Mother Infant Retention for Health: MIR4Health (MIR4HEALTH)
|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: NCT01962220|
Recruitment Status : Completed
First Posted : October 14, 2013
Last Update Posted : December 22, 2015
|Condition or disease||Intervention/treatment||Phase|
|HIV/AIDS||Behavioral: Study Intervention for Retention (APFU)||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||680 participants|
|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|
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:
Additional intervention components include:
- Proportion of mothers and infants non-retained in care at 6 months [ Time Frame: 6 months ]Mother/infant attrition at 6 months postpartum
- Proportion of women completing the 2nd ANC visit and all ANC and PN visits [ Time Frame: 6 months ]Completion ANC and PN visits
- Proportion of women who had a hospital delivery [ Time Frame: 6 months ]Hospital delivery
- Proportion of infants receiving PCR testing at 6 weeks of age and 6 months [ Time Frame: 6 months ]Infant PCR testing
- Proportion of male partners receiving HIV testing [ Time Frame: 12 months ]Male Partner HIV tests
- Proportion of infants exclusively breastfeeding at 6 months and number of months infant spent breastfeeding [ Time Frame: 6 months ]Exclusive Breastfeeding
- Change in CD4+ cell count from study enrollment to 6 month postpartum for women [ Time Frame: 12 months ]CD4+ Cell Count
- Proportion of women with undetectable HIV RNA at delivery and 6 months postpartum [ Time Frame: 12 months ]Undetectable Viral RNA
- Proportion of women adherent to ARV regimen during pregnancy and postpartum period [ Time Frame: 12 months ]Mother ARV Adherence
- Proportion of infants adherent to postnatal ARV regimen during first six weeks of life [ Time Frame: 1.5 months ]Infant ARV Adherence
- Proportion of women & staff reporting APFU highly acceptable [ Time Frame: 12 months ]Intervention Acceptability
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
|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|
|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|