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The Welcome Incoming Neighbor (WIN) Community Trial (WIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03915899
Recruitment Status : Not yet recruiting
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
HIV Behavioral: WIN (Welcome Incoming Neighbor) Not Applicable

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9080 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Community-Randomized Trial to Reduce HIV Acquisition and Viral Load Among Migrants in Rakai, Uganda
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : April 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: WIN Intervention
WIN Intervention
Behavioral: WIN (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.

No Intervention: Standard of Care
No WIN intervention.



Primary Outcome Measures :
  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



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Ages Eligible for Study:   15 Years to 49 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Residing in study community

Exclusion Criteria:

  • Unable or unwilling to provide informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915899


Contacts
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Contact: Maria Wawer (410) 955-1701 mwawer1@jhu.edu

Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Maria Wawer, MD Johns Hopkins Bloomberg School of Public Health
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03915899    
Other Study ID Numbers: WIRB20031318
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Time Frame: After Publication of Final Study Outcomes
Access Criteria: Email PI. See plan description.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No