Clinical trial NCT03351556: 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
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Adherence, Medication
Adherence, Patient
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Rasello
name: Health for a Prosperous Nation
name: Management and Development for Health in Tanzania
First posted: 2017-11-24
Enrollment: 530
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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.

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

Primary outcomes:
measure: HIV viral suppression at 6 months
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kahama
country: Tanzania
facility: Kahama Hospital
state: Shinyanga Region
city: Shinyanga
country: Tanzania
facility: Kagongwa Health Center
state: Shinyanga Region
city: Shinyanga
country: Tanzania
facility: Kambarage Health Center
state: Shinyanga Region
city: Shinyanga
country: Tanzania
facility: Shinyanga Regional Referral Hospital
state: Shinyanga Region
Study officials:
affiliation: University of California, Berkeley
name: Sandra I McCoy, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Health for a Prosperous Nation and Ministry of Health, Community Development, Gender, Elderly, and Children
name: Prosper Njau, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.