Clinical trial NCT04571684: Evaluating HITSystem 2.1 to Improve Viral Suppression in Kenya
Official title: Evaluating the HITSystem to Improve PMTCT Retention and Maternal Viral Suppression in Kenya
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Pregnancy
Keywords: Prevention of mother-to-child transmission (PMTCT) services
maternal viral load monitoring
early infant diagnosis (EID)
Kenya
perinatal HIV transmission
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Kenya Medical Research Institute
name: Children's Mercy Hospital Kansas City
name: Global Health Innovations Foundation - Kenya
name: National Institute of Mental Health (NIMH)
First posted: 2020-10-01
Enrollment: 1648
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Matched, cluster randomized controlled design
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this project is to rigorously evaluate the efficacy of HIV Infant Tracking System 2.1 (HITSystem, an eHealth intervention that uses short message service (SMS) texts to patients and algorithm-driven electronic alerts for providers) to increase retention in guideline-adherent prevention of mother-to-child transmission of HIV services (PMTCT) and to increase viral suppression and appropriate clinical action through the extended period of 6 months postpartum, compared to standard of care PMTCT services in a matched, cluster randomized controlled trial.

Detailed description: Despite progress in providing comprehensive prevention of mother-to-child transmission of HIV (PMTCT) services, significant gaps in the timely uptake and provision of guideline-adherent services and maternal retention in care remain. Such gaps create missed opportunities for preventing mother-to-child transmission and result in nearly 6,100 infants becoming infected with HIV each year in Kenya. Effective interventions that routinize the delivery of evidence-based PMTCT services and foster consistent patient engagement are essential to close the remaining gaps and eliminate mother-to-child transmission of HIV. Building off of a successful R34 grant to develop and pilot test the HITSystem 2.0, an eHealth intervention targeting PMTCT services, the overall goal of this proposal is to use a cluster randomized control design at 12 Kenyan government hospitals to evaluate a modified HITSystem 2.1 intervention. HITSystem 2.1 reflects the 2018 Kenyan PMTCT guidelines, including routine viral load monitoring and interventions to suppress maternal viral load. The investigators aim to evaluate the impact of HITSystem 2.1 to optimize the provision of guideline-adherent services and viral suppression through the antenatal, delivery, and early postpartum periods. Aim 1 of the proposed study will assess the efficacy of the HITSystem 2.1 to increase the proportion of mothers who receive complete PMTCT services (including appointment attendance, medication adherence support, viral load testing, hospital-based delivery, and infant testing per Kenyan National Guidelines) through 6 months postpartum. The investigators hypothesize that mothers receiving the HITSystem 2.1 intervention will have a significantly higher completion rate for guideline-adherence PMTCT services compared to mothers receiving standard of care PMTCT services. In Aim 1b, the investigators will evaluate HITSystem 2.1 implementation using the RE-AIM model to inform sustainable scale up. Aim 2 will assess the efficacy of HITSystem 2.1 to increase viral suppression (\<1,000 copies/mL) among pregnant and postpartum women, including those who disengage from care. The investigators hypothesize that mothers at HITSystem 2.1 sites will have higher rates of viral suppression at delivery and 6 months postpartum. Aim 3 will evaluate the cost-effectiveness of the HITSystem 2.1. Driven by differences in PMTCT retention, viral suppression, and modeled estimates of pediatric HIV infections averted, the investigators hypothesize that the HITSystem 2.1 will be cost-effective, based on World Health Organization criteria. This proposal is aimed at improving the quality of PMTCT services in the health facility setting. If efficacious and cost-effective, HITSystem 2.1 holds strong promise for national dissemination.

Eligibility criteria: Inclusion Criteria:

* Pregnant women living with HIV who present for care at one of the study hospitals by 36 weeks gestation and provide written informed consent are eligible for enrollment in the study.

Exclusion Criteria:

* Pregnant women living with HIV will be excluded from study participation if she has any condition (including drug abuse, alcohol abuse, or psychiatric disorder) that study or hospital staff feel precludes her from providing informed consent.
* Women who transfer care from one study site to another during their PMTCT services will be ineligible for enrollment at their new facility.

Primary outcomes:
measure: Proportion receiving complete PMTCT
timeFrame: 7-15 months (PMTCT enrollment date through 6 months postpartum)
measure: Viral suppression
timeFrame: 1-15 months, (first VL test and followed through 6 months postpartum)
measure: Cost-effectiveness
timeFrame: Years 2 and 4
Secondary outcomes:
measure: PMTCT retention duration (weeks)
timeFrame: 7-15 months (PMTCT enrollment date through 6 months postpartum)
measure: Antiretroviral therapy (ART) adherence
timeFrame: 7-15 months (PMTCT enrollment date through 6 months postpartum)
measure: Viral load test coverage
timeFrame: 7-15 months (PMTCT enrollment date through 6 months postpartum)
measure: Viral load test utility
timeFrame: 7-15 months (PMTCT enrollment date through 6 months postpartum)
measure: Turnaround time of viral load results and patient notification
timeFrame: 7-15 months (PMTCT enrollment date through 6 months postpartum)
measure: Turnaround time of viral load patient notification
timeFrame: 7-15 months (PMTCT enrollment date through 6 months postpartum)
measure: Moderators of HITSystem 2.1 effectiveness
timeFrame: Baseline, delivery, 6 months postpartum (participants), Pre and post study implementation (provider and facility assessment)
measure: Mediators of HITSystem 2.1 effectiveness
timeFrame: Baseline, delivery, 6 months postpartum (participants), Pre and Post study implementation (providers)
Other outcomes:
Locations:
city: Mariakani
country: Kenya
facility: Mariakani Subcounty Hospital
state: Kilifi
city: Mtwapa
country: Kenya
facility: Mtwapa Subcounty Hospital
state: Kilifi
city: Vipingo
country: Kenya
facility: Vipingo Subcounty Hospital
state: Kilifi
city: Likoni
country: Kenya
facility: Likoni Subcounty Hospital
state: Mombasa
city: Ambira
country: Kenya
facility: Ambira Subcounty Hospital
state: Siaya
city: Bondo
country: Kenya
facility: Bondo Subcounty Hospital
state: Siaya
city: Malanga
country: Kenya
facility: Malanga Subcounty Hospital
state: Siaya
city: Sigomere
country: Kenya
facility: Sigomere Health Center
state: Siaya
city: Ukwala
country: Kenya
facility: Ukwala Subcounty Hospital
state: Siaya
city: Yala
country: Kenya
facility: Yala Subcounty Hospital
state: Siaya
city: Siaya
country: Kenya
facility: Akala Subcounty Hospital
city: Siaya
country: Kenya
facility: Siaya County Hospital
Study officials:
affiliation: University of Kansas Medical Center
name: Sarah Finocchario-Kessler, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mokua S, Maloba M, Wexler C, Goggin K, Staggs V, Mabachi N, Maosa N, Babu S, Hurley E, Finocchario-Kessler S. Evaluating the efficacy of the HITSystem 2.1 to improve PMTCT retention and maternal viral suppression in Kenya: Study protocol of a cluster-randomized trial. PLoS One. 2022 Jul 26;17(7):e0263988. doi: 10.1371/journal.pone.0263988. eCollection 2022.