HIVNCT07900750
Bwelela Easy Study
A study testing Navigation plus Community-Based Medication Delivery / Navigation (NAV+CB-Med/NAV) in people with HIV and HIV - Human Immunodeficiency Virus, run by Washington University School of Medicine at 1 site in Zambia.
Trial summary
Treatment interruption in HIV care is one of the most enduring challenges to HIV programs globally and is associated with high rates of detectable virus in the blood and overall morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, HIV - Human Immunodeficiency Virus, Treatment Interruption
- What is being tested?
- Navigation plus Community-Based Medication Delivery / Navigation (NAV+CB-Med/NAV)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteZambia
- Study dates
- 15 Dec 2026to 31 May 2029
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults living with HIV age≥18 years
- Between 30 and 180 days late for a scheduled appointment at one of the study clinics based on EHR and clinic registers.
- Previously agreed to be contacted by the clinic for routine care purposes (e.g., track and trace)
Who cannot join
- Previously refused being contacted by the clinic for routine care purposes
- Due for switch to second-line ART regimens due to two or more consecutive elevated viral loads
- Individuals who have documented transfers or death in the EHR or clinic registers
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zambia1 site
Centre for Infectious Disease Research in Zambia (CIDRZ)
Lusaka
Njekwa Mukamba, +260966934531, njekwa.mukamba@cidrz.org
Natalie Vhlahakis
About this study
Official title: Sequential Strategies to Reach and Reengage Individuals After Lapses From HIV Care in Zambia (Bwelela Easy) Study
Treatment interruption in HIV care is one of the most enduring challenges to HIV programs globally and is associated with high rates of detectable virus in the blood and overall morbidity and mortality. Existing approaches to reengaging people living with HIV (PLH) have largely focused on return-to-care strategies but have not adequately addressed long-term retention after return. Effective strategies must integrate interventions that not only facilitate the return to care but also sustain engagement to prevent future lapses. Active follow-up of clients is a strategy that can promote both timely return to care and sustained long-term engagement.
The Bwelela Easy study seeks to identify person centered strategies using combinations of navigation and community-based medication delivery to both facilitate return to HIV care as well as sustain long-term reengagement post-return among individuals with treatment lapses in Zambia. The study is designed to randomly assign participants to different approaches at two different points, with the second assignment based on their earlier response. This is to compare different step-by-step combinations of approaches for improving return to care and staying in care after treatment interruptions for people living with HIV.
In the first stage (return) we will randomly assign individuals who are more than 30 days late for an appointment to routine phone outreach alone (control) versus Navigator+ Community Based medication groups. Among those who return to care, we will then re-randomly assign them in the second-stage (return and stay in care) to routine care and counseling (control), Navigator only, Navigator+ Community Based medication groups. This study advances a high priority research agenda to identify the most effective and efficient strategies for improving reengagement in care and will help maximize not only the public health impact of HIV programs but also advance strategies to improve care delivery for chronic diseases worldwide.
Read the detailed description
Treatment lapses remain one of the most enduring challenges to viral suppression in Africa. These individuals have higher rates of viremia (~70%), morbidity, and mortality, and now represent the majority of those hospitalized with advanced HIV. Even among those who return to care, 30-50% have repeat lapses due to ongoing challenges with care such competing obligations, travel/mobility, clinic-based, or psychosocial barriers.
Effective strategies for durably reengaging individuals with treatment lapses must address two steps: they must first be brought back into care, but after return, person-centered strategies are needed to prevent repeat lapses and keep them reengaged long-term. Navigation (NAV) and community-based medication delivery (CB-Med) are strategies that have been found to improve outcomes among those newly initiating or stable on ART, and our preliminary data indicates their complementary mechanisms hold promise to address key challenges at both the return and reengage stages. NAV offers a flexible approach to tailor outreach, care coordination, and psychosocial support to match individuals' unique barriers to care. Leveraging navigators to provide ongoing CB-Med efficiently adds instrumental support to further reduce challenges with medication access. Still, rigorous evidence on the use, timing, and optimal combinations of NAV and CB-Med after treatment lapses is lacking.
