HIVNCT02072603
Evaluation of the HITSystem to Improve Early Infant Diagnosis Outcomes in Kenya
A study testing HITSystem in people with HIV, run by Sarah Kessler, PhD, MPH at 2 sites in 2 countries.
Trial summary
The purpose of this study is to determine the effectiveness of the HITSystem in maximizing early infant diagnosis (EID) service utilization for HIV-exposed infants and early antiretroviral therapy (ART) initiation for infants diagnosed with HIV. 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?
- HITSystem
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,815 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 30 Mar 2014to 30 Apr 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+ mother whose infant is <18 months of age
- Ability to provide consent
Who cannot join
- -
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
The purpose of this study is to determine the effectiveness of the HITSystem in maximizing early infant diagnosis (EID) service utilization for HIV-exposed infants and early antiretroviral therapy (ART) initiation for infants diagnosed with HIV.
Read the detailed description
The current EID system is hampered by significant structural barriers that contribute to late and sporadic testing of HIV-exposed infants, lost or delayed test results from the laboratory, and the absence of a reliable system to notify mothers of test results or the need to return to the hospital.
Consequently, in Kenya only about one-third of HIV-exposed infants receive complete EID care through 18 months of age, and less than 20% of diagnosed HIV+ infants are initiated on life saving ART.
To maximize both the benefits and efficiencies of EID efforts, the investigators have developed a system strengthening intervention called the HIV Infant Tracking System (HITSystem©). The HITSystem intervention is an online, automated intervention designed to overcome current EID barriers by providing efficient prospective tracking of HIV- exposed infants and triggering electronic action 'alerts' for both EID providers and lab technicians when time sensitive interventions are overdue for specific infants. A built-in text messaging system sends text messages to mothers' cell phones when test results are ready or follow up visits are needed. The ultimate goals of the HITSystem are to maximize (a) EID service utilization for HIV-exposed infants (retention until 18 months) and (b) early ART initiation for infants diagnosed HIV+, by facilitating collaboration and accountability between key stakeholders (hospitals, laboratories and mothers) to improve EID outcomes.
Our pilot data from two hospitals in Kenya (one urban, one peri-urban) demonstrate the acceptability and feasibility of implementing this intervention. Using a pre-post intervention design the investigators compared EID outcomes from n=330 mother-infant pairs assessed by retrospective chart review during the 12 months prior to the initiation of the intervention to n=460 mother-infant pairs enrolled in the HITSystem intervention over the course of several months (9 and 6 months, respectively). Pilot data indicate a 3 fold increase in EID retention (31% vs. 97%, p<0.001), and more than doubled infant ART initiation rates (44% vs. 95%, p<0.001).14 These data have resulted in great interest and support from the Kenya Ministry of Health for this study, the findings of which will influence national EID dissemination decisions.
To more rigorously evaluate the impact of the HITSystem intervention on EID care in a low-resource country and implications for the feasibility of scaling up this intervention, the investigators will use a cluster randomized control trial among 6 Kenyan government hospitals (3 intervention and 3 standard of care; matched). Three specific aims guide the proposed study:
Aim 1. Conduct a randomized controlled trial to evaluate the efficacy of the HITSystem in improving the timely provision of 8 critical intervention benchmarks for optimal Early Infant Diagnosis of HIV and management.
Aim 2. To identify among HIV-exposed infants predictors of (1) incomplete EID care and (2) time periods most vulnerable to loss of contact at both intervention and control sites.
Aim 3. To estimate the incremental cost-effectiveness of the HITSystem in improving complete EID care across study arms, and to assess user satisfaction among key stakeholders.
This study will scientifically evaluate the public health impact of the HITSystem to improve critical EID outcomes in low-resource settings. Cost-effectiveness analyses will inform the feasibility of scaling up the HITSystem in other settings, and opportunities to adapt the technology to address other health outcomes.
- Conditions
- HIV
- Being tested
- HITSystem, Standard of Care
- Keywords
- Infant HIV, Kenya, HITSystem, EID care, Early Infant Diagnosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HITSystemOther
Also called HIV Infant Tracking System
Online, automated program designed to overcome current EID barriers by providing efficient prospective tracking of HIV-exposed infants and triggering electronic action "alerts" for both EID providers and lab technicians when time sensitive interventions are overdue for specific infants.
