Skip to content

The Welcome Incoming Neighbor (WIN) Community Trial

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03915899
Acronym
WIN
Enrollment
9080
Registered
2019-04-16
Start date
2019-05-01
Completion date
2025-07-01
Last updated
2026-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Brief summary

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

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 Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) 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.

Interventions

BEHAVIORALWIN (Welcome Incoming Neighbor)

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.

Sponsors

Johns Hopkins Bloomberg School of Public Health
Lead SponsorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
15 Years to 49 Years
Healthy volunteers
Yes

Inclusion criteria

* Residing in study community

Exclusion criteria

* Unable or unwilling to provide informed consent.

Design outcomes

Primary

MeasureTime frameDescription
Antiretroviral Therapy (ART) Coverage as assessed by Proportion of HIV positive Reporting ART Use3 years
Male Circumcision Coverage assessed by Proportion of Men Reporting Circumcision3 years
Proportion of participants with HIV Viral Suppression3 years
Incidence of HIV infection3 yearsRate of New HIV Infections

Countries

Uganda

Contacts

PRINCIPAL_INVESTIGATORMaria Wawer, MD

Johns Hopkins Bloomberg School of Public Health

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 21, 2026