For example, offering NAV+CB-Med may improve rates of ART re-initiation, but this may not translate to better longer-term outcomes if it is stopped after return and individuals then receive the same care that previously failed. In this study we will use a sequential multiple assignment randomized trial (SMART) among 1270 individuals who are >30 days late for an appointment to assess different sequential combinations of return to care and reengagement strategies. We randomize participants in the first-stage to receive (1) routine phone outreach only (standard of care [SOC]) or (2) NAV+CB-Med for rapid ART re-initiation in the community and reentry support. Among those who return to care, we re-randomize them in the second-stage to: (1) routine care and counseling after return (RCC [SOC]), (2) NAV only after return, or (3) NAV+CB-Med after return. In Aim 1a, we compare phone outreach only vs. NAV+CB-Med on time to ART re-initiation and return to care. In Aim 1b, among individuals who return, we compare RCC, NAV alone, and NAV+CB-Med on retention in care after return (time to missing a pharmacy refill by >14 days). In Aim 2, we assess the overall effectiveness and cost-effectiveness of the six sequential combination return-and-reengage strategies embedded within the SMART design on viral suppression at 18- months after initial randomization (primary outcome). Lastly, in Aim 3 we conduct a mixed-methods evaluation to understand implementation (e.g., reach, adoption, fidelity, acceptability), mechanisms of action, and potential for sustainability among diverse stakeholders (e.g., participants, health care workers, public health officials).
- Being tested
- Standard of Care - Routine Phone Outreach / Standard of Care - Routine Care and Counseling (SOC-RPO/SOC-RCC), Standard of Care - Routine Phone Outreach / Navigation (SOC-RPO/NAV), Standard of Care - Routine Phone Outreach / Navigation plus Community-Based Medication Delivery (SOC-RPO/NAV+CB-Med), Navigation plus Community-Based Medication Delivery / Standard of Care - Routine Care and Counseling (NAV+CB-Med/SOC-RCC), Navigation plus Community-Based Medication Delivery / Navigation (NAV+CB-Med/NAV)
- Keywords
- HIV, Zambia, Treatment Interruption, Reengagement, Navigator, Community ART
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care - Routine Phone Outreach / Standard of Care - Routine Care and Counseling (SOC-RPO/SOC-RCC)Behavioural
SOC-RPO is a Stage 1 intervention to promote return to HIV care following a treatment lapse. Clinic outreach workers attempt to contact participants by telephone using information available in clinic records, with at least three call attempts over a 4-week period. Participants who are reached are encouraged to return to care and receive verbal reminders regarding treatment continuity. No in-person tracing, navigation, or community-based medication delivery is provided. Participants who return to care within 12-18 months are re-randomized to a Stage 2 intervention. SOC-RCC is a Stage 2 intervention in which participants receive routine adherence counseling, facility-based HIV care, and medication refills according to standard practice. Counseling generally consists of four sessions over 1-2 months, with follow-up visits initially scheduled at shorter intervals. Viral load is assessed approximately 6 months after return to care.
Standard of Care - Routine Phone Outreach / Navigation (SOC-RPO/NAV)Behavioural
SOC-RPO is a Stage 1 intervention to promote return to HIV care following a treatment lapse. Clinic outreach workers make at least three telephone contact attempts over a 4-week period using information available in clinic records. Participants who are reached are encouraged to return to care and receive reminders about treatment continuity. No in-person tracing, navigation, or community-based medication delivery is provided during Stage 1. Participants who return to care within 12-18 months are re-randomized to a Stage 2 intervention. NAV is a Stage 2 intervention in which trained navigators facilitate adherence counseling, assess existing or new barriers to care, provide reminders for upcoming visits, facilitate transfers when needed, and conduct outreach following missed visits. Navigators maintain contact between visits, with frequency and intensity adjusted according to participant needs, through the end of study follow-up.
