HivPIE-eMMsNCT06999928
Enhanced Mentor Mother Strategy for Pregnant and Postpartum Women Living With HIV
A study testing Enhanced Mentor Mother Strategy in people with Hiv and Transmission Vertical, run by Indiana University at 1 site in Kenya.
Trial summary
Mentor Mothers (MMs) are peer supporters who help pregnant and postpartum women living with HIV (WLHIV) as they receive prevention of mother-to-child transmission of HIV (PMTCT) services in resource-limited settings like Kenya. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hiv, Transmission Vertical, Viremia
- What is being tested?
- Enhanced Mentor Mother Strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteKenya
- Study dates
- 10 Jul 2025to 12 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant and postpartum women living with HIV (and their infants born during the study)
- ≥18 years of age
- Enrolled in PMTCT services at BFSDH
- Able to understand and provide informed consent in English or Kiswahili
Who cannot join
- Women who are not pregnant or postpartum
- <18 years of age
- Not enrolled in PMTCT services at BFSDH
- Unable to understand and provide informed consent in English or Kiswahili
- Cognitive impairment that would interfere with ability to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kenya1 site, 1 recruiting
- Recruiting
Burnt Forest Sub-District Hospital
Burnt Forest, Uasin Gishu County, 30100
Rosa Chemwey, MBChB, MMed, +254 721 382 663, rosachemwey@gmail.com
About this study
Official title: Pilot Implementation-Effectiveness Study of an Enhanced Mentor Mother Strategy
Mentor Mothers (MMs) are peer supporters who help pregnant and postpartum women living with HIV (WLHIV) as they receive prevention of mother-to-child transmission of HIV (PMTCT) services in resource-limited settings like Kenya. Differentiated service delivery (DSD) is a care model that tailors services based on clients' needs, helping to improve both the quality and efficiency of care.
This hybrid implementation-effectiveness study will test whether an enhanced MM strategy that uses DSD can be successfully carried out and improve health outcomes for mothers and infants. The study will take place at Burnt Forest Sub-District Hospital (BFSDH) in Kenya.
Read more
Researchers will ask:
- Can the enhanced MM strategy be delivered as planned and accepted by patients and staff?
- Does the strategy improve clinical outcomes like keeping mothers in PMTCT care, achieving HIV viral suppression, completing infant HIV testing, and preventing HIV transmission to infants? Researchers will compare health outcomes before and after the strategy is introduced at BFSDH, and also compare outcomes at other similar clinics that continue with standard MM services.
Women who choose to participate will meet with a MM during their routine antenatal and postnatal clinic visits. They will be offered the enhanced MM support, but can choose to receive standard care if they prefer.
Read the detailed description
This is a hybrid implementation-effectiveness study of an enhanced Mentor Mother (MM) strategy for delivering risk-based, differentiated prevention of mother-to-child transmission of HIV (PMTCT) services to pregnant and postpartum women living with HIV (WLHIV) and their infants. The study will be conducted at Burnt Forest Sub-District Hospital (BFSDH), an Academic Model Providing Access to Healthcare (AMPATH)-supported public health facility in Uasin Gishu County, Kenya.
Mentor Mothers (MMs) are peer advocates who support WLHIV in PMTCT programs, providing adherence counseling, psychosocial support, and retention assistance. Although MMs are a widely implemented, evidence-based intervention, current models generally do not differentiate services based on clients' individual risk profiles. The enhanced MM strategy evaluated in this study builds on the World Health Organization and Kenya Ministry of Health's recommendation for differentiated service delivery (DSD)-a patient-centered model that tailors services to individual needs.
This study will evaluate implementation outcomes (feasibility, acceptability, fidelity) while also gathering preliminary clinical effectiveness data of the enhanced MM strategy. The strategy includes structured, iterative risk stratification by MMs and PMTCT clinicians at each clinical encounter to identify clients at higher risk for poor PMTCT outcomes. Identified risk factors include HIV viremia, stigma and non-disclosure, and socioeconomic barriers. Based on the identified risk(s), MMs will deliver individualized, problem-focused support. WLHIV with no identifiable risk factors will receive a less-intensive service schedule aligned with national differentiated care guidelines.
Specific Aims:
- Aim 1: Use a mixed-methods approach to evaluate fidelity, feasibility, and acceptability of the enhanced MM strategy over a 15-month period. Data will include quantitative fidelity checklists, MM activity logs, chart audits, observation logs, and stakeholder focus group discussions.
