Clinical trial NCT01962220: Mother Infant Retention for Health: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: HIV/AIDS
PMTCT
Pregnant Women
Kenya
Maternal Health
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Kenya Ministry of Health
First posted: 2013-10-14
Enrollment: 680
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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.

Eligibility 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.

Primary outcomes:
measure: Proportion of mothers and infants non-retained in care at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Proportion of women completing the 2nd ANC visit and all ANC and PN visits
timeFrame: 6 months
measure: Proportion of women who had a hospital delivery
timeFrame: 6 months
measure: Proportion of infants receiving PCR testing at 6 weeks of age and 6 months
timeFrame: 6 months
measure: Proportion of male partners receiving HIV testing
timeFrame: 12 months
measure: Proportion of infants exclusively breastfeeding at 6 months and number of months infant spent breastfeeding
timeFrame: 6 months
measure: Change in CD4+ cell count from study enrollment to 6 month postpartum for women
timeFrame: 12 months
measure: Proportion of women with undetectable HIV RNA at delivery and 6 months postpartum
timeFrame: 12 months
measure: Proportion of women adherent to ARV regimen during pregnancy and postpartum period
timeFrame: 12 months
measure: Proportion of infants adherent to postnatal ARV regimen during first six weeks of life
timeFrame: 1.5 months
measure: Proportion of women & staff reporting APFU highly acceptable
timeFrame: 12 months
Other outcomes:
Locations:
city: Ahero
country: Kenya
facility: Ahero Sub-district Hospital
state: Nyanza
city: Ambira
country: Kenya
facility: Ambira Sub-District Hospital
state: Nyanza
city: Bondo
country: Kenya
facility: Bondo District Hospital
state: Nyanza
city: Got Agulu
country: Kenya
facility: Got Agulu Sub-district Hospital
state: Nyanza
city: Kisumu
country: Kenya
facility: Jaramoji Oginga Oginga Referral Hospital
state: Nyanza
city: Madiany
country: Kenya
facility: Madiany District Hospital
state: Nyanza
city: Masogo
country: Kenya
facility: Masogo Sub-district Hospital
state: Nyanza
city: Nyakatch
country: Kenya
facility: Nyakatch District Hospital
state: Nyanza
city: Siaya
country: Kenya
facility: Siaya District Hospital
state: Nyanza
city: Ukwala
country: Kenya
facility: Ukwala Health Center
state: Nyanza
Study officials:
affiliation: ICAP Columbia University
name: Ruby Fayorsey, MD/MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: ICAP Columbia University
name: William Reidy, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: ICAP - Kenya
name: Eluid Mwangi, MD/MPH/MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: ICAP - Kenya
name: Duncan Chege, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.