Kenya Enhanced Mentor Mother ProgrAm (EMMA)

Summary

Kenya recently adopted new treatment guidelines for pregnant women with HIV, which calls for all women to initiate triple-drug antiretroviral therapy (ART) at or soon after their first visit for antenatal care. As part of this new standard of care to prevent mother to child transmission of HIV (PMTCT), Kenya also established the Kenya Mentor Mother Program (KMMP) in 2012 to provide guidance for standardizing peer education and psychosocial support services within the national PMTCT program. This new standard of care (life-long ART and the KMMP) will only yield significant improvements in preventing mother to child transmission if women accept the triple-drug treatment during pregnancy and adhere to visit schedules so that they receive uninterrupted supplies of their medications during pregnancy through at least the cessation of breastfeeding. The primary objectives of this study are: (1) to evaluate implementation of the new guidelines in Kenya under actual, real-world conditions in major maternal and child health clinics in the southern Rift Valley region of Kenya; and (2) to evaluate, also under routine program conditions, the benefits of an innovative intervention package designed to improve implementation of the new treatment guidelines. The intervention uses the existing Mentor Mothers, who already are part of the PMTCT program staff at clinics. At the end of each clinic visit, the Mentor Mother will review with patients their treatment plan and schedule their next visit. The Mentor Mother will also offer, at each encounter, to send a text message reminder to the patient for their next clinic visit and offer to set up an automatic reminder directly on the patient's cell phone. The intervention strategy was developed in close collaboration with local health facility and PMTCT program staff based on their prior and on-going experience providing PMTCT services in the region, and this strategy has the potential to dramatically improve PMTCT service delivery and support global goals to eliminate mother to child transmission.

The study is taking place in 12 clinics in the south-rift valley region of Kenya. A total of 360 patients will be enrolled into the study (approximately 30 at each clinic). The investigators are enrolling patients to receive their permission to look at information recorded in their medical records. All patients eligible for the study, who provide written consent, will be included in the study until the target number of 360 is obtained. After consenting, the study will have no further contact with patients. Because the study only reviews information in medical files that clinics already collect as part of routine care, risks to patients are minimal. The only possible risk is the accidental disclosure of HIV status, but the study is designed to minimize such a risk. There are no direct benefits to study participants, as the study is designed to understand existing adherence to PMTCT care and treatment and to improve such adherence. The study is expected to start in 2016 and end in 2019.

Conditions

• HIV
• Pregnancy

Interventions

OTHER

Standard of Care + EMMA

Mother Mentors will provide enhanced care, above that of the standard of care, to include clinic visit exit discussions, visit reminder messages, and patient follow-up in the event that a clinic visit is missed.

Sponsors & Collaborators

• Kenya Medical Research Institute

  collaborator OTHER

• United States President's Emergency Plan for AIDS Relief

  collaborator FED

• Kenya Ministry of Health

  collaborator OTHER_GOV

• Boston University

  collaborator OTHER

• Henry M. Jackson Foundation for the Advancement of Military Medicine

  lead OTHER

Principal Investigators

• Fredrick Sawe, MBChB, MMED · KEMRI/WRP

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-01-18

Primary Completion

2019-09-30

Completion

2019-09-30

Countries

• Kenya

Study Locations