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Sequential Strategies to Reach and Reengage Individuals After Lapses From HIV Care in Zambia (Bwelela Easy) Study
Sponsor study identifier
Secondary identifiers
interventional
1,500
1 country
1
Study Start
December 15, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
May 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 21, 2026
Actual (reported)October 28, 2026
Actual (reported)December 15, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
May 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
May 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
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
From Treatment Interruption until 18-months
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.
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 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.
Centre for Infectious Disease Research in Zambia (CIDRZ)
Lusaka, Zambia
Aaloke Mody, MD
Washington University School of Medicine
First Submitted
October 21, 2026
First Posted
October 28, 2026
Study Start
December 15, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Viral Suppression
12-18 months
Percentage of Participants Engaged in Care 12 to 18 Months After Initial Randomization
12 to 18 months after initial treatment interruption
Time to return for a clinic visit
From initial treatment interruption through end of study follow-up, up to 12 months
Proportion who return to clinic within 3-months
At 3-months initial treatment interruption
Proportion successfully contacted via phone or in-person
At 3-months initial treatment interruption
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.
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.
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.
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.
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.
Contact the study team to confirm eligibility.
Primary Completion
May 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 28, 2026
Record last verified: 2026-10
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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Source: ClinicalTrials.gov.
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