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

NCT ID: NCT03351556

Last Updated: 2022-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

530 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-24

Study Completion Date

2019-06-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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HIV/AIDS Adherence, Medication Adherence, Patient

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants
Participants in the cash transfer arms will be masked to the knowledge that there are two cash value arms.

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Active Arm 1

Intervention Type BEHAVIORAL

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 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.

Group Type EXPERIMENTAL

Active Arm 2

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Rasello

INDUSTRY

Sponsor Role collaborator

Health for a Prosperous Nation

OTHER

Sponsor Role collaborator

Management and Development for Health in Tanzania

UNKNOWN

Sponsor Role collaborator

University of California, Berkeley

OTHER

Sponsor Role lead

Responsible Party

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Sandra McCoy

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sandra I McCoy, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Berkeley

Prosper Njau, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Health for a Prosperous Nation and Ministry of Health, Community Development, Gender, Elderly, and Children

Locations

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Kahama Hospital

Kahama, Shinyanga, Tanzania

Site Status

Kagongwa Health Center

Shinyanga, Shinyanga, Tanzania

Site Status

Kambarage Health Center

Shinyanga, Shinyanga, Tanzania

Site Status

Shinyanga Regional Referral Hospital

Shinyanga, Shinyanga, Tanzania

Site Status

Countries

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Tanzania

References

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Winters S, Sabasaba A, Fahey CA, Packel L, Katabaro E, Ndungile Y, Njau PF, McCoy SI. Increased prevalence of depression and anxiety among adults initiating antiretroviral therapy during the COVID-19 pandemic in Shinyanga region, Tanzania. AIDS Res Ther. 2023 Jun 10;20(1):36. doi: 10.1186/s12981-023-00534-y.

Reference Type DERIVED
PMID: 37301833 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34556176 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32891234 (View on PubMed)

Other Identifiers

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R01MH112432-01A1

Identifier Type: NIH

Identifier Source: secondary_id

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R01MH112432-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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