- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01962220
Mother Infant Retention for Health: MIR4Health (MIR4HEALTH)
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 Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Nyanza
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Ahero, Nyanza, Kenya
- Ahero Sub-District Hospital
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Ambira, Nyanza, Kenya
- Ambira Sub-District Hospital
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Bondo, Nyanza, Kenya
- Bondo District Hospital
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Got Agulu, Nyanza, Kenya
- Got Agulu Sub-district Hospital
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Kisumu, Nyanza, Kenya
- Jaramoji Oginga Oginga Referral Hospital
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Madiany, Nyanza, Kenya
- Madiany District Hospital
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Masogo, Nyanza, Kenya
- Masogo Sub-district Hospital
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Nyakatch, Nyanza, Kenya
- Nyakatch District Hospital
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Siaya, Nyanza, Kenya
- Siaya District Hospital
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Ukwala, Nyanza, Kenya
- Ukwala Health Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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). |
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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.
|
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:
Additional intervention components include:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of mothers and infants non-retained in care at 6 months
Time Frame: 6 months
|
Mother/infant attrition at 6 months postpartum
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of women completing the 2nd ANC visit and all ANC and PN visits
Time Frame: 6 months
|
Completion ANC and PN visits
|
6 months
|
Proportion of women who had a hospital delivery
Time Frame: 6 months
|
Hospital delivery
|
6 months
|
Proportion of infants receiving PCR testing at 6 weeks of age and 6 months
Time Frame: 6 months
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Infant PCR testing
|
6 months
|
Proportion of male partners receiving HIV testing
Time Frame: 12 months
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Male Partner HIV tests
|
12 months
|
Proportion of infants exclusively breastfeeding at 6 months and number of months infant spent breastfeeding
Time Frame: 6 months
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Exclusive Breastfeeding
|
6 months
|
Change in CD4+ cell count from study enrollment to 6 month postpartum for women
Time Frame: 12 months
|
CD4+ Cell Count
|
12 months
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Proportion of women with undetectable HIV RNA at delivery and 6 months postpartum
Time Frame: 12 months
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Undetectable Viral RNA
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12 months
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Proportion of women adherent to ARV regimen during pregnancy and postpartum period
Time Frame: 12 months
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Mother ARV Adherence
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12 months
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Proportion of infants adherent to postnatal ARV regimen during first six weeks of life
Time Frame: 1.5 months
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Infant ARV Adherence
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1.5 months
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Proportion of women & staff reporting APFU highly acceptable
Time Frame: 12 months
|
Intervention Acceptability
|
12 months
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Collaborators and Investigators
Sponsor
Collaborators
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
Publications and helpful links
General Publications
- 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.
- DiCarlo 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.
- Fayorsey 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- AAAL5557
- 1R01HD075163-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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