Evaluation of the HITSystem to Improve Early Infant Diagnosis Outcomes in Kenya

HIV Clinical Trial

Official title:

Evaluation of the HITSystem to Improve Early Infant Diagnosis Outcomes in Kenya

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02072603
• Other study ID #: 13793
• Secondary ID: 1R01HD076673-01A
• Status: Completed
• Phase: N/A
• Start date: March 30, 2014
• Est. completion date: April 30, 2020

Study information

• Verified date: July 2020
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1815
• Est. completion date: April 30, 2020
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• HIV+ mother whose infant is <18 months of age

• Ability to provide consent

Exclusion Criteria:

-

Related Conditions & MeSH terms

• HIV

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Kenya	Kenyan Medical Research Institute	Nairobi
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Sarah Kessler, PhD, MPH	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Countries where clinical trial is conducted

United States,  Kenya, 

References & Publications (9)

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; — View Citation

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 e — View Citation

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:S313-21. doi: 10.1097/QAD.0000000000000332. — View Citation

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. — View Citation

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. 201 — View Citation

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/ — View Citation

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 — View Citation

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. — View Citation

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): — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete EID Retention	An aggregate measure of complete EID retention will be calculated (y/n) for each infant. Complete EID retention indicates the infant received all indicated services along the EID cascade as detailed below in the 8 critical interventions for EID of HIV. The proportion of HIV-exposed infants with complete EID retention will be compared between groups.; Initiation of OI prophylaxis.; Collect dried blood spot (DBS) for PCR test.; Receipt of DBS at lab.; Return of PCR results from lab.; Notify mother of PCR results.; Initiate all HIV-infected infants on ART.; Retest all HIV-negative infants at 9 m, initiate ART if applicable.; Retest all HIV-negative infants at 18 ms, initiate ART if applicable	18 months
Secondary	Efficiency of EID testing and notification cycle	Measuring turn-around time for the complete testing and notification cycle i.e, from sample collection to notifying mothers of results. Measured in number of weeks.	18 months
Secondary	Rapid treatment initiation among HIV+ infants	Time from notifying mother of HIV+ test result and initiating infant on ART, measured in days	18 months
Secondary	Mother-to-child transmission of HIV occurring between first and follow up tests	Mother-to-child transmission of HIV occurring between first and follow up tests, e.g. infants who are uninfected at first test (6 wks) but test positive at either the 9 or 18 month follow up test	18 months
Secondary	Cost effectiveness of HITSystem	Intervention costs per outcome achieved using the HITSystem versus the standard of care control condition. Savings resulting from HITSystem use will also be measured.	18 months
Secondary	Infant Mortality	Document the number of infants enrolled in EID who die before the end of the study period. Cause of death will be recorded.	18 months
Secondary	Infant age at ART initiation	The age at which an HIV+ infant was initiated on ART	18 months
Secondary	Optimal EID Index	To calculate a score for the Optimal EID Index, the infant will receive a score for each of the 8 EID interventions for which they were eligible; if it was completed (1-point) or never completed (0 points) and whether it was completed on-time (1 point) or off-time (0 points) for a maximum score of 16 and a minimum score of 0.; Initiation of OI prophylaxis at 6 wks.; Collect dried blood spot (DBS) for PCR test by 6 wks.; Receipt of DBS at lab within 10 days of collection.; Return of PCR results from lab within 2 wks.; Notify mother within 2 wks of the EID provider receiving results.; Initiate all HIV-infected infants on ART w/in 4 weeks of notifying the mother.; Retest all HIV-negative infants at 9 m, initiate ART w/in 4 wks if applicable.; Retest all HIV-negative infants at 18 ms, initiate ART w/in 4 wks if applicable.	18 months