Clinical trial NCT04201353: Optimizing the Efficiency and Implementation of Cash Transfers to Improve Adherence to Antiretroviral Therapy Phase II
Official title: Optimizing the Efficiency and Implementation of Cash Transfers to Improve Adherence to Antiretroviral Therapy, Phase II: Effectiveness Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV (Human Immunodeficiency Virus)
Keywords: Antiretroviral Treatment Adherence
Conditional Cash Transfers
Tanzania
People Living With HIV
Behavioral Economics
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
Collaborators: name: Health for a Prosperous Nation
name: Rasello
name: Tanzania Ministry of Health, Community Development, Gender, Elderly and Children
First posted: 2019-12-17
Enrollment: 1984
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2-arm cluster randomized control trial, with HIV primary care clinic as the unit of randomization
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

-

Primary outcomes:
measure: 12-month Viral Suppression
timeFrame: 12 months
Secondary outcomes:
measure: Appointment Attendance
timeFrame: 12 months
measure: 6-month Viral Suppression
timeFrame: 6 month
measure: Proportion Virally Suppressed
timeFrame: 12 months
Other outcomes:
Locations:
city: Dar Es Salaam
country: Tanzania
facility: Health for a Prosperous Nation (HPON)
Study officials:
affiliation: University of California, Berkeley
name: Sandra McCoy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.