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Mother Infant Retention for Health: MIR4Health (MIR4HEALTH)

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ClinicalTrials.gov Identifier: NCT01962220
Recruitment Status : Completed
First Posted : October 14, 2013
Last Update Posted : December 22, 2015
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Kenya Ministry of Health
Information provided by (Responsible Party):
Elaine J. Abrams, MD, Columbia University

Study Description
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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).

Condition or disease Intervention/treatment Phase
HIV/AIDS Behavioral: Study Intervention for Retention (APFU) Not Applicable

Detailed Description:

Mother Infant Retention for Health (MIR4HEALTH) is an innovative implementation science study focused on testing an effective multicomponent strategy to improve linkage and retention of newly identified HIV‐infected pregnant women accessing maternal child health (MCH) services in Nyanza Province, Kenya. MIR4HEALTH is distinguished by several innovations including the recognition that newly identified HIV-infected pregnant woman are especially vulnerable to poor retention within PMTCT services and that both mother and child must be retained in care to ensure optimal health outcomes.

The study is a randomized trial to compare the effectiveness of a novel strategy using Active Patient Follow-Up (APFU) to the current standard of care (SOC) routinely provided for the retention of women and their exposed infants postpartum. The proposed APFU includes a package of evidence-based interventions including health education, provision of phone and short message service (SMS) appointment reminders, active tracking of patients for linkage and retention, and individualized retention and adherence support. Patients enrolled in the APFU intervention arm will complete three antenatal study visits after enrollment as well as two postnatal study visits with their infants at 6 weeks and 6 months postpartum. Laboratory blood specimens will be collected from mothers and infants at two separate visits to assess viral load and and drug levels. Additionally, all staff will be offered a chance to participate in an interview assessing the feasibility and acceptability of APFU.

Study participants will be recruited from various clinics in the Nyanza Province in Kenya. This study will enroll pregnant women who test positive for HIV during their first antenatal visit and have no prior HIV diagnosis. Upon live birth, the infants of participating women will also be included in the study. The study will enroll 214 newly-infected pregnant women, with 107 participants in the APFU arm (intervention) and 107 participants in the SOC arm. Infants born to women enrolled in the study will also be included so there will be a total of 214 mother-infant pairs, totaling 428 participants.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 680 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Mother Infant Retention for Health: Evaluation of a Multicomponent Strategy to Link and Retain Newly Identified HIV-infected Pregnant Women and Their Infants Throughout the Antenatal and Post-partum Period
Study Start Date : March 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Standard of Care

Routine 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).
Experimental: Study Intervention for Retention (APFU)
Participants 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.
 Behavioral: Study Intervention for Retention (APFU)

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.


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of mothers and infants non-retained in care at 6 months [ Time Frame: 6 months ]
    Mother/infant attrition at 6 months postpartum


Secondary Outcome Measures :
  1. Proportion of women completing the 2nd ANC visit and all ANC and PN visits [ Time Frame: 6 months ]
    Completion ANC and PN visits

  2. Proportion of women who had a hospital delivery [ Time Frame: 6 months ]
    Hospital delivery

  3. Proportion of infants receiving PCR testing at 6 weeks of age and 6 months [ Time Frame: 6 months ]
    Infant PCR testing

  4. Proportion of male partners receiving HIV testing [ Time Frame: 12 months ]
    Male Partner HIV tests

  5. Proportion of infants exclusively breastfeeding at 6 months and number of months infant spent breastfeeding [ Time Frame: 6 months ]
    Exclusive Breastfeeding

  6. Change in CD4+ cell count from study enrollment to 6 month postpartum for women [ Time Frame: 12 months ]
    CD4+ Cell Count

  7. Proportion of women with undetectable HIV RNA at delivery and 6 months postpartum [ Time Frame: 12 months ]
    Undetectable Viral RNA

  8. Proportion of women adherent to ARV regimen during pregnancy and postpartum period [ Time Frame: 12 months ]
    Mother ARV Adherence

  9. Proportion of infants adherent to postnatal ARV regimen during first six weeks of life [ Time Frame: 1.5 months ]
    Infant ARV Adherence

  10. Proportion of women & staff reporting APFU highly acceptable [ Time Frame: 12 months ]
    Intervention Acceptability


Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients who fail to meet any of the inclusion criteria will be excluded
  • 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.
Contacts and Locations
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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): NCT01962220


Locations
Kenya
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
Sponsors and Collaborators
Columbia University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Kenya Ministry of Health
Investigators
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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Elaine J. Abrams, MD, Director Research Unit, ICAP, Columbia University
ClinicalTrials.gov Identifier: NCT01962220     History of Changes
Other Study ID Numbers: AAAL5557
1R01HD075163-01 ( U.S. NIH Grant/Contract )
First Posted: October 14, 2013    Key Record Dates
Last Update Posted: December 22, 2015
Last Verified: December 2015

Keywords provided by Elaine J. Abrams, MD, Columbia University:
HIV/AIDS
PMTCT
Pregnant Women
Kenya
Maternal Health