CROI 2015 Program and Abstracts

Abstract Listing

Oral Abstracts

Methods: A total of 34 (16BNY/18DC) HIV test sites and 37 (20 BNY/ 17 DC) care sites were randomized to FI or standard of care. At FI test sites, HIV+ persons received coupons ($125) redeemable if care visit occurred within 3 months (M). At FI care sites, patients (Pts) on ART could earn $70 gift card per quarter with VS. Lab data reported to HIV Surveillance were used for primary site-level outcomes: for L2C, CD4 or VL within 3M of HIV+ test; for VS, VL<400 copies/ml in engaged Pts (>2 visits in last 15 M); for continuity in care, CD4 or VL in 4 of prior 5 quarters. FI sites reported numbers of eligible Pts, coupons, and gift cards dispensed. GEE were used to compare FI and SOC outcomes (Figure). Results: 1,346 HIV+ PTS (443 BNY/903 DC) were included in evaluation of L2C at 15 hospitals and 19 community sites: In BNY/DC, respectively, 66%/76%were men, 35%/49% MSM, 50%/70% Black, 46%/10% Hispanic; 20%<25 years in both cities. On average 15,780 Pts were in care (8,927 BNY/6,853 DC) at 17 hospitals and 20 community sites: 57%/74%were men, 19%/48%MSM, 47%/72% Black and 48%/6% Hispanic in BNY/DC. For L2C, 1,061 coupons (238 BNY/823 DC) were dispensed and 194 (82%)/644(78%) redeemed in BNY/DC. For VS, 9,641 Pts (5,275 BNY/4,366 DC) were potentially eligible for gift cards, 84% of 49,650 visits qualified for cards (81% BNY/87% DC) and 39,359 gift cards were dispensed (23,265 BNY/16,094 DC). For L2C, FI did not significantly increase overall L2C above SOC (OR: 1.05, 95%CI: 0.69, 1.58, p0.83) and no effect was noted in subsets of sites. For VS, while FI did not significantly increase VS overall (3.9%, CI: –3.5%, 11.2%, p0.3), substantial increases were noted at hospital clinics (4.9%, CI: 0.9%, 8.9%, p0.02), smaller sites (<185 patients in care) (9.6%, CI:1.2%,17.9%, p0.03), sites with lower VS at baseline (<65%) (10.4%, CI: 2.0%,18.7%, p0.01) and at peak of intervention (5.5%, CI:0.6%,10.5%, p0.03). No difference was noted by city for L2C or VS. FI increased continuity of care by 8% overall (CI: 2.1%, 13.9%, p0.008), and at community clinics, smaller sites, and sites with higher baseline VS.

Oral Abstracts

Conclusions: FI did not increase L2C. However, use of FI for VS showed promising effectiveness for sites with fewer patients, lower VS and hospital-based clinics and offers potential for treatment as prevention. 30 Medical Male Circumcision of HIV-Infected Men Reduces Long-Term Penile HIV Shedding Jordyn L. Manucci 1 ; Godfrey Kigozi 3 ; Mary K. Grabowski 2 ; David Serwadda 3 ; Ronald H. Gray 2 ; Maria J.Wawer 2 ; Fred Nalugoda 3 ; Andrew D. Redd 4 ;Thomas C. Quinn 4 ; Aaron A.Tobian 1 1 Johns Hopkins University School of Medicine, Baltimore, MD, US; 2 Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, US; 3 Makerere University College of Health Sciences, Kampala, Uganda; 4 National Institute of Allergy and Infectious Diseases (NIAID), Bethesda, DC, US Background: Medical male circumcision (MMC) for HIV prevention in uninfected men is increasing. In HIV-infected men, MMC is safe and reduces genital ulceration and HPV acquisition. MMC of HIV+men reduced male-to-female transmission in observational studies, but in a randomized trial MMC was associated with increased HIV transmission to female partners if couples resumed intercourse prior to wound-healing. HIV shedding fromMMC wounds is detectable in 39% of HIV+men during the wound-healing (weeks 1-4), but decreased to 2.6% at six weeks post-MMC. We assessed penile HIV shedding before and three months after MMC among HIV-infected men in Rakai, Uganda to determine whether low HIV shedding is sustained and might reduce female HIV exposures. Methods: HIV shedding was evaluated among 160 self-reported antiretroviral therapy (ART)-naïve HIV-infected men using a lavage of 5 mL of phosphate buffered saline (PBS, pH=7.2) at the coronal sulcus immediately prior to MMC and at MMC three month postoperatively. Penile HIV-1 RNA viral levels (VL) were determined by reverse transcriptase polymerase-chain-reaction (RT-PCR) assay (Abbott Laboratories. Abbott Park, IL). Matched odds ratios (MOR) of detectable HIV-1 post-MMC relative to pre-MMC were estimated using conditional logistic regression. Differences in amount of HIV shedding (log 10 copies/mL of lavage fluid) among those with detectable lavage were assessed using Wilcoxon- Mann-Whitney tests. Results: HIV shedding among ART-naive men was detected in 8.8% (n=14/160) of men prior to surgery and in 1.9% (n=3/160) 3 months post-MMC (M0R=0.15, 95%CI=0.35- 0.68, p=0.01). Among men with detectable HIV shedding at enrollment, the median HIV VL was 2.47 log 10 /ml (IQR=2.19-3.10) compared to 2.20 log 10 /ml (IQR=2.06-2.23) at month three post-MMC (p=0.20). In a sensitivity analysis of men with CD4 count >350 cells/uL, HIV shedding was detected in 7.2% (n=8/106) of men prior to surgery and in 1.9% (n=2/106) 3 months post-MMC (M0R=0.25, 95%CI=0.05-1.17, p=0.08). Conclusions: Detectable penile HIV shedding is reduced by 85% three months after MMC in ART-naïve HIV+men. The data suggest that MMC in HIV-infected men may reduce HIV exposure and potentially transmission to uninfected female partners after wound healing.

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CROI 2015