HivNCT06629753
Differentiated Service Delivery for Pregnant and Postpartum Women Living With HIV and Their Infants
A study testing Differentiated service delivery model in people with Hiv and Transmission Vertical, run by Indiana University at 1 site in Kenya.
Trial summary
Differentiated service delivery (DSD) is an evidence-based HIV care and treatment model endorsed by the World Health Organization (WHO) that simplifies HIV services for clients who are clinically stable, improving the quality and efficiency of HIV services. Read more about this study
- Who is it for?
- Ages 1 day and olderHealthy volunteers can take part
- Conditions the study is for
- Hiv, Transmission Vertical, Viremia
- What is being tested?
- Differentiated service delivery model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 1 siteKenya
- Study dates
- 13 Sep 2024to 5 Mar 2026
- 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 1 day and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- ≥18 years of age
- Able to understand English or Kiswahili
- Works as a clinician, nurse, peer counsellor, social worker, pharmacist, or clinic supervisor involved in providing PMTCT services in the maternal-child health clinic at Huruma Sub-District Hospital
- 5. Woman is ≥15 years of age 6. Woman is enrolled in maternal-child health services at HSDH 7. Woman is living with HIV 8. Woman is able to understand English or Kiswahili
Who cannot join
- none
- Eligibility criteria for PPHIV and their infants enrolled prospectively (n=500)
- Cognitive impairment that would impair participation in the study
- All infants born to enrolled women during the study will be included.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Implementation of Differentiated Service Delivery for Pregnant and Postpartum Women Living With HIV and Their Infants
Differentiated service delivery (DSD) is an evidence-based HIV care and treatment model endorsed by the World Health Organization (WHO) that simplifies HIV services for clients who are clinically stable, improving the quality and efficiency of HIV services. The goal of this implementation-effectiveness pilot study is to evaluate the implementation of a DSD model for pregnant and postpartum women living with HIV and their infants enrolled in care at Huruma Sub-District Hospital in Kenya.
Read the detailed description
For pregnant and postpartum women living with HIV (PPHIV) in resource-limited settings, maintaining retention in care and viral suppression, and preventing mother-to-child transmission of HIV, are major implementation challenges in the PMTCT cascade. The goal of this study is to execute and evaluate the implementation of a differentiated service delivery (DSD) model for PMTCT to address these challenges. Specifically, this is a pilot study that will evaluate the implementation of a DSD model for PMTCT in a resource-constrained setting in Kenya. The objective of the DSD model is to improve retention in care and viral suppression for PPHIV. In the DSD approach, clinical services are simplified and adapted to the needs and preferences of clients who are clinically stable, allowing the health system to provide intensified services to the clients who unstable according to their needs. Set clinical criteria will be used to determine which PPHIV and their HIV-exposed children are clinically stable and which are unstable. The DSD model will be implemented at Huruma Sub-District Hospital in western Kenya which offers integrated PMTCT services. Over a period of 12 months, all PPHIV that attend this clinic will be recruited to participate in the DSD model as part of the study. The clinical staff will be responsible for triaging PPHIV and their children as stable or unstable according to the DSD eligibility criteria. The implementation success of the DSD model will be determined using the RE-AIM implementation outcomes. This will involve semi-structured interviews with PPHIV and focus group discussions with PMTCT providers participating in the model. Time-motion analysis and medical record review will also be performed to better understand the implementation process and data needed in preparation a future implementation-effectiveness clinical trial. Commensurate with the scope of this pilot implementation study, participants will not be randomized and there will not be a required minimum sample size. The findings from this study will serve as a foundation for a future, large-scale trial to test the effectiveness and implementation of the DSD model for PMTCT in a resource-limited setting.
