HIVNCT02726607
Adapting the HITSystem to Support Prevention of Mother-to-child HIV Transmission
A study testing HIV Infant Tracking System (HITSystem) 2.0 and Standard of PMTCT care in people with HIV, run by University of Kansas Medical Center at 3 sites in 2 countries.
Trial summary
The purpose of this study is to modify the HITSystem to engage and retain HIV+ pregnant women before, during and after delivery and evaluate the HITSystem impact on prevention of mother-to-child transmission (PMTCT) related behaviors and outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV
- What is being tested?
- HIV Infant Tracking System (HITSystem) 2.0 and Standard of PMTCT care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 15 Aug 2015to 20 Mar 2020
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV+ pregnant women
- Present for first PMTCT appointment at one of the study Hospitals
- Own or have reliable access to mobile phone
Who cannot join
- N/A
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Kenya2 sites
Bungoma County Hospital
Bungoma, Nandi, 30301
Kapsabet Hospital
Kapsabet, Nandi, 30300
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
The purpose of this study is to modify the HITSystem to engage and retain HIV+ pregnant women before, during and after delivery and evaluate the HITSystem impact on prevention of mother-to-child transmission (PMTCT) related behaviors and outcomes. HITSystem 2.0 intervention will support a range of PMTCT outcomes including retention in care, ART adherence, and integration of maternal and pediatric HIV services in low-resource settings.
Read the detailed description
The study will be conducted in three phases:
Phases 1: The researchers will conduct formative research (focus groups and interviews) with HIV+ pregnant women and PMTCT providers to customize communication strategies for text messaging and inform patient flow and optimal implementation across the various PMTCT-related services at the intervention site.
Phase 2: The researchers will design and refine the HITSystem 2.0 technical components to support PMTCT outcomes guided by clinical content experts, technology analysts, and findings from Phase 1.
Phase 3: The researchers will implement HITSystem 2.0 at one hospital over an 18 month period, and compare targeted PMTCT outcomes to those at a matched control hospital.
The study will be conducted at two government hospitals in Kenya. HIV+ pregnant women will be enrolled in the HITSystem 2.0 at Kapsabet Hospital. HIV+ pregnant women receiving the current standard of PMTCT care at Nandi Hills Hospital will be the comparison group.
- Conditions
- HIV
- Being tested
- HIV Infant Tracking System (HITSystem) 2.0, Standard of PMTCT care
- Keywords
- Prevention of mother-to-child transmission (PMTCT), Kenya, HITSystem 2.0, retention through PMTCT cascade of care, Early Infant Diagnosis, eHealth system-level intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV Infant Tracking System (HITSystem) 2.0Behavioural
The HITsystem 2.0 intervention will be designed to: (1) utilize electronic prompts to notify providers and program managers when actions are required, and (2) send text messages to women's mobile phones to (a) motivate adherence to medication, (b) remind women of antenatal (ANC) appointments and medication refills, (c) prompt preparation for a hospital delivery, and (d) support early infant testing. Given advancements in the approach and protocols for care, HITSystem 2.0 will continue to engage mothers and encourage postnatal medication adherence. The researchers will design HITSystem 2.0 to integrate seamlessly into the existing HITSystem to link PMTCT and early infant diagnosis (EID) services through one coordinated system-level intervention.
Standard of PMTCT careBehavioural
Also called no HITSystem 2.0 intervention
Pregnant women enrolled in PMTCT services at the control site will receive the current standard of PMTCT care and will not be enrolled in the HITSystem 2.0.
| Study group | Role | What they receive |
|---|---|---|
| HITSystem 2.0 | Experimental | Pregnant women who are eligible for PMTCT services will be enrolled in the HIV Infant Tracking System 2.0 (HITSystem 2.0) intervention during their first PMTCT appointment and followed until 12 weeks postpartum. Receives: Behavioral: HIV Infant Tracking System (HITSystem) 2.0 |
| Standard of PMTCT Care | Active comparator | Pregnant women who are eligible for PMTCT services will receive standard of care PMTCT services at the control hospital. The records of women enrolled during their first PMTCT appointment will be used to assess outcomes during the same follow-up period. Receives: Behavioral: Standard of PMTCT care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete PMTCT retention
The primary outcome is retention (complete or incomplete), measured from first PMTCT appointment until HIV status determination of the HIV-exposed infant at 12 weeks postnatal. This aggregate outcome includes completion of several intermediate outcomes throughout the PMTCT cascade of care, including: ART initiation (if not already on ART at time of pregnancy) (Yes/No), attendance at PMTCT appointments (Yes/No), a hospital delivery (Yes/No), infant enrollment in EID prior to hospital discharge (Yes/No), infant blood sample collected and HIV DNA PCR test result obtained (Yes/No). Complete retention requires completion of all of these steps.