Standard of Care - Routine Phone Outreach / Navigation plus Community-Based Medication Delivery (SOC-RPO/NAV+CB-Med)Behavioural
SOC-RPO is a Stage 1 intervention to promote return to HIV care following a treatment lapse through routine telephone outreach. Clinic outreach workers make at least three telephone contact attempts over a 4-week period. Participants who are reached are encouraged to return to care and receive reminders regarding treatment continuity. No in-person tracing, navigation, or community-based medication delivery is provided during Stage 1. Participants who return to care within 12-18 months are re-randomized to a Stage 2 intervention. NAV+CB-Med is a Stage 2 intervention that includes all NAV services plus ongoing community-based antiretroviral medication delivery when clinically appropriate. Navigators contact participants before ART refills are due and arrange delivery of a 3- to 6-month medication supply at a mutually agreed location, consistent with Zambian guidelines. Navigators also support attendance for required clinical evaluations and viral load monitoring.
Navigation plus Community-Based Medication Delivery / Standard of Care - Routine Care and Counseling (NAV+CB-Med/SOC-RCC)Behavioural
NAV+CB-Med is a Stage 1 intervention to promote return to HIV care following a treatment lapse. Trained navigators first attempt telephone contact and, when telephone contact is unsuccessful, may use available locator information and other appropriate sources to conduct in-person tracing. After contact and consent, navigators identify barriers to care, provide logistical and emotional support, facilitate re-entry or transfer as needed, and offer a one-time community-based ART delivery of approximately 30-90 days of the participant's current regimen, consistent with Zambian guidelines. Participants who return to care within 12-18 months are re-randomized to a Stage 2 intervention. SOC-RCC is a Stage 2 intervention consisting of routine adherence counseling, facility-based HIV care, and medication refills according to standard practice. Viral load is assessed approximately 6 months after return to care.
Navigation plus Community-Based Medication Delivery / Navigation (NAV+CB-Med/NAV)Behavioural
NAV+CB-Med is a Stage 1 intervention to promote return to HIV care following a treatment lapse. Navigators attempt telephone contact and may conduct in-person tracing when telephone contact is unsuccessful. After contact and consent, navigators assess barriers, provide logistical and emotional support, facilitate return or transfer to care, and offer a one-time community-based ART delivery of approximately 30-90 days when appropriate. Participants who return to care within 12-18 months are re-randomized to a Stage 2 intervention. NAV is a Stage 2 intervention in which trained navigators facilitate adherence counseling, assess barriers to care, provide appointment reminders, facilitate transfers when needed, conduct outreach following missed visits, and maintain contact between visits. Participants initially assigned to NAV+CB-Med in Stage 1 maintain their existing navigator relationship when assigned to NAV in Stage 2.
Navigation plus Community-Based Medication Delivery / Navigation plus Community-Based Medication Delivery (NAV+CB-Med/NAV+CB-Med)Behavioural
NAV+CB-Med is a Stage 1 intervention to promote return to HIV care following a treatment lapse. Navigators attempt telephone contact and may use in-person tracing when necessary. After contact and consent, navigators identify barriers to care, provide logistical and emotional support, facilitate return or transfer to care, and offer a one-time community-based ART delivery of approximately 30-90 days when appropriate. Participants who return to care within 12-18 months are re-randomized to a Stage 2 intervention. In Stage 2, participants continue NAV+CB-Med, including navigation services and the option for ongoing community-based ART delivery. Navigators generally contact participants 2-4 weeks before refills are due and may arrange delivery of a 3- to 6-month supply at a mutually agreed location, consistent with Zambian guidelines. Navigators also support attendance for required clinical monitoring and viral load testing.