- Being tested
- Differentiated service delivery model
- Keywords
- prevention of mother-to-child transmission, retention, service delivery, maternal-child health, Kenya
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Viremia, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Differentiated service delivery modelBehavioural
The differentiated service delivery (DSD) intervention is a clinic-level intervention in which PMTCT clients are differentiated into those who are clinically stable or unstable, with each group offered a different package of services to meet their needs. The DSD model that is being tested in this study is an individual-focused, facility-based model designed for implementation within maternal-child health clinics offering integrated HIV services.
| Study group | Role | What they receive |
|---|---|---|
| DSD arm for stable clients | Experimental | PPHIV who meet the following criteria will be considered stable clients: on current antiretroviral therapy ≥6 months; no active illness in the past 6 months; retained in care; viral load <50 copies/mL within the last 6 months; age ≥18 years; not primigravida; not high-risk pregnancy. PPHIV meeting these criteria will be offered postnatal clinic visits monthly for the first 6 months followed by visits every 2-3 months, flexible ART refills, and encounters with a clinician at each visit and mentor mother as needed. Clients who do not meet these criteria will continue to receive standard-of-care services which include monthly visits and ART refills during pregnancy through 18 months postpartum. Receives: Behavioral: Differentiated service delivery model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of barriers and facilitators to DSD implementation
The primary outcome for the analysis in Aim 1 (i.e., the pre-implementation phase) of this study will be the number of barriers/facilitators to implementation as elicited through rapid qualitative analysis of the pre-implementation workshop transcripts
Measured: One month before implementation of the DSD model in the clinic
Median difference in number of minutes of PMTCT appointment duration before versus after DSD implementation
The outcome of interest in this analysis will be the difference in clinic encounter durations (i.e., encounters with clinicians, mentor mother) between clients who are classified as stable versus unstable according to the DSD eligibility criteria, as measured through direct observation and time-motion analysis before an after DSD implementation
Measured: One month before and 6 months after implementation of the DSD model in the clinic
Reach
The proportion of eligible WLH who sign consent to participate in the study among the total number of WLH who attend the PMTCT clinic during the recruitment periods.
Measured: One month before and 6 months after implementation of the DSD model in the clinic
Effectiveness, clinic operations level
The primary outcome will be a ≥20% median reduction in the total clinic visit duration for stable clients compared to their pre-implementation baseline.
Measured: One month before and during the 12-month period of DSD implementation in the clinic
Proportion of participants who are virally suppressed <50 copies/mL
Maternal viral suppression will be assessed among all WLH after enrollment in the study during pregnancy and from delivery to 6 months postpartum, 7-12, and 13-18 months postpartum.
Measured: One month before and during the 12-month period of DSD implementation in the clinic
Proportion of children alive and HIV negative
HIV-free child survival will be assessed among all children of enrolled WLH from birth to 6, 7-12, and 13-18 months postpartum.
Measured: One month before and during the 12-month period of DSD implementation in the clinic
Proportion of participants retained in care
Retention in care will be assessed among all WLH after enrollment in the study during pregnancy and from delivery to 6 months postpartum, 7-12, and 13-18 months postpartum.
Measured: One month before and during the 12-month period of DSD implementation in the clinic
Proportion of healthcare workers who adopt the DSD model
The degree to which the clinic commits to and takes on the DSDp model, determined through rapid qualitative analysis of audit/feedback workshop transcripts conducted during the implementation phase
Measured: During the 12-month period of DSD implementation in the clinic
Proportion of PMTCT clients triaged correctly according to the DSD model
The proportion of PMTCT clients triaged correctly according to the DSD model eligibility criteria.
Measured: During the initial 6 months of DSD implementation in the clinic
Proportion of patients who perceive the DSD model to be acceptable
How satisfactory or agreeable the DSD model is perceived by its end-users, assessed through structured questionnaires administered to patients and providers.
Measured: During the 12-month period of DSD implementation in the clinic
Proportion of PMTCT clients triaged correctly according to the DSD model at 12 months
The extent to which a program is part of routine organizational practice, measured through a final time motion analysis and chart review among enrolled participants, conducted over 10 consecutive working days at 6 months at the end of the implementation phase at 12 months
Measured: At 12 months following the start of DSD implementation in the clinic
Proportion of providers who perceive the DSD model to be acceptable
How satisfactory or agreeable the DSD model is perceived by its end-users, assessed through structured questionnaires administered to patients and providers.
Measured: During the 12-month period of DSD implementation in the clinic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start13 Sep 2024
- Primary completion5 Mar 2026
- Study completion5 Mar 2026
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
- PPHIV and their children identified who are clinically stable will be differentiated to a care pathway that provides simplified PMTCT services that are adapted to their needs and preferences. PPHIV and their children who are clinically unstable will be differentiated to a care pathway that provides intensified PMTCT services.
