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

HIV (Human Immunodeficiency Virus) Clinical Trial

— Afya 2 Phase2  

Official title:

Optimizing the Efficiency and Implementation of Cash Transfers to Improve Adherence to Antiretroviral Therapy, Phase II: Effectiveness Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04201353
• Other study ID #: R01MH112432-01A2
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 9, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: University of California, Berkeley
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1984
• Est. completion date: June 30, 2024
• Est. primary completion date: November 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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: -

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV (Human Immunodeficiency Virus)
• HIV Infections

Intervention

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

Locations

Country	Name	City	State
Tanzania	Health for a Prosperous Nation (HPON)	Dar Es Salaam

Sponsors (4)

Lead Sponsor	Collaborator
University of California, Berkeley	Health for a Prosperous Nation, Rasello, Tanzania Ministry of Health, Community Development, Gender, Elderly and Children

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Appointment Attendance	The proportion of scheduled visits that were completed during the 0-12 month period	12 months
Secondary	6-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).	6 month
Secondary	Proportion Virally Suppressed	• The proportion virally suppressed (<1000 copies/ml) of those PLHIV with a viral load result	12 months