Kenya Enhanced Mentor Mother ProgrAm (EMMA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02848235|
Recruitment Status : Active, not recruiting
First Posted : July 28, 2016
Last Update Posted : August 22, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV Pregnancy||Other: Standard of Care + EMMA||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||360 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Implementing the PMTCT Standard of Care Under Routine Conditions With and Without the Enhanced Mentor Mother ProgrAm (EMMA): A Site-randomized Impact Evaluation Study Among Maternal and Child Health Clinics Supported by the South Rift Valley PEPFAR Program in Kenya|
|Actual Study Start Date :||January 18, 2017|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||November 2019|
No Intervention: Group 1 (Standard of Care)
Participants in group 1 will receive the standard of care for the Prevention of Mother to Child Transmission (PMCTC) of HIV from the clinic's Mentor Mothers.
Experimental: Group 2 (Standard of Care + EMMA)
Participants in group 2 will receive the standard of care for Prevention of Mother to Child Transmission (PMCTC) of HIV plus study-specific enhanced care interventions from the clinic's Mentor Mothers.
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.
- Patient adherence to anti-retroviral therapy (ART) and retention to care [ Time Frame: From date of ART initiation to date of next clinic visit until 72 (+/- 4) weeks post-pardum ]Proportion of pregnant women with HIV receiving an uninterrupted supply (enough medication for each day) of ART from treatment initiation to the next clinic visit, clinic visit to clinic visit, etc. until 72 (+/- 4) weeks post-pardum. Potential for adherence to ART and retention to care (assessed by clinic visit attendance) will be evaluated with this information.
- Proportion of patients initiating ART within 30 days of their first antenatal care (ANC) visit [ Time Frame: 30 days after the first ANC visit ]The proportion of women initiating ART within 30 days of their first ANC visit will be assessed via prescriptions written as noted in medical records.
- Proportion of HIV-exposed infants with known HIV results at 72 (+/- 4) weeks post-pardum [ Time Frame: 72 (+/- 4) weeks post-pardum ]Kenyan PMTCT guidelines recommend HIV testing for HIV-exposed babies at 6 weeks, 9 months, and 18 months (72 weeks) of life. Thus, all infants should have a final HIV diagnosis by 72 weeks (either negative at 72 weeks or positive at or before 72 weeks). From the perspective of the clinic, it is critical to getting care to all HIV-infected children that all HIV-exposed babies get a final HIV diagnosis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02848235
|Bomet Health Centre|
|Kapsabet District Hospital|
|Kapkatet District Hospital|
|Kericho District Hospital|
|Bodi Health Centre|
|Munyuanda Health Centre|
|Ratta Health Centre|
|Kombewa County Hospital|
|Longisa District Hospital|
|Nandi Hills, Kenya|
|Nandi Hills District Hospital|
|Nandi Hills, Kenya|
|Transmara District Hospital|
|Principal Investigator:||Fredrick Sawe, MBChB, MMED||KEMRI/WRP|