ENGAGE4HEALTH: A Combination Intervention Strategy for Linkage and Retention in Mozambique
NCT ID: NCT01930084
Last Updated: 2017-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
2004 participants
INTERVENTIONAL
2013-04-30
2016-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Combination intervention + incentives
1. Point of care CD4+ after HIV diagnosis
2. Accelerated ART initiation
3. SMS appointment reminders
4. 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
Combination intervention strategy(CIS)
1. Point of care (POC) CD4+ after HIV diagnosis
2. Accelerated ART initiation
3. 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
Standard of care (SOC)
Standard of care, no intervention
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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United States Agency for International Development (USAID)
FED
Columbia University
OTHER
Responsible Party
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Batya Elul
Assistant Professor of Epidemiology
Principal Investigators
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Batya Elul, PhD, MSc
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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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, , Mozambique
Countries
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References
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Elul B, Lamb MR, Lahuerta M, Abacassamo F, Ahoua L, Kujawski SA, Tomo M, Jani I. A combination intervention strategy to improve linkage to and retention in HIV care following diagnosis in Mozambique: A cluster-randomized study. PLoS Med. 2017 Nov 14;14(11):e1002433. doi: 10.1371/journal.pmed.1002433. eCollection 2017 Nov.
Sutton R, Lahuerta M, Abacassamo F, Ahoua L, Tomo M, Lamb MR, Elul B. Feasibility and Acceptability of Health Communication Interventions Within a Combination Intervention Strategy for Improving Linkage and Retention in HIV Care in Mozambique. J Acquir Immune Defic Syndr. 2017 Jan 1;74 Suppl 1(Suppl 1):S29-S36. doi: 10.1097/QAI.0000000000001208.
Elul B, Lahuerta M, Abacassamo F, Lamb MR, Ahoua L, McNairy ML, Tomo M, Horowitz D, Sutton R, Mussa A, Gurr D, Jani I. A combination strategy for enhancing linkage to and retention in HIV care among adults newly diagnosed with HIV in Mozambique: study protocol for a site-randomized implementation science study. BMC Infect Dis. 2014 Oct 15;14:549. doi: 10.1186/s12879-014-0549-5.
Other Identifiers
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USAID-OAA-A-12-00027
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
AAAL1354
Identifier Type: -
Identifier Source: org_study_id
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