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

Not Applicable

Completed

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

• Registration Number: NCT01930084
• Lead Sponsor: Columbia University

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.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-08-23
• Study First Submitted QC: 2013-08-23
• Study First Posted: 2013-08-28
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-06
• Last Update Posted: 2017-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2004

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination intervention + incentives	Point of care CD4+ after HIV diagnosis	1. Point of care CD4+ after HIV diagnosis 2. Accelerated ART initiation 3. SMS appointment reminders 4. Non-cash financial incentives (FI)
Combination intervention strategy(CIS)	SMS appointment reminders	1. Point of care (POC) CD4+ after HIV diagnosis 2. Accelerated ART initiation 3. SMS appointment reminders
Combination intervention + incentives	SMS appointment reminders	1. Point of care CD4+ after HIV diagnosis 2. Accelerated ART initiation 3. SMS appointment reminders 4. Non-cash financial incentives (FI)
Combination intervention + incentives	Non-cash Financial Incentives	1. Point of care CD4+ after HIV diagnosis 2. Accelerated ART initiation 3. SMS appointment reminders 4. Non-cash financial incentives (FI)
Combination intervention + incentives	Accelerated ART initiation	1. Point of care CD4+ after HIV diagnosis 2. Accelerated ART initiation 3. SMS appointment reminders 4. Non-cash financial incentives (FI)
Combination intervention strategy(CIS)	Point of care CD4+ after HIV diagnosis	1. Point of care (POC) CD4+ after HIV diagnosis 2. Accelerated ART initiation 3. SMS appointment reminders
Combination intervention strategy(CIS)	Accelerated ART initiation	1. Point of care (POC) CD4+ after HIV diagnosis 2. Accelerated ART initiation 3. SMS appointment reminders

Primary Outcome Measures

Name	Time	Method
Linkage to HIV care within 1 month of HIV testing and retention in care 12 months after testing.	1 month and 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).

Secondary Outcome Measures

Name	Time	Method
Time to linkage to care	12 months	A decrease in the median time to linkage to care

Trial Locations

Locations (10)

Urbano Health Center; 🇲🇿 Inhambane, Mozambique

Zavala Health Center and Inharrime Health Center; 🇲🇿 Inhambane, Mozambique

Mavalane General Hospital; 🇲🇿 Maputo, Mozambique

Jose Macamo Health Center; 🇲🇿 Maputo, Mozambique

Bagamoio Health Center; 🇲🇿 Maputo, Mozambique

Morrumbene Health Center; 🇲🇿 Inhambane, Mozambique

Chicuque Health Center; 🇲🇿 Inhambane, Mozambique

Massinga Health Center; 🇲🇿 Inhambane, Mozambique

Maxixe Health Center; 🇲🇿 Inhambane, Mozambique

Zimpeto Health Center; 🇲🇿 Maputo, Mozambique