Overview

This trial is active, not recruiting.

Condition hiv
Treatments point of care cd4+ after hiv diagnosis, accelerated art initiation, sms appointment reminders, non-cash financial incentives
Sponsor Columbia University
Start date April 2013
End date June 2016
Trial size 2004 participants
Trial identifier NCT01930084, AAAL1354, USAID-OAA-A-12-00027

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(Experimental)
Point of care CD4+ after HIV diagnosis Accelerated ART initiation SMS appointment reminders Non-cash financial incentives (FI)
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
sms appointment reminders
Cellular appointment reminders delivered by study personnel
non-cash financial incentives
Non-cash Financial Incentives
(Experimental)
Point of care (POC) CD4+ after HIV diagnosis Accelerated ART initiation SMS appointment reminders
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
sms appointment reminders
Cellular appointment reminders delivered by study personnel
(No Intervention)
Standard of care, no intervention

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
Time to linkage to care
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title ENGAGE4HEALTH: A Combination Strategy for Linkage and Retention in HIV Care Among Adults in Mozambique
Principal investigator Batya Elul, PhD, MSc
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. Study Duration: This study is 4 years in duration. Participants will be enrolled and followed for 12 months after enrollment.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Columbia University.