Clinical trial NCT02726607: Adapting the HITSystem to Support Prevention of Mother-to-child HIV Transmission
Official title: Adapting the HITSystem to Support Prevention of Mother-to-child HIV Transmission
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: Prevention of mother-to-child transmission (PMTCT)
Kenya
HITSystem 2.0
retention through PMTCT cascade of care
Early Infant Diagnosis
eHealth system-level intervention
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Kenya Medical Research Institute
name: Global Health Innovations
name: Children's Mercy Hospital Kansas City
First posted: 2016-04-01
Enrollment: 157
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We employed a matched randomized pilot study design in two government hospitals; one randomized to receive the HITSystem 2.0 intervention while the other maintained standard of care PMTCT services.
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Complete PMTCT retention
timeFrame: first PMTCT visit during pregnancy to the return of the infant's first HIV DNA PCR test result by 12 weeks postnatal
Secondary outcomes:
measure: Duration of PMTCT Retention
timeFrame: Date of first PMTCT appointment through date of last PMTCT service. Final eligible service is date of infant HIV PCR test.
measure: Infant HIV status
timeFrame: Results obtained by 12 weeks postnatal
measure: Number of antenatal PMTCT appointments attended
timeFrame: First antenatal PMTCT appointment through delivery date
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Bungoma
country: Kenya
facility: Bungoma County Hospital
state: Nandi
city: Kapsabet
country: Kenya
facility: Kapsabet Hospital
state: Nandi
Study officials:
affiliation: University of Kansas Medical Center
name: Sarah F Kessler, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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):18-28. doi: 10.1007/s10461-019-02451-6.