Evaluating HITSystem 2.1 to Improve Viral Suppression in Kenya

Not Applicable

Completed

Conditions: HIV
Pregnancy

Registration Number: NCT04571684

Lead Sponsor: University of Kansas Medical Center

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 1639

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Participants Receiving Complete PMTCT	7-15 months (PMTCT enrollment date through 6 months postpartum)	documented receipt of all of the following: maternal ART initiation, antenatal appointment attendance, facility delivery, EID linkage by 7 weeks of age, maternal viral load testing and clinical action per national guidelines through 6 months postpartum (Table 6). Participants who receive all indicated services per guidelines will be coded as 1 or 'yes'. Participants missing \> 1 service will be coded as 0 or incomplete PMTCT services.
Viral Suppression	1-9 months	Number of clients with a suppressed viral load(\<1000 copies/mL) at delivery

Secondary Outcome Measures

Name	Time	Method
PMTCT Retention Duration (Weeks)	7-15 months (PMTCT enrollment date through 6 months postpartum)	The number of weeks women were engaged in PMTCT services
Antenatal Viral Load (VL) Test Coverage	Within one month of enrollment in PMTCT	The number of women receiving viral load testing upon enrolling in prevention of mother to child transmission of HIV services (PMTCT).
Postnatal Viral Load (VL) Test Coverage	Between delivery and 7 months postpartum	The number of women receiving postpartum viral load testing per the Kenyan national guidelines.
Viral Load Test Utility	PMTCT enrollment date through 6 months postpartum	Number of detectable viral load results with clinical action per guidelines, such as: intensified adherence counseling and/or ARV regimen change
Turnaround Time of Viral Load Sample Collection to Patient Notification	PMTCT enrollment date through 6 months postpartum	The median number of days from the date of VL sample collection to patient notification, among all viral load tests
Antiretroviral Therapy (ART) Adherence	7-15 months (PMTCT enrollment date through 6 months postpartum)	The number of participants with ART adherence \> 95%

Trial Locations

Locations (12): Mariakani Subcounty Hospital
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Mariakani, Kilifi, Kenya
Mtwapa Subcounty Hospital
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Mtwapa, Kilifi, Kenya
Vipingo Subcounty Hospital
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Vipingo, Kilifi, Kenya
Likoni Subcounty Hospital
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Likoni, Mombasa, Kenya
Ambira Subcounty Hospital
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Ambira, Siaya, Kenya
Bondo Subcounty Hospital
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Bondo, Siaya, Kenya
Malanga Subcounty Hospital
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Malanga, Siaya, Kenya
Sigomere Health Center
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Sigomere, Siaya, Kenya
Ukwala Subcounty Hospital
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Ukwala, Siaya, Kenya
Yala Subcounty Hospital
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Yala, Siaya, Kenya
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Mariakani Subcounty Hospital
🇰🇪Mariakani, Kilifi, Kenya