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

Not Applicable

Completed

• Conditions: HIV (Human Immunodeficiency Virus)

• Registration Number: NCT04201353
• Lead Sponsor: University of California, Berkeley

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-11
• Study First Submitted QC: 2019-12-13
• Study First Posted: 2019-12-17
• Study Start: 2020-03-09
• Primary Completion: 2023-11-10
• Study Completion: 2024-06-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-15
• Last Update Posted: 2024-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1984

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
12-month Viral Suppression	12 months	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).

Secondary Outcome Measures

Name	Time	Method
Proportion Virally Suppressed	12 months	• The proportion virally suppressed (\<1000 copies/ml) of those PLHIV with a viral load result
Appointment Attendance	12 months	The proportion of scheduled visits that were completed during the 0-12 month period
6-month Viral Suppression	6 month	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).

Trial Locations

Locations (1)

Health for a Prosperous Nation (HPON); 🇹🇿 Dar Es Salaam, Tanzania