Project AWARE Study Overview. Lisa Metsch, PhD Grant Colfax, MD Dan Feaster, PhD

(1)

Project AWARE

Study Overview

Lisa Metsch, PhD

Grant Colfax, MD

Dan Feaster, PhD

January 9, 2012

(2)

Two Testing Strategies

Evaluated in 2-arm RCT



On-site HIV rapid testing (via fingerstick) with

brief participant-tailored prevention counseling

vs.



On-site HIV rapid testing (via fingerstick) with

(3)

In 2012, is there still some

benefit from counseling;

if so, for whom and at

what cost?

(4)

Comparative Effectiveness Research

“Compare the effectiveness of HIV screening strategies based on recent Centers for Disease Control and

Prevention recommendations and traditional screening in primary care settings with significant prevention counseling.”

(5)

HIV Testing and Counseling in STD

Clinics in the U.S.: An Adaptation of CTN0032

L. Metsch, PI (University of Miami) ; G. Colfax, PI (San Francisco Department of Public Health)



This study will evaluate

the effect of counseling

on 1 primary outcome:

 STI incidence



Secondary outcomes:

 Reduction of sexual risk

behaviors

 Reduction of substance

use during sex

 Cost and

cost-effectiveness of counseling

Recruitment and Enrollment STI Testing

Baseline Assessment Randomization RESPECT-2 counseling

with on-site rapid HIV test

Information with on-site rapid HIV test STI testing and ACASI repeated at 6

months

STUDY DESIGN

5012 participants randomized across 9 STD clinics in the U.S.

SITES Columbia, SC Jacksonville, FL Los Angeles, CA Miami, FL San Francisco, CA Pittsburg, PA Portland, OR Seattle, WA Washington, DC

(6)

STD Clinics and

University Counterparts

Allegheny County Health Department University of Pittsburgh

CPCDS

Duval County Health Department University of Miami

Los Angeles Gay & Lesbian Center University of California, San Francisco Miami-Dade County Health Department

Downtown Miami STD Clinic

University of Miami Multnomah County Health Department

STD Prevention Program

Oregon Health & Science University CODA

Public Health - Seattle & King County Health Department

University of California, San Francisco Richland County Health Department Medical University of South Carolina

LRADAC San Francisco Department of Public

Health

University of California, San Francisco Whitman Walker Clinic Columbia University

(7)

Overview of Methods



Recruitment - Minimal eligibility criteria



Screening, Informed Consent, HIPAA and Medical Release Forms



STI testing



Use of electronic case report forms



Behavioral risk assessment



Participant-level randomization



5012 persons were randomized at 9 STD clinics in the U.S.



Approximately 556 patients from each clinic



18 per week at each clinic



Patient Exit Interviews



Intervention Fidelity and Quality Control



Cost and Cost-Effectiveness Analysis – led by Dr. Bruce

(8)

Recruitment & Screening



First sites launched April 01, 2010



All sites were launched by April 22, 2010



6237 screened



5012 randomized



80.4% of those screened were randomized



Six-month follow-up window

(9)

Retention by Site

STD Clinic # of Participants Randomized Completed Study Allegheny CHD* (Pittsburgh, PA) 600 85.5% Duval CHD (Jacksonville, FL) 824 74.3% LA Gay & Lesbian Ctr (Los Angeles, CA) 569 93.3% Miami CHD (Miami, FL) 595 94.1% Multnomah CHD (Portland, OR) 556 87.8% Public Health – Seattle/King CHD (Seattle,

WA) 571 83.2%

Richland CHD (Columbia, SC) 542 79.3% San Francisco DPH* (San Francisco, CA) 570 91.9% Whitman Walker Clinic (Washington, DC) 484 91.9%

All Sites 5012 84.3%

(10)

Biologic Testing



The primary outcome is composite STI

incidence at 6-month follow-up in which a

person is considered positive for STIs if they are

positive on any tested STI.



All participants will be screened for the

following STIs:



Herpes Simplex 2 (HSV-2)



Treponema pallidum (syphilis)

(11)

Biologic Testing (cont.)