Standard of CareOther
current procedures that follow Kenyan National EID guidelines to diagnose and manage HIV infection among HIV-exposed infants.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Hospitals | Experimental | HITSystem implementation at hospital and its affiliated laboratory Receives: Other: HITSystem |
| Control Hospitals | Active comparator | Existing standard of EID care Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete EID Retention
An aggregate measure of complete EID retention will be calculated (y/n) for each infant. Complete EID retention indicates the infant received all indicated services along the EID cascade as detailed below in the 8 critical interventions for EID of HIV. The proportion of HIV-exposed infants with complete EID retention will be compared between groups.
- Initiation of OI prophylaxis.
- Collect dried blood spot (DBS) for PCR test.
- Receipt of DBS at lab.
- Return of PCR results from lab.
- Notify mother of PCR results.
- Initiate all HIV-infected infants on ART.
- Retest all HIV-negative infants at 9 m, initiate ART if applicable.
- Retest all HIV-negative infants at 18 ms, initiate ART if applicable
Measured: 18 months
Secondary outcomes (7)
Efficiency of EID testing and notification cycle
Measuring turn-around time for the complete testing and notification cycle i.e, from sample collection to notifying mothers of results. Measured in number of weeks.
Measured: 18 months
Rapid treatment initiation among HIV+ infants
Time from notifying mother of HIV+ test result and initiating infant on ART, measured in days
Measured: 18 months
Mother-to-child transmission of HIV occurring between first and follow up tests
Mother-to-child transmission of HIV occurring between first and follow up tests, e.g. infants who are uninfected at first test (6 wks) but test positive at either the 9 or 18 month follow up test
Measured: 18 months
Cost effectiveness of HITSystem
Intervention costs per outcome achieved using the HITSystem versus the standard of care control condition. Savings resulting from HITSystem use will also be measured.
Measured: 18 months
Infant Mortality
Document the number of infants enrolled in EID who die before the end of the study period. Cause of death will be recorded.
Measured: 18 months
Infant age at ART initiation
The age at which an HIV+ infant was initiated on ART
Measured: 18 months
Optimal EID Index
To calculate a score for the Optimal EID Index, the infant will receive a score for each of the 8 EID interventions for which they were eligible; if it was completed (1-point) or never completed (0 points) and whether it was completed on-time (1 point) or off-time (0 points) for a maximum score of 16 and a minimum score of 0.
- Initiation of OI prophylaxis at 6 wks.
- Collect dried blood spot (DBS) for PCR test by 6 wks.
- Receipt of DBS at lab within 10 days of collection.
- Return of PCR results from lab within 2 wks.
- Notify mother within 2 wks of the EID provider receiving results.
- Initiate all HIV-infected infants on ART w/in 4 weeks of notifying the mother.
- Retest all HIV-negative infants at 9 m, initiate ART w/in 4 wks if applicable.
- Retest all HIV-negative infants at 18 ms, initiate ART w/in 4 wks if applicable.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study start30 Mar 2014
- Primary completion30 Sep 2018
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 1,815 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sarah Kessler, PhD, MPH
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor-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
- NCT02072603
- Sponsor's protocol ID
- 13793
- Other IDs
- 1R01HD076673-01A1
- Status last verified
- Jul 2020
- First submitted
- 24 Feb 2014
- Last updated
- 13 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Finocchario-Kessler S, Goggin K, Khamadi S, Gautney B, Dariotis JK, Bawcom C, Cheng AL, Nazir N, Martin C, Ruff A, Sweat M, Okoth V. Improving early infant HIV diagnosis in Kenya: study protocol of a cluster-randomized efficacy trial of the HITSystem. Implement Sci. 2015 Jul 9;10:96. doi: 10.1186/s13012-015-0284-3.
PubMed 26155932Finocchario-Kessler S, Gautney BJ, Khamadi S, Okoth V, Goggin K, Spinler JK, Mwangi A, Kimanga D, Clark KF, Olungae HD, Preidis GA; HITSystem Team. If you text them, they will come: using the HIV infant tracking system to improve early infant diagnosis quality and retention in Kenya. AIDS. 2014 Jul;28 Suppl 3(0 3):S313-21. doi: 10.1097/QAD.0000000000000332.
PubMed 24991904Goggin K, Wexler C, Nazir N, Staggs VS, Gautney B, Okoth V, Khamadi SA, Ruff A, Sweat M, Cheng AL, Finocchario-Kessler S. Predictors of Infant Age at Enrollment in Early Infant Diagnosis Services in Kenya. AIDS Behav. 2016 Sep;20(9):2141-50. doi: 10.1007/s10461-016-1404-z.
