Clinical trial NCT03915899: The Welcome Incoming Neighbor (WIN) Community Trial
Official title: A Community-Randomized Trial to Reduce HIV Acquisition and Viral Load Among Migrants in Rakai, Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2019-04-16
Enrollment: 9080
Sex: ALL
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* Residing in study community

Exclusion Criteria:

* Unable or unwilling to provide informed consent.

Primary outcomes:
measure: Antiretroviral Therapy (ART) Coverage as assessed by Proportion of HIV positive Reporting ART Use
timeFrame: 3 years
measure: Male Circumcision Coverage assessed by Proportion of Men Reporting Circumcision
timeFrame: 3 years
measure: Proportion of participants with HIV Viral Suppression
timeFrame: 3 years
measure: Incidence of HIV infection
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kalisizo
country: Uganda
facility: Rakai Health Sciences Program
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Maria Wawer, MD
role: PRINCIPAL_INVESTIGATOR
References: