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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed 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.

Official Title
-----------------
ENGAGE4HEALTH: A Combination Strategy for Linkage and Retention in HIV Care Among Adults in Mozambique

Conditions
-----------------
HIV

Intervention / Treatment
-----------------
* Other: Point of care CD4+ after HIV diagnosis
* Other: Accelerated ART initiation
* Behavioral: SMS appointment reminders
* Other: Non-cash Financial Incentives


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combination intervention + incentives<br>Point of care CD4+ after HIV diagnosis Accelerated ART initiation SMS appointment reminders Non-cash financial incentives (FI) | Other: Point of care CD4+ after HIV diagnosis<br>* Point of care (POC) CD4+ testing immediately following HIV diagnosis<br>Other: Accelerated ART initiation<br>* Accelerated ART initiation for eligible participants delivered by facility personnel<br>Behavioral: SMS appointment reminders<br>* Cellular appointment reminders delivered by study personnel<br>Other: Non-cash Financial Incentives<br>* Non-cash Financial Incentives<br>|
| Experimental: Combination intervention strategy(CIS)<br>Point of care (POC) CD4+ after HIV diagnosis Accelerated ART initiation SMS appointment reminders | Other: Point of care CD4+ after HIV diagnosis<br>* Point of care (POC) CD4+ testing immediately following HIV diagnosis<br>Other: Accelerated ART initiation<br>* Accelerated ART initiation for eligible participants delivered by facility personnel<br>Behavioral: SMS appointment reminders<br>* Cellular appointment reminders delivered by study personnel<br>|
| No Intervention: Standard of care (SOC)<br>Standard of care, no intervention | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Linkage to HIV care within 1 month of HIV testing and retention in care 12 months after testing. | An increase in linkage to HIV care within 1 month of HIV testing and retention in care 12 months after testing. Participants are considered to achieve this outcome if they successfully link to the SU HIV care services within 1 month of testing HIV positive as measured from the electronic patient-level database used at the HIV care clinic (EPTS). | 1 month and 12 months after testing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to linkage to care | A decrease in the median time to linkage to care | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, linkage, retention