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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Columbia University
Sponsor:
Information provided by (Responsible Party):
Batya Elul, Columbia University
ClinicalTrials.gov Identifier:
NCT01930084
First received: August 23, 2013
Last updated: NA
Last verified: August 2013
History: No changes posted
  Purpose

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.


Condition Intervention
HIV
Other: Point of care CD4+ testing
Other: Accelerated ART initiation
Behavioral: SMS appointment reminders
Other: Non-cash Financial Incentives

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: ENGAGE4HEALTH: A Combination Strategy for Linkage and Retention in HIV Care Among Adults in Mozambique

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Linkage to HIV care within 1 month of HIV testing and retention in care 12 months after testing. [ Time Frame: 1 month and 12 months after testing ] [ Designated as safety issue: No ]
    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:
  • Time to linkage to care [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    A decrease in the median time to linkage to care


Other Outcome Measures:
  • Time from ART eligibility to ART initiation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Proportion of participants with new WHO Stage III/IV event or hospitalization [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Median CD4+ cell count 12 months after HIV diagnosis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Mortality rate 12 months after HIV diagnosis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Costs, QALY, DALY and incremental cost-effectiveness ratio of CIS and of CIS+FI [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Proportion of patients receiving POC CD4+ test, SMS reminders, accelerated ART initiation (among those eligible based on POC CD+ test result), and FI [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Proportion of patients reporting that interventions were highly acceptable [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 3000
Study Start Date: April 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Combination intervention + non-cash financial incentives
  1. Point of care CD4+ testing immediately following HIV diagnosis
  2. Accelerated ART initiation for eligible participants delivered by facility personnel
  3. Cellular appointment reminders delivered by study personnel
  4. Non-cash financial incentives (FI)
Other: Point of care CD4+ testing
Other Name: 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
Other Name: Cellular appointment reminders delivered by study personnel
Other: Non-cash Financial Incentives
Experimental: Combination intervention strategy (CIS)
  1. Point of care (POC) CD4+ testing immediately following HIV diagnosis
  2. Accelerated ART initiation for eligible participants delivered by facility personnel
  3. Cellular appointment reminders delivered by study personnel
Other: Point of care CD4+ testing
Other Name: 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
Other Name: Cellular appointment reminders delivered by study personnel
No Intervention: Standard of care (SOC)
Standard of care, no intervention

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 3,000 adults from the 10 study units will be included in the study, 1,000 in the SOC arm, and 2,000 in the CIS arm with 1,000 receiving CIS without FI and 1,000 receiving CIS+FI.

Study Duration: This study is 3 years in duration. Participants will be enrolled for 6 months and followed for 12 months after enrollment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 (PMTCT) or tuberculosis) at the study unit (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, home-based interviews 1 and 12 months after study enrollment, home-based CD4+ count assessment 12 months after enrollment, and extraction of data from the HIV care and treatment electronic database
  • Able to provide informed consent

Exclusion Criteria:

  • 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
  • Pregnant at the time of recruitment
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01930084

Contacts
Contact: Fatima Abacassamo, MD, MPH (+258) 82 0636630 fatimaabacassamo@ccsaude.org.mz
Contact: Laurence Ahoua, MD, MPH (+258) 84 310 25 03 laurenceahoua@columbia.org.mz

Locations
Mozambique
Chicuque Health Center Not yet recruiting
Inhambane, Mozambique
Morrumbene Health Center Not yet recruiting
Inhambane, Mozambique
Zavala Health Center Not yet recruiting
Inhambane, Mozambique
Massinga Health Center Not yet recruiting
Inhambane, Mozambique
Maxixe Health Center Not yet recruiting
Inhambane, Mozambique
Urban Chabeco Health Center Not yet recruiting
Inhambane, Mozambique
Bagamoio Health Center Recruiting
Maputo, Mozambique
Jose Macamo Health Center Recruiting
Maputo, Mozambique
Zimpeto Health Center Recruiting
Maputo, Mozambique
Mavalane General Hospital Recruiting
Maputo, Mozambique
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Batya Elul, PhD, MSc Columbia University
  More Information

No publications provided

Responsible Party: Batya Elul, Assistant Professor of Epidemiology, Columbia University
ClinicalTrials.gov Identifier: NCT01930084     History of Changes
Other Study ID Numbers: AAAL1354, USAID-OAA-A-12-00027
Study First Received: August 23, 2013
Last Updated: August 23, 2013
Health Authority: United States: Institutional Review Board
Mozambique: Ministry of Health (MISAU)

Keywords provided by Columbia University:
HIV
linkage
retention

ClinicalTrials.gov processed this record on September 14, 2014