Evaluation of the HITSystem to Improve Early Infant Diagnosis Outcomes in Kenya
NCT ID: NCT02072603
Last Updated: 2020-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
1815 participants
INTERVENTIONAL
2014-03-30
2020-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Piloting At-birth Point of Care HIV Testing Strategies in Kenya
NCT03435887
Long Term Outcomes of Therapy in Women Initiated on Lifelong ART Because of Pregnancy in DR Congo
NCT03048669
Healthy Beginning Initiative
NCT01795261
Improving Uptake of Early Infant Diagnosis of HIV for the Prevention of Mother-to-child Transmission of HIV
NCT01433185
A Study to Collect Information About HIV-Positive Pregnant Women and Their Babies
NCT00000910
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention Hospitals
HITSystem implementation at hospital and its affiliated laboratory
HITSystem
Online, automated program 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.
Control Hospitals
Existing standard of EID care
Standard of Care
current procedures that follow Kenyan National EID guidelines to diagnose and manage HIV infection among HIV-exposed infants.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
HITSystem
Online, automated program 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.
Standard of Care
current procedures that follow Kenyan National EID guidelines to diagnose and manage HIV infection among HIV-exposed infants.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Ability to provide consent
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Sarah Kessler, PhD, MPH
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sarah Kessler, PhD, MPH
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sarah F Kessler, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Kansas Medical Center
Kansas City, Kansas, United States
Kenyan Medical Research Institute
Nairobi, , Kenya
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Finocchario-Kessler S, Goggin K, Khamadi S, Gautney B, Dariotis JK, Bawcom C, Cheng AL, Nazir N, Martin C, Ruff A, Sweat M, Okoth V. Improving early infant HIV diagnosis in Kenya: study protocol of a cluster-randomized efficacy trial of the HITSystem. Implement Sci. 2015 Jul 9;10:96. doi: 10.1186/s13012-015-0284-3.
Finocchario-Kessler S, Gautney BJ, Khamadi S, Okoth V, Goggin K, Spinler JK, Mwangi A, Kimanga D, Clark KF, Olungae HD, Preidis GA; HITSystem Team. If you text them, they will come: using the HIV infant tracking system to improve early infant diagnosis quality and retention in Kenya. AIDS. 2014 Jul;28 Suppl 3(0 3):S313-21. doi: 10.1097/QAD.0000000000000332.
Goggin K, Wexler C, Nazir N, Staggs VS, Gautney B, Okoth V, Khamadi SA, Ruff A, Sweat M, Cheng AL, Finocchario-Kessler S. Predictors of Infant Age at Enrollment in Early Infant Diagnosis Services in Kenya. AIDS Behav. 2016 Sep;20(9):2141-50. doi: 10.1007/s10461-016-1404-z.
Wexler C, Brown M, Hurley EA, Ochieng M, Goggin K, Gautney B, Maloba M, Lwembe R, Khamadi S, Finocchario-Kessler S. Implementing eHealth Technology to Address Gaps in Early Infant Diagnosis Services: Qualitative Assessment of Kenyan Provider Experiences. JMIR Mhealth Uhealth. 2018 Aug 22;6(8):e169. doi: 10.2196/mhealth.9725.
Finocchario-Kessler S, Gautney B, Cheng A, Wexler C, Maloba M, Nazir N, Khamadi S, Lwembe R, Brown M, Odeny TA, Dariotis JK, Sandbulte M, Mabachi N, Goggin K. Evaluation of the HIV Infant Tracking System (HITSystem) to optimise quality and efficiency of early infant diagnosis: a cluster-randomised trial in Kenya. Lancet HIV. 2018 Dec;5(12):e696-e705. doi: 10.1016/S2352-3018(18)30245-5. Epub 2018 Oct 8.
Brown M, Wexler C, Gautney B, Goggin K, Hurley EA, Odeny B, Maloba M, Lwembe R, Sandbulte M, Finocchario-Kessler S. eHealth Interventions for Early Infant Diagnosis: Mothers' Satisfaction with the HIV Infant Tracking System in Kenya. AIDS Behav. 2019 Nov;23(11):3093-3102. doi: 10.1007/s10461-019-02579-5.
Goggin K, Hurley EA, Staggs VS, Wexler C, Nazir N, Gautney B, Khamadi SA, Maloba M, Lwembe R, Finocchario-Kessler S. Rates and Predictors of HIV-Exposed Infants Lost to Follow-Up During Early Infant Diagnosis Services in Kenya. AIDS Patient Care STDS. 2019 Aug;33(8):346-353. doi: 10.1089/apc.2019.0050.
Wexler C, Nazir N, Gautney B, Maloba M, Brown M, Goggin K, Lwembe R, Finocchario-Kessler S. Predictors of Early ART Initiation Among HIV + Infants in Kenya: A Retrospective Review of HITSystem Data from 2013 to 2017. Matern Child Health J. 2020 Jun;24(6):739-747. doi: 10.1007/s10995-020-02909-3.
Hurley EA, Odeny B, Wexler C, Brown M, MacKenzie A, Goggin K, Maloba M, Gautney B, Finocchario-Kessler S. "It was my obligation as mother": 18-Month completion of Early Infant Diagnosis as identity control for mothers living with HIV in Kenya. Soc Sci Med. 2020 Apr;250:112866. doi: 10.1016/j.socscimed.2020.112866. Epub 2020 Feb 27.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
13793
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.