Kenya Enhanced Mentor Mother ProgrAm (EMMA)

NCT02848235 | Completed

• 1 other identifier: RV 465/WRAIR 2330/EMMA Study
• Study Type: interventional
• Target: 363
• Locations: 1 country
• Sites: 12

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.

Conditions

HIV; Pregnancy

Keywords

Prevention of Mother to Child Transmission; Antenatal Care for HIV positive women; Kenya

Outcome Measures

Primary Outcomes (1)

• Patient adherence to anti-retroviral therapy (ART) and retention to care

  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.

  From date of ART initiation to date of next clinic visit until 72 (+/- 4) weeks post-pardum

Secondary Outcomes (2)

• Proportion of patients initiating ART within 30 days of their first antenatal care (ANC) visit

  30 days after the first ANC visit

• Proportion of HIV-exposed infants with known HIV results at 72 (+/- 4) weeks post-pardum

  72 (+/- 4) weeks post-pardum

Study Arms (2)

Group 1 (Standard of Care)

NO INTERVENTION

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.

Group 2 (Standard of Care + EMMA)

EXPERIMENTAL

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

Interventions

Standard of Care + EMMA OTHER

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.

Group 2 (Standard of Care + EMMA)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Henry M. Jackson Foundation for the Advancement of Military Medicine: lead
• Kenya Medical Research Institute: collaborator
• United States President's Emergency Plan for AIDS Relief: collaborator
• Kenya Ministry of Health: collaborator
• Boston University: collaborator

Study Sites (12)

Bomet Health Centre

Bomet, Kenya

Location

Kapsabet District Hospital

Kapsabet, Kenya

Location

Kapkatet District Hospital

Kericho, Kenya

Location

Kericho District Hospital

Kericho, Kenya

Location

Bodi Health Centre

Kisumu, Kenya

Location

Munyuanda Health Centre

Kisumu, Kenya

Location

Ratta Health Centre

Kisumu, Kenya

Location

Kombewa County Hospital

Kombewa, Kenya

Location

Longisa District Hospital

Longisa, Kenya

Location

Meteitei-Sub-district Hospital

Nandi Hills, Kenya

Location

Nandi Hills District Hospital

Nandi Hills, Kenya

Location

Transmara District Hospital

Narok, Kenya

Location

Related Publications (3)

• Larson BA, Tsikhutsu I, Bii M, Halim N, Agaba P, Sugut W, Muli J, Sawe F. The effects of revised peer-counselor support on the PMTCT cascade of care: results from a cluster-randomized trial in Kenya (the EMMA study). BMC Infect Dis. 2023 Apr 25;23(1):257. doi: 10.1186/s12879-023-08246-4.

  PMID: 37098468 RESULT

• Larson BA, Halim N, Tsikhutsu I, Bii M, Coakley P, Rockers PC. A tool for estimating antiretroviral medication coverage for HIV-infected women during pregnancy (PMTCT-ACT). Glob Health Res Policy. 2019 Oct 15;4:29. doi: 10.1186/s41256-019-0121-3. eCollection 2019.

  PMID: 31637308 RESULT

• Larson BA, Bii M, Tsikhutsu I, Halim N, Wolfman V, Coakley P, Sugut W, Sawe F. 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. Trials. 2018 Oct 30;19(1):594. doi: 10.1186/s13063-018-2975-y.

  PMID: 30376872 DERIVED

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Fredrick Sawe, MBChB, MMED

  KEMRI/WRP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2016
• First Posted: July 28, 2016
• Study Start: January 18, 2017
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: June 8, 2023

Record last verified: 2023-06

Locations

KE (12)