PubMed 27108002Wexler C, Brown M, Hurley EA, Ochieng M, Goggin K, Gautney B, Maloba M, Lwembe R, Khamadi S, Finocchario-Kessler S. Implementing eHealth Technology to Address Gaps in Early Infant Diagnosis Services: Qualitative Assessment of Kenyan Provider Experiences. JMIR Mhealth Uhealth. 2018 Aug 22;6(8):e169. doi: 10.2196/mhealth.9725.
PubMed 30135052Finocchario-Kessler S, Gautney B, Cheng A, Wexler C, Maloba M, Nazir N, Khamadi S, Lwembe R, Brown M, Odeny TA, Dariotis JK, Sandbulte M, Mabachi N, Goggin K. Evaluation of the HIV Infant Tracking System (HITSystem) to optimise quality and efficiency of early infant diagnosis: a cluster-randomised trial in Kenya. Lancet HIV. 2018 Dec;5(12):e696-e705. doi: 10.1016/S2352-3018(18)30245-5. Epub 2018 Oct 8.
PubMed 30309787Brown M, Wexler C, Gautney B, Goggin K, Hurley EA, Odeny B, Maloba M, Lwembe R, Sandbulte M, Finocchario-Kessler S. eHealth Interventions for Early Infant Diagnosis: Mothers' Satisfaction with the HIV Infant Tracking System in Kenya. AIDS Behav. 2019 Nov;23(11):3093-3102. doi: 10.1007/s10461-019-02579-5.
PubMed 31313093Goggin K, Hurley EA, Staggs VS, Wexler C, Nazir N, Gautney B, Khamadi SA, Maloba M, Lwembe R, Finocchario-Kessler S. Rates and Predictors of HIV-Exposed Infants Lost to Follow-Up During Early Infant Diagnosis Services in Kenya. AIDS Patient Care STDS. 2019 Aug;33(8):346-353. doi: 10.1089/apc.2019.0050.
PubMed 31369296Wexler C, Nazir N, Gautney B, Maloba M, Brown M, Goggin K, Lwembe R, Finocchario-Kessler S. Predictors of Early ART Initiation Among HIV + Infants in Kenya: A Retrospective Review of HITSystem Data from 2013 to 2017. Matern Child Health J. 2020 Jun;24(6):739-747. doi: 10.1007/s10995-020-02909-3.
PubMed 32285335Hurley EA, Odeny B, Wexler C, Brown M, MacKenzie A, Goggin K, Maloba M, Gautney B, Finocchario-Kessler S. "It was my obligation as mother": 18-Month completion of Early Infant Diagnosis as identity control for mothers living with HIV in Kenya. Soc Sci Med. 2020 Apr;250:112866. doi: 10.1016/j.socscimed.2020.112866. Epub 2020 Feb 27.
PubMed 32145483Lapke B, Atcheson K, Wexler C, Maloba M, Goggin K, Hoefferle R, Staggs V, Babu S, Maosa N, Finocchario-Kessler S. Preferences for and Experiences of Antenatal and Postpartum Male Partner Support Among Kenyan Women Living with HIV. AIDS Behav. 2026 Jul 28. doi: 10.1007/s10461-026-05249-5. Online ahead of print.
PubMed 42509418
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the HITSystem to Improve Early Infant Diagnosis Outcomes in Kenya
- ClinicalTrials.gov ID
- NCT02072603
- Acronym / sponsor ID
- 13793
- Conditions
- HIV
- Keywords
- Infant HIV, Kenya, HITSystem, EID care, Early Infant Diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,815 participants (actual)
- Lead sponsor
- Sarah Kessler, PhD, MPHUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 30 Mar 2014 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 26 Feb 2014 (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 determine the effectiveness of the HITSystem in maximizing early infant diagnosis (EID) service utilization for HIV-exposed infants and early antiretroviral therapy (ART) initiation for infants diagnosed with HIV.
Detailed description
The current EID system is hampered by significant structural barriers that contribute to late and sporadic testing of HIV-exposed infants, lost or delayed test results from the laboratory, and the absence of a reliable system to notify mothers of test results or the need to return to the hospital.
Consequently, in Kenya only about one-third of HIV-exposed infants receive complete EID care through 18 months of age, and less than 20% of diagnosed HIV+ infants are initiated on life saving ART.
