Rudi Kundini, Pamoja Kundini

Study Overview
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Brief Summary
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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).

Detailed Description
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This protocol describes a 2-armed parallel individually randomized controlled trial for which 692 PLHIV who meet eligibility criteria, are currently accessing care at one of two participating health facilities (Katoro Health Facility and Geita Regional Referral Hospital), 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 Geita Regional Referral Hospital and Katoro Health Facility 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 at Katoro Health Facility and Geita Regional Referral Hospitals 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. At Geita Regional Referral Hospital, sessions are conducted in an individual, 1:1 setting with a trained counselor who is on the clinical staff. At Katoro Health Facility, sessions are conducted either in a group or in an individual, 1:1 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 durable viral load suppression (<1000 copies/ml) at 12 months following study enrollment.

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

Conditions
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HIV (Human Immunodeficiency Virus)

Intervention / Treatment
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* Behavioral: PKC (adapted adherence counseling) and Conditional Cash Transfers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PLHIV on ART who have had a viral load test with a valid result in the last 6 months; 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adapted Adherence Counseling (PKC) and Conditional Cash Transfers<br>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<br>* 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.<br>|
| No Intervention: Enhanced Adherence Counseling only for those who qualify<br>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. | |

What is the study measuring?
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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 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tanzania, Conditional Cash Transfers, People Living With HIV, Machine Learning