Measured: first PMTCT visit during pregnancy to the return of the infant's first HIV DNA PCR test result by 12 weeks postnatal
Secondary outcomes (3)
Duration of PMTCT Retention
The mean (sd) duration of PMTCT retention (number of weeks from date of PMTCT enrollment to date of last documented PMTCT service).
Measured: Date of first PMTCT appointment through date of last PMTCT service. Final eligible service is date of infant HIV PCR test.
Infant HIV status
Result of infant HIV DNA Polymerase Chain Reaction (PCR) test: HIV-positive, HIV-negative, indeterminate, unknown, missing
Measured: Results obtained by 12 weeks postnatal
Number of antenatal PMTCT appointments attended
The mean (sd) number of ANC appointments attended, and the proportion of women who received the recommended 4 or more antenatal appointments prior to delivery.
Measured: First antenatal PMTCT appointment through delivery date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study start15 Aug 2015
- Primary completion30 Jul 2019
- Study completion20 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We employed a matched randomized pilot study design in two government hospitals; one randomized to receive the HITSystem 2.0 intervention while the other maintained standard of care PMTCT services.
- Masking
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Kenya Medical Research Institute, Global Health Innovations, Children's Mercy Hospital Kansas City
- Responsible party
- Principal investigator, Sarah Kessler, PhD, MPH, University of Kansas Medical Center
- Investigators
- Sarah F Kessler, PhD, MPH, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02726607
- Sponsor's protocol ID
- STUDY00002009
- Other IDs
- R34MH107337-01
- Status last verified
- Mar 2020
- First submitted
- 24 Mar 2016
- Last updated
- 1 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Finocchario-Kessler S, Maloba M, Brown M, Gautney B, Goggin K, Wexler C, Mabachi N, Odeny B, Lagat S, Koech S, Dariotis JK, Odeny TA. Adapting the HIV Infant Tracking System to Support Prevention of Mother-to-Child Transmission of HIV in Kenya: Protocol for an Intervention Development Pilot Study in Two Hospitals. JMIR Res Protoc. 2019 Jun 8;8(6):e13268. doi: 10.2196/13268.
PubMed 31199305Mabachi NM, Brown M, Sandbulte M, Wexler C, Goggin K, Maloba M, Finocchario-Kessler S. Using a Social Support Framework to Understand How HIV Positive Kenyan Men Engage in PMTCT/EID Care: Qualitative Insights From Male Partners. AIDS Behav. 2020 Jan;24(1):18-28. doi: 10.1007/s10461-019-02451-6.
PubMed 30877581
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting the HITSystem to Support Prevention of Mother-to-child HIV Transmission
- ClinicalTrials.gov ID
- NCT02726607
- Acronym / sponsor ID
- STUDY00002009
- Conditions
- HIV
- Keywords
- Prevention of mother-to-child transmission (PMTCT), Kenya, HITSystem 2.0, retention through PMTCT cascade of care, Early Infant Diagnosis, eHealth system-level intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Kenya Medical Research Institute, Global Health Innovations, Children's Mercy Hospital Kansas City
- Study start
- 15 Aug 2015 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 1 Apr 2016 (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.
The purpose of this study is to modify the HITSystem to engage and retain HIV+ pregnant women before, during and after delivery and evaluate the HITSystem impact on prevention of mother-to-child transmission (PMTCT) related behaviors and outcomes. HITSystem 2.0 intervention will support a range of PMTCT outcomes including retention in care, ART adherence, and integration of maternal and pediatric HIV services in low-resource settings.
Detailed description
The study will be conducted in three phases:
Phases 1: The researchers will conduct formative research (focus groups and interviews) with HIV+ pregnant women and PMTCT providers to customize communication strategies for text messaging and inform patient flow and optimal implementation across the various PMTCT-related services at the intervention site.
Phase 2: The researchers will design and refine the HITSystem 2.0 technical components to support PMTCT outcomes guided by clinical content experts, technology analysts, and findings from Phase 1.
Phase 3: The researchers will implement HITSystem 2.0 at one hospital over an 18 month period, and compare targeted PMTCT outcomes to those at a matched control hospital.
