Mother Infant Retention for Health: MIR4Health

HIV/AIDS Clinical Trial

— MIR4HEALTH  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01962220
• Other study ID #: AAAL5557
• Secondary ID: 1R01HD075163-01
• Status: Completed
• Phase: N/A
• First received: October 10, 2013
• Last updated: December 19, 2015
• Start date: March 2013
• Est. completion date: June 2015

Study information

• Verified date: December 2015
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 680
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• HIV/AIDS

Intervention

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.

Locations

Country	Name	City	State
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

Sponsors (3)

Lead Sponsor	Collaborator
Columbia University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Kenya Ministry of Health

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of mothers and infants non-retained in care at 6 months	Mother/infant attrition at 6 months postpartum	6 months	No
Secondary	Proportion of women completing the 2nd ANC visit and all ANC and PN visits	Completion ANC and PN visits	6 months	No
Secondary	Proportion of women who had a hospital delivery	Hospital delivery	6 months	No
Secondary	Proportion of infants receiving PCR testing at 6 weeks of age and 6 months	Infant PCR testing	6 months	No
Secondary	Proportion of male partners receiving HIV testing	Male Partner HIV tests	12 months	No
Secondary	Proportion of infants exclusively breastfeeding at 6 months and number of months infant spent breastfeeding	Exclusive Breastfeeding	6 months	No
Secondary	Change in CD4+ cell count from study enrollment to 6 month postpartum for women	CD4+ Cell Count	12 months	No
Secondary	Proportion of women with undetectable HIV RNA at delivery and 6 months postpartum	Undetectable Viral RNA	12 months	No
Secondary	Proportion of women adherent to ARV regimen during pregnancy and postpartum period	Mother ARV Adherence	12 months	No
Secondary	Proportion of infants adherent to postnatal ARV regimen during first six weeks of life	Infant ARV Adherence	1.5 months	No
Secondary	Proportion of women & staff reporting APFU highly acceptable	Intervention Acceptability	12 months	No