Clinical trial NCT01930084: ENGAGE4HEALTH: A Combination Intervention Strategy for Linkage and Retention in Mozambique
Official title: ENGAGE4HEALTH: A Combination Strategy for Linkage and Retention in HIV Care Among Adults in Mozambique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
linkage
retention
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
First posted: 2013-08-28
Enrollment: 2004
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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 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.

Eligibility 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 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

Primary outcomes:
measure: Linkage to HIV care within 1 month of HIV testing and retention in care 12 months after testing.
timeFrame: 1 month and 12 months after testing
Secondary outcomes:
measure: Time to linkage to care
timeFrame: 12 months
Other outcomes:
measure: Time from ART eligibility to ART initiation
timeFrame: 12 months
measure: Proportion of participants with new WHO Stage III/IV event or hospitalization
timeFrame: 12 months
measure: Mortality rate 12 months after HIV diagnosis
timeFrame: 12 months
measure: Costs and incremental cost-effectiveness ratio of CIS and of CIS+FI
timeFrame: 12 months
measure: 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
timeFrame: 12 months
measure: Proportion of patients reporting that interventions were highly acceptable
timeFrame: 12 months
Locations:
city: Inhambane
country: Mozambique
facility: Chicuque Health Center
city: Inhambane
country: Mozambique
facility: Massinga Health Center
city: Inhambane
country: Mozambique
facility: Maxixe Health Center
city: Inhambane
country: Mozambique
facility: Morrumbene Health Center
city: Inhambane
country: Mozambique
facility: Urbano Health Center
city: Inhambane
country: Mozambique
facility: Zavala Health Center and Inharrime Health Center
city: Maputo
country: Mozambique
facility: Bagamoio Health Center
city: Maputo
country: Mozambique
facility: Jose Macamo Health Center
city: Maputo
country: Mozambique
facility: Mavalane General Hospital
city: Maputo
country: Mozambique
facility: Zimpeto Health Center
Study officials:
affiliation: Columbia University
name: Batya Elul, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.