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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03351556
Recruitment Status : Suspended (Data collection and recruitment has been suspended due to the COVID-19 pandemic)
First Posted : November 24, 2017
Last Update Posted : April 1, 2020
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Rasello
Health for a Prosperous Nation
Management and Development for Health in Tanzania
Information provided by (Responsible Party):
Sandra McCoy, University of California, Berkeley

Brief 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).

Condition or disease Intervention/treatment Phase
HIV/AIDS Adherence, Medication Adherence, Patient Behavioral: Active Arm 1 Behavioral: Active Arm 2 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 519 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Participants in the cash transfer arms will be masked to the knowledge that there are two cash value arms.
Primary Purpose: Health Services Research
Official Title: Optimizing the Efficiency and Implementation of Cash Transfers to Improve Adherence to Antiretroviral Therapy
Actual Study Start Date : April 24, 2018
Actual Primary Completion Date : June 30, 2019
Estimated Study Completion Date : July 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.




Primary Outcome Measures :
  1. HIV viral suppression at 6 months [ Time Frame: 6 months ]
    <1000 copies/ml



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03351556


Locations
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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, Tanzania
Sponsors and Collaborators
University of California, Berkeley
National Institute of Mental Health (NIMH)
Rasello
Health for a Prosperous Nation
Management and Development for Health in Tanzania
Investigators
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Principal Investigator: Sandra I McCoy, PhD University of California, Berkeley
Principal Investigator: Prosper Njau, MD, MPH Health for a Prosperous Nation and Ministry of Health, Community Development, Gender, Elderly, and Children
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Responsible Party: Sandra McCoy, PI, University of California, Berkeley
ClinicalTrials.gov Identifier: NCT03351556    
Other Study ID Numbers: R01MH112432-01A1 ( U.S. NIH Grant/Contract )
R01MH112432-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: April 1, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No