Clinical Trial

Rudi Kundini, Pamoja Kundini

Study acronym: RKPK: Phase II
Completed
View on ClinicalTrials.gov →
Summary
This protocol describes an individually randomized trial that will include adult people living with HIV (PLHIV) currently receiving HIV care at one of two participating health facilities and identified as high risk for disengagement from care by a machine learning algorithm. Participants randomized to the control arm will receive standard of care HIV clinical services according to Tanzania's National Guidelines for the management of HIV. For those who meet clinic eligibility criteria for enhanced adherence counseling, which at the included study sites is when client's viral load reaches a detectable level (\>1000 copies/ml), this includes the standard provision of three, once-monthly, 60-minute nurse-led individual, enhanced adherence counseling sessions, starting on the day of the result and for two months after. Intervention arm participants will receive the same standard HIV care services plus the offer of a cash transfer paired with visit attendance and attendance at each of the three adapted enhanced adherence counseling sessions (referred to as PKC sessions).
Protocol Amendment History 3 changes
critical Trial completed 2026-08-15
notable Primary completion pushed: 2026-01-20 -> 2026-04-10 2026-08-15
minor Completion pushed: 2026-01-20 -> 2026-04-10 2026-08-15
Trial Details
NCT Number NCT05373095
Lead Sponsor University of California, Berkeley
Collaborators: Health for a Prosperous Nation, Rasello, Management and Development for Health, Ministry of Health, Tanzania, National Institute of Mental Health (NIMH)
Conditions HIV (Human Immunodeficiency Virus)
Enrollment 692 participants
Start Date 2023-10-23
Primary Completion 2026-04-10 (estimated)
Study Completion 2026-04-10 (estimated)
Updated on ClinicalTrials.gov 2026-08-14