Kenya Enhanced Mentor Mother ProgrAm (EMMA)
Kenya Enhanced Mentor Mother ProgrAm (EMMA)
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.
Treatment guidelines for women with HIV during pregnancy and after delivery in
 resource-constrained settings changed significantly with the WHO 2013 guidelines, which
 recommended that all pregnant women with HIV should initiate triple-combination ART (Option
 B). With these guidelines, women previously eligible for life-long ART at initiation should
 continue for life, while the rest should remain on ART at least through the duration of
 breastfeeding. A related recommendation was that all pregnant women newly diagnosed with HIV
 should initiate ART as lifelong treatment. As of 2014, the Kenyan Ministry of Health (MOH)
 recommends Option B+, which includes the "immediate initiation of life-long ART in pregnant
 and breastfeeding women upon HIV diagnosis with continuous adherence support" regardless of
 CD4 count. Throughout this document, the 2014 policy is referred to as standard of care
 (SOC).

 Recognizing the barriers pregnant women newly diagnosed with HIV during antenatal care would
 face if they were referred elsewhere for HIV care and treatment, in 2005 the South Rift
 Valley PEPFAR program established a policy to integrate all HIV-related care including ART
 into PMTCT services provided at the larger MCH clinics within the region. As of 2013, this
 policy began to be implemented in the 12 largest facilities in the program accounting for
 more than 85% of women newly diagnosed with HIV during pregnancy in the region.

 As part of the standard of care, Kenya also developed the National Guidelines for PMTCT Peer
 Education and Psychosocial Support in Kenya: The Kenya Mentor Mother Program (KMMP). Mentor
 Mothers are clinic staff members who are also women living with HIV. They are trained and
 employed to be part of the clinic's medical team to provide pre-test group education
 sessions, one-on-one and couples counseling, support groups and defaulter tracing. As part of
 their routine clinic activities, Mentor Mothers obtain consent from their clients for various
 forms to follow up, including full consent for both phone and SMS follow up (or only phone
 follow up, or no follow up) as well as consent for home follow up by her or a community
 health worker.

 Successful implementation of the PMTCT services requires that: (1) pregnant women with HIV
 initiate life-long ART with minimal delay after their first ANC visit (and women already on
 ART should continue on ART); (2) they continue on treatment through delivery; (3) they
 continue on treatment after delivery and the cessation of breastfeeding (and continuing for
 life for their health); and (4) their child completes HIV testing at 6, 36, and 72 weeks so
 that they are known to be uninfected after the cessation of breast feeding. Kenya does not
 yet know if the new policy will lead to better PMTCT outcomes, much less how much better,
 than under the old policy. Information continues to be lacking in Kenya and elsewhere on the
 ability of PMTCT programs to initiate pregnant women with HIV on ART during pregnancy and
 retain them on treatment along the PMTCT cascade of care through delivery, cessation of
 breastfeeding and for the longer term. This information is largely lacking for the time
 period when countries implemented prior PMTCT policies (e.g., Option A), and such information
 does not yet exist for the new policy in Kenya.

 What information exists suggests significant room for improvement. For example, a recently
 published study from a treatment program in western Kenya, with an active outreach
 department, reported that 32% of women initiated on ART during pregnancy disengaged from
 treatment before delivery. Although the data for this study were from 2006-2009, they
 indicate the difficulties with retaining pregnant women on ART during pregnancy. Information
 on other key outcomes, such as the proportion of those eligible who actually initiated
 treatment are not reported. 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 PMTCT program. In two hospitals between Kericho and Nairobi (Gigil and
 Naivasha), only 4% of women eligible for ART initiated treatment within six months of their
 HIV diagnosis.

 Some evidence suggests that integration of ART within MCH clinics improves linkage to and
 initiation of treatment. For example, a study from Zambia found that integration of PMTCT
 including ART into 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%). While integration improved upon these basic outcomes,
 more than the majority of patients still did not initiate PMTCT care or initiate ART if
 eligible. Early evidence on the implementation of life-long ART for pregnant women from
 Malawi suggests that eliminating CD4 counts as an eligibility criterion might facilitate
 initiation, but some significant share may still not agree to initiate ART, and retention on
 treatment during and after delivery may remain problematic without specific attention
 directed towards these issues.

 To support effective implementation of then Kenya PMTCT SOC in the South Rift Valley, other
 regions of Kenya, and in other resource limited settings, better and up-to-date information
 remains needed on implementation as currently provided in the study region. And recognizing
 the importance of both timely initiation and retention on treatment during and after
 pregnancy, active strategies for retaining patients in care are preferable to after-the-fact
 follow up to re-engage a patient in care who previously disengaged. Thus, feasible
 programmatic interventions can support successfully implementation of the SOC and long-term
 patient care beyond pregnancy.

 The study proposed here is designed to fill this information gap and to improve
 implementation of the Kenyan PMTCT SOC. The investigators will evaluate the impacts and costs
 of an innovative strategy to improve implementation of the SOC. The strategy, called the
 Enhanced Mentor Mother ProgrAm (EMMA), provides specific structure to the use of Mentor
 Mothers within PMTCT programs. The EMMA 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 and support global goals to eliminate mother to
 child transmission. This enhancement to the existing Mentor Mother program is consistent with
 the KMMP guidelines, which emphasize that "The National Guidelines do not intend to remove
 the space for creativity and innovation in these approaches. On the contrary, the MOH hopes
 to inspire ongoing dialogue about quality improvements from the clearly defined starting
 point outlined herein".
Inclusion Criteria:

 -  Adult patients (>18 years)

 -  Pregnant women with HIV presenting for antenatal care at a study site

 -  The ability to understand and the willingness to sign/mark a written informed consent
 document in English or Kiswahili during 1st or 2nd visit for antenatal care at a study
 site.

 Exclusion Criteria:

 -  Indication that patient does not intend to receive further antenatal, postnatal, or
 PMTCT care at the site.

 -  Patient is not physically and/or emotionally able to complete the informed consent
 process to initiate/participate in study (mentally ill, drug abuse, etc.)