- Aim 2: Assess preliminary effectiveness of the enhanced MM strategy on key maternal and infant outcomes using aggregate, routinely collected clinical data from AMPATH's medical record system. Outcomes include maternal retention in care, maternal HIV viral suppression, infant uptake of HIV diagnostic testing, and HIV vertical transmission. A within-site pre-post analysis will compare outcomes at BFSDH during the 12 months before and after implementation (excluding the first 3 months of roll out). A contemporaneous across-site analysis will compare outcomes at BFSDH (enhanced MM strategy) and three comparable clinics providing standard MM services during the same 12-month period.
The study is supported by the NIH through a K23 award (K23HD109056), and builds on extensive formative research, including qualitative interviews and human-centered design workshops with WLHIV, MMs, PMTCT clinicians, and policymakers. Pilot implementation is being guided by local stakeholders and is expected to inform the design of a future pragmatic trial. The enhanced MM strategy, if successful, may provide a scalable model for improving PMTCT outcomes in resource-constrained settings.
- Conditions
- Hiv, Transmission Vertical, Viremia, Adherence, Treatment, Stigmatization, Socioeconomic Adversity
- Being tested
- Enhanced Mentor Mother Strategy
- Keywords
- prevention of mother-to-child transmission, retention, implementation, mentor mothers, differentiated service delivery, maternal-child health, Kenya
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Viremia, Treatment Adherence and Compliance, Stereotyping, Financial Stress, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Mentor Mother StrategyBehavioural
The enhanced Mentor Mother strategy introduces a structured approach to differentiated PMTCT support, led by trained peer counselors/Mentor Mothers (MM). Mentor Mothers will be trained on how to perform risk stratification, and they will use a standardized form to identify and document psychosocial and clinical risk factors. Based on these, MMs then deliver tailored interventions, including additional counseling, community outreach, and referrals. Fidelity assessments and a process of audit and feedback will be used to further refine the strategy, which builds on national differentiated service delivery guidelines and integrates into routine care without requiring added clinic staff.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Mentor Mother Strategy | Experimental | Participants will receive support from a Mentor Mother (MM) who delivers a risk-based, differentiated package of PMTCT services tailored to the needs of pregnant and postpartum women living with HIV (WLHIV). At each clinic visit, the MM will assess maternal and infant risk using a structured tool. Based on the result, the MM provides tailored support, such as counseling, navigation, linkage to resources, or increased follow-up. WLHIV without identified risks receive a streamlined support package. The strategy is integrated into routine antenatal and postnatal care at the study site. Receives: Behavioral: Enhanced Mentor Mother Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fidelity: Proportion of enhanced Mentor Mother strategy tasks completed and services correctly assigned/delivered, as assessed by checklists, audits, and observations.
Fidelity is defined as the degree to which an intervention is implemented as intended. In this study, fidelity to the enhanced Mentor Mother (MM) strategy will be assessed using quantitative (checklists, audits) and qualitative (observations, logs) methods. A checklist of essential tasks will quantify adherence to MM workflows, calculated as the proportion of tasks completed out of those intended. Audits of clinical records, screening tools, and MM logs will assess accuracy of risk-based service delivery, calculated as the proportion of correctly assigned and delivered services. Direct observations will assess the quality of MM service delivery, and content logs will capture which MM components are delivered and how participants respond.
Measured: Fidelity to the enhanced MM strategy will be assessed throughout the 15-month implementation period, and a process of audit and feedback will be used to enhance fidelity and further refine the strategy.
Acceptability: Participant ratings of acceptability of the enhanced Mentor Mother strategy, assessed by AIM scores, satisfaction surveys, and focus group discussions.
Acceptability is the perception among implementation stakeholders that an intervention is agreeable or satisfactory. In this study, acceptability of the enhanced Mentor Mother (MM) strategy will be assessed using quantitative (questionnaires) and qualitative (focus group discussions) methods. The Acceptability of Intervention Measure (AIM) is a brief, validated questionnaire that will be administered to participants. A satisfaction survey will also be administered to identify parts of the strategy that cause frustration or other negative emotions and parts of the strategy that cause positive emotions. Results from AIM and satisfaction surveys will then be used to guide focus group discussions that will qualitatively assess perspectives about the acceptability of the enhanced MM strategy. Focus group discussions will be audio recorded, translated, and transcribed for thematic analysis.
Measured: Acceptability of the enhanced MM strategy will be assessed at the end of the 15-month implementation period.
Feasibility: Participant ratings of feasibility of the enhanced Mentor Mother strategy, assessed by FIM scores and focus group discussions.
