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Completed

NCT Number: NCT01930084

ENGAGE4HEALTH: A Combination Intervention Strategy for Linkage and Retention 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.

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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chicuque Health Center, Inhambane, Mozambique

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Point of care CD4+ after HIV diagnosis

Other

Point of care (POC) CD4+ testing immediately following HIV diagnosis

Accelerated ART initiation

Other

Accelerated ART initiation for eligible participants delivered by facility personnel

SMS appointment reminders

Behavioral

Cellular appointment reminders delivered by study personnel

Non-cash Financial Incentives

Other

Non-cash Financial Incentives

Primary outcomes

  1. 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

    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 outcomes

  1. Time to linkage to care

    Time frame: 12 months

    A decrease in the median time to linkage to care

Other outcomes

  1. Time from ART eligibility to ART initiation

    Time frame: 12 months

  2. Proportion of participants with new WHO Stage III/IV event or hospitalization

    Time frame: 12 months

  3. Mortality rate 12 months after HIV diagnosis

    Time frame: 12 months

  4. Costs and incremental cost-effectiveness ratio of CIS and of CIS+FI

    Time frame: 12 months

  5. 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

    Time frame: 12 months

  6. Proportion of patients reporting that interventions were highly acceptable

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • United States Agency for International Development (USAID)

Registry information

Official study title

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

Acronym: E4H

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Aug 28, 2013
Registry last updated
Feb 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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