NCT07900750Not yet recruiting
Bwelela Easy Study
Sequential Strategies to Reach and Reengage Individuals After Lapses From HIV Care in Zambia (Bwelela Easy) Study
Source: ClinicalTrials.gov · Last updated 28 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 1500 (estimated)
- First submitted
- 21 Oct 2026
- Start date
- 15 Dec 2026
- Primary completion date
- 31 May 2029
- Lead sponsor
- Washington University School of Medicine
- Diseases
- HIV
- NCT number
- NCT07900750
What you commit to
- Study type: Interventional
- Planned participants: 1500
- From 15 Dec 2026 to the primary completion date, 31 May 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously refused being contacted by the clinic for routine care purposes
Other
- 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
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre for Infectious Disease Research in Zambia (CIDRZ) Coordinator of this site? Confirm its status | Lusaka | Zambia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.