Feasibility is the extent to which an intervention can be successfully carried out within a given context. In this study, feasibility of the enhanced Mentor Mother (MM) strategy will be assessed using quantitative (questionnaires) and qualitative (focus group discussions) methods. The Feasibility of Intervention Measure (FIM) is a brief, validated questionnaire that will be administered to participants. Results from the FIM will then be used to guide focus group discussions that will qualitatively assess perspectives about the feasibility and readiness for scale-up of the enhanced MM strategy. Focus group discussions will be audio recorded, translated, and transcribed for thematic analysis.
Measured: Feasibility of the enhanced MM strategy will be assessed at the end of the 15-month implementation period.
Secondary outcomes (7)
Proportion of mothers retained in care
Proportion of women living with HIV (WLHIV) enrolled in PMTCT services (those pregnant and ≤18 months postpartum) who were not lost to follow-up during the period of observation, excluding those who died or transferred out.
Measured: Assessed at baseline (pre-implementation), 6-months (interim analysis), and at the end of the 15-month implementation period.
Proportion of mothers with HIV viral suppression
Proportion of WLHIV enrolled in PMTCT services who received antiretroviral therapy for at least 3 months, had at least one HIV viral load test, and never had a result >200 copies/ml during the period of observation.
Measured: Assessed at baseline (pre-implementation), 6-months (interim analysis), and at the end of the 15-month implementation period.
Proportion of mothers who died
Proportion of WLHIV enrolled in PMTCT services who died during the period of observation.
Measured: Assessed at baseline (pre-implementation), 6-months (interim analysis), and at the end of the 15-month implementation period.
Proportion of mothers who transferred out
Proportion of WLHIV enrolled in PMTCT services who transferred to another clinic during the period of observation.
Measured: Assessed at baseline (pre-implementation), 6-months (interim analysis), and at the end of the 15-month implementation period.
Proportion of infants receiving HIV diagnostic testing
Proportion of infants with perinatal HIV exposure (those 0-18 months of age) who had their first HIV test performed by 10 weeks of age during the period of observation.
Measured: Assessed at baseline (pre-implementation), 6-months (interim analysis), and at the end of the 15-month implementation period.
Proportion of infants infected with HIV (vertical transmission)
Proportion of infants with perinatal HIV exposure with any positive HIV DNA PCR test result between 0-18 months of age during the month period of observation.
Measured: Assessed at baseline (pre-implementation), 6-months (interim analysis), and at the end of the 15-month implementation period.
Proportion of infants who died
Proportion of infants with perinatal HIV exposure who died during the period of observation.
Measured: Assessed at baseline (pre-implementation), 6-months (interim analysis), and at the end of the 15-month implementation period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start10 Jul 2025
- Primary completion12 Oct 2026 (estimated)
- Study completion12 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by Indiana 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pregnant and postpartum WLHIV will be screened for risk factors, then those with risk factors will received problem-focused MM support, while those without risk factors will receive less intensive MM support.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, James G. Carlucci, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06999928
- Sponsor's protocol ID
- 24102
- Other IDs
- K23HD109056
- Acronym
- PIE-eMMs
- Status last verified
- Aug 2026
- First submitted
- 22 May 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Implementation-Effectiveness Study of an Enhanced Mentor Mother Strategy
- ClinicalTrials.gov ID
- NCT06999928
- Acronym / sponsor ID
- PIE-eMMs / 24102
- Conditions
- Hiv, Transmission Vertical, Viremia, Adherence, Treatment, Stigmatization, Socioeconomic Adversity
- Keywords
- prevention of mother-to-child transmission, retention, implementation, mentor mothers, differentiated service delivery, maternal-child health, Kenya
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 10 Jul 2025 (actual)
- Primary completion
- 12 Oct 2026 (estimated)
- Study completion
- 12 Oct 2026 (estimated)
- First posted
- 31 May 2025 (actual)
- 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.
Mentor Mothers (MMs) are peer supporters who help pregnant and postpartum women living with HIV (WLHIV) as they receive prevention of mother-to-child transmission of HIV (PMTCT) services in resource-limited settings like Kenya. Differentiated service delivery (DSD) is a care model that tailors services based on clients' needs, helping to improve both the quality and efficiency of care.
This hybrid implementation-effectiveness study will test whether an enhanced MM strategy that uses DSD can be successfully carried out and improve health outcomes for mothers and infants. The study will take place at Burnt Forest Sub-District Hospital (BFSDH) in Kenya.
Researchers will ask:
- Can the enhanced MM strategy be delivered as planned and accepted by patients and staff?
- Does the strategy improve clinical outcomes like keeping mothers in PMTCT care, achieving HIV viral suppression, completing infant HIV testing, and preventing HIV transmission to infants? Researchers will compare health outcomes before and after the strategy is introduced at BFSDH, and also compare outcomes at other similar clinics that continue with standard MM services.
