Adapting the HITSystem to Support Prevention of Mother-to-child HIV Transmission

HIV Clinical Trial

Official title:

Adapting the HITSystem to Support Prevention of Mother-to-child HIV Transmission

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02726607
• Other study ID #: STUDY00002009
• Secondary ID: R34MH107337-01
• Status: Completed
• Phase: N/A
• Start date: August 15, 2015
• Est. completion date: March 20, 2020

Study information

• Verified date: March 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 modify the HITSystem to engage and retain HIV+ pregnant women before, during and after delivery and evaluate the HITSystem impact on prevention of mother-to-child transmission (PMTCT) related behaviors and outcomes. HITSystem 2.0 intervention will support a range of PMTCT outcomes including retention in care, ART adherence, and integration of maternal and pediatric HIV services in low-resource settings.

Description:

The study will be conducted in three phases:

Phases 1: The researchers will conduct formative research (focus groups and interviews) with HIV+ pregnant women and PMTCT providers to customize communication strategies for text messaging and inform patient flow and optimal implementation across the various PMTCT-related services at the intervention site.

Phase 2: The researchers will design and refine the HITSystem 2.0 technical components to support PMTCT outcomes guided by clinical content experts, technology analysts, and findings from Phase 1.

Phase 3: The researchers will implement HITSystem 2.0 at one hospital over an 18 month period, and compare targeted PMTCT outcomes to those at a matched control hospital.

The study will be conducted at two government hospitals in Kenya. HIV+ pregnant women will be enrolled in the HITSystem 2.0 at Kapsabet Hospital. HIV+ pregnant women receiving the current standard of PMTCT care at Nandi Hills Hospital will be the comparison group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: March 20, 2020
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Phase 3

Inclusion Criteria:

• HIV+ pregnant women

• Present for first PMTCT appointment at one of the study Hospitals

• Own or have reliable access to mobile phone

Exclusion Criteria:

• N/A

Related Conditions & MeSH terms

• HIV

Intervention

Behavioral:
• HIV Infant Tracking System (HITSystem) 2.0
The HITsystem 2.0 intervention will be designed to: (1) utilize electronic prompts to notify providers and program managers when actions are required, and (2) send text messages to women's mobile phones to (a) motivate adherence to medication, (b) remind women of antenatal (ANC) appointments and medication refills, (c) prompt preparation for a hospital delivery, and (d) support early infant testing. Given advancements in the approach and protocols for care, HITSystem 2.0 will continue to engage mothers and encourage postnatal medication adherence. The researchers will design HITSystem 2.0 to integrate seamlessly into the existing HITSystem to link PMTCT and early infant diagnosis (EID) services through one coordinated system-level intervention.
• Standard of PMTCT care
Pregnant women enrolled in PMTCT services at the control site will receive the current standard of PMTCT care and will not be enrolled in the HITSystem 2.0.

Locations

Country	Name	City	State
Kenya	Bungoma County Hospital	Bungoma	Nandi
Kenya	Kapsabet Hospital	Kapsabet	Nandi
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (5)

Lead Sponsor	Collaborator
University of Kansas Medical Center	Children's Mercy Hospital Kansas City, Global Health Innovations, Kenya Medical Research Institute, National Institute of Mental Health (NIMH)

Countries where clinical trial is conducted

United States,  Kenya, 

References & Publications (2)

Finocchario-Kessler S, Maloba M, Brown M, Gautney B, Goggin K, Wexler C, Mabachi N, Odeny B, Lagat S, Koech S, Dariotis JK, Odeny TA. Adapting the HIV Infant Tracking System to Support Prevention of Mother-to-Child Transmission of HIV in Kenya: Protocol for an Intervention Development Pilot Study in Two Hospitals. JMIR Res Protoc. 2019 Jun 8;8(6):e13268. doi: 10.2196/13268. — View Citation

Mabachi NM, Brown M, Sandbulte M, Wexler C, Goggin K, Maloba M, Finocchario-Kessler S. Using a Social Support Framework to Understand How HIV Positive Kenyan Men Engage in PMTCT/EID Care: Qualitative Insights From Male Partners. AIDS Behav. 2020 Jan;24(1) — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete PMTCT retention	The primary outcome is retention (complete or incomplete), measured from first PMTCT appointment until HIV status determination of the HIV-exposed infant at 12 weeks postnatal. This aggregate outcome includes completion of several intermediate outcomes throughout the PMTCT cascade of care, including: ART initiation (if not already on ART at time of pregnancy) (Yes/No), attendance at PMTCT appointments (Yes/No), a hospital delivery (Yes/No), infant enrollment in EID prior to hospital discharge (Yes/No), infant blood sample collected and HIV DNA PCR test result obtained (Yes/No). Complete retention requires completion of all of these steps.	first PMTCT visit during pregnancy to the return of the infant's first HIV DNA PCR test result by 12 weeks postnatal
Secondary	Duration of PMTCT Retention	The mean (sd) duration of PMTCT retention (number of weeks from date of PMTCT enrollment to date of last documented PMTCT service).	Date of first PMTCT appointment through date of last PMTCT service. Final eligible service is date of infant HIV PCR test.
Secondary	Infant HIV status	Result of infant HIV DNA Polymerase Chain Reaction (PCR) test: HIV-positive, HIV-negative, indeterminate, unknown, missing	Results obtained by 12 weeks postnatal
Secondary	Number of antenatal PMTCT appointments attended	The mean (sd) number of ANC appointments attended, and the proportion of women who received the recommended 4 or more antenatal appointments prior to delivery.	First antenatal PMTCT appointment through delivery date