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Completed

NCT Number: NCT03915899

The Welcome Incoming Neighbor (WIN) Community Trial

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.

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Key information

Conditions

HIV

Age range

15 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rakai Health Sciences Program

Kalisizo, Uganda

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Residing in study community

Exclusion criteria

  • Unable or unwilling to provide informed consent.

Treatment and study plan

WIN (Welcome Incoming Neighbor)

Behavioral

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.

Primary outcomes

  1. Antiretroviral Therapy (ART) Coverage as assessed by Proportion of HIV positive Reporting ART Use

    Time frame: 3 years

  2. Male Circumcision Coverage assessed by Proportion of Men Reporting Circumcision

    Time frame: 3 years

  3. Proportion of participants with HIV Viral Suppression

    Time frame: 3 years

  4. Incidence of HIV infection

    Time frame: 3 years

    Rate of New HIV Infections

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

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

Acronym: WIN

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Apr 16, 2019
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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