NCT02072603

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,815

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable hiv

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 26, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

March 30, 2014

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

July 13, 2020

Status Verified

July 1, 2020

Enrollment Period

4.5 years

First QC Date

February 24, 2014

Last Update Submit

July 9, 2020

Conditions

HIV

Keywords

Infant HIVKenyaHITSystemEID careEarly Infant Diagnosis

Outcome Measures

Primary Outcomes (1)

  • 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. 1. Initiation of OI prophylaxis. 2. Collect dried blood spot (DBS) for PCR test. 3. Receipt of DBS at lab. 4. Return of PCR results from lab. 5. Notify mother of PCR results. 6. Initiate all HIV-infected infants on ART. 7. Retest all HIV-negative infants at 9 m, initiate ART if applicable. 8. Retest all HIV-negative infants at 18 ms, initiate ART if applicable

    18 months

Secondary Outcomes (7)

  • Efficiency of EID testing and notification cycle

    18 months

  • Rapid treatment initiation among HIV+ infants

    18 months

  • Mother-to-child transmission of HIV occurring between first and follow up tests

    18 months

  • Cost effectiveness of HITSystem

    18 months

  • Infant Mortality

    18 months

  • +2 more secondary outcomes

Study Arms (2)

Intervention Hospitals

EXPERIMENTAL

HITSystem implementation at hospital and its affiliated laboratory

Other: HITSystem

Control Hospitals

ACTIVE COMPARATOR

Existing standard of EID care

Other: Standard of Care

Interventions

HITSystemOTHER

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.

Also known as: HIV Infant Tracking System
Intervention Hospitals
Standard of CareOTHER

current procedures that follow Kenyan National EID guidelines to diagnose and manage HIV infection among HIV-exposed infants.

Control Hospitals

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Kenyan Medical Research Institute

Nairobi, Kenya

Location

Related Publications (9)

  • 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.

    PMID: 26155932BACKGROUND

  • 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.

    PMID: 24991904BACKGROUND

  • 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.

    PMID: 27108002RESULT

  • 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.

    PMID: 30135052RESULT

  • 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.

    PMID: 30309787RESULT

  • 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.

    PMID: 31313093RESULT

  • 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.

    PMID: 31369296RESULT

  • 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.

    PMID: 32285335RESULT

  • 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.

    PMID: 32145483RESULT

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Sarah F Kessler, PhD, MPH

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 24, 2014

First Posted

February 26, 2014

Study Start

March 30, 2014

Primary Completion

September 30, 2018

Study Completion

April 30, 2020

Last Updated

July 13, 2020

Record last verified: 2020-07

Locations

KE(1)US(1)