Project AWARE Study Overview Lisa Metsch, PhD Grant Colfax, MD Dan Feaster, PhD January 9, 2012
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 information only
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 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.
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 costeffectiveness of counseling SITES Columbia, SC Jacksonville, FL Los Angeles, CA Miami, FL San Francisco, CA Pittsburg, PA Portland, OR Seattle, WA Washington, DC 5012 participants randomized across 9 STD clinics in the U.S. RESPECT-2 counseling with on-site rapid HIV test STUDY DESIGN Recruitment and Enrollment STI Testing Baseline Assessment Randomization Information with on-site rapid HIV test STI testing and ACASI repeated at 6 months
STD Clinics and University Counterparts Allegheny County Health Department Duval County Health Department University of Pittsburgh CPCDS University of Miami Los Angeles Gay & Lesbian Center University of California, San Francisco Miami-Dade County Health Department Downtown Miami STD Clinic Multnomah County Health Department STD Prevention Program Public Health - Seattle & King County Health Department Richland County Health Department San Francisco Department of Public Health Whitman Walker Clinic University of Miami Oregon Health & Science University CODA University of California, San Francisco Medical University of South Carolina LRADAC University of California, San Francisco Columbia University
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 Schackman
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 September 21, 2010 July 15, 2011
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, 571 83.2% WA) 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% *CHD = County Health Dept.; DPH = Dept.of Public Health
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) Human Immonodeficiency Virus (HIV)
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 CT (via vaginal swab).
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
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 or Severe Drug abuse
STI Baseline STI Prevalence MSM Male n=1402 by Gender 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) Overall (Any STI) 410 (29.2) 533 (27.9) 728 (42.7) 1671 (33.3)
Baseline STI Prevalence by Site Clinic n/total % Allegheny CHD (Pittsburgh, PA) 253/600 42.2 Duval CHD (Jacksonville, FL) 221/525 42.1 LA Gay & Lesbian Ctr (Los Angeles, CA) 137/569 24.1 Miami CHD (Miami, FL) 351/595 59.0 Multnomah CHD (Portland, OR) 137/556 24.6 Public Health - Seattle & King CHD (Seattle, WA) 145/571 25.4 Richland CHD (Columbia, SC) 217/542 40.0 San Francisco DPH (San Francisco, CA) 103/570 18.1 Whitman Walker Clinic (Washington, DC) 107/484 22.1 All Sites 1671/5012 33.3
Baseline STI Prevalence by Site (excludes HSV-2) Clinic n/total % Allegheny CHD (Pittsburgh, PA) 115/600 19.2 Duval CHD (Jacksonville, FL) 121/525 23.0 LA Gay & Lesbian Ctr (Los Angeles, CA) 99/569 17.4 Miami CHD (Miami, FL) 202/595 33.9 Multnomah CHD (Portland, OR) 77/556 13.8 Public Health - Seattle & King CHD (Seattle, WA) 65/571 11.4 Richland CHD (Columbia, SC) 152/542 28.0 San Francisco DPH (San Francisco, CA) 62/570 10.9 Whitman Walker Clinic (Washington, DC) 88/484 18.2 All Sites 981/5012 19.6
Baseline STI Prevalence by Site (excludes Syphilis & HSV-2) Clinic n/total % Allegheny CHD (Pittsburgh, PA) 115/600 19.2 Duval CHD (Jacksonville, FL) 109/525 20.8 LA Gay & Lesbian Ctr (Los Angeles, CA) 88/569 15.5 Miami CHD (Miami, FL) 165/595 27.7 Multnomah CHD (Portland, OR) 74/556 13.3 Public Health - Seattle & King CHD (Seattle, WA) 65/571 11.4 Richland CHD (Columbia, SC) 149/542 27.5 San Francisco DPH (San Francisco, CA) 62/570 10.9 Whitman Walker Clinic (Washington, DC) 85/484 17.6 All Sites 912/5012 18.2
I CCTN NIDA U. of Miami San Francisco Dept. of Health University Counterparts AIDS Research Program NIDA 9 STD Clinics DCRI NKI CTN CTPs Cornell California State, Long Beach EMMES