Rudi Kundini, Pamoja Kundini: Phase I

NCT05248100 | Completed DMC

• 1 other identifier: R01MH125746
• Study Type: interventional
• Target: 567
• Locations: 1 country
• Sites: 2

Brief Summary

This protocol describes a 2-arm cluster, randomized controlled trial designed to test the effectiveness of a conditional cash transfer on viral suppression at 6 months among people living with HIV infection (PLHIV) in Tanzania who have disengaged from HIV care. Randomization will take place at the clinic level (HIV primary care clinics). The comparison group receives standard of care standard of care HIV tracing services according to Tanzania's National Guidelines for the Management of HIV and the Ministry of Health to locate potential participants, including home based care (HBC) tracing of PLHIV who have disengaged from primary care, the provision of counseling to return to HIV care, and the offer to schedule an HIV primary care appointment on the spot. Eligible adult PLHIV disengaged from HIV care and living in an intervention facility catchment area will receive the same standard of care HIV tracing and clinical services as control participants, plus the opportunity to receive a one-time cash transfer incentive, conditional upon confirmed completion of a clinical visit if within 90 days of study enrollment. The primary endpoint is viral suppression (\<1000 copies/ml) at 6 months after study enrollment.

Conditions

HIV (Human Immunodeficiency Virus)

Keywords

Conditional Cash Transfers; Tanzania; People Living With HIV

Outcome Measures

Primary Outcomes (1)

• 6-month Viral Suppression

  The proportion of people living with HIV (PLHIV) retained in HIV primary care and with suppressed HIV viral load 6 months following study enrollment. The primary outcome is expressed as a binary variable, defined as PLHIV who are on ART and with sufficient HIV viral suppression (\<1000 copies/ml, WHO's threshold for virologic failure in LMICs) versus not on ART or viral failure (≥1000 copies/ml).

  6 months

Secondary Outcomes (10)

• 12-month Viral Suppression

  12 months

• Durable 12-month Viral Suppression

  12 months

• 6-month Appointment Attendance

  6 months

• 12-month Appointment Attendance

  12 months

• 12-month Mortality

  12 months

Study Arms (2)

Conditional Cash Transfer

EXPERIMENTAL

Eligible and consenting participants living in an intervention health facility catchment area will receive the same standard of care HIV tracing and clinical services as control participants, plus the opportunity to receive a one-time incentive of 22,500 Tanzanian Shillings (TSH) (\~$10), with half (11,250 TSH) delivered upon enrollment in the study and half delivered after confirmation of the completion of a clinical visit if within 90 days of study enrollment.

Behavioral: Conditional Cash Transfer

Control

NO INTERVENTION

Eligible and consenting participants living in a control health facility catchment area will receive the standard of care HIV tracing and clinical services.

Interventions

Conditional Cash Transfer BEHAVIORAL

The intervention is a one-time cash transfer of 22,500 Tanzanian Shillings (\~$10), with half (11,250 TSH) delivered upon enrollment in the study and half delivered after confirmation of the completion of a clinical visit if within 90 days of study enrollment.

Conditional Cash Transfer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PLHIV living in the catchment area of a study health facility;
• Age 18 years or older;
• Phone ownership OR phone consistent phone access;
• Classified as lost to follow up (LTFU) from HIV care (not attended a clinic appointment for ≥28 days since last scheduled appointment);
• Has had a clinic appointment within the last 24 months, and
• Provides written informed consent for participation

Sponsors & Collaborators

• University of California, Berkeley: lead
• Health for a Prosperous Nation: collaborator
• Rasello: collaborator
• Management and Development for Health: collaborator
• Ministry of Health, Tanzania: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Geita Region

Geita, Tanzania

Location

Kagera Region

Kagera, Tanzania

Location

Related Publications (2)

• Kadota JL, Packel LJ, Mlowe M, Ulenga N, Mwenda N, Njau PF, Dow WH, Wang J, Sabasaba A, McCoy SI. 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. Trials. 2024 Feb 10;25(1):114. doi: 10.1186/s13063-024-07960-x.

  PMID: 38336793 DERIVED

• Kadota JL, Packel LJ, Mlowe M, Ulenga N, Mwenda N, Njau PF, Dow WH, Wang J, Sabasaba A, McCoy SI. 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. Res Sq [Preprint]. 2023 Dec 20:rs.3.rs-3315136. doi: 10.21203/rs.3.rs-3315136/v1.

  PMID: 38196655 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Jingshen Wang, PhD

  University of California, Berkeley

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants will not be told during the consent process that as part of the study there are intervention and control clinics. Laboratory staff analyzing viral load samples will be blind to intervention/control attribution.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Residence

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: February 21, 2022
• Study Start: July 13, 2022
• Primary Completion: July 12, 2024
• Study Completion: December 3, 2024
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Access Criteria: Provided upon request

Locations

TA (2)