Rudi Kundini, Pamoja Kundini (RKPK: Phase II)

Strengthening the Continuity of HIV Care in Tanzania With Economic Support: Phase II

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).

Study Overview

• Status: Recruiting
• Conditions: HIV (Human Immunodeficiency Virus)
• Intervention / Treatment: Behavioral: PKC (adapted adherence counseling) and Conditional Cash Transfers

Detailed Description

This protocol describes a 2-armed parallel individually randomized controlled trial for which 692 PLHIV who meet eligibility criteria, are currently accessing care at a participating health facility (Katoro Health Center, Geita Town Council Hospital, Geita Regional Referral Hospital, or Nyankumbu Health Center), and have provided informed consent to be part of the study will be randomized in a 1:1 ratio (n=346 PLHIV in each arm), stratified by site, to the control or intervention group. The investigators will use machine learning to finalize a predictive model based on routinely collected medical and pharmacy record data to identify and recruit PLHIV for participation at participating facilities who are at high-risk for disengaging from HIV care.

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. Criteria for enrollment into enhanced adherence counseling sessions includes when client's viral load reaches a detectable level (>1000 copies/ml). Enhanced adherence counseling 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. Counseling focuses on the meaning of viral loads and supportive, non-judgmental strategies for adherence and visit attendance. Sessions are conducted in an individual, 1:1 setting with a trained counselor who is on the clinical staff, or in a group setting with a trained counselor who is on the clinical staff. A minimum of three sessions are required. Eligible and consenting participants randomized to the intervention arm 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 (PKC 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. Due to the nature of the intervention, participants will not be blinded to intervention assignment. The primary endpoint is viral load suppression (<1000 copies/ml) at 12 months following study enrollment.

• Study Type: Interventional
• Enrollment (Estimated): 692
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sandra I McCoy, PhD, MPH; Phone Number: +15106420513; Email: smccoy@berkeley.edu

Study Locations

• Tanzania
  • Geita, Tanzania
    • Not yet recruiting
    • Geita Regional Referral Hospital
    • Contact: Matilda Mlowe
  • Geita, Tanzania
    • Recruiting
    • Geita Town Council Hospital
    • Contact: Matilda Mlowe
  • Geita, Tanzania
    • Not yet recruiting
    • Nyankumbu Health Center
    • Contact: Matilda Mlowe
  • Katoro, Tanzania
    • Recruiting
    • Katoro Health Center
    • Contact: Matilda Mlowe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Enhanced Adherence Counseling only for those who qualify; 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.
Experimental: Adapted Adherence Counseling (PKC) and Conditional Cash Transfers; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-month retention in care	The proportion of people living with HIV (PLHIV) on ART at 6 months after study enrollment (PEPFAR considers those not retained on ART to include those who died, disengaged from care, stopped ART, or had no evidence of care for ≥28 days after a missed visit. Participants not found after exhaustive tracing efforts to rule out silent transfers will be classified as not retained on ART)	6 months
12-month retention in care	The proportion of people living with HIV (PLHIV) on ART at 12 months after study enrollment (PEPFAR considers those not retained on ART to include those who died, disengaged from care, stopped ART, or had no evidence of care for ≥28 days after a missed visit. Participants not found after exhaustive tracing efforts to rule out silent transfers will be classified as not retained on ART)	12 months
12-month Appointment Attendance	The proportion of scheduled visits that were completed during the 0-12 month period	12 months
6-month Appointment Attendance	The proportion of scheduled visits that were completed during the 0-6 month period	6 months
12-month Mortality	The cumulative incidence of mortality at 12 months after study enrollment	12 months
6-month Predictive value positive (PVP) of machine learning algorithm	Predictive value positive (PVP) of the machine learning algorithm in identifying PLHIV at-risk of disengagement from HIV care within 6 months	6 months
12-month Predictive value positive (PVP) of machine learning algorithm	Predictive value positive (PVP) of the machine learning algorithm in identifying PLHIV at-risk of disengagement from HIV care within 12 months	12 months
6-month PVP of routine clinical criteria	PVP of the routine clinical criteria (i.e. recent missed visit or detectable viral load, >1000 copies/ml) for identifying PLHIV at-risk of disengagement from HIV care within 6 months	6 months
12-month PVP of routine clinical criteria	PVP of the routine clinical criteria (i.e. recent missed visit or detectable viral load, >1000 copies/ml) for identifying PLHIV at-risk of disengagement from HIV care within 12 months	12 months
6-month Predictive value negative (PVN) of the machine learning algorithm	Predictive value negative (PVN) of the machine learning algorithm in identifying PLHIV not at-risk of disengagement from HIV care within 6 months	6 months
12-month PVN of the machine learning algorithm	PVN of the machine learning algorithm in identifying PLHIV not at-risk of disengagement from HIV care within 12 months	12 months
6-month PVN of routine clinical criteria	PVN of the routine clinical criteria for identifying PLHIV not at-risk of disengagement from HIV care within 6 months	6 months
12-month PVN of routine clinical criteria	PVN of the routine clinical criteria for identifying PLHIV not at-risk of disengagement from HIV care within 12 months	12 months
Enhanced Adherence Counseling Session Attendance	Proportion of enhanced adherence counseling sessions completed among sessions scheduled	6 months
Viral Suppression with enhanced adherence counseling completion	Proportion with HIV viral suppression after completion of enhanced adherence counseling sessions	6 months
12-month durable viral load	Proportion with durable HIV viral suppression 12 months after enrollment: at least 2 viral load measurements taken from up to 6 months prior to study enrollment and up to and including 12 months following study enrollment and all are undetectable (<1000 copies/ml) will have met criteria for durable viral suppression at 12 months.	12 months
6-Month Viral Suppression (<1000 copies/ml)	The proportion of people living with HIV (PLHIV) and on ART with suppressed HIV viral load ( <1000 copies/ml) at 6 months after study enrollment.	6 months
6-Month Viral Suppression (<50 copies/ml)	The proportion of people living with HIV (PLHIV) and on ART with suppressed HIV viral load ( <50 copies/ml) at 6 months after study enrollment.	6 months
12-Month Viral Suppression (<50 copies/ml)	The proportion of people living with HIV (PLHIV) and on ART with suppressed HIV viral load ( <50 copies/ml) at 12 months after study enrollment.	12 months

Collaborators and Investigators

• Sponsor: University of California, Berkeley
• Collaborators: National Institute of Mental Health (NIMH); Ministry of Health, Tanzania; Management and Development for Health; Health for a Prosperous Nation; Rasello
• Investigators: Principal Investigator: Sandra I McCoy, PhD, MPH, University of California, Berkeley

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: May 9, 2022
• First Submitted That Met QC Criteria: May 9, 2022
• First Posted (Actual): May 13, 2022

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Tanzania; Machine Learning; Conditional Cash Transfers; People Living With HIV
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Urogenital Diseases; Genital Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: R01MH125746 - Phase II; R01MH125746 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Access Criteria: Provided upon request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No