The Enhanced Mentor Mother ProgrAm (EMMA) for the prevention of mother-to-child transmission of HIV in Kenya: study protocol for a cluster randomized controlled trial

Abstract

Background: As 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.

Methods: We 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.

Discussion: The 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 registration: ClinicalTrials.gov, NCT02848235 . Registered on 19 July 2016.

Keywords: AIDS; Antiretroviral therapy; EMMA; Kenya; Mentor mothers; Prevention of mother to child transmission.

Conflict of interest statement

Ethics approval and consent to participate

The study will be conducted according to the Declaration of Helsinki, local regulatory requirements, and Protection of Human Subjects (45 CFR 46). The protocol has been reviewed and approved by the Institutional Review Boards (IRBs) or Independent Ethics Committees (IECs) of the following organizations:

1. The Kenya Medical Research Institute (KEMRI), which includes The Center for Clinical Research (CCR) Scientific Committee (SC) and the KEMRI Scientific and Ethics Review Unit (SERU) (0026/3246);

2. The WRAIR IRB (#2330; RV 465; HRPO Log Number: A-17044.46);

3. The BU Medical Campus IRB (H-35152).

The investigator will regularly inform the IRBs/IEC as to the progress of the study, at a minimum once a year. No changes to the study protocol can be made without prior approval by all IRBs.

Informed consent will be obtained from each participant before enrollment in the study. The Informed Consent Form (ICF) will be written in English and translated into Kiswahili and Luo so that participants can consent for participation in the study in the language in which they are comfortable and able to comprehend. The investigator or designee will ask the interested participants to consent to study enrollment with an ICF that explains all pertinent aspects of the study. The investigator or designee will ensure that before the volunteer decides to participate in the study, she understands its purpose, the procedure, and any risks or benefits associated with the study. The participant will be given ample time to read the ICF and have a chance to ask questions about the study. Participants must understand that taking part in the study is their choice. A participant may decide not to take part in the study or stop being in the study at any time without consequence to their medical care at the time of study withdrawal or subsequently. A copy of the signed ICF(s) will be offered to the participant. The consenting process will be conducted in a private room. No study procedures will occur before the participant giving informed consent.

Consistent with the Common Federal Policy for the Protection of Human Subjects, if an individual cannot give his or her own consent to participate in a research study, then he or she is ineligible for the study. For participants with low literacy, a member of the study staff will read the ICF to the participant and will ask the participant to document their consent by applying a thumbprint or their mark in the presence of an independent witness. The independent witness must be present for the entire informed consent process for participants with low literacy. We recognize that the presence of a witness during the consenting process could be a possible breach of confidentiality. The witness’ role is to ensure that the participant with low literacy is participating in the study voluntarily and to witness the participant signing or applying a thumbprint or their mark on the consent form. The witness will be either an adult, literate individual of the participant’s choice or a member of staff not directly involved in this protocol who will abide by the confidentiality requirement of the site, clinic, or hospital.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

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Figures

Map 1

Location of study sites (numbers 1 - 12)

Fig. 1

SPIRIT figure (Study timeline)

Fig. 2

Timeline showing primary (P) and secondary (S) outcomes to be evaluated