- Masking
- None (open label)
- Enrolment
- 278 participants (actual)
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, John Moore Humphrey, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629753
- Sponsor's protocol ID
- 23897
- Other IDs
- K23HD105495
- Status last verified
- May 2026
- First submitted
- 2 Oct 2024
- Last updated
- 28 May 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 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Implementation of Differentiated Service Delivery for Pregnant and Postpartum Women Living With HIV and Their Infants
- ClinicalTrials.gov ID
- NCT06629753
- Acronym / sponsor ID
- 23897
- Keywords
- prevention of mother-to-child transmission, retention, service delivery, maternal-child health, Kenya
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 13 Sep 2024 (actual)
- Primary completion
- 5 Mar 2026 (actual)
- Study completion
- 5 Mar 2026 (actual)
- First posted
- 8 Oct 2024 (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.
Differentiated service delivery (DSD) is an evidence-based HIV care and treatment model endorsed by the World Health Organization (WHO) that simplifies HIV services for clients who are clinically stable, improving the quality and efficiency of HIV services. The goal of this implementation-effectiveness pilot study is to evaluate the implementation of a DSD model for pregnant and postpartum women living with HIV and their infants enrolled in care at Huruma Sub-District Hospital in Kenya.
Detailed description
For pregnant and postpartum women living with HIV (PPHIV) in resource-limited settings, maintaining retention in care and viral suppression, and preventing mother-to-child transmission of HIV, are major implementation challenges in the PMTCT cascade. The goal of this study is to execute and evaluate the implementation of a differentiated service delivery (DSD) model for PMTCT to address these challenges. Specifically, this is a pilot study that will evaluate the implementation of a DSD model for PMTCT in a resource-constrained setting in Kenya. The objective of the DSD model is to improve retention in care and viral suppression for PPHIV. In the DSD approach, clinical services are simplified and adapted to the needs and preferences of clients who are clinically stable, allowing the health system to provide intensified services to the clients who unstable according to their needs. Set clinical criteria will be used to determine which PPHIV and their HIV-exposed children are clinically stable and which are unstable. The DSD model will be implemented at Huruma Sub-District Hospital in western Kenya which offers integrated PMTCT services. Over a period of 12 months, all PPHIV that attend this clinic will be recruited to participate in the DSD model as part of the study. The clinical staff will be responsible for triaging PPHIV and their children as stable or unstable according to the DSD eligibility criteria. The implementation success of the DSD model will be determined using the RE-AIM implementation outcomes. This will involve semi-structured interviews with PPHIV and focus group discussions with PMTCT providers participating in the model. Time-motion analysis and medical record review will also be performed to better understand the implementation process and data needed in preparation a future implementation-effectiveness clinical trial. Commensurate with the scope of this pilot implementation study, participants will not be randomized and there will not be a required minimum sample size. The findings from this study will serve as a foundation for a future, large-scale trial to test the effectiveness and implementation of the DSD model for PMTCT in a resource-limited setting.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- PPHIV and their children identified who are clinically stable will be differentiated to a care pathway that provides simplified PMTCT services that are adapted to their needs and preferences. PPHIV and their children who are clinically unstable will be differentiated to a care pathway that provides intensified PMTCT services.
| Arm | Type | Receives |
|---|---|---|
| DSD arm for stable clients | Experimental | Behavioral: Differentiated service delivery modelPPHIV who meet the following criteria will be considered stable clients: on current antiretroviral therapy ≥6 months; no active illness in the past 6 months; retained in care; viral load <50 copies/mL within the last 6 months; age ≥18 years; not primigravida; not high-risk pregnancy. PPHIV meeting these criteria will be offered postnatal clinic visits monthly for the first 6 months followed by visits every 2-3 months, flexible ART refills, and encounters with a clinician at each visit and mentor mother as needed. Clients who do not meet these criteria will continue to receive standard-of-care services which include monthly visits and ART refills during pregnancy through 18 months postpartum. |
Who may qualify
- Ages
- 1 day and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- ≥18 years of age
- Able to understand English or Kiswahili
- Works as a clinician, nurse, peer counsellor, social worker, pharmacist, or clinic supervisor involved in providing PMTCT services in the maternal-child health clinic at Huruma Sub-District Hospital
- 5. Woman is ≥15 years of age 6. Woman is enrolled in maternal-child health services at HSDH 7. Woman is living with HIV 8. Woman is able to understand English or Kiswahili
Key exclusion criteria (4 listed)
- none
- Eligibility criteria for PPHIV and their infants enrolled prospectively (n=500)
- Cognitive impairment that would impair participation in the study
- All infants born to enrolled women during the study will be included.
