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

HIV Clinical Trial

— E4H  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01930084
• Other study ID #: AAAL1354
• Secondary ID: USAID-OAA-A-12-0
• Status: Completed
• Phase: N/A
• First received: August 23, 2013
• Last updated: February 6, 2017
• Start date: April 2013
• Est. completion date: July 2016

Study information

• Verified date: February 2017
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2004
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

Other:
• Point of care CD4+ after HIV diagnosis
Point of care (POC) CD4+ testing immediately following HIV diagnosis
• 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

Locations

Country	Name	City	State
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	Inhambane
Mozambique	Bagamoio Health Center	Maputo
Mozambique	Jose Macamo Health Center	Maputo
Mozambique	Mavalane General Hospital	Maputo
Mozambique	Zimpeto Health Center	Maputo

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	United States Agency for International Development (USAID)

Country where clinical trial is conducted

Mozambique, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time from ART eligibility to ART initiation		12 months
Other	Proportion of participants with new WHO Stage III/IV event or hospitalization		12 months
Other	Mortality rate 12 months after HIV diagnosis		12 months
Other	Costs and incremental cost-effectiveness ratio of CIS and of CIS+FI		12 months
Other	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
Other	Proportion of patients reporting that interventions were highly acceptable		12 months
Primary	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	Time to linkage to care	A decrease in the median time to linkage to care	12 months