Mother Infant Retention for Health: MIR4Health
MIR4HEALTH
2 other identifiers
interventional
680
1 country
10
Brief Summary
Linking HIV-infected pregnant women into prevention of mother to child transmission (PMTCT) services and keeping them in care is important in ensuring that both mother and infant benefit from interventions that improve maternal health and decrease HIV transmission to infants. We propose an evaluation of strategies to link newly diagnosed HIV-infected women to care and keep them in care during pregnancy and after delivery in our study called MIR4HEALTH. The study will be conducted in Nyanza Province, Kenya. All participants will provide informed consent and will be randomized to receive the intervention, including individualized patient education, adherence support and phone call/Short Message Service (SMS) reminders for clinic appointments, or the standard of care (no additional intervention services).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2013
Typical duration for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 10, 2013
CompletedFirst Posted
Study publicly available on registry
October 14, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedDecember 22, 2015
December 1, 2015
2.3 years
October 10, 2013
December 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of mothers and infants non-retained in care at 6 months
Mother/infant attrition at 6 months postpartum
6 months
Secondary Outcomes (10)
Proportion of women completing the 2nd ANC visit and all ANC and PN visits
6 months
Proportion of women who had a hospital delivery
6 months
Proportion of infants receiving PCR testing at 6 weeks of age and 6 months
6 months
Proportion of male partners receiving HIV testing
12 months
Proportion of infants exclusively breastfeeding at 6 months and number of months infant spent breastfeeding
6 months
- +5 more secondary outcomes
Study Arms (2)
Standard of Care
NO INTERVENTIONRoutine ANC, Delivery and Postpartum Care: All consenting women will receive routine ANC/Delivery and Postpartum care offered to pregnant women in Kenya as per national guidelines at the MCH of the respective facility. Routine PMTCT and HIV Care: All newly diagnosed HIV-infected pregnant women are enrolled into HIV care in the MCH and receive PMTCT/HIV care per Kenya national guidelines (Revised 2012 PMTCT Guidelines).
Study Intervention for Retention (APFU)
EXPERIMENTALParticipants randomized to the experimental arm of the study will receive routine antenatal and HIV services as described above per Kenya national guidelines. In addition each newly identified HIV-infected pregnant woman randomized to the experimental arm will be assigned an outreach worker/counselor (Mama Mshauri), who will perform numerous tasks described in the intervention. In addition to the Mama Mshauri, this arm will receive phone/SMS appointment reminders, and default patient tracking if participants miss an appointment.
Interventions
Each newly identified HIV-infected pregnant woman randomized to the experimental arm will be assigned an outreach worker/counselor (Mama Mshauri). Mama Mshauri tasks will include: * Immediately engaging the newly identified pregnant woman, providing individualized adherence and disclosure support, management of ART side effects, and helping the client navigate the health system. * Providing tailored individualized health education during home visits. Additional intervention components include: * Appointments and Reminders: SMS or telephone reminders 1 week and 3 days before appointments. Reinforcement of importance of follow-up during home visits and every contact. * Patient Tracking and Defaulter Tracing: Monthly visits and immediate calls/home visit if she misses an appointment.
Eligibility Criteria
You may qualify if:
- Documented HIV-infection according to two finger-prick rapid tests (both previously diagnosed and newly detected)
- Confirmed pregnancy by urine pregnancy test or clinical assessment
- Age 16 years or older
- Able to provide informed consent for research
- Fluent in Luo or English
- Own a cell phone or have access to one in their households
- Live born infants of women enrolled in the study
You may not qualify if:
- Significant obstetric condition documented at the first antenatal visit requiring urgent referral to another facility for specialized obstetric care (e.g., significant hypertension or active bleeding per vagina).
- Denial of HIV status or refusal to initiate ART/ARV prophylaxis.
- Stated intention to move from study site area during the pregnancy or within six months postpartum.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Ahero Sub-district Hospital
Ahero, Nyanza, Kenya
Ambira Sub-District Hospital
Ambira, Nyanza, Kenya
Bondo District Hospital
Bondo, Nyanza, Kenya
Got Agulu Sub-district Hospital
Got Agulu, Nyanza, Kenya
Jaramoji Oginga Oginga Referral Hospital
Kisumu, Nyanza, Kenya
Madiany District Hospital
Madiany, Nyanza, Kenya
Masogo Sub-district Hospital
Masogo, Nyanza, Kenya
Nyakatch District Hospital
Nyakatch, Nyanza, Kenya
Siaya District Hospital
Siaya, Nyanza, Kenya
Ukwala Health Center
Ukwala, Nyanza, Kenya
Related Publications (3)
Fayorsey RN, Wang C, Chege D, Reidy W, Syengo M, Owino SO, Koech E, Sirengo M, Hawken MP, Abrams EJ. Effectiveness of a Lay Counselor-Led Combination Intervention for Retention of Mothers and Infants in HIV Care: A Randomized Trial in Kenya. J Acquir Immune Defic Syndr. 2019 Jan 1;80(1):56-63. doi: 10.1097/QAI.0000000000001882.
PMID: 30399035DERIVEDDiCarlo A, Fayorsey R, Syengo M, Chege D, Sirengo M, Reidy W, Otieno J, Omoto J, Hawken MP, Abrams EJ. Lay health worker experiences administering a multi-level combination intervention to improve PMTCT retention. BMC Health Serv Res. 2018 Jan 10;18(1):17. doi: 10.1186/s12913-017-2825-8.
PMID: 29321026DERIVEDFayorsey RN, Chege D, Wang C, Reidy W, Peters Z, Syengo M, Barasa C, Owino SO, Sirengo M, Hawken MP, Abrams EJ. Mother Infant Retention for Health (MIR4Health): Study Design, Adaptations, and Challenges With PMTCT Implementation Science Research. J Acquir Immune Defic Syndr. 2016 Aug 1;72 Suppl 2(Suppl 2):S137-44. doi: 10.1097/QAI.0000000000001060.
PMID: 27355501DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ruby Fayorsey, MD/MPH
ICAP Columbia University
- PRINCIPAL INVESTIGATOR
William Reidy, PhD
ICAP Columbia University
- PRINCIPAL INVESTIGATOR
Eluid Mwangi, MD/MPH/MBA
ICAP - Kenya
- PRINCIPAL INVESTIGATOR
Duncan Chege, PhD
ICAP - Kenya
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director Research Unit, ICAP
Study Record Dates
First Submitted
October 10, 2013
First Posted
October 14, 2013
Study Start
March 1, 2013
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
December 22, 2015
Record last verified: 2015-12