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NCT05373095: RKPK: Phase II

Rudi Kundini, Pamoja Kundini

Active, enrolled NA Last updated 30 July 2025
What this trial tests

NA trial testing PKC (adapted adherence counseling) and Conditional Cash Transfers in HIV (Human Immunodeficiency Virus) in 692 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
23 October 2023
Primary endpoint
20 January 2026
20 January 2026

Quick facts

Lead sponsorUniversity of California, Berkeley
PhaseNA
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeother
Enrollment692
Start date23 October 2023
Primary completion20 January 2026
Estimated completion20 January 2026
Sites4 locations across Tanzania

Drugs / interventions tested

Conditions studied

Sponsor

University of California, Berkeley

Who can join

18 and older, any sex, with HIV (Human Immunodeficiency Virus). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Impact of financial incentives on viral suppression among adults initiating HIV treatment in Tanzania: a hybrid effectiveness-implementation trial.
    Njau PF, Katabaro E, Winters S, Sabasaba A, et al · · 2024 · cited 5× · PMID 39098325 · DOI 10.1016/s2352-3018(24)00149-8
  2. Prevention of adverse HIV treatment outcomes: machine learning to enable proactive support of people at risk of HIV care disengagement in Tanzania.
    Xie Z, Hu H, Kadota JL, Packel LJ, et al · · 2024 · cited 2× · PMID 39317499 · DOI 10.1136/bmjopen-2024-088782
  3. Rudi Kundini, Pamoja Kundini (RKPK): study protocol for a hybrid type 1 randomized effectiveness-implementation trial using data science and economic incentive strategies to strengthen the continuity of care among people living with HIV in Tanzania.
    Kadota JL, Packel LJ, Mlowe M, Ulenga N, et al · · 2024 · cited 1× · PMID 38336793 · DOI 10.1186/s13063-024-07960-x
  4. Rudi Kundini, Pamoja Kundini (RKPK): study protocol for a hybrid type 1 randomized effectiveness-implementation trial using data science and economic incentive strategies to strengthen the continuity of care among people living with HIV in Tanzania
    Kadota JL, Packel LJ, Mlowe M, Ulenga N, et al · · 2023 · DOI 10.21203/rs.3.rs-3315136/v1

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Other recruiting trials for HIV (Human Immunodeficiency Virus)

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Data sources for this page

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