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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
Sponsor:
Collaborators:
Kenya Medical Research Institute
United States President's Emergency Plan for AIDS Relief
Kenya Ministry of Health
Boston University
Information provided by (Responsible Party):
Henry M. Jackson Foundation for the Advancement of Military Medicine

Brief 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.


Condition or disease Intervention/treatment Phase
HIV Pregnancy Other: Standard of Care + EMMA Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.)

Information from the National Library of Medicine

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


Locations
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Kenya
Bomet Health Centre
Bomet, Kenya
Kapsabet District Hospital
Kapsabet, Kenya
Kapkatet District Hospital
Kericho, Kenya
Kericho District Hospital
Kericho, Kenya
Bodi Health Centre
Kisumu, Kenya
Munyuanda Health Centre
Kisumu, Kenya
Ratta Health Centre
Kisumu, Kenya
Kombewa County Hospital
Kombewa, Kenya
Longisa District Hospital
Longisa, Kenya
Meteitei-Sub-district Hospital
Nandi Hills, Kenya
Nandi Hills District Hospital
Nandi Hills, Kenya
Transmara District Hospital
Narok, Kenya
Sponsors and Collaborators
Henry M. Jackson Foundation for the Advancement of Military Medicine
Kenya Medical Research Institute
United States President's Emergency Plan for AIDS Relief
Kenya Ministry of Health
Boston University
Investigators
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Principal Investigator: Fredrick Sawe, MBChB, MMED KEMRI/WRP

Publications:
National AIDS & STI Control Programme. Guidelines for Prevention of Mother to Child Transmission (PMTCT) of HIV/AIDS in Kenya, Third Edition. In. Nairobi, Kenya: Republic of Kenya, Ministry of Health; 2009.
Ministry of Health; National AIDS and STI Control Program (NASCOP). Guidelines on Use of Antiretroviral Drugs for Treating and Preventing HIV Infection: A rapid advice. 2014.
National AIDS and STD Control Program (NASCOP). National Guidelines for PMTCT Peer Education and Psychosocial Support in Kenya: The Kenya Mentor Mother Program. In. Edited by Ministry of Public Health and Sanitation: Government of Kenya; 2012. (http://nascop.or.ke/index.php/download/national-guidelines-for-pmtct-peereducation-and-psychosocial-support-in-kenya/?wpdmdl=1423)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Henry M. Jackson Foundation for the Advancement of Military Medicine
ClinicalTrials.gov Identifier: NCT02848235     History of Changes
Other Study ID Numbers: RV 465/WRAIR 2330/EMMA Study
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Henry M. Jackson Foundation for the Advancement of Military Medicine:
Prevention of Mother to Child Transmission
Antenatal Care for HIV positive women
Kenya