The study will be conducted at two government hospitals in Kenya. HIV+ pregnant women will be enrolled in the HITSystem 2.0 at Kapsabet Hospital. HIV+ pregnant women receiving the current standard of PMTCT care at Nandi Hills Hospital will be the comparison group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We employed a matched randomized pilot study design in two government hospitals; one randomized to receive the HITSystem 2.0 intervention while the other maintained standard of care PMTCT services.
| Arm | Type | Receives |
|---|---|---|
| HITSystem 2.0 | Experimental | Behavioral: HIV Infant Tracking System (HITSystem) 2.0Pregnant women who are eligible for PMTCT services will be enrolled in the HIV Infant Tracking System 2.0 (HITSystem 2.0) intervention during their first PMTCT appointment and followed until 12 weeks postpartum. |
| Standard of PMTCT Care | Active comparator | Behavioral: Standard of PMTCT carePregnant women who are eligible for PMTCT services will receive standard of care PMTCT services at the control hospital. The records of women enrolled during their first PMTCT appointment will be used to assess outcomes during the same follow-up period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- HIV+ pregnant women
- Present for first PMTCT appointment at one of the study Hospitals
- Own or have reliable access to mobile phone
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| HIV Infant Tracking System (HITSystem) 2.0The HITsystem 2.0 intervention will be designed to: (1) utilize electronic prompts to notify providers and program managers when actions are required, and (2) send text messages to women's mobile phones to (a) motivate adherence to medication, (b) remind women of antenatal (ANC) appointments and medication refills, (c) prompt preparation for a hospital delivery, and (d) support early infant testing. Given advancements in the approach and protocols for care, HITSystem 2.0 will continue to engage mothers and encourage postnatal medication adherence. The researchers will design HITSystem 2.0 to integrate seamlessly into the existing HITSystem to link PMTCT and early infant diagnosis (EID) services through one coordinated system-level intervention. | Behavioural | HITSystem 2.0 |
| Standard of PMTCT careAlso: no HITSystem 2.0 interventionPregnant women enrolled in PMTCT services at the control site will receive the current standard of PMTCT care and will not be enrolled in the HITSystem 2.0. | Behavioural | Standard of PMTCT Care |
Primary outcome
Complete PMTCT retention
Time frame: first PMTCT visit during pregnancy to the return of the infant's first HIV DNA PCR test result by 12 weeks postnatal
The primary outcome is retention (complete or incomplete), measured from first PMTCT appointment until HIV status determination of the HIV-exposed infant at 12 weeks postnatal. This aggregate outcome includes completion of several intermediate outcomes throughout the PMTCT cascade of care, including: ART initiation (if not already on ART at time of pregnancy) (Yes/No), attendance at PMTCT appointments (Yes/No), a hospital delivery (Yes/No), infant enrollment in EID prior to hospital discharge (Yes/No), infant blood sample collected and HIV DNA PCR test result obtained (Yes/No). Complete retention requires completion of all of these steps.
3 secondary outcomes
Duration of PMTCT Retention
Time frame: Date of first PMTCT appointment through date of last PMTCT service. Final eligible service is date of infant HIV PCR test.
Infant HIV status
Time frame: Results obtained by 12 weeks postnatal
Number of antenatal PMTCT appointments attended
Time frame: First antenatal PMTCT appointment through delivery date
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 1 Apr 2020.
- Background: PubMed 31199305Finocchario-Kessler S, Maloba M, Brown M, Gautney B, Goggin K, Wexler C, Mabachi N, Odeny B, Lagat S, Koech S, Dariotis JK, Odeny TA. Adapting the HIV Infant Tracking System to Support Prevention of Mother-to-Child Transmission of HIV in Kenya: Protocol for an Intervention Development Pilot Study in Two Hospitals. JMIR Res Protoc. 2019 Jun 8;8(6):e13268. doi: 10.2196/13268.
- Results publication: PubMed 30877581Mabachi NM, Brown M, Sandbulte M, Wexler C, Goggin K, Maloba M, Finocchario-Kessler S. Using a Social Support Framework to Understand How HIV Positive Kenyan Men Engage in PMTCT/EID Care: Qualitative Insights From Male Partners. AIDS Behav. 2020 Jan;24(1):18-28. doi: 10.1007/s10461-019-02451-6.
- Individual participant dataSharing planned: No
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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.
Sarah F Kessler, PhD, MPH principal investigator
University of Kansas Medical Center
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIV Infant Tracking System (HITSystem) 2.0 and Standard of PMTCT care in people with HIV, run by University of Kansas Medical Center at 3 sites in 2 countries.
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 3 inclusion and 1 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 1 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Kenya, United States. 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?
Complete PMTCT retention (time frame: first PMTCT visit during pregnancy to the return of the infant's first HIV DNA PCR test result by 12 weeks postnatal). 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 NCT02726607, which also lists 2 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 1 Apr 2020.