Optimizing the Efficiency and Implementation of Cash Transfers to Improve Adherence to Antiretroviral Therapy Phase II

Study Overview
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Brief Summary
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This protocol describes a 2-arm cluster, randomized controlled trial designed to test the effectiveness of a conditional cash transfer on viral suppression at 12 months post-ART initiation among PHWHIV who have initiated ART within the past 30 days. Randomization will take place at the clinic level (HIV primary care clinics), and eligible participants attending intervention clinics will have the opportunity to receive up to 6 consecutive monthly cash transfers of 22,500 TSH ( $10) each, conditional on visit attendance with the HIV care provider. The study will take place at 32 clinics across four regions in Tanzania: Gaeta, Mwanza, Kagera and Shinyanga. The primary endpoint is viral suppression at 12 months, defined as the proportion of people living with HIV (PLHIV) retained in HIV primary care and with suppressed HIV viral load 12 months after starting ART.

Official Title
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Optimizing the Efficiency and Implementation of Cash Transfers to Improve Adherence to Antiretroviral Therapy, Phase II: Effectiveness Study

Conditions
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HIV (Human Immunodeficiency Virus)

Intervention / Treatment
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* Behavioral: Conditional Cash Transfer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Greater than or equal to 18 years of age Living with HIV infection Initiated on antiretroviral therapy less than or equal to 1 month prior to enrollment in the study Have access to a mobile phone (ownership, shared ownership, or access to a trusted person's phone) Do not intend to transfer to a different facility for HIV care within the following 12 months. Exclusion Criteria: -

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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Accepts Healthy Volunteers

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
Interventional Model Description: 2-arm cluster randomized control trial, with HIV primary care clinic as the unit of randomization
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conditional Cash Transfer<br>Participants attending intervention clinics will have the opportunity to receive up to 6 consecutive monthly cash transfers of 22,500 TSH ( $10) each, conditional on visit attendance with the HIV care provider. Cash transfers will be given once monthly for up to 6 months, spaced ≥25 days apart (consistent with National Guidelines for monthly or bimonthly visits) and are conditional on visit attendance. This means that the cash transfer is only given when the patient visits the clinic for their routine appointment, regardless of whether the visit is earlier or later than the scheduled appointment. | Behavioral: Conditional Cash Transfer<br>* The intervention is a monthly cash transfer of 22,500 Tanzanian Shillings ( $10) for up to 6 months conditional on visit attendance.<br>|
| No Intervention: Control<br>Participants attending control clinics will receive the standard of care. | |

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) retained in HIV primary care and with suppressed HIV viral load 12 months after starting ART. 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). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appointment Attendance | The proportion of scheduled visits that were completed during the 0-12 month period | 12 months | 
| 6-month Viral Suppression | the proportion of people living with HIV (PLHIV) retained in HIV primary care and with suppressed HIV viral load 12 months after starting ART. 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 month | 
| Proportion Virally Suppressed | • The proportion virally suppressed (<1000 copies/ml) of those PLHIV with a viral load result | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antiretroviral Treatment Adherence, Conditional Cash Transfers, Tanzania, People Living With HIV, Behavioral Economics