To maximize both the benefits and efficiencies of EID efforts, the investigators have developed a system strengthening intervention called the HIV Infant Tracking System (HITSystem©). The HITSystem intervention is an online, automated intervention designed to overcome current EID barriers by providing efficient prospective tracking of HIV- exposed infants and triggering electronic action 'alerts' for both EID providers and lab technicians when time sensitive interventions are overdue for specific infants. A built-in text messaging system sends text messages to mothers' cell phones when test results are ready or follow up visits are needed. The ultimate goals of the HITSystem are to maximize (a) EID service utilization for HIV-exposed infants (retention until 18 months) and (b) early ART initiation for infants diagnosed HIV+, by facilitating collaboration and accountability between key stakeholders (hospitals, laboratories and mothers) to improve EID outcomes.
Our pilot data from two hospitals in Kenya (one urban, one peri-urban) demonstrate the acceptability and feasibility of implementing this intervention. Using a pre-post intervention design the investigators compared EID outcomes from n=330 mother-infant pairs assessed by retrospective chart review during the 12 months prior to the initiation of the intervention to n=460 mother-infant pairs enrolled in the HITSystem intervention over the course of several months (9 and 6 months, respectively). Pilot data indicate a 3 fold increase in EID retention (31% vs. 97%, p<0.001), and more than doubled infant ART initiation rates (44% vs. 95%, p<0.001).14 These data have resulted in great interest and support from the Kenya Ministry of Health for this study, the findings of which will influence national EID dissemination decisions.
To more rigorously evaluate the impact of the HITSystem intervention on EID care in a low-resource country and implications for the feasibility of scaling up this intervention, the investigators will use a cluster randomized control trial among 6 Kenyan government hospitals (3 intervention and 3 standard of care; matched). Three specific aims guide the proposed study:
Aim 1. Conduct a randomized controlled trial to evaluate the efficacy of the HITSystem in improving the timely provision of 8 critical intervention benchmarks for optimal Early Infant Diagnosis of HIV and management.
Aim 2. To identify among HIV-exposed infants predictors of (1) incomplete EID care and (2) time periods most vulnerable to loss of contact at both intervention and control sites.
Aim 3. To estimate the incremental cost-effectiveness of the HITSystem in improving complete EID care across study arms, and to assess user satisfaction among key stakeholders.
This study will scientifically evaluate the public health impact of the HITSystem to improve critical EID outcomes in low-resource settings. Cost-effectiveness analyses will inform the feasibility of scaling up the HITSystem in other settings, and opportunities to adapt the technology to address other health outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Hospitals | Experimental | Other: HITSystemHITSystem implementation at hospital and its affiliated laboratory |
| Control Hospitals | Active comparator | Other: Standard of CareExisting standard of EID care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- HIV+ mother whose infant is <18 months of age
- Ability to provide consent
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| HITSystemAlso: HIV Infant Tracking SystemOnline, automated program designed to overcome current EID barriers by providing efficient prospective tracking of HIV-exposed infants and triggering electronic action "alerts" for both EID providers and lab technicians when time sensitive interventions are overdue for specific infants. | Other | Intervention Hospitals |
| Standard of Carecurrent procedures that follow Kenyan National EID guidelines to diagnose and manage HIV infection among HIV-exposed infants. | Other | Control Hospitals |
Primary outcome
Complete EID Retention
Time frame: 18 months
An aggregate measure of complete EID retention will be calculated (y/n) for each infant. Complete EID retention indicates the infant received all indicated services along the EID cascade as detailed below in the 8 critical interventions for EID of HIV. The proportion of HIV-exposed infants with complete EID retention will be compared between groups. 1. Initiation of OI prophylaxis. 2. Collect dried blood spot (DBS) for PCR test. 3. Receipt of DBS at lab. 4. Return of PCR results from lab. 5. Notify mother of PCR results. 6. Initiate all HIV-infected infants on ART. 7. Retest all HIV-negative infants at 9 m, initiate ART if applicable. 8. Retest all HIV-negative infants at 18 ms, initiate ART if applicable
7 secondary outcomes
Efficiency of EID testing and notification cycle
Time frame: 18 months
Rapid treatment initiation among HIV+ infants
Time frame: 18 months
Mother-to-child transmission of HIV occurring between first and follow up tests
Time frame: 18 months
Cost effectiveness of HITSystem
Time frame: 18 months
Infant Mortality
Time frame: 18 months
Infant age at ART initiation
Time frame: 18 months
Optimal EID Index
Time frame: 18 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 13 Jul 2020.
- Background: PubMed 26155932Finocchario-Kessler S, Goggin K, Khamadi S, Gautney B, Dariotis JK, Bawcom C, Cheng AL, Nazir N, Martin C, Ruff A, Sweat M, Okoth V. Improving early infant HIV diagnosis in Kenya: study protocol of a cluster-randomized efficacy trial of the HITSystem. Implement Sci. 2015 Jul 9;10:96. doi: 10.1186/s13012-015-0284-3.