| Study group | Role | What they receive |
|---|---|---|
| SOC-RPO/SOC-RCC | Active comparator | Participants are initially randomized to standard-of-care routine phone outreach (SOC-RPO) to promote return to HIV care following a treatment lapse. Participants who return to care within 12-18 months are re-randomized to standard-of-care routine care and counseling (SOC-RCC) for ongoing HIV care and adherence support. Receives: Behavioral: Standard of Care - Routine Phone Outreach / Standard of Care - Routine Care and Counseling (SOC-RPO/SOC-RCC) |
| SOC-RPO/NAV | Experimental | Participants are initially randomized to standard-of-care routine phone outreach (SOC-RPO) to promote return to HIV care following a treatment lapse. Participants who return to care within 12-18 months are re-randomized to receive navigation (NAV) for ongoing support with care engagement, adherence, and retention. Receives: Behavioral: Standard of Care - Routine Phone Outreach / Navigation (SOC-RPO/NAV) |
| SOC-RPO/NAV+CB-Med | Experimental | Participants are initially randomized to standard-of-care routine phone outreach (SOC-RPO) to promote return to HIV care following a treatment lapse. Participants who return to care within 12-18 months are re-randomized to receive navigation plus community-based medication delivery (NAV+CB-Med) to support continued HIV care engagement and treatment adherence. Receives: Behavioral: Standard of Care - Routine Phone Outreach / Navigation plus Community-Based Medication Delivery (SOC-RPO/NAV+CB-Med) |
| NAV+CB-Med/SOC-RCC | Experimental | Participants are initially randomized to navigation plus community-based medication delivery (NAV+CB-Med) to facilitate return to HIV care following a treatment lapse. Participants who return to care within 12-18 months are re-randomized to standard-of-care routine care and counseling (SOC-RCC) for ongoing HIV care and adherence support. Receives: Behavioral: Navigation plus Community-Based Medication Delivery / Standard of Care - Routine Care and Counseling (NAV+CB-Med/SOC-RCC) |
| NAV+CB-Med/NAV | Experimental | Participants are initially randomized to navigation plus community-based medication delivery (NAV+CB-Med) to facilitate return to HIV care following a treatment lapse. Participants who return to care within 12-18 months are re-randomized to navigation (NAV) for continued support with care engagement, adherence, and retention. Receives: Behavioral: Navigation plus Community-Based Medication Delivery / Navigation (NAV+CB-Med/NAV) |
| NAV+CB-Med/NAV+CB-Med | Experimental | Participants are initially randomized to navigation plus community-based medication delivery (NAV+CB-Med) to facilitate return to HIV care following a treatment lapse. Participants who return to care within 12-18 months are re-randomized to continue navigation plus community-based medication delivery (NAV+CB-Med) to support sustained HIV care engagement and treatment adherence. Receives: Behavioral: Navigation plus Community-Based Medication Delivery / Navigation plus Community-Based Medication Delivery (NAV+CB-Med/NAV+CB-Med) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to ART re-initiation (Stage 1)
Time to confirmed receipt of ART during a return clinic visit or community-based medication delivery by a navigator
Measured: From initial randomization through end of study follow-up, up to 12 months
Time to Repeat Treatment Interruption after Return (Stage 2)
Time to missing a pharmacy refill by >14 days after return
Measured: From Return to Care and Second Stage Randomization to 12 months later
Proportion of Time Spent in Care and with medications (Stage 1 + Stage 2)
Days spent in care and not >14 days late for ART pick-up
Measured: From Treatment Interruption until 18-months
Secondary outcomes (8)
Viral Suppression
Percentage of participants with documented viral suppression, defined as HIV RNA <400 copies/mL, compared across the six embedded sequential return-and-reengagement strategies. Viral load data are drawn from the national electronic health record (SmartCare), supplemented by field-based viral load collection where necessary.
