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

August 18, 2022 updated by: Sandra McCoy, University of California, Berkeley
  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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

530

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tanzania
    • Shinyanga Region
      • Kahama, Shinyanga Region, Tanzania
        • Kahama Hospital
      • Shinyanga, Shinyanga Region, Tanzania
        • Kambarage Health Center
      • Shinyanga, Shinyanga Region, Tanzania
        • Kagongwa Health Center
      • Shinyanga, Shinyanga Region, Tanzania
        • Shinyanga Regional Referral Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Comparison Arm
Participants in the comparison group will receive the standard HIV primary care services according to Tanzania's National Guidelines for the Management of HIV and AIDS.
Experimental: Active Intervention 1
Participants 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 (~$4.50) for up to 6 months conditional on visit attendance.
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.
Experimental: Active Intervention 2
Participants 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 (~$10.00) for up to 6 months conditional on visit attendance.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HIV viral suppression at 6 months
Time Frame: 6 months
<1000 copies/ml
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Berkeley

Collaborators

National Institute of Mental Health (NIMH)
Health for a Prosperous Nation
Rasello
Management and Development for Health in Tanzania

Investigators

  • Principal Investigator: Prosper Njau, MD, MPH, Health for a Prosperous Nation and Ministry of Health, Community Development, Gender, Elderly, and Children

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2018

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

November 19, 2017

First Submitted That Met QC Criteria

November 19, 2017

First Posted (Actual)

November 24, 2017

Study Record Updates

Last Update Posted (Actual)

August 22, 2022

Last Update Submitted That Met QC Criteria

August 18, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH112432-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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