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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sarah Kessler, PhD, MPH, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT02072603
First received: February 24, 2014
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
HIV
Other: HITSystem
Other: Standard of Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of the HITSystem to Improve Early Infant Diagnosis Outcomes in Kenya

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Timely provision of 8 intervention benchmarks for optimal EID diagnosis of HIV [ Time Frame: 18 months ] [ Designated as safety issue: No ]

    The investigators will compare differences in 8 critical intervention benchmarks for optimal EID diagnosis of HIV between control hospitals and hospitals using HITSystem. For each of the 8 EID intervention points, measures include whether it was completed at all (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.

    1. Initiation of OI prophylaxis at 6 weeks.
    2. Collect dried blood spot (DBS) for PCR test by 6 weeks.
    3. Receipt of DBS at lab within 10 days of collection.
    4. Return of PCR results from lab within 2 weeks.
    5. Notify mother within 2 weeks of the EID provider receiving results.
    6. Initiate all HIV-infected infants on ART within 4 weeks of notifying the mother.
    7. Retest all HIV- infants at 9 months, initiate ART w/in 4 weeks if applicable.
    8. Retest all HIV-negative infants at 18 months, initiate ART w/in 4 weeks if applicable, complete EID.


Secondary Outcome Measures:
  • Efficiency of EID testing and notification cycle [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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.

  • Rapid treatment initiation among HIV+ infants [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Time from notifying mother of HIV+ test result and initiating infant on ART, measured in days

  • Mother-to-child transmission of HIV occurring between first and follow up tests [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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

  • Cost effectiveness of HITSystem [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Intervention costs per outcome achieved using the HITSystem versus the standard of care control condition. Savings resulting from HITSystem use will also be measured.

  • Infant Mortality [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Document the number of infants enrolled in EID who die before the end of the study period. Cause of death will be recorded.


Estimated Enrollment: 720
Study Start Date: August 2013
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Hospitals
HITSystem implementation at hospital and its affiliated laboratory
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.
Other Name: HIV Infant Tracking System
Active Comparator: Control Hospitals
Existing standard of EID care
Other: Standard of Care
current procedures that follow Kenyan National EID guidelines to diagnose and manage HIV infection among HIV-exposed infants.

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.11-12 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. 13

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV+ mother whose infant is <18 months of age
  • Ability to provide consent

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02072603

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Kenya
Kenyan Medical Research Institute
Nairobi, Kenya
Sponsors and Collaborators
Sarah Kessler, PhD, MPH
Investigators
Principal Investigator: Sarah F Kessler, PhD, MPH University of Kansas
  More Information

No publications provided

Responsible Party: Sarah Kessler, PhD, MPH, Assistant Professor, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT02072603     History of Changes
Other Study ID Numbers: 13793, 1R01HD076673-01A1
Study First Received: February 24, 2014
Last Updated: March 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
Infant HIV
Kenya
HITSystem
EID care
Early Infant Diagnosis

ClinicalTrials.gov processed this record on September 22, 2014