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NCT03351556 Clinical Trial

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
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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