ENGAGE4HEALTH: A Combination Intervention Strategy for Linkage and Retention in Mozambique

Columbia University

Status: Completed

Conditions: HIV

Treatments: Behavioral: SMS appointment reminders; Other: Non-cash Financial Incentives; Other: Accelerated ART initiation; Other: Point of care CD4+ after HIV diagnosis

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01930084

USAID-OAA-A-12-00027 (Other Grant/Funding Number)

AAAL1354

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 2,004 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age or older
• Testing HIV positive at the largest-volume HIV point of testing (other than prevention of mother-to-child transmission or tuberculosis) at SU with written proof of test result
• Agreeing to be referred to the HIV care services associated with the SU
• Agreeing to provide locator information
• Agreeing to adhere to study procedures, including a baseline interview, interviews 1 and 12 months after study enrollment, and extraction of data from the HIV care and treatment electronic database
• Able to provide informed consent

Exclusion criteria

• Being pregnant at study enrollment
• Planning on leaving the community where they currently reside in the next 12 months
• Enrolled in HIV care in the past 6 months at any clinic
• Initiated ART (for any duration) in the past 6 months at any clinic
• Currently on ART
• Does not speak or understand Portuguese or Xitswa/Matswa

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,004 participants in 3 patient groups

Combination intervention + incentives

Experimental group

Description:

1. Point of care CD4+ after HIV diagnosis 2. Accelerated ART initiation 3. SMS appointment reminders 4. Non-cash financial incentives (FI)

Treatment:

Other: Non-cash Financial Incentives

Behavioral: SMS appointment reminders

Other: Accelerated ART initiation

Other: Point of care CD4+ after HIV diagnosis

Combination intervention strategy(CIS)

Experimental group

Description:

1. Point of care (POC) CD4+ after HIV diagnosis 2. Accelerated ART initiation 3. SMS appointment reminders

Treatment:

Behavioral: SMS appointment reminders

Other: Accelerated ART initiation

Other: Point of care CD4+ after HIV diagnosis

Standard of care (SOC)

No Intervention group

Description:

Standard of care, no intervention