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

NCT03351556 | Completed DMC

• 1 other identifier: R01MH112432-01A1
• Study Type: interventional
• Target: 530
• Locations: 1 country
• Sites: 4

Brief Summary

1. 1.Determine the "dose-response" relationship between a cash transfer amount and HIV viral suppression at 6 months
2. 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).

Conditions

HIV/AIDS; Adherence, Medication; Adherence, Patient

Outcome Measures

Primary Outcomes (1)

• HIV viral suppression at 6 months

  \<1000 copies/ml

  6 months

Study Arms (3)

Comparison Arm

NO INTERVENTION

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.

Active Intervention 1

EXPERIMENTAL

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

Active Intervention 2

EXPERIMENTAL

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

Interventions

Active Arm 1 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 1

Active Arm 2 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.

Active Intervention 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years
• Living with HIV infection
• Initiated antiretroviral therapy ≤1 month prior to enrollment in the study

You may not qualify if:

• \- Participants who do no provide informed consent

Sponsors & Collaborators

• University of California, Berkeley: lead
• National Institute of Mental Health (NIMH): collaborator
• Rasello: collaborator
• Health for a Prosperous Nation: collaborator
• Management and Development for Health in Tanzania: collaborator

Study Sites (4)

Kahama Hospital

Kahama, Shinyanga, Tanzania

Location

Kagongwa Health Center

Shinyanga, Shinyanga, Tanzania

Location

Kambarage Health Center

Shinyanga, Shinyanga, Tanzania

Location

Shinyanga Regional Referral Hospital

Shinyanga, Shinyanga, Tanzania

Location

Related Publications (3)

• 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.

  PMID: 37301833 DERIVED

• 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.

  PMID: 34556176 DERIVED

• 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.

  PMID: 32891234 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Medication Adherence; Patient Compliance

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants in the cash transfer arms will be masked to the knowledge that there are two cash value arms.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: November 19, 2017
• First Posted: November 24, 2017
• Study Start: April 24, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: August 22, 2022

Record last verified: 2022-08

Locations

TA (4)