Cost-Effectiveness of Needle and Syringe Exchange for the Prevention of HIV in New York City

Shared needle and syringe use among injection drug users continues to be a major mode of transmission of HIV. Needle and syringe exchange (NSE) may be a viable strategy to reduce the transmission of the virus; yet the difficulty in measuring the actual efficacy of NSE has limited attempts to evaluate the cost-effectiveness of the intervention. Using data specific to the Lower East Side Harm Reduction Center in New York City, we assessed the cost-effectiveness of NSE over a range of conservative estimates of efficacy, obtained from both longitudinal and small-area studies. A decision-analysis model was created to compare the outcomes and costs associated with NSE. Model inputs included the cost of living with HIV and the seroprevalence of HIV among injection drug users in New York City. This analysis was conducted from both the government and societal perspectives. Tested over a range of conservative parameter estimates, NSE appears to save money and lives. The NSE program we evaluated cost $502 per client and produced a gain of 0.01 quality adjusted life years per client. It also reduced HIV treatment costs by$325,000 per case of HIV averted, and averted 4–7 HIV infections per 1000 clients, producing a net cost savings

Outpatient treatment of COVID-19 and incidence of post-COVID-19 condition over 10 months (COVID-OUT): a multicentre, randomised, quadruple-blind, parallel-group, phase 3 trial.

BACKGROUND: Post-COVID-19 condition (also known as long COVID) is an emerging chronic illness potentially affecting millions of people. We aimed to evaluate whether outpatient COVID-19 treatment with metformin, ivermectin, or fluvoxamine soon after SARS-CoV-2 infection could reduce the risk of long COVID. METHODS: We conducted a decentralised, randomised, quadruple-blind, parallel-group, phase 3 trial (COVID-OUT) at six sites in the USA. We included adults aged 30-85 years with overweight or obesity who had COVID-19 symptoms for fewer than 7 days and a documented SARS-CoV-2 positive PCR or antigen test within 3 days before enrolment. Participants were randomly assigned via 2 × 3 parallel factorial randomisation (1:1:1:1:1:1) to receive metformin plus ivermectin, metformin plus fluvoxamine, metformin plus placebo, ivermectin plus placebo, fluvoxamine plus placebo, or placebo plus placebo. Participants, investigators, care providers, and outcomes assessors were masked to study group assignment. The primary outcome was severe COVID-19 by day 14, and those data have been published previously. Because the trial was delivered remotely nationwide, the a priori primary sample was a modified intention-to-treat sample, meaning that participants who did not receive any dose of study treatment were excluded. Long COVID diagnosis by a medical provider was a prespecified, long-term secondary outcome. This trial is complete and is registered with ClinicalTrials.gov, NCT04510194. FINDINGS: Between Dec 30, 2020, and Jan 28, 2022, 6602 people were assessed for eligibility and 1431 were enrolled and randomly assigned. Of 1323 participants who received a dose of study treatment and were included in the modified intention-to-treat population, 1126 consented for long-term follow-up and completed at least one survey after the assessment for long COVID at day 180 (564 received metformin and 562 received matched placebo; a subset of participants in the metformin vs placebo trial were also randomly assigned to receive ivermectin or fluvoxamine). 1074 (95%) of 1126 participants completed at least 9 months of follow-up. 632 (56·1%) of 1126 participants were female and 494 (43·9%) were male; 44 (7·0%) of 632 women were pregnant. The median age was 45 years (IQR 37-54) and median BMI was 29·8 kg/m2 (IQR 27·0-34·2). Overall, 93 (8·3%) of 1126 participants reported receipt of a long COVID diagnosis by day 300. The cumulative incidence of long COVID by day 300 was 6·3% (95% CI 4·2-8·2) in participants who received metformin and 10·4% (7·8-12·9) in those who received identical metformin placebo (hazard ratio [HR] 0·59, 95% CI 0·39-0·89; p=0·012). The metformin beneficial effect was consistent across prespecified subgroups. When metformin was started within 3 days of symptom onset, the HR was 0·37 (95% CI 0·15-0·95). There was no effect on cumulative incidence of long COVID with ivermectin (HR 0·99, 95% CI 0·59-1·64) or fluvoxamine (1·36, 0·78-2·34) compared with placebo. INTERPRETATION: Outpatient treatment with metformin reduced long COVID incidence by about 41%, with an absolute reduction of 4·1%, compared with placebo. Metformin has clinical benefits when used as outpatient treatment for COVID-19 and is globally available, low-cost, and safe. FUNDING: Parsemus Foundation; Rainwater Charitable Foundation; Fast Grants; UnitedHealth Group Foundation; National Institute of Diabetes, Digestive and Kidney Diseases; National Institutes of Health; and National Center for Advancing Translational Sciences