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 |
|---|---|---|
| Differentiated service delivery modelThe differentiated service delivery (DSD) intervention is a clinic-level intervention in which PMTCT clients are differentiated into those who are clinically stable or unstable, with each group offered a different package of services to meet their needs. The DSD model that is being tested in this study is an individual-focused, facility-based model designed for implementation within maternal-child health clinics offering integrated HIV services. | Behavioural | DSD arm for stable clients |
Primary outcome
Number of barriers and facilitators to DSD implementation
Time frame: One month before implementation of the DSD model in the clinic
The primary outcome for the analysis in Aim 1 (i.e., the pre-implementation phase) of this study will be the number of barriers/facilitators to implementation as elicited through rapid qualitative analysis of the pre-implementation workshop transcripts
Median difference in number of minutes of PMTCT appointment duration before versus after DSD implementation
Time frame: One month before and 6 months after implementation of the DSD model in the clinic
The outcome of interest in this analysis will be the difference in clinic encounter durations (i.e., encounters with clinicians, mentor mother) between clients who are classified as stable versus unstable according to the DSD eligibility criteria, as measured through direct observation and time-motion analysis before an after DSD implementation
Reach
Time frame: One month before and 6 months after implementation of the DSD model in the clinic
The proportion of eligible WLH who sign consent to participate in the study among the total number of WLH who attend the PMTCT clinic during the recruitment periods.
Effectiveness, clinic operations level
Time frame: One month before and during the 12-month period of DSD implementation in the clinic
The primary outcome will be a ≥20% median reduction in the total clinic visit duration for stable clients compared to their pre-implementation baseline.
Proportion of participants who are virally suppressed <50 copies/mL
Time frame: One month before and during the 12-month period of DSD implementation in the clinic
Maternal viral suppression will be assessed among all WLH after enrollment in the study during pregnancy and from delivery to 6 months postpartum, 7-12, and 13-18 months postpartum.
Proportion of children alive and HIV negative
Time frame: One month before and during the 12-month period of DSD implementation in the clinic
HIV-free child survival will be assessed among all children of enrolled WLH from birth to 6, 7-12, and 13-18 months postpartum.
Proportion of participants retained in care
Time frame: One month before and during the 12-month period of DSD implementation in the clinic
Retention in care will be assessed among all WLH after enrollment in the study during pregnancy and from delivery to 6 months postpartum, 7-12, and 13-18 months postpartum.
Proportion of healthcare workers who adopt the DSD model
Time frame: During the 12-month period of DSD implementation in the clinic
The degree to which the clinic commits to and takes on the DSDp model, determined through rapid qualitative analysis of audit/feedback workshop transcripts conducted during the implementation phase
Proportion of PMTCT clients triaged correctly according to the DSD model
Time frame: During the initial 6 months of DSD implementation in the clinic
The proportion of PMTCT clients triaged correctly according to the DSD model eligibility criteria.
Proportion of patients who perceive the DSD model to be acceptable
Time frame: During the 12-month period of DSD implementation in the clinic
How satisfactory or agreeable the DSD model is perceived by its end-users, assessed through structured questionnaires administered to patients and providers.
Proportion of PMTCT clients triaged correctly according to the DSD model at 12 months
Time frame: At 12 months following the start of DSD implementation in the clinic
The extent to which a program is part of routine organizational practice, measured through a final time motion analysis and chart review among enrolled participants, conducted over 10 consecutive working days at 6 months at the end of the implementation phase at 12 months
Proportion of providers who perceive the DSD model to be acceptable
Time frame: During the 12-month period of DSD implementation in the clinic
How satisfactory or agreeable the DSD model is perceived by its end-users, assessed through structured questionnaires administered to patients and providers.
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 28 May 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Differentiated service delivery model 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 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 28 May 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?
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?
Number of barriers and facilitators to DSD implementation (time frame: One month before implementation of the DSD model in the clinic). The study lists 12 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 28 May 2026.