster randomized control trial among 6 Kenyan government hospitals (3 intervention and 3 standard of care; matched). Three specific aims guide the proposed study:
Aim 1. Conduct a randomized controlled trial to evaluate the efficacy of the HITSystem in improving the timely provision of 8 critical intervention benchmarks for optimal Early Infant Diagnosis of HIV and management.
Aim 2. To identify among HIV-exposed infants predictors of (1) incomplete EID care and (2) time periods most vulnerable to loss of contact at both intervention and control sites.
Aim 3. To estimate the incremental cost-effectiveness of the HITSystem in improving complete EID care across study arms, and to assess user satisfaction among key stakeholders.
This study will scientifically evaluate the public health impact of the HITSystem to improve critical EID outcomes in low-resource settings. Cost-effectiveness analyses will inform the feasibility of scaling up the HITSystem in other settings, and opportunities to adapt the technology to address other health outcomes.
Consequently, in Kenya only about one-third of HIV-exposed infants receive complete EID care through 18 months of age, and less than 20% of diagnosed HIV+ infants are initiated on life saving ART.
To maximize both the benefits and efficiencies of EID efforts, the investigators have developed a system strengthening intervention called the HIV Infant Tracking System (HITSystem©). The HITSystem intervention is an online, automated intervention designed to overcome current EID barriers by providing efficient prospective tracking of HIV- exposed infants and triggering electronic action 'alerts' for both EID providers and lab technicians when time sensitive interventions are overdue for specific infants. A built-in text messaging system sends text messages to mothers' cell phones when test results are ready or follow up visits are needed. The ultimate goals of the HITSystem are to maximize (a) EID service utilization for HIV-exposed infants (retention until 18 months) and (b) early ART initiation for infants diagnosed HIV+, by facilitating collaboration and accountability between key stakeholders (hospitals, laboratories and mothers) to improve EID outcomes.
Our pilot data from two hospitals in Kenya (one urban, one peri-urban) demonstrate the acceptability and feasibility of implementing this intervention. Using a pre-post intervention design the investigators compared EID outcomes from n=330 mother-infant pairs assessed by retrospective chart review during the 12 months prior to the initiation of the intervention to n=460 mother-infant pairs enrolled in the HITSystem intervention over the course of several months (9 and 6 months, respectively). Pilot data indicate a 3 fold increase in EID retention (31% vs. 97%, p\<0.001), and more than doubled infant ART initiation rates (44% vs. 95%, p\<0.001).14 These data have resulted in great interest and support from the Kenya Ministry of Health for this study, the findings of which will influence national EID dissemination decisions.
To more rigorously evaluate the impact of the HITSystem intervention on EID care in a low-resource country and implications for the feasibility of scaling up this intervention, the investigators will use a cluster randomized control trial among 6 Kenyan government hospitals (3 intervention and 3 standard of care; matched). Three specific aims guide the proposed study:
Aim 1. Conduct a randomized controlled trial to evaluate the efficacy of the HITSystem in improving the timely provision of 8 critical intervention benchmarks for optimal Early Infant Diagnosis of HIV and management.
Aim 2. To identify among HIV-exposed infants predictors of (1) incomplete EID care and (2) time periods most vulnerable to loss of contact at both intervention and control sites.
Aim 3. To estimate the incremental cost-effectiveness of the HITSystem in improving complete EID care across study arms, and to assess user satisfaction among key stakeholders.
This study will scientifically evaluate the public health impact of the HITSystem to improve critical EID outcomes in low-resource settings. Cost-effectiveness analyses will inform the feasibility of scaling up the HITSystem in other settings, and opportunities to adapt the technology to address other health outcomes.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R01HD076673-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |