Abstract
BackgroundAs of September 2014, Kenya implemented the WHO recommended Option B+ guidelines in which all newly diagnosed HIV-infected pregnant women are immediately eligible for triple antiretroviral therapy (ART) for life regardless of CD4 count. In addition, Kenya previously established the Kenya Mentor Mother Program (KMMP) in 2012 to improve peer education and psychosocial support services within the national prevention of mother-to-child transmission (PMTCT) program. The primary objectives of the study described in the current protocol are: (1) to evaluate implementation of these new guidelines (Option B+ with Mentor Mothers) as part of routine service delivery; and (2) to evaluate potential benefits of a package of services within the KMMP (called EMMA) to improve PMTCT service delivery.MethodsWe will conduct a cluster randomized controlled trial in western Kenya. We will allocate 12 clinics providing PMTCT services including ART to two study arms using pair matching: the standard of care (SOC) arm, which includes the KMMP as implemented by the clinics; and the intervention arm, which is the SOC (including KMMP) with the EMMA package of services (a targeted exit interview, visit reminders, and targeted follow-up). At the intervention clinics, the EMMA package of services is implemented as part of routine service delivery. A total of 360 (180 in each arm) pregnant women will be enrolled in the study at or near their first visit for antenatal care for prospective records review through 72 weeks post-partum. The primary and secondary outcomes are uninterrupted supplies of ART medications throughout the PMTCT cascade of care as well as infants completing HIV testing on schedule.DiscussionThe EMMA package of services provides specific structure to the use of Mentor Mothers within PMTCT programs. This strategy was developed in collaboration with local health facility and PMTCT program staff based on their experience providing PMTCT services within the integrated ART-MCH facilities. If successful, this approach has the potential to improve dramatically PMTCT service delivery with minor additional costs beyond the basic mother–mentor program and support global goals to eliminate mother-to-child transmission.Trial registrationClinicalTrials.gov, NCT02848235. Registered on 19 July 2016.
Highlights
As of September 2014, Kenya implemented the WHO recommended Option B+ guidelines in which all newly diagnosed Human immunodeficiency virus (HIV)-infected pregnant women are immediately eligible for triple antiretroviral therapy (ART) for life regardless of CD4 count
Another study from roughly the same region of Kenya during the same time period reported that 38% of women newly diagnosed with HIV during pregnancy did not register in the prevention of mother-tochild transmission (PMTCT) program [9]
A study from Zambia found that integration of PMTCT services including ART into maternal and child health (MCH) services increased the percentage of women who initiated PMTCT care (44% compared to 25%) and increased the percentage of those eligible who initiated treatment during pregnancy (32% compared to 4%) [11]
Summary
This form contains the basic information to be extracted from the individual’s medical record for visits to the clinic This process allows us to create a longitudinal dataset (multiple visits for each patient) to complete the data analysis to create the primary and secondary study outcomes for each study participant (the mother); The EMMA study mother-infant data extraction form (see Additional file 4). This form contains the basic information needed to assess primary and secondary outcomes for the infant (date of delivery, dates of HIV tests, etc.). For this minimal risk study addressing behavioral and staff management issues, a data monitoring committee was not organized [26]
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