Women who choose to participate will meet with a MM during their routine antenatal and postnatal clinic visits. They will be offered the enhanced MM support, but can choose to receive standard care if they prefer.
Detailed description
This is a hybrid implementation-effectiveness study of an enhanced Mentor Mother (MM) strategy for delivering risk-based, differentiated prevention of mother-to-child transmission of HIV (PMTCT) services to pregnant and postpartum women living with HIV (WLHIV) and their infants. The study will be conducted at Burnt Forest Sub-District Hospital (BFSDH), an Academic Model Providing Access to Healthcare (AMPATH)-supported public health facility in Uasin Gishu County, Kenya.
Mentor Mothers (MMs) are peer advocates who support WLHIV in PMTCT programs, providing adherence counseling, psychosocial support, and retention assistance. Although MMs are a widely implemented, evidence-based intervention, current models generally do not differentiate services based on clients' individual risk profiles. The enhanced MM strategy evaluated in this study builds on the World Health Organization and Kenya Ministry of Health's recommendation for differentiated service delivery (DSD)-a patient-centered model that tailors services to individual needs.
This study will evaluate implementation outcomes (feasibility, acceptability, fidelity) while also gathering preliminary clinical effectiveness data of the enhanced MM strategy. The strategy includes structured, iterative risk stratification by MMs and PMTCT clinicians at each clinical encounter to identify clients at higher risk for poor PMTCT outcomes. Identified risk factors include HIV viremia, stigma and non-disclosure, and socioeconomic barriers. Based on the identified risk(s), MMs will deliver individualized, problem-focused support. WLHIV with no identifiable risk factors will receive a less-intensive service schedule aligned with national differentiated care guidelines.
Specific Aims:
- Aim 1: Use a mixed-methods approach to evaluate fidelity, feasibility, and acceptability of the enhanced MM strategy over a 15-month period. Data will include quantitative fidelity checklists, MM activity logs, chart audits, observation logs, and stakeholder focus group discussions.
- Aim 2: Assess preliminary effectiveness of the enhanced MM strategy on key maternal and infant outcomes using aggregate, routinely collected clinical data from AMPATH's medical record system. Outcomes include maternal retention in care, maternal HIV viral suppression, infant uptake of HIV diagnostic testing, and HIV vertical transmission. A within-site pre-post analysis will compare outcomes at BFSDH during the 12 months before and after implementation (excluding the first 3 months of roll out). A contemporaneous across-site analysis will compare outcomes at BFSDH (enhanced MM strategy) and three comparable clinics providing standard MM services during the same 12-month period.
The study is supported by the NIH through a K23 award (K23HD109056), and builds on extensive formative research, including qualitative interviews and human-centered design workshops with WLHIV, MMs, PMTCT clinicians, and policymakers. Pilot implementation is being guided by local stakeholders and is expected to inform the design of a future pragmatic trial. The enhanced MM strategy, if successful, may provide a scalable model for improving PMTCT outcomes in resource-constrained settings.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pregnant and postpartum WLHIV will be screened for risk factors, then those with risk factors will received problem-focused MM support, while those without risk factors will receive less intensive MM support.
| Arm | Type | Receives |
|---|---|---|
| Enhanced Mentor Mother Strategy | Experimental | Behavioral: Enhanced Mentor Mother StrategyParticipants will receive support from a Mentor Mother (MM) who delivers a risk-based, differentiated package of PMTCT services tailored to the needs of pregnant and postpartum women living with HIV (WLHIV). At each clinic visit, the MM will assess maternal and infant risk using a structured tool. Based on the result, the MM provides tailored support, such as counseling, navigation, linkage to resources, or increased follow-up. WLHIV without identified risks receive a streamlined support package. The strategy is integrated into routine antenatal and postnatal care at the study site. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pregnant and postpartum women living with HIV (and their infants born during the study)
- ≥18 years of age
- Enrolled in PMTCT services at BFSDH
- Able to understand and provide informed consent in English or Kiswahili
Key exclusion criteria (5 listed)
- Women who are not pregnant or postpartum
- <18 years of age
- Not enrolled in PMTCT services at BFSDH
- Unable to understand and provide informed consent in English or Kiswahili
- Cognitive impairment that would interfere with ability to participate in the study
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 |
|---|---|---|
| Enhanced Mentor Mother StrategyThe enhanced Mentor Mother strategy introduces a structured approach to differentiated PMTCT support, led by trained peer counselors/Mentor Mothers (MM). Mentor Mothers will be trained on how to perform risk stratification, and they will use a standardized form to identify and document psychosocial and clinical risk factors. Based on these, MMs then deliver tailored interventions, including additional counseling, community outreach, and referrals. Fidelity assessments and a process of audit and feedback will be used to further refine the strategy, which builds on national differentiated service delivery guidelines and integrates into routine care without requiring added clinic staff. | Behavioural | Enhanced Mentor Mother Strategy |
Primary outcome
Fidelity: Proportion of enhanced Mentor Mother strategy tasks completed and services correctly assigned/delivered, as assessed by checklists, audits, and observations.
