Rudi Kundini, Pamoja Kundini

NCT05373095 | Active Not Recruiting DMC

• 2 other identifiers: R01MH125746 - Phase IIR01MH125746
• Study Type: interventional
• Target: 692
• Locations: 1 country
• Sites: 4

Brief 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)

Keywords

Tanzania; Conditional Cash Transfers; People Living With HIV; Machine Learning

Outcome Measures

Primary Outcomes (1)

• 12-Month Viral Suppression

  The proportion of people living with HIV (PLHIV) and on ART with suppressed HIV viral load ( \<1000 copies/ml) at 12 months after study enrollment.

  12 months

Secondary Outcomes (19)

• 6-month retention in care

  6 months

• 12-month retention in care

  12 months

• 12-month durable viral load

  12 months

• 12-month Appointment Attendance

  12 months

• 6-month Appointment Attendance

  6 months

Study Arms (2)

Adapted Adherence Counseling (PKC) and Conditional Cash Transfers

EXPERIMENTAL

Eligible and consenting participants randomized to the intervention arm will receive the same standard HIV clinical services according Tanzania's National Guidelines for the Management of HIV as the comparison arm, which includes provision of three, once-monthly, 60-minute nurse-led individual, enhanced adherence counseling sessions adapted for study purposes (PKC sessions). Counseling focuses on the meaning of viral loads and supportive, non-judgmental strategies for adherence and visit attendance. A minimum of three sessions are required. In addition to enhanced adherence counseling, intervention participants will receive the offer of a cash transfer paired with attendance at each of the three enhanced adherence counseling sessions. The first payment will occur at enrollment; the next two cash transfers are payable upon visit attendance and attendance of the two remaining enhanced adherence counseling sessions.

Behavioral: PKC (adapted adherence counseling) and Conditional Cash Transfers

Enhanced Adherence Counseling only for those who qualify

NO INTERVENTION

Eligible and consenting 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, this includes the standard provision of three, once-monthly, 60-minute nurse-led individual, enhanced adherence counseling sessions, starting on the day of a detectable viral load result and for two months after. Counseling focuses on the meaning of viral loads and supportive, non-judgmental strategies for adherence and visit attendance. A minimum of three sessions are required.

Interventions

PKC (adapted adherence counseling) and Conditional Cash Transfers BEHAVIORAL

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.

Adapted Adherence Counseling (PKC) and Conditional Cash Transfers

Eligibility Criteria

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

You may qualify if:

• PLHIV on ART;
• Age 18 years or older;
• Phone ownership OR consistent phone access;
• Not already enrolled in/currently attending enhanced adherence counseling sessions at the facility
• Living in Geita Region and intends to receive care at a study facility for the next 12 months;
• Classified as "high-risk" for loss to follow-up (LTFU) from HIV care, 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 (4)

Geita Regional Referral Hospital

Geita, Tanzania

Location

Geita Town Council Hospital

Geita, Tanzania

Location

Nyankumbu Health Center

Geita, Tanzania

Location

Katoro Health Center

Katoro, 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: Laboratory staff analyzing viral load samples will be blind to intervention/control attribution.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 13, 2022
• Study Start: October 23, 2023
• Primary Completion: January 20, 2026
• Study Completion: January 20, 2026
• 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 (4)