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

NCT04201353 | Completed DMC

• 1 other identifier: R01MH112432-01A2
• Study Type: interventional
• Target: 1,984
• Locations: 1 country
• Sites: 1

Brief Summary

This protocol describes a 2-arm cluster, randomized controlled trial designed to test the effectiveness of a conditional cash transfer on viral suppression at 12 months post-ART initiation among PHWHIV who have initiated ART within the past 30 days. Randomization will take place at the clinic level (HIV primary care clinics), and eligible participants attending intervention clinics will have the opportunity to receive up to 6 consecutive monthly cash transfers of 22,500 TSH (\~$10) each, conditional on visit attendance with the HIV care provider. The study will take place at 32 clinics across four regions in Tanzania: Gaeta, Mwanza, Kagera and Shinyanga. The primary endpoint is viral suppression at 12 months, defined as the proportion of people living with HIV (PLHIV) retained in HIV primary care and with suppressed HIV viral load 12 months after starting ART.

Conditions

HIV (Human Immunodeficiency Virus)

Keywords

Antiretroviral Treatment Adherence; Conditional Cash Transfers; Tanzania; People Living With HIV; Behavioral Economics

Outcome Measures

Primary Outcomes (1)

• 12-month Viral Suppression

  the proportion of people living with HIV (PLHIV) retained in HIV primary care and with suppressed HIV viral load 12 months after starting ART. The primary outcome is expressed as a binary variable, defined as PLHIV who are on ART and with sufficient HIV viral suppression (\<1000 copies/ml, WHO's threshold for virologic failure in LMICs) versus not on ART or viral failure (≥1000 copies/ml).

  12 months

Secondary Outcomes (3)

• Appointment Attendance

  12 months

• 6-month Viral Suppression

  6 month

• Proportion Virally Suppressed

  12 months

Study Arms (2)

Conditional Cash Transfer

EXPERIMENTAL

Participants attending intervention clinics will have the opportunity to receive up to 6 consecutive monthly cash transfers of 22,500 TSH (\~$10) each, conditional on visit attendance with the HIV care provider. Cash transfers will be given once monthly for up to 6 months, spaced ≥25 days apart (consistent with National Guidelines for monthly or bimonthly visits) and are conditional on visit attendance. This means that the cash transfer is only given when the patient visits the clinic for their routine appointment, regardless of whether the visit is earlier or later than the scheduled appointment.

Behavioral: Conditional Cash Transfer

Control

NO INTERVENTION

Participants attending control clinics will receive the standard of care.

Interventions

Conditional Cash Transfer BEHAVIORAL

The intervention is a monthly cash transfer of 22,500 Tanzanian Shillings (\~$10) for up to 6 months conditional on visit attendance.

Conditional Cash Transfer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Greater than or equal to 18 years of age
• Living with HIV infection
• Initiated on antiretroviral therapy less than or equal to 1 month prior to enrollment in the study
• Have access to a mobile phone (ownership, shared ownership, or access to a trusted person's phone)
• Do not intend to transfer to a different facility for HIV care within the following 12 months.

Sponsors & Collaborators

• University of California, Berkeley: lead
• Health for a Prosperous Nation: collaborator
• Rasello: collaborator
• Tanzania Ministry of Health, Community Development, Gender, Elderly and Children: collaborator

Study Sites (1)

Health for a Prosperous Nation (HPON)

Dar es Salaam, Tanzania

Location

Related Publications (4)

• Katabaro E, Joseph B, Mwenda N, Bhattarai P, Msasa J, Mnyippembe A, Maila H, Hassan K, Kunesh J, Sabasaba A, Winters S, Njau P, Hemono R, McCoy SI, Packel L. Scaling-up an mHealth system to deliver financial incentives to improve adherence to antiretroviral therapy in Tanzania. Implement Sci Commun. 2025 Oct 3;6(1):100. doi: 10.1186/s43058-025-00766-1.

  PMID: 41044777 DERIVED

• Njau PF, Katabaro E, Winters S, Sabasaba A, Hassan K, Joseph B, Maila H, Msasa J, Fahey CA, Packel L, Dow WH, Jewell NP, Ulenga N, Mwenda N, McCoy SI. Impact of financial incentives on viral suppression among adults initiating HIV treatment in Tanzania: a hybrid effectiveness-implementation trial. Lancet HIV. 2024 Sep;11(9):e586-e597. doi: 10.1016/S2352-3018(24)00149-8. Epub 2024 Aug 1.

  PMID: 39098325 DERIVED

• 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, Njau P, Fahey C, Ramadhani A, Dow WH, Jewell NP, McCoy S. Optimizing the efficiency and implementation of cash transfers to improve adherence to antiretroviral therapy: study protocol for a cluster randomized controlled trial. Trials. 2020 Nov 23;21(1):963. doi: 10.1186/s13063-020-04899-7.

  PMID: 33228757 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

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

Study Officials

• Sandra McCoy, PhD

  University of California, Berkeley

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Facility staff will not be blinded to intervention assignment. However, all other research staff will be blinded to intervention assignment. In addition, participants will not be told during the consent process that as part of the study there are intervention and control clinics. The rationale for this is to prevent patients transferring from intervention to control clinics if they find out that there are some clinics offering cash transfers to new ART clients. Large numbers of transferring patients will compromise the integrity of the study and will create an undue burden for facility staff at intervention clinics.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Residence

Model Details: 2-arm cluster randomized control trial, with HIV primary care clinic as the unit of randomization

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: December 17, 2019
• Study Start: March 9, 2020
• Primary Completion: November 10, 2023
• Study Completion: June 30, 2024
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TA (1)