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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1984 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-09

Study Completion Date

2024-06-30

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.

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Detailed Description

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Conditions

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HIV (Human Immunodeficiency Virus)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2-arm cluster randomized control trial, with HIV primary care clinic as the unit of randomization

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Facility staff will not be blinded to intervention assignment. However, all other research staff will be blinded to intervention assignment. In addition, participants will not be told during the consent process that as part of the study there are intervention and control clinics. The rationale for this is to prevent patients transferring from intervention to control clinics if they find out that there are some clinics offering cash transfers to new ART clients. Large numbers of transferring patients will compromise the integrity of the study and will create an undue burden for facility staff at intervention clinics.

Study Groups

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Conditional Cash Transfer

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.

Group Type EXPERIMENTAL

Conditional Cash Transfer

Intervention Type BEHAVIORAL

The intervention is a monthly cash transfer of 22,500 Tanzanian Shillings (\~$10) for up to 6 months conditional on visit attendance.

Control

Participants attending control clinics will receive the standard of care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Conditional Cash Transfer

The intervention is a monthly cash transfer of 22,500 Tanzanian Shillings (\~$10) for up to 6 months conditional on visit attendance.

Intervention Type BEHAVIORAL

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.