Measured: 12-18 months
Percentage of Participants Engaged in Care 12 to 18 Months After Initial Randomization
Measured: 12 to 18 months after initial treatment interruption
Time to return for a clinic visit
Time from initial randomization to first completed HIV clinic visit
Measured: From initial treatment interruption through end of study follow-up, up to 12 months
Proportion who return to clinic within 3-months
Measured: At 3-months initial treatment interruption
Proportion successfully contacted via phone or in-person
Measured: At 3-months initial treatment interruption
Percent with at least one pharmacy refill missed by >30 days
Measured: From second-stage re-randomization up to 12 months
Percentage of Participants Attending Any Clinic Visit 6 to 12 Months After Return to Care
Measured: 6 to 12 months after return to care
Cost Effectiveness
Assessing the cost-effectiveness of return strategies (Aim 1a), reengage strategies (Aim 1b), and sequential combination return-and-reengage strategies (Aim 2).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start15 Dec 2026 (estimated)
- Primary completion31 May 2029 (estimated)
- Study completion31 May 2029 (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 Washington University School of MedicineThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Sequential Multiple Assignment Randomized Trial (SMART) Design
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Johns Hopkins University, Centre for Infectious Disease Research in Zambia
- Responsible party
- Sponsor
- Investigators
- Aaloke Mody, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07900750
- Sponsor's protocol ID
- 202602051
- Other IDs
- R01MH135819-01
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential Strategies to Reach and Reengage Individuals After Lapses From HIV Care in Zambia (Bwelela Easy) Study
- ClinicalTrials.gov ID
- NCT07900750
- Acronym / sponsor ID
- 202602051
- Keywords
- HIV, Zambia, Treatment Interruption, Reengagement, Navigator, Community ART
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Johns Hopkins University, Centre for Infectious Disease Research in Zambia
- Study start
- 15 Dec 2026 (estimated)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 28 Oct 2026 (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.
Treatment interruption in HIV care is one of the most enduring challenges to HIV programs globally and is associated with high rates of detectable virus in the blood and overall morbidity and mortality. Existing approaches to reengaging people living with HIV (PLH) have largely focused on return-to-care strategies but have not adequately addressed long-term retention after return. Effective strategies must integrate interventions that not only facilitate the return to care but also sustain engagement to prevent future lapses. Active follow-up of clients is a strategy that can promote both timely return to care and sustained long-term engagement.
The Bwelela Easy study seeks to identify person centered strategies using combinations of navigation and community-based medication delivery to both facilitate return to HIV care as well as sustain long-term reengagement post-return among individuals with treatment lapses in Zambia. The study is designed to randomly assign participants to different approaches at two different points, with the second assignment based on their earlier response. This is to compare different step-by-step combinations of approaches for improving return to care and staying in care after treatment interruptions for people living with HIV.
In the first stage (return) we will randomly assign individuals who are more than 30 days late for an appointment to routine phone outreach alone (control) versus Navigator+ Community Based medication groups. Among those who return to care, we will then re-randomly assign them in the second-stage (return and stay in care) to routine care and counseling (control), Navigator only, Navigator+ Community Based medication groups. This study advances a high priority research agenda to identify the most effective and efficient strategies for improving reengagement in care and will help maximize not only the public health impact of HIV programs but also advance strategies to improve care delivery for chronic diseases worldwide.
Detailed description
Treatment lapses remain one of the most enduring challenges to viral suppression in Africa. These individuals have higher rates of viremia (~70%), morbidity, and mortality, and now represent the majority of those hospitalized with advanced HIV. Even among those who return to care, 30-50% have repeat lapses due to ongoing challenges with care such competing obligations, travel/mobility, clinic-based, or psychosocial barriers.
Effective strategies for durably reengaging individuals with treatment lapses must address two steps: they must first be brought back into care, but after return, person-centered strategies are needed to prevent repeat lapses and keep them reengaged long-term. Navigation (NAV) and community-based medication delivery (CB-Med) are strategies that have been found to improve outcomes among those newly initiating or stable on ART, and our preliminary data indicates their complementary mechanisms hold promise to address key challenges at both the return and reengage stages. NAV offers a flexible approach to tailor outreach, care coordination, and psychosocial support to match individuals' unique barriers to care. Leveraging navigators to provide ongoing CB-Med efficiently adds instrumental support to further reduce challenges with medication access. Still, rigorous evidence on the use, timing, and optimal combinations of NAV and CB-Med after treatment lapses is lacking.
