Afya 2 Phase2: Optimizing the Efficiency and Implementation of Cash Transfers to Improve Adherence to Antiretroviral Therapy Phase II

Sponsor

University of California, Berkeley (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04201353

Collaborator

Health for a Prosperous Nation (Other), Rasello (Other), Tanzania Ministry of Health, Community Development, Gender, Elderly and Children (Other)

1,984

Enrollment

Location

Arms

44.7

Anticipated Duration (Months)

44.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
HIV (Human Immunodeficiency Virus)	Behavioral: Conditional Cash Transfer	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1984 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

2-arm cluster randomized control trial, with HIV primary care clinic as the unit of randomization2-arm cluster randomized control trial, with HIV primary care clinic as the unit of randomization

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Mar 9, 2020

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: Control Participants attending control clinics will receive the standard of care.

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: 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.

No Intervention: Control

Participants attending control clinics will receive the standard of care.

Outcome Measures

Primary Outcome Measures

12-month Viral Suppression [12 months]
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).

Secondary Outcome Measures

Appointment Attendance [12 months]
The proportion of scheduled visits that were completed during the 0-12 month period
6-month Viral Suppression [6 month]
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).
Proportion Virally Suppressed [12 months]
• The proportion virally suppressed (<1000 copies/ml) of those PLHIV with a viral load result

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Health for a Prosperous Nation (HPON)	Dar Es Salaam		Tanzania

Sponsors and Collaborators

University of California, Berkeley
Health for a Prosperous Nation
Rasello
Tanzania Ministry of Health, Community Development, Gender, Elderly and Children