Time frame: Fidelity to the enhanced MM strategy will be assessed throughout the 15-month implementation period, and a process of audit and feedback will be used to enhance fidelity and further refine the strategy.
Fidelity is defined as the degree to which an intervention is implemented as intended. In this study, fidelity to the enhanced Mentor Mother (MM) strategy will be assessed using quantitative (checklists, audits) and qualitative (observations, logs) methods. A checklist of essential tasks will quantify adherence to MM workflows, calculated as the proportion of tasks completed out of those intended. Audits of clinical records, screening tools, and MM logs will assess accuracy of risk-based service delivery, calculated as the proportion of correctly assigned and delivered services. Direct observations will assess the quality of MM service delivery, and content logs will capture which MM components are delivered and how participants respond.
Acceptability: Participant ratings of acceptability of the enhanced Mentor Mother strategy, assessed by AIM scores, satisfaction surveys, and focus group discussions.
Time frame: Acceptability of the enhanced MM strategy will be assessed at the end of the 15-month implementation period.
Acceptability is the perception among implementation stakeholders that an intervention is agreeable or satisfactory. In this study, acceptability of the enhanced Mentor Mother (MM) strategy will be assessed using quantitative (questionnaires) and qualitative (focus group discussions) methods. The Acceptability of Intervention Measure (AIM) is a brief, validated questionnaire that will be administered to participants. A satisfaction survey will also be administered to identify parts of the strategy that cause frustration or other negative emotions and parts of the strategy that cause positive emotions. Results from AIM and satisfaction surveys will then be used to guide focus group discussions that will qualitatively assess perspectives about the acceptability of the enhanced MM strategy. Focus group discussions will be audio recorded, translated, and transcribed for thematic analysis.
Feasibility: Participant ratings of feasibility of the enhanced Mentor Mother strategy, assessed by FIM scores and focus group discussions.
Time frame: Feasibility of the enhanced MM strategy will be assessed at the end of the 15-month implementation period.
Feasibility is the extent to which an intervention can be successfully carried out within a given context. In this study, feasibility of the enhanced Mentor Mother (MM) strategy will be assessed using quantitative (questionnaires) and qualitative (focus group discussions) methods. The Feasibility of Intervention Measure (FIM) is a brief, validated questionnaire that will be administered to participants. Results from the FIM will then be used to guide focus group discussions that will qualitatively assess perspectives about the feasibility and readiness for scale-up of the enhanced MM strategy. Focus group discussions will be audio recorded, translated, and transcribed for thematic analysis.
7 secondary outcomes
Proportion of mothers retained in care
Time frame: Assessed at baseline (pre-implementation), 6-months (interim analysis), and at the end of the 15-month implementation period.
Proportion of mothers with HIV viral suppression
Time frame: Assessed at baseline (pre-implementation), 6-months (interim analysis), and at the end of the 15-month implementation period.
Proportion of mothers who died
Time frame: Assessed at baseline (pre-implementation), 6-months (interim analysis), and at the end of the 15-month implementation period.
Proportion of mothers who transferred out
Time frame: Assessed at baseline (pre-implementation), 6-months (interim analysis), and at the end of the 15-month implementation period.
Proportion of infants receiving HIV diagnostic testing
Time frame: Assessed at baseline (pre-implementation), 6-months (interim analysis), and at the end of the 15-month implementation period.
Proportion of infants infected with HIV (vertical transmission)
Time frame: Assessed at baseline (pre-implementation), 6-months (interim analysis), and at the end of the 15-month implementation period.
Proportion of infants who died
Time frame: Assessed at baseline (pre-implementation), 6-months (interim analysis), and at the end of the 15-month implementation period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Mentor Mother Strategy in people with Hiv and Transmission Vertical, run by Indiana University at 1 site 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James G Carlucci, MD, MPH (+1 317 944 7260, jimcarlu@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fidelity: Proportion of enhanced Mentor Mother strategy tasks completed and services correctly assigned/delivered, as assessed by checklists, audits, and observations. (time frame: Fidelity to the enhanced MM strategy will be assessed throughout the 15-month implementation period, and a process of audit and feedback will be used to enhance fidelity and further refine the strategy.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2026.