ENGAGE4HEALTH: A Combination Intervention Strategy for Linkage and Retention in Mozambique (E4H)

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.

Study Overview

• Status: Completed
• 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

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 Type: Interventional
• Enrollment (Actual): 2004
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mozambique
  • Inhambane, Mozambique
    • Chicuque Health Center
  • Inhambane, Mozambique
    • Massinga Health Center
  • Inhambane, Mozambique
    • Maxixe Health Center
  • Inhambane, Mozambique
    • Morrumbene Health Center
  • Inhambane, Mozambique
    • Urbano Health Center
  • Inhambane, Mozambique
    • Zavala Health Center and Inharrime Health Center
  • Maputo, Mozambique
    • Bagamoio Health Center
  • Maputo, Mozambique
    • Jose Macamo Health Center
  • Maputo, Mozambique
    • Mavalane General Hospital
  • Maputo, Mozambique
    • Zimpeto Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

Other Outcome Measures

Outcome Measure	Time Frame
Time from ART eligibility to ART initiation	12 months
Proportion of participants with new WHO Stage III/IV event or hospitalization	12 months
Mortality rate 12 months after HIV diagnosis	12 months
Costs and incremental cost-effectiveness ratio of CIS and of CIS+FI	12 months
Proportion of patients receiving POC CD4+ test, short message service (SMS) reminders, accelerated ART initiation (among those eligible based on POC CD4+ test result), and FI	12 months
Proportion of patients reporting that interventions were highly acceptable	12 months

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: United States Agency for International Development (USAID)
• Investigators: Principal Investigator: Batya Elul, PhD, MSc, Columbia University

Publications and helpful links

General Publications

• Elul B, Lamb MR, Lahuerta M, Abacassamo F, Ahoua L, Kujawski SA, Tomo M, Jani I. A combination intervention strategy to improve linkage to and retention in HIV care following diagnosis in Mozambique: A cluster-randomized study. PLoS Med. 2017 Nov 14;14(11):e1002433. doi: 10.1371/journal.pmed.1002433. eCollection 2017 Nov.
• Sutton R, Lahuerta M, Abacassamo F, Ahoua L, Tomo M, Lamb MR, Elul B. Feasibility and Acceptability of Health Communication Interventions Within a Combination Intervention Strategy for Improving Linkage and Retention in HIV Care in Mozambique. J Acquir Immune Defic Syndr. 2017 Jan 1;74 Suppl 1(Suppl 1):S29-S36. doi: 10.1097/QAI.0000000000001208.
• Elul B, Lahuerta M, Abacassamo F, Lamb MR, Ahoua L, McNairy ML, Tomo M, Horowitz D, Sutton R, Mussa A, Gurr D, Jani I. A combination strategy for enhancing linkage to and retention in HIV care among adults newly diagnosed with HIV in Mozambique: study protocol for a site-randomized implementation science study. BMC Infect Dis. 2014 Oct 15;14:549. doi: 10.1186/s12879-014-0549-5.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2013
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: August 23, 2013
• First Submitted That Met QC Criteria: August 23, 2013
• First Posted (Estimate): August 28, 2013

Study Record Updates

• Last Update Posted (Estimate): February 8, 2017
• Last Update Submitted That Met QC Criteria: February 6, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: HIV; retention; linkage
• Other Study ID Numbers: AAAL1354; USAID-OAA-A-12-00027 (Other Grant/Funding Number: USAID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No