HIV/AIDSMIR4HEALTHNCT01962220
Mother Infant Retention for Health: MIR4Health
A study testing Study Intervention for Retention (APFU) in people with HIV/AIDS, run by Columbia University at 10 sites in Kenya.
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. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Study Intervention for Retention (APFU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 680 participants
- Where
- 10 sitesKenya
- Study dates
- Mar 2013to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Kenya10 sites
Ahero Sub-district Hospital
Ahero, Nyanza
Ambira Sub-District Hospital
Ambira, Nyanza
Bondo District Hospital
Bondo, Nyanza
Got Agulu Sub-district Hospital
Got Agulu, Nyanza
Jaramoji Oginga Oginga Referral Hospital
Kisumu, Nyanza
Madiany District Hospital
Madiany, Nyanza
Masogo Sub-district Hospital
Masogo, Nyanza
Nyakatch District Hospital
Nyakatch, Nyanza
Siaya District Hospital
Siaya, Nyanza
Ukwala Health Center
Ukwala, Nyanza
About this study
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
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).
Read the 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.
- Conditions
- HIV/AIDS
- Being tested
- Study Intervention for Retention (APFU)
- Keywords
- HIV/AIDS, PMTCT, Pregnant Women, Kenya, Maternal Health
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study Intervention for Retention (APFU)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | 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). |
| Study Intervention for Retention (APFU) | Experimental | 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. Receives: Behavioral: Study Intervention for Retention (APFU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of mothers and infants non-retained in care at 6 months
Mother/infant attrition at 6 months postpartum
Measured: 6 months
Secondary outcomes (10)
Proportion of women completing the 2nd ANC visit and all ANC and PN visits
Completion ANC and PN visits
Measured: 6 months
Proportion of women who had a hospital delivery
Hospital delivery
Measured: 6 months
Proportion of infants receiving PCR testing at 6 weeks of age and 6 months
Infant PCR testing
Measured: 6 months
Proportion of male partners receiving HIV testing
Male Partner HIV tests
Measured: 12 months
Proportion of infants exclusively breastfeeding at 6 months and number of months infant spent breastfeeding
Exclusive Breastfeeding
Measured: 6 months
Change in CD4+ cell count from study enrollment to 6 month postpartum for women
CD4+ Cell Count
Measured: 12 months
Proportion of women with undetectable HIV RNA at delivery and 6 months postpartum
Undetectable Viral RNA
Measured: 12 months
Proportion of women adherent to ARV regimen during pregnancy and postpartum period
Mother ARV Adherence
Measured: 12 months
Proportion of infants adherent to postnatal ARV regimen during first six weeks of life
Infant ARV Adherence
Measured: 1.5 months
Proportion of women & staff reporting APFU highly acceptable
Intervention Acceptability
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2013 (estimated)
- Study startMar 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 680 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Kenya Ministry of Health
- Responsible party
- Principal investigator, Elaine J. Abrams, MD, Columbia University
- Investigators
- Ruby Fayorsey, MD/MPH, Principal investigator, Columbia UniversityWilliam Reidy, PhD, Principal investigator, Columbia UniversityEluid Mwangi, MD/MPH/MBA, Principal investigator, ICAP - KenyaDuncan Chege, PhD, Principal investigator, ICAP - Kenya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01962220
- Sponsor's protocol ID
- AAAL5557
- Other IDs
- 1R01HD075163-01
- Acronym
- MIR4HEALTH
- Status last verified
- Dec 2015
- First submitted
- 10 Oct 2013
- Last updated
- 22 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 30399035DiCarlo 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.
PubMed 29321026Fayorsey 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.
PubMed 27355501
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01962220
- Acronym / sponsor ID
- MIR4HEALTH / AAAL5557
- Conditions
- HIV/AIDS
- Keywords
- HIV/AIDS, PMTCT, Pregnant Women, Kenya, Maternal Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 680 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Kenya Ministry of Health
- Study start
- Mar 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 14 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –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). |
| Study Intervention for Retention (APFU) | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Study Intervention for Retention (APFU) |
Primary outcome
Proportion of mothers and infants non-retained in care at 6 months
Time frame: 6 months
Mother/infant attrition at 6 months postpartum
10 secondary outcomes
Proportion of women completing the 2nd ANC visit and all ANC and PN visits
Time frame: 6 months
Proportion of women who had a hospital delivery
Time frame: 6 months
Proportion of infants receiving PCR testing at 6 weeks of age and 6 months
Time frame: 6 months
Proportion of male partners receiving HIV testing
Time frame: 12 months
Proportion of infants exclusively breastfeeding at 6 months and number of months infant spent breastfeeding
Time frame: 6 months
Change in CD4+ cell count from study enrollment to 6 month postpartum for women
Time frame: 12 months
Proportion of women with undetectable HIV RNA at delivery and 6 months postpartum
Time frame: 12 months
Proportion of women adherent to ARV regimen during pregnancy and postpartum period
Time frame: 12 months
Proportion of infants adherent to postnatal ARV regimen during first six weeks of life
Time frame: 1.5 months
Proportion of women & staff reporting APFU highly acceptable
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2015.
- Derived from this study: PubMed 30399035Fayorsey 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.
- Derived from this study: PubMed 29321026DiCarlo 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.
- Derived from this study: PubMed 27355501Fayorsey 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruby Fayorsey, MD/MPH principal investigator
Columbia University
William Reidy, PhD principal investigator
Columbia University
Eluid Mwangi, MD/MPH/MBA principal investigator
ICAP - Kenya
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study Intervention for Retention (APFU) in people with HIV/AIDS, run by Columbia University at 10 sites in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of mothers and infants non-retained in care at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01962220, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2015.