For example, offering NAV+CB-Med may improve rates of ART re-initiation, but this may not translate to better longer-term outcomes if it is stopped after return and individuals then receive the same care that previously failed. In this study we will use a sequential multiple assignment randomized trial (SMART) among 1270 individuals who are >30 days late for an appointment to assess different sequential combinations of return to care and reengagement strategies. We randomize participants in the first-stage to receive (1) routine phone outreach only (standard of care [SOC]) or (2) NAV+CB-Med for rapid ART re-initiation in the community and reentry support. Among those who return to care, we re-randomize them in the second-stage to: (1) routine care and counseling after return (RCC [SOC]), (2) NAV only after return, or (3) NAV+CB-Med after return. In Aim 1a, we compare phone outreach only vs. NAV+CB-Med on time to ART re-initiation and return to care. In Aim 1b, among individuals who return, we compare RCC, NAV alone, and NAV+CB-Med on retention in care after return (time to missing a pharmacy refill by >14 days). In Aim 2, we assess the overall effectiveness and cost-effectiveness of the six sequential combination return-and-reengage strategies embedded within the SMART design on viral suppression at 18- months after initial randomization (primary outcome). Lastly, in Aim 3 we conduct a mixed-methods evaluation to understand implementation (e.g., reach, adoption, fidelity, acceptability), mechanisms of action, and potential for sustainability among diverse stakeholders (e.g., participants, health care workers, public health officials).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Sequential Multiple Assignment Randomized Trial (SMART) Design
| Arm | Type | Receives |
|---|---|---|
| SOC-RPO/SOC-RCC | Active comparator | Behavioral: Standard of Care - Routine Phone Outreach / Standard of Care - Routine Care and Counseling (SOC-RPO/SOC-RCC)Participants are initially randomized to standard-of-care routine phone outreach (SOC-RPO) to promote return to HIV care following a treatment lapse. Participants who return to care within 12-18 months are re-randomized to standard-of-care routine care and counseling (SOC-RCC) for ongoing HIV care and adherence support. |
| SOC-RPO/NAV | Experimental | Behavioral: Standard of Care - Routine Phone Outreach / Navigation (SOC-RPO/NAV)Participants are initially randomized to standard-of-care routine phone outreach (SOC-RPO) to promote return to HIV care following a treatment lapse. Participants who return to care within 12-18 months are re-randomized to receive navigation (NAV) for ongoing support with care engagement, adherence, and retention. |
| SOC-RPO/NAV+CB-Med | Experimental | Behavioral: Standard of Care - Routine Phone Outreach / Navigation plus Community-Based Medication Delivery (SOC-RPO/NAV+CB-Med)Participants are initially randomized to standard-of-care routine phone outreach (SOC-RPO) to promote return to HIV care following a treatment lapse. Participants who return to care within 12-18 months are re-randomized to receive navigation plus community-based medication delivery (NAV+CB-Med) to support continued HIV care engagement and treatment adherence. |
| NAV+CB-Med/SOC-RCC | Experimental | Behavioral: Navigation plus Community-Based Medication Delivery / Standard of Care - Routine Care and Counseling (NAV+CB-Med/SOC-RCC)Participants are initially randomized to navigation plus community-based medication delivery (NAV+CB-Med) to facilitate return to HIV care following a treatment lapse. Participants who return to care within 12-18 months are re-randomized to standard-of-care routine care and counseling (SOC-RCC) for ongoing HIV care and adherence support. |
| NAV+CB-Med/NAV | Experimental | Behavioral: Navigation plus Community-Based Medication Delivery / Navigation (NAV+CB-Med/NAV)Participants are initially randomized to navigation plus community-based medication delivery (NAV+CB-Med) to facilitate return to HIV care following a treatment lapse. Participants who return to care within 12-18 months are re-randomized to navigation (NAV) for continued support with care engagement, adherence, and retention. |
| NAV+CB-Med/NAV+CB-Med | Experimental | Behavioral: Navigation plus Community-Based Medication Delivery / Navigation plus Community-Based Medication Delivery (NAV+CB-Med/NAV+CB-Med)Participants are initially randomized to navigation plus community-based medication delivery (NAV+CB-Med) to facilitate return to HIV care following a treatment lapse. Participants who return to care within 12-18 months are re-randomized to continue navigation plus community-based medication delivery (NAV+CB-Med) to support sustained HIV care engagement and treatment adherence. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults living with HIV age≥18 years
- Between 30 and 180 days late for a scheduled appointment at one of the study clinics based on EHR and clinic registers.
