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Mother Infant Retention for Health: MIR4Health

NCT01962220 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 680

Last updated 2015-12-22

No results posted yet for this study

Summary

Linking HIV-infected pregnant women into prevention of mother to child transmission (PMTCT) services and keeping them in care is important in ensuring that both mother and infant benefit from interventions that improve maternal health and decrease HIV transmission to infants. We propose an evaluation of strategies to link newly diagnosed HIV-infected women to care and keep them in care during pregnancy and after delivery in our study called MIR4HEALTH. The study will be conducted in Nyanza Province, Kenya. All participants will provide informed consent and will be randomized to receive the intervention, including individualized patient education, adherence support and phone call/Short Message Service (SMS) reminders for clinic appointments, or the standard of care (no additional intervention services).

Conditions

Interventions

BEHAVIORAL

Study Intervention for Retention (APFU)

Each newly identified HIV-infected pregnant woman randomized to the experimental arm will be assigned an outreach worker/counselor (Mama Mshauri). Mama Mshauri tasks will include: * Immediately engaging the newly identified pregnant woman, providing individualized adherence and disclosure support, management of ART side effects, and helping the client navigate the health system. * Providing tailored individualized health education during home visits. Additional intervention components include: * Appointments and Reminders: SMS or telephone reminders 1 week and 3 days before appointments. Reinforcement of importance of follow-up during home visits and every contact. * Patient Tracking and Defaulter Tracing: Monthly visits and immediate calls/home visit if she misses an appointment.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Kenya Ministry of Health

    collaborator OTHER_GOV

  • Columbia University

    lead OTHER

Principal Investigators

  • Ruby Fayorsey, MD/MPH · ICAP Columbia University

  • William Reidy, PhD · ICAP Columbia University

  • Eluid Mwangi, MD/MPH/MBA · ICAP - Kenya

  • Duncan Chege, PhD · ICAP - Kenya

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • Kenya

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01962220 on ClinicalTrials.gov