MWCCS
STAR
ACTION & CROWN
Recruitment, Retention and Community Engagement
Regulatory
100

What does MWCCS stand for?

MACS/WIHS Combined Cohort Study

100

What does STAR stand for?

Study of Treatment and Reproductive Outcomes

100

What does CROWN or ACTION stand for?

Comprehensive Research on Oral and mental health among Women

A Comprehensive Translational Initiative On Novel coronavirus

100

What does CAB and NCAB stand for?

Community Advisory Board and National Community Advisory Board

100

Which system is used for IRB submissions at UM?

IBISResearch / IBIS

200

What is the age range for new MWCCS participants?

30 to 70 years old

200

Name at least three states or cities where STAR recruitment occurs.

Georgia (Atlanta), Alabama (Birmingham), Mississippi (Jackson), Florida (Miami), North Carolina (Chapel Hill), Washington D.C.

200

What is the primary goal of ACTION 3 or CROWN?

To establish a Miami COVID cohort for research on SARS-CoV-2 persistence, immune response, and variant prediction

To examine the interplay between mental health and oral health among women with HI

200

Name one types of retention message sent to MWCCS participants.

Examples: Appointment reminders, birthday messages, holiday greetings, public health messages, newsletters

200

What is one training that must be completed by all team members before engaging in human subject research?

CITI Human Subjects Research training (every 3 years) and Good Clinical Practice

300

Name two types of specimens collected at MWCCS core visits besides blood.

Examples: urine, saliva, stool, cervicovaginal lavage, or oral rinse

300

Name two biospecimen collected in STAR besides blood.

Examples: urine, saliva, vaginal swab, oral swab, rectal swab, hair

300

How soon after a positive COVID-19 test must participants be enrolled in ACTION 3?

Within 7 days of documented SARS-CoV-2 diagnosis

300

How often are MWCCS community newsletters sent?

Four times per year

300

Which UM policy requires disclosure of financial interests from all personnel participating in research before IRB submission?

UDisclose Conflict of Interest policy

400

What is the primary purpose of MWCCS?

To study HIV infection and comorbidities among men and women in the U.S.

400

At what temperature should vaginal swabs be stored before shipment to the NICHD repository?

Frozen at −80°C

400

What study used Artificial Intelligence (AI) algorithm?

ACTION 3

400

How does STAR maintain participant engagement over time?

Semi-annual visits for at least 2 years, plus phone check-ins/retention calls every 3–6 months

400

What must be submitted within 10 business days if a protocol deviation occurs?

Reportable New Information (RNI) form

500

What is one NIH institutes that co-fund MWCCS for its major aims?

NHLBI, NIA, NCI, NIMH, NIDA, NIMHD

500

List one pregnancy-related outcomes STAR will evaluate.

Examples: preterm birth, hypertensive disorders (pre-eclampsia/eclampsia), gestational diabetes, miscarriage, fetal growth restriction

500

What unique population does the CROWN SOURI supplement focus on?

Haitian women with and without HIV in Miami

500

Name two types of services offered by CONNECT to facilitate recruitment, retention, and completion of study visits.

Examples: Mobile procedures/study coordination, driving coordination, sample collection (phlebotomy, saliva, swabs), rapid testing (HIV, COVID, pregnancy), anthropometry

500

What is the minimum retention period for HIPAA authorization documents after study completion?

Six years