- Previously agreed to be contacted by the clinic for routine care purposes (e.g., track and trace)
Key exclusion criteria (3 listed)
- Previously refused being contacted by the clinic for routine care purposes
- Due for switch to second-line ART regimens due to two or more consecutive elevated viral loads
- Individuals who have documented transfers or death in the EHR or clinic registers
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 |
|---|---|---|
| Standard of Care - Routine Phone Outreach / Standard of Care - Routine Care and Counseling (SOC-RPO/SOC-RCC)SOC-RPO is a Stage 1 intervention to promote return to HIV care following a treatment lapse. Clinic outreach workers attempt to contact participants by telephone using information available in clinic records, with at least three call attempts over a 4-week period. Participants who are reached are encouraged to return to care and receive verbal reminders regarding treatment continuity. No in-person tracing, navigation, or community-based medication delivery is provided. Participants who return to care within 12-18 months are re-randomized to a Stage 2 intervention. SOC-RCC is a Stage 2 intervention in which participants receive routine adherence counseling, facility-based HIV care, and medication refills according to standard practice. Counseling generally consists of four sessions over 1-2 months, with follow-up visits initially scheduled at shorter intervals. Viral load is assessed approximately 6 months after return to care. | Behavioural | SOC-RPO/SOC-RCC |
| Standard of Care - Routine Phone Outreach / Navigation (SOC-RPO/NAV)SOC-RPO is a Stage 1 intervention to promote return to HIV care following a treatment lapse. Clinic outreach workers make at least three telephone contact attempts over a 4-week period using information available in clinic records. Participants who are reached are encouraged to return to care and receive reminders about treatment continuity. No in-person tracing, navigation, or community-based medication delivery is provided during Stage 1. Participants who return to care within 12-18 months are re-randomized to a Stage 2 intervention. NAV is a Stage 2 intervention in which trained navigators facilitate adherence counseling, assess existing or new barriers to care, provide reminders for upcoming visits, facilitate transfers when needed, and conduct outreach following missed visits. Navigators maintain contact between visits, with frequency and intensity adjusted according to participant needs, through the end of study follow-up. | Behavioural | SOC-RPO/NAV |
| Standard of Care - Routine Phone Outreach / Navigation plus Community-Based Medication Delivery (SOC-RPO/NAV+CB-Med)SOC-RPO is a Stage 1 intervention to promote return to HIV care following a treatment lapse through routine telephone outreach. Clinic outreach workers make at least three telephone contact attempts over a 4-week period. Participants who are reached are encouraged to return to care and receive reminders regarding treatment continuity. No in-person tracing, navigation, or community-based medication delivery is provided during Stage 1. Participants who return to care within 12-18 months are re-randomized to a Stage 2 intervention. NAV+CB-Med is a Stage 2 intervention that includes all NAV services plus ongoing community-based antiretroviral medication delivery when clinically appropriate. Navigators contact participants before ART refills are due and arrange delivery of a 3- to 6-month medication supply at a mutually agreed location, consistent with Zambian guidelines. Navigators also support attendance for required clinical evaluations and viral load monitoring. | Behavioural | SOC-RPO/NAV+CB-Med |
| Navigation plus Community-Based Medication Delivery / Standard of Care - Routine Care and Counseling (NAV+CB-Med/SOC-RCC)NAV+CB-Med is a Stage 1 intervention to promote return to HIV care following a treatment lapse. Trained navigators first attempt telephone contact and, when telephone contact is unsuccessful, may use available locator information and other appropriate sources to conduct in-person tracing. After contact and consent, navigators identify barriers to care, provide logistical and emotional support, facilitate re-entry or transfer as needed, and offer a one-time community-based ART delivery of approximately 30-90 days of the participant's current regimen, consistent with Zambian guidelines. Participants who return to care within 12-18 months are re-randomized to a Stage 2 intervention. SOC-RCC is a Stage 2 intervention consisting of routine adherence counseling, facility-based HIV care, and medication refills according to standard practice. Viral load is assessed approximately 6 months after return to care. | Behavioural | NAV+CB-Med/SOC-RCC |
