NCT03915899

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,080

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
15 days until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

July 24, 2025

Status Verified

July 1, 2025

Enrollment Period

6.2 years

First QC Date

April 12, 2019

Last Update Submit

July 21, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

WIN Intervention

EXPERIMENTAL

WIN Intervention

Behavioral: WIN (Welcome Incoming Neighbor)

Standard of Care

NO INTERVENTION

No WIN intervention.

Interventions

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.

WIN Intervention

Eligibility Criteria

Age15 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Residing in study community

You may not qualify if:

  • Unable or unwilling to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rakai Health Sciences Program

Kalisizo, Uganda

Location

Study Officials

  • Maria Wawer, MD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2019

First Posted

April 16, 2019

Study Start

May 1, 2019

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

July 24, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

The Rakai Health Sciences Program (RHSP) has a written policy on the sharing of data and of laboratory specimens. Institutions, groups or researchers who propose to use Rakai data or specimens are required to submit a brief proposal/data request form describing the goals and methods of the proposed analyses. Based on this document and additional discussions with the party(ies) proposing the collaboration, the decision as to whether and/or how to proceed is made by consensus between senior Ugandan and US-based Investigators. The decision takes into account Uganda Ministry of Health directives regarding the maximization of research findings and safeguards regarding misuse, misappropriation or misinterpretation of data. Feasibility, availability of resources (such as Rakai Program analysts' time to help prepare and anonymize data sets to ensure no potential loss of confidentiality), and research importance/priority are also taken into consideration.

Shared Documents
STUDY PROTOCOL
Time Frame
After Publication of Final Study Outcomes
Access Criteria
Email PI. See plan description.

Locations