The Welcome Incoming Neighbor (WIN) Community Trial

Study Overview
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Brief Summary
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Migration is common in rural Africa: in-migrants have higher HIV incidence and prevalence than community residents, but underutilize combined HIV prevention and care services, including voluntary medical male circumcision and antiretroviral therapy, increasing the risks of HIV acquisition and onward transmission. Uptake of combined HIV prevention (CHP) is critical in this vulnerable population. The investigators will conduct a community randomized trial to rapidly identify and link migrants to CHP in rural Uganda; if effective, the intervention could be widely implemented as an important strategy towards HIV epidemic control.

Detailed Description
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The Rakai Health Sciences Program (RHSP), Uganda, proposes an implementation science community- randomized controlled trial (CRCT) of a novel intervention to newly in-migrated individuals (Welcome Incoming Neighbor [WIN]), to optimize in-migrated individuals' rapid linkage to combination HIV prevention (CHP) services. RHSP data show that within the first 36 months after in-migration, compared to residents, HIV-negative in-migrants are at increased risk of HIV acquisition and HIV+ in-migrants underutilize antiretroviral therapy (ART) increasing the risk of onward transmission. The theory-based WIN intervention includes community sensitization and community-based WIN scouts (WINs). WINs will conduct active community surveillance to rapidly identify and welcome in-migrants, provide the in-migrants with information about the availability of CHP and high rates of use by residents (to normalize uptake), utilize a motivational interviewing approach to encourage CHP adoption, refer in-migrants to free services, and follow-up in-migrants to assess and further encourage engagement in CHP. Specific Aims: Aim 1: To randomize 40 individually matched communities in a 1:1 ratio to the WIN intervention or control arm. In-migrants aged 15-49 in each arm will undergo a baseline and 2 follow-up surveys at  18-month intervals. Study end points are CHP coverage rates, HIV incidence in initially HIV-negative in-migrants (n  3,800 py per arm), and viral load suppression in HIV+ (n  740 per arm). Aim 2a: To use a mixed methods approach (in-depth interviews, process & survey data) and RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) to (i) guide interim intervention adaptation as necessary; (ii) interpret trial results; and, (iii) translate the research into future action. Aim 2b: To conduct cost studies to provide information on affordability and sustainability. Innovation and Impact: This novel intervention will rapidly engage a vulnerable priority population of in-migrants, to optimize CHP and HIV impact in rural Uganda.

Official Title
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A Community-Randomized Trial to Reduce HIV Acquisition and Viral Load Among Migrants in Rakai, Uganda

Conditions
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HIV

Intervention / Treatment
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* Behavioral: WIN (Welcome Incoming Neighbor)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Residing in study community Exclusion Criteria: Unable or unwilling to provide informed consent.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WIN Intervention<br>WIN Intervention | Behavioral: WIN (Welcome Incoming Neighbor)<br>* WINs will conduct active community surveillance to rapidly identify and welcome in-migrants, provide them with information about the availability of CHP, utilize a motivational interviewing approach to encourage CHP adoption, refer in-migrants to free services, and follow-up in-migrants to assess and further encourage engagement in CHP.<br>|
| No Intervention: Standard of Care<br>No WIN intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antiretroviral Therapy (ART) Coverage as assessed by Proportion of HIV positive Reporting ART Use |  | 3 years | 
| Male Circumcision Coverage assessed by Proportion of Men Reporting Circumcision |  | 3 years | 
| Proportion of participants with HIV Viral Suppression |  | 3 years | 
| Incidence of HIV infection | Rate of New HIV Infections | 3 years |