Rudi Kundini, Pamoja Kundini

NCT05373095 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 692

Last updated 2025-07-30

No results posted yet for this study

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).

Conditions

  • HIV (Human Immunodeficiency Virus)

Interventions

BEHAVIORAL

PKC (adapted adherence counseling) and Conditional Cash Transfers

The intervention includes up to 3 cash transfers of 22,500 Tanzanian Shillings (\~$10) paired with attendance at each of the three adapted enhanced adherence counseling sessions (PKC sessions). The first cash transfer will occur at enrollment; the next two cash transfers are payable upon visit attendance and attendance of the two remaining PKC sessions. The cash transfers will include extra funds for transaction fees, typically \<$1.

Sponsors & Collaborators

  • Health for a Prosperous Nation

    collaborator OTHER
  • Rasello

    collaborator INDUSTRY
  • Management and Development for Health

    collaborator UNKNOWN
  • Ministry of Health, Tanzania

    collaborator OTHER_GOV
  • National Institute of Mental Health (NIMH)

    collaborator NIH
  • University of California, Berkeley

    lead OTHER

Principal Investigators

  • Jingshen Wang, PhD · University of California, Berkeley

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-23
Primary Completion
2026-01-20
Completion
2026-01-20

Countries

  • Tanzania

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05373095 on ClinicalTrials.gov