Harm reduction readiness for illicit IV drug use among safety-net primary care practices in the San Fernando Valley

BackgroundHarm reduction is an accumulation of strategies aimed at preventing adverse health outcomes associated with illicit substance use. Several harm reduction programs and services exist within Los Angeles County (LAC), however their success relies in part on the application of harm reduction principles by local primary care providers serving patients with substance use disorders. This study aims to assess the readiness of patient-centered medical homes in the San Fernando Valley to provide effective harm reduction to patients who use injection drugs and identify barriers to doing so.MethodsAn online survey was distributed to primary care providers and social workers via email at federally qualified health centers and LAC Department of Health Services clinics in the San Fernando Valley between May and June 2019. It consisted of 22 multiple-choice, Likert scale, and short answer questions. The survey assessed knowledge of injection drug use (IDU), familiarity and utilization of harm-reduction and resources, and self-evaluation of attitudes and skills.ResultsThere were a total of 41 survey respondents across all clinics. Of respondents, 98% correctly identified heroin as a drug typically injected, and 93% identified Hepatitis C as an infectious risk of IDU. 63% of respondents use harm reduction strategies every few months or less. 34% prescribe buprenorphine routinely, and 76% prescribe pre-exposure prophylaxis to those at risk for Human Immunodeficiency Virus (HIV). 76% are comfortable discussing IDU with their patients, but 59% indicate that they lack the necessary skills, and 42% agree that they lack the time to address it.ConclusionKnowledge of IDU was adequate among those surveyed, although overall utilization of harm reduction was infrequent. There is a perceived deficit in skills and time to effectively provide harm reduction to primary care patients in the San Fernando Valley

HIV risk perception and behavior among sex workers in three major urban centers of Mozambique.

HIV risk perceptions and behaviors of 236 commercial sex workers from three major Mozambican urban centers were studied using the International Rapid Assessment, Response and Evaluation (I-RARE) methodology. All were offered HIV testing and, in Maputo, syphilis testing was offered as well. Sixty-three of the 236 opted for HIV testing, with 30 (48%) testing positive for HIV. In Maputo, all 30 receiving HIV tests also had syphilis testing, with 6 (20%) found to be positive. Results include interview excerpts and qualitative results using I-RARE methodology and AnSWR-assisted analyses of the interviews and focus group sessions

Results of Voluntary Counseling and Testing (VCT) for HIV and Syphilis, Mozambique, 2007–2008.

<p>*syphilis testing only offered in Maputo.</p

Characteristics of all 236 Commercial Sex Workers Interviewed, Mozambique, 2007–2008.

<p>*Calculations based only on number actually responding to the question.</p><p>**Calculations based only on those responding ‘yes’ to the question.</p

Commercial sex-worker interviews and focus groups by study site, Mozambique, 2007–2008.

<p>*Numbers in parentheses = numbers of focus groups conducted.</p

Strategies used for the COVID-OUT decentralized trial of outpatient treatment of SARS-CoV-2

The COVID-19 pandemic accelerated the development of decentralized clinical trials (DCT). DCT’s are an important and pragmatic method for assessing health outcomes yet comprise only a minority of clinical trials, and few published methodologies exist. In this report, we detail the operational components of COVID-OUT, a decentralized, multicenter, quadruple-blinded, randomized trial that rapidly delivered study drugs nation-wide. The trial examined three medications (metformin, ivermectin, and fluvoxamine) as outpatient treatment of SARS-CoV-2 for their effectiveness in preventing severe or long COVID-19. Decentralized strategies included HIPAA-compliant electronic screening and consenting, prepacking investigational product to accelerate delivery after randomization, and remotely confirming participant-reported outcomes. Of the 1417 individuals with the intention-to-treat sample, the remote nature of the study caused an additional 94 participants to not take any doses of study drug. Therefore, 1323 participants were in the modified intention-to-treat sample, which was the a priori primary study sample. Only 1.4% of participants were lost to follow-up. Decentralized strategies facilitated the successful completion of the COVID-OUT trial without any in-person contact by expediting intervention delivery, expanding trial access geographically, limiting contagion exposure, and making it easy for participants to complete follow-up visits. Remotely completed consent and follow-up facilitated enrollment