The Welcome Incoming Neighbor (WIN) Community Trial
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| 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. |
Outcome Measures
Primary Outcome Measures
- 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 [3 years]
Rate of New HIV Infections
Eligibility Criteria
Criteria
Inclusion Criteria:
- Residing in study community
Exclusion Criteria:
- Unable or unwilling to provide informed consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rakai Health Sciences Program | Kalisizo | Uganda |
Sponsors and Collaborators
- Johns Hopkins Bloomberg School of Public Health
Investigators
- Principal Investigator: Maria Wawer, MD, Johns Hopkins Bloomberg School of Public Health
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- WIRB20031318