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NOT YET RECRUITING
NCT07900750
NA

Bwelela Easy Study

Sponsor: Washington University School of Medicine

View on ClinicalTrials.gov

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. 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.

Official title: Sequential Strategies to Reach and Reengage Individuals After Lapses From HIV Care in Zambia (Bwelela Easy) Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1500

Start Date

2026-12-15

Completion Date

2029-05-31

Last Updated

2026-10-28

Healthy Volunteers

No

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

Locations (1)

Centre for Infectious Disease Research in Zambia (CIDRZ)

Lusaka, Zambia