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

HIV/AIDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03351556
• Other study ID #: R01MH112432-01A1
• Secondary ID: R01MH112432-01A1
• Status: Completed
• Phase: N/A
• Start date: April 24, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: August 2022
• Source: University of California, Berkeley
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

1. Determine the "dose-response" relationship between a cash transfer amount and HIV viral suppression at 6 months

2. Identify the most effective cash transfer size to increase the proportion of people living with HIV infection (PLHIV) retained in care and with suppressed viral load (<1000 copies/ml) after 6 months. (This amount will be further evaluated in a cluster randomized trial in Phase 2).

Description:

Participants in the control group will receive the standard HIV primary care services according to Tanzania's National Guidelines for the Management of HIV and AIDS.

The study has two active intervention arms:

1. The opportunity to earn 10,000 TZS/month (~$4.50) for up to 6 months conditional on visit attendance, and

2. The opportunity to earn 22,500 TZS/month (~$10.00) for up to 6 months conditional on visit attendance

In both intervention arms, cash transfers will be delivered a maximum of once monthly, spaced ≥28 days apart, for up to six months and delivered via an automatic mobile money system linked to a biometric identification system.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 530
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• =18 years

• Living with HIV infection

• Initiated antiretroviral therapy =1 month prior to enrollment in the study

Exclusion Criteria:

• Participants who do no provide informed consent

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Adherence, Medication
• Adherence, Patient
• HIV Infections
• HIV/AIDS

Intervention

Behavioral:
• Active Arm 1
Participants in this arm will receive the standard HIV primary care services according to Tanzania's National Guidelines for the Management of HIV and AIDS plus the opportunity to earn 10,000 TZS/month conditional on visit attendance.
• Active Arm 2
Participants in this arm will receive the standard HIV primary care services according to Tanzania's National Guidelines for the Management of HIV and AIDS plus the opportunity to earn 22,500 TZS/month conditional on visit attendance.

Locations

Country	Name	City	State
Tanzania	Kahama Hospital	Kahama	Shinyanga Region
Tanzania	Kagongwa Health Center	Shinyanga	Shinyanga Region
Tanzania	Kambarage Health Center	Shinyanga	Shinyanga Region
Tanzania	Shinyanga Regional Referral Hospital	Shinyanga	Shinyanga Region

Sponsors (5)

Lead Sponsor	Collaborator
University of California, Berkeley	Health for a Prosperous Nation, Management and Development for Health in Tanzania, National Institute of Mental Health (NIMH), Rasello

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV viral suppression at 6 months	<1000 copies/ml	6 months