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

Primary Purpose

HIV/AIDS, Adherence, Medication, Adherence, Patient

Status
Completed
Phase
Not Applicable
Locations
Tanzania
Study Type
Interventional
Intervention
Active Arm 1
Active Arm 2
Sponsored by
University of California, Berkeley
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for HIV/AIDS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kahama Hospital
  • Kagongwa Health Center
  • Kambarage Health Center
  • Shinyanga Regional Referral Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Comparison Arm

Active Intervention 1

Active Intervention 2

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

HIV viral suppression at 6 months
<1000 copies/ml

Secondary Outcome Measures

Full Information

First Posted
November 19, 2017
Last Updated
August 18, 2022
Sponsor
University of California, Berkeley
Collaborators
National Institute of Mental Health (NIMH), Rasello, Health for a Prosperous Nation, Management and Development for Health in Tanzania
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1. Study Identification

Unique Protocol Identification Number
NCT03351556
Brief Title
Optimizing the Efficiency and Implementation of Cash Transfers to Improve Adherence to Antiretroviral Therapy
Official Title
Optimizing the Efficiency and Implementation of Cash Transfers to Improve Adherence to Antiretroviral Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
April 24, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Berkeley
Collaborators
National Institute of Mental Health (NIMH), Rasello, Health for a Prosperous Nation, Management and Development for Health in Tanzania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Determine the "dose-response" relationship between a cash transfer amount and HIV viral suppression at 6 months 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).
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: The opportunity to earn 10,000 TZS/month (~$4.50) for up to 6 months conditional on visit attendance, and 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, Adherence, Medication, Adherence, Patient

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participants in the cash transfer arms will be masked to the knowledge that there are two cash value arms.
Allocation
Randomized
Enrollment
530 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Comparison Arm
Arm Type
No Intervention
Arm Description
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.
Arm Title
Active Intervention 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Active Intervention 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Active Arm 1
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Active Arm 2
Intervention Description
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 Measure Information:
Title
HIV viral suppression at 6 months
Description
<1000 copies/ml
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra I McCoy, PhD
Organizational Affiliation
University of California, Berkeley
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Prosper Njau, MD, MPH
Organizational Affiliation
Health for a Prosperous Nation and Ministry of Health, Community Development, Gender, Elderly, and Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kahama Hospital
City
Kahama
State/Province
Shinyanga Region
Country
Tanzania
Facility Name
Kagongwa Health Center
City
Shinyanga
State/Province
Shinyanga Region
Country
Tanzania
Facility Name
Kambarage Health Center
City
Shinyanga
State/Province
Shinyanga Region
Country
Tanzania
Facility Name
Shinyanga Regional Referral Hospital
City
Shinyanga
State/Province
Shinyanga Region
Country
Tanzania

12. IPD Sharing Statement

Citations:
PubMed Identifier
34556176
Citation
Packel L, Fahey C, Kalinjila A, Mnyippembe A, Njau P, McCoy SI. Preparing a financial incentive program to improve retention in HIV care and viral suppression for scale: using an implementation science framework to evaluate an mHealth system in Tanzania. Implement Sci Commun. 2021 Sep 23;2(1):109. doi: 10.1186/s43058-021-00214-w.
Results Reference
derived
PubMed Identifier
32891234
Citation
Fahey CA, Njau PF, Katabaro E, Mfaume RS, Ulenga N, Mwenda N, Bradshaw PT, Dow WH, Padian NS, Jewell NP, McCoy SI. Financial incentives to promote retention in care and viral suppression in adults with HIV initiating antiretroviral therapy in Tanzania: a three-arm randomised controlled trial. Lancet HIV. 2020 Nov;7(11):e762-e771. doi: 10.1016/S2352-3018(20)30230-7. Epub 2020 Sep 3.
Results Reference
derived

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

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