| Navigation plus Community-Based Medication Delivery / Navigation (NAV+CB-Med/NAV)NAV+CB-Med is a Stage 1 intervention to promote return to HIV care following a treatment lapse. Navigators attempt telephone contact and may conduct in-person tracing when telephone contact is unsuccessful. After contact and consent, navigators assess barriers, provide logistical and emotional support, facilitate return or transfer to care, and offer a one-time community-based ART delivery of approximately 30-90 days when appropriate. Participants who return to care within 12-18 months are re-randomized to a Stage 2 intervention. NAV is a Stage 2 intervention in which trained navigators facilitate adherence counseling, assess barriers to care, provide appointment reminders, facilitate transfers when needed, conduct outreach following missed visits, and maintain contact between visits. Participants initially assigned to NAV+CB-Med in Stage 1 maintain their existing navigator relationship when assigned to NAV in Stage 2. | Behavioural | NAV+CB-Med/NAV |
| Navigation plus Community-Based Medication Delivery / Navigation plus Community-Based Medication Delivery (NAV+CB-Med/NAV+CB-Med)NAV+CB-Med is a Stage 1 intervention to promote return to HIV care following a treatment lapse. Navigators attempt telephone contact and may use in-person tracing when necessary. After contact and consent, navigators identify barriers to care, provide logistical and emotional support, facilitate return or transfer to care, and offer a one-time community-based ART delivery of approximately 30-90 days when appropriate. Participants who return to care within 12-18 months are re-randomized to a Stage 2 intervention. In Stage 2, participants continue NAV+CB-Med, including navigation services and the option for ongoing community-based ART delivery. Navigators generally contact participants 2-4 weeks before refills are due and may arrange delivery of a 3- to 6-month supply at a mutually agreed location, consistent with Zambian guidelines. Navigators also support attendance for required clinical monitoring and viral load testing. | Behavioural | NAV+CB-Med/NAV+CB-Med |
Primary outcome
Time to ART re-initiation (Stage 1)
Time frame: From initial randomization through end of study follow-up, up to 12 months
Time to confirmed receipt of ART during a return clinic visit or community-based medication delivery by a navigator
Time to Repeat Treatment Interruption after Return (Stage 2)
Time frame: From Return to Care and Second Stage Randomization to 12 months later
Time to missing a pharmacy refill by >14 days after return
Proportion of Time Spent in Care and with medications (Stage 1 + Stage 2)
Time frame: From Treatment Interruption until 18-months
Days spent in care and not >14 days late for ART pick-up
8 secondary outcomes
Viral Suppression
Time frame: 12-18 months
Percentage of Participants Engaged in Care 12 to 18 Months After Initial Randomization
Time frame: 12 to 18 months after initial treatment interruption
Time to return for a clinic visit
Time frame: From initial treatment interruption through end of study follow-up, up to 12 months
Proportion who return to clinic within 3-months
Time frame: At 3-months initial treatment interruption
Proportion successfully contacted via phone or in-person
Time frame: At 3-months initial treatment interruption
Percent with at least one pharmacy refill missed by >30 days
Time frame: From second-stage re-randomization up to 12 months
Percentage of Participants Attending Any Clinic Visit 6 to 12 Months After Return to Care
Time frame: 6 to 12 months after return to care
Cost Effectiveness
Time frame: 12 months
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 28 Oct 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable.
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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.
Aaloke Mody, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Navigation plus Community-Based Medication Delivery / Navigation (NAV+CB-Med/NAV) in people with HIV and HIV - Human Immunodeficiency Virus, run by Washington University School of Medicine at 1 site in Zambia.
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 3 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: opening soon, as of the sponsor's last update on 28 Oct 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 Zambia. 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 Njekwa Mukamba (+260966964531, njekwa.mukamba@cidrz.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to ART re-initiation (Stage 1) (time frame: From initial randomization through end of study follow-up, up to 12 months). 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 28 Oct 2026; AzTrials last refreshed its copy on 28 Oct 2026.