HIV Clinical Trial
Official title:
ENGAGE4HEALTH: A Combination Strategy for Linkage and Retention in HIV Care Among Adults in Mozambique
Purpose: To compare the effectiveness of a combination intervention strategy (CIS), consisting of point of care (POC) CD4+ testing immediately following HIV diagnosis and accelerated ART initiation for eligible participants delivered by facility personnel, and cellular appointment reminders delivered by study personnel, to the standard of care (SOC) on linkage to and retention in HIV care at 12 months among adults testing positive for HIV in Mozambique. Additionally, the protocol will assess the incremental effectiveness of CIS+ non-cash financial incentives (FI) compared to CIS without FI on study outcomes.
Design: Two-arm cluster site-randomized trial with a pre-post intervention two-sample design
nested in the intervention arm.
Study Population: The study population is any adult who tests HIV positive at the HIV
counseling and testing points participating in this study. The study unit (SU), the level of
randomization for the study, includes specific HIV counseling and testing points at primary
health care clinics and the HIV care and treatment services located in the same health
facility. A total of 10 SU will be included.
Sample Size: A total of 2,250 adults from the 10 study units will be included in the study,
750 in the SOC arm, 750 receiving CIS without FI and 750 receiving CIS+FI.
Participants will be enrolled and followed for 12 months after enrollment.
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