An interventional study of Standard of Care - Routine Phone Outreach / Standard of Care - Routine Care and Counseling (SOC-RPO/SOC-RCC) and Standard of Care - Routine Phone Outreach / Navigation (SOC-RPO/NAV) in HIV, HIV - Human Immunodeficiency Virus and Treatment Interruption, sponsored by Washington University School of Medicine. Not yet recruiting at 1 site in Zambia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Health services research
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.
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).
3,035 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 306 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 96 across 2,251 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
Compared within Acquired Immunodeficiency Syndrome, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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 receive navigation (NAV) for ongoing support with care engagement, adherence, and retention.
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 plus community-based medication delivery (NAV+CB-Med) to support continued HIV care engagement and treatment adherence.
Behavioral: Standard of Care - Routine Phone Outreach / Navigation plus Community-Based Medication Delivery (SOC-RPO/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 standard-of-care routine care and counseling (SOC-RCC) for ongoing HIV care and adherence support.
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 navigation (NAV) for continued support with care engagement, adherence, and retention.
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 continue navigation plus community-based medication delivery (NAV+CB-Med) to support sustained HIV care engagement and treatment adherence.
Behavioral: Navigation plus Community-Based Medication Delivery / Navigation plus Community-Based Medication Delivery (NAV+CB-Med/NAV+CB-Med)
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.
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.
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.
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.
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.
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.
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
Time frame: 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
Time frame: 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
Time frame: From Treatment Interruption until 18-months
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.
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 from initial randomization to first completed HIV 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
Assessing the cost-effectiveness of return strategies (Aim 1a), reengage strategies (Aim 1b), and sequential combination return-and-reengage strategies (Aim 2).
Time frame: 12 months
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Beginning 9 and continuing for 36 months following publication
Access criteria: Investigator has approved IRB, IEC, or REB.
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for May 2029, 29 months later.
Of 641 non-industry interventional studies with no phase under Acquired Immunodeficiency Syndrome, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 45. This study's planned 29 months is close to that.
Counting every sponsor, half of 647 studies reached it within 29 months; a quarter within 17 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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