An interventional study of Study Intervention for Retention (APFU) in HIV/AIDS, sponsored by Columbia University. Completed at 10 sites in Kenya. Open to female participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2015-12-22.
Sponsored by Columbia University · Not applicable, Interventional, and Supportive care
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).
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.
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This study's enrollment of 680 is above the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.
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Exclusion Criteria:
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).
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.
Proportion of mothers and infants non-retained in care at 6 months
Mother/infant attrition at 6 months postpartum
Time frame: 6 months
Proportion of women completing the 2nd ANC visit and all ANC and PN visits
Completion ANC and PN visits
Time frame: 6 months
Proportion of women who had a hospital delivery
Hospital delivery
Time frame: 6 months
Proportion of infants receiving PCR testing at 6 weeks of age and 6 months
Infant PCR testing
Time frame: 6 months
Proportion of male partners receiving HIV testing
Male Partner HIV tests
Time frame: 12 months
Proportion of infants exclusively breastfeeding at 6 months and number of months infant spent breastfeeding
Exclusive Breastfeeding
Time frame: 6 months
Change in CD4+ cell count from study enrollment to 6 month postpartum for women
CD4+ Cell Count
Time frame: 12 months
Proportion of women with undetectable HIV RNA at delivery and 6 months postpartum
Undetectable Viral RNA
Time frame: 12 months
Proportion of women adherent to ARV regimen during pregnancy and postpartum period
Mother ARV Adherence
Time frame: 12 months
Proportion of infants adherent to postnatal ARV regimen during first six weeks of life
Infant ARV Adherence
Time frame: 1.5 months
Proportion of women & staff reporting APFU highly acceptable
Intervention Acceptability
Time frame: 12 months
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome→
Columbia University