- Background: PubMed 24991904Finocchario-Kessler S, Gautney BJ, Khamadi S, Okoth V, Goggin K, Spinler JK, Mwangi A, Kimanga D, Clark KF, Olungae HD, Preidis GA; HITSystem Team. If you text them, they will come: using the HIV infant tracking system to improve early infant diagnosis quality and retention in Kenya. AIDS. 2014 Jul;28 Suppl 3(0 3):S313-21. doi: 10.1097/QAD.0000000000000332.
- Results publication: PubMed 27108002Goggin K, Wexler C, Nazir N, Staggs VS, Gautney B, Okoth V, Khamadi SA, Ruff A, Sweat M, Cheng AL, Finocchario-Kessler S. Predictors of Infant Age at Enrollment in Early Infant Diagnosis Services in Kenya. AIDS Behav. 2016 Sep;20(9):2141-50. doi: 10.1007/s10461-016-1404-z.
- Results publication: PubMed 30135052Wexler C, Brown M, Hurley EA, Ochieng M, Goggin K, Gautney B, Maloba M, Lwembe R, Khamadi S, Finocchario-Kessler S. Implementing eHealth Technology to Address Gaps in Early Infant Diagnosis Services: Qualitative Assessment of Kenyan Provider Experiences. JMIR Mhealth Uhealth. 2018 Aug 22;6(8):e169. doi: 10.2196/mhealth.9725.
- Results publication: PubMed 30309787Finocchario-Kessler S, Gautney B, Cheng A, Wexler C, Maloba M, Nazir N, Khamadi S, Lwembe R, Brown M, Odeny TA, Dariotis JK, Sandbulte M, Mabachi N, Goggin K. Evaluation of the HIV Infant Tracking System (HITSystem) to optimise quality and efficiency of early infant diagnosis: a cluster-randomised trial in Kenya. Lancet HIV. 2018 Dec;5(12):e696-e705. doi: 10.1016/S2352-3018(18)30245-5. Epub 2018 Oct 8.
- Results publication: PubMed 31313093Brown M, Wexler C, Gautney B, Goggin K, Hurley EA, Odeny B, Maloba M, Lwembe R, Sandbulte M, Finocchario-Kessler S. eHealth Interventions for Early Infant Diagnosis: Mothers' Satisfaction with the HIV Infant Tracking System in Kenya. AIDS Behav. 2019 Nov;23(11):3093-3102. doi: 10.1007/s10461-019-02579-5.
- Results publication: PubMed 31369296Goggin K, Hurley EA, Staggs VS, Wexler C, Nazir N, Gautney B, Khamadi SA, Maloba M, Lwembe R, Finocchario-Kessler S. Rates and Predictors of HIV-Exposed Infants Lost to Follow-Up During Early Infant Diagnosis Services in Kenya. AIDS Patient Care STDS. 2019 Aug;33(8):346-353. doi: 10.1089/apc.2019.0050.
- Results publication: PubMed 32285335Wexler C, Nazir N, Gautney B, Maloba M, Brown M, Goggin K, Lwembe R, Finocchario-Kessler S. Predictors of Early ART Initiation Among HIV + Infants in Kenya: A Retrospective Review of HITSystem Data from 2013 to 2017. Matern Child Health J. 2020 Jun;24(6):739-747. doi: 10.1007/s10995-020-02909-3.
- Results publication: PubMed 32145483Hurley EA, Odeny B, Wexler C, Brown M, MacKenzie A, Goggin K, Maloba M, Gautney B, Finocchario-Kessler S. "It was my obligation as mother": 18-Month completion of Early Infant Diagnosis as identity control for mothers living with HIV in Kenya. Soc Sci Med. 2020 Apr;250:112866. doi: 10.1016/j.socscimed.2020.112866. Epub 2020 Feb 27.
- Derived from this study: PubMed 42509418Lapke B, Atcheson K, Wexler C, Maloba M, Goggin K, Hoefferle R, Staggs V, Babu S, Maosa N, Finocchario-Kessler S. Preferences for and Experiences of Antenatal and Postpartum Male Partner Support Among Kenyan Women Living with HIV. AIDS Behav. 2026 Jul 28. doi: 10.1007/s10461-026-05249-5. Online ahead of print.
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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
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HITSystem in people with HIV, run by Sarah Kessler, PhD, MPH at 2 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 2 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 13 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, 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?
Complete EID Retention (time frame: 18 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 NCT02072603, which also lists 10 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 13 Jul 2020.