ENGAGE4HEALTH: A Combination Intervention Strategy for Linkage and Retention in Mozambique
This trial is active, not recruiting.
|Treatments||point of care cd4+ after hiv diagnosis, accelerated art initiation, sms appointment reminders, non-cash financial incentives|
|Start date||April 2013|
|End date||June 2016|
|Trial size||2004 participants|
|Trial identifier||NCT01930084, AAAL1354, USAID-OAA-A-12-00027|
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|
|Inhambane, Mozambique||Chicuque Health Center||no longer recruiting|
|Inhambane, Mozambique||Massinga Health Center||no longer recruiting|
|Inhambane, Mozambique||Maxixe Health Center||no longer recruiting|
|Inhambane, Mozambique||Morrumbene Health Center||no longer recruiting|
|Inhambane, Mozambique||Urbano Health Center||no longer recruiting|
|Inhambane, Mozambique||Zavala Health Center and Inharrime Health Center||no longer recruiting|
|Maputo, Mozambique||Bagamoio Health Center||no longer recruiting|
|Maputo, Mozambique||Jose Macamo Health Center||no longer recruiting|
|Maputo, Mozambique||Mavalane General Hospital||no longer recruiting|
|Maputo, Mozambique||Zimpeto Health Center||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Primary purpose||health services research|
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
Time to linkage to care
time frame: 12 months
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
|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.|
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