In addition to the previous 3 STIs…



All men will be screened for urethral GC and

CT (via urine testing).



Men who have sex with men will also be

screened for rectal Neisseria gonorrhea (GC) and

Chlamydia trachomatis (CT).



All women will be screened for vaginal GC and

(12)

Demographics of Persons

Randomized (n=5012)



Gender



65.6% Male



33.8% Female



0.5% Transgender



Race/Ethnicity



31.7% Non-Hispanic White



45.0% Non-Hispanic Black



15.3% Hispanic



8.0% Other



28% MSM



Age Range



53.4% 18-29



22.4% 30-39



14.8% 40-49



7.8% 50-59



1.4% 60-69



0.2% >69

(13)

Self-Reported Substance Use

(n=5012)



55.% reported using drugs



45.2% Marijuana



17.0% Stimulants



4.2% Speed/Meth



15% Cocaine

 9.8% Powder  6.7% Crack 

9.3% Club Drugs



8.3% Opioids



6.0% Current Injectors



24.6% Severe drug

abuse (DAST-10>3)



16.2% Binge Drinking



33.3% Binge Drinking

(14)

Baseline STI Prevalence

by Gender

STI MSM Male n=1402 Non-MSM Male n=1907 Female n=1703 Total n=5012 n (%) n (%) n (%) n (%) Gonorrhea 133 (9.5) 95 (5.0) 52 (3.1) 280 (5.6) Chlamydia 164 (11.7) 178 (9.3) 144 (8.5) 486 (9.7) Trichomonas NA NA 242 (14.2) NA Syphilis 63 (4.5) 22 (1.2) 22 (1.3) 107 (2.1) Herpes 138 (9.8) 296 (15.5) 488 (28.7) 922 (18.4) HIV 36 (2.6) 9 (0.5) 6 (0.4) 51 (1.0)

Project AWARE Study Overview. Lisa Metsch, PhD Grant Colfax, MD Dan Feaster, PhD

Project AWARE

Study Overview

Lisa Metsch, PhD

Grant Colfax, MD

Dan Feaster, PhD

Two Testing Strategies

Evaluated in 2-arm RCT



On-site HIV rapid testing (via fingerstick) with

brief participant-tailored prevention counseling

vs.



On-site HIV rapid testing (via fingerstick) with

In 2012, is there still some

benefit from counseling;

if so, for whom and at

what cost?

Top 100 Priority Topics for

Comparative Effectiveness Research

HIV Testing and Counseling in STD

Clinics in the U.S.: An Adaptation of CTN0032

This study will evaluate

the effect of counseling

on 1 primary outcome:

Secondary outcomes:

STD Clinics and

University Counterparts

Overview of Methods

Recruitment - Minimal eligibility criteria

Screening, Informed Consent, HIPAA and Medical Release Forms

STI testing

Use of electronic case report forms

Behavioral risk assessment

Participant-level randomization

5012 persons were randomized at 9 STD clinics in the U.S.

Approximately 556 patients from each clinic

18 per week at each clinic

Patient Exit Interviews

Intervention Fidelity and Quality Control

Cost and Cost-Effectiveness Analysis – led by Dr. Bruce

Recruitment & Screening



First sites launched April 01, 2010



All sites were launched by April 22, 2010



6237 screened



5012 randomized



80.4% of those screened were randomized



Six-month follow-up window

Retention by Site

Biologic Testing



The primary outcome is composite STI

incidence at 6-month follow-up in which a

person is considered positive for STIs if they are

positive on any tested STI.



All participants will be screened for the

following STIs:

Herpes Simplex 2 (HSV-2)

Treponema pallidum (syphilis)

Biologic Testing (cont.)

In addition to the previous 3 STIs…



All men will be screened for urethral GC and

CT (via urine testing).



Men who have sex with men will also be

screened for rectal Neisseria gonorrhea (GC) and

Chlamydia trachomatis (CT).



All women will be screened for vaginal GC and

Demographics of Persons

Randomized (n=5012)

