GAIN Study Activities and Visul Overview

TESTING, PEP & PrEP GROUPS

Seeking HIV/STI
testing, nPEP or
PrEP
Gay City
N = 2,400
or
Madison Clinic
N = 1,900

SURVEY GROUP

Test HIV negative

Test HIV positive

Aim 4:
• 100 HIV-negative
participants from both Gay
City and Madison Clinic
• 50 HIV-positive
participants from both Gay
City and Madison Clinic
• Offered participation at
study visit, will have one
week to complete Patient
Acceptability CASI via
emailed link
• $10 Amazon gift card
N = 300

Link to care

Aim 3:

HIV+ seeking care @
Gay City

HIV POSITIVE GROUPS

Aims 1 & 2:
• Consent, HIPAA, ROI
• POC NAT (SAMBA II Qual)
• 10 mL Serum  pooled lab NAT
• Gay City: f/u calls @, 1, 3, 6 mos

N = 400

HIV+ seeking care @
Madison Clinic
(could include those
that test positive in
Testing & PrEP
Group)

•
•
•
•
•

Consent, HIPAA, ROI
POC NAT (SAMBA II Semi-Q)
10 mL EDTA  indiv lab NAT
Link to care if needed
Follow up calls @ 1, 3, 6 mos

• 10 in each group offered
interviews or focus groups
• $40 stipend
N = 40

Aim 3:
• Consent, HIPAA, ROI
• RANDOMIZE: POC NAT or SoC
• PCP  Adherence Intervention
• indiv lab NAT  ordered by clinic
• $20 cash stipend
• F/u call with result: physician?
N = 932

 most should have detectable HIV RNA
based on adherence challenges,
plasma or visit history
 PCP will call patient to f/u with results

Aim 5 after Aim 3 ok after 12 months.
Aim 3 not possible after Aim 5.
Aim 5:
• Consent
• SAMBA II Semi-Q & Cepheid Xpert
• One 4 mL EDTA  Cepheid Xpert plasma
• Two 10 mL EDTAs  indiv lab NAT, storage
• $20 cash stipend
N = 800

 half should have detectable HIV RNA
based on plasma or visit history

Sample Sizes &
Study Flow

Samples stored for this group to ship to CDC