TakeMeHome: A novel method for reaching previously untested people through online ordering and self-collect HIV and STI testing.

BACKGROUND: Despite national testing guidelines, rates of testing for HIV, sexually transmitted infections, and hepatitis C remain lower than recommended for men who have sex with men (MSM) in the US. To help address this, the TakeMeHome (TMH) program was started in March 2020 by a consortium of public health organizations and dating apps - Building Healthy Online Communities - to work with health departments to increase access to HIV testing for MSM on dating apps. METHODS: Users of participating dating apps were sent messages about opportunities for testing with self-collected specimens through TMH. Program users were eligible to receive test kits if they lived in a participating zip code and were aged at least 18. Users who were interested in testing could order kits to be mailed to them for lab-based testing of HIV, hepatitis C, chlamydia, gonorrhea, and/or syphilis, depending on risk and availability in their zip code. Orders were sent via application programming interface (API) to Molecular Testing Labs (MTL) for fulfillment; kits were provided at no cost to the program user. Within approximately 24 hours of order receipt, MTL mailed program users a kit with required collection supplies, directions, and a link to a video instruction for self-collection. Program users received an automated email after testing was complete with a link to access results through their online account. Individuals with positive results on any of the relevant tests were directed to additional information and supported with linkage to additional testing or treatment, depending on local protocols. RESULTS: The positivity rate of specimens processed through TMH was 1.4% for HIV, 0.6% for hepatitis C, and 2.9% for all STIs combined. The per-person positivity rate was 15.3% across all STIs.Conclusions: The TakeMeHome program demonstrates that self-collected lab-processed testing is feasible and effective at identifying new HIV and STI cases.

Implementation of pre-exposure prophylaxis at a community pharmacy through a collaborative practice agreement with San Francisco Department of Public Health.

OBJECTIVE: To discuss the design and implementation of a community pharmacy-initiated HIV pre-exposure prophylaxis (PrEP) and postexposure prophylaxis (PEP) program developed in collaboration with the San Francisco Department of Public Health (SFDPH). SETTING: A community pharmacy in San Francisco and the SFDPH developed a collaborative practice agreement (CPA) that allowed community pharmacists to initiate PrEP and PEP to prevent HIV acquisition and increase uptake in vulnerable populations. PRACTICE DESCRIPTION: A community pharmacy in San Francisco's Mission District, an urban, historically Hispanic/Latino/Latinx neighborhood. The primary collaborative practice team consisted of 1 community pharmacy technician, 4 community pharmacists, and 1 designated overseeing physician at SFDPH. PRACTICE INNOVATION: The pharmacy and the SFDPH collaborated together for 20 months from start to implementation of the CPA and the PrEP program. An interdisciplinary team of pharmacists, pharmacy personnel, public health physicians, and health department staff members worked together to design, launch, and maintain the program. Pharmacists were trained by SFDPH staff members on HIV testing and counseling and implementation of the PrEP protocol, including PEP initiation and sexually transmitted disease testing. A Department of Public Health secure portal was used to share patient information. An SFDPH physician reviewed patients' charts regularly and communicated with PrEP pharmacists as needed. RESULTS: Between April 2018 and the end of March 2019, 6 patients received PEP and 53 patients completed a PrEP initiation visit, of whom 96% (n = 51) filled their prescription. Approximately 47% (n = 24) of clients who started PrEP self-identified as Hispanic or Latino, 10% (n = 5) were black or African American, and 82% (n = 42) identified as men who have sex with men. CONCLUSION: Implementation of a CPA between a community pharmacy and a local health department enabled the launch of pharmacist-delivered PrEP, further expanding the landscape of access points to vulnerable populations in San Francisco.

Home Screening for Bacterial Vaginosis to Prevent Sexually Transmitted Diseases.

BACKGROUND: Longitudinal studies have consistently found a significant association between bacterial vaginosis (BV) and acquisition of sexually transmitted diseases. However, there are limited prospective data to confirm these findings. METHODS: We conducted a prospective, randomized, open-label trial of home screening and treatment of young women with asymptomatic BV who were also at high risk for sexually transmitted diseases. These women were screened every 2 months for 12 months and randomized to treatment with oral metronidazole 500 mg twice daily for 7 days or observation alone. The primary outcome was the incidence of gonorrhea and/or chlamydia. RESULTS: A total of 1365 subjects were enrolled in the study across 10 sites. Adherence with mailing specimens obtained at home was excellent in both groups (84%-88%). The incidence of gonorrhea and/or chlamydia was 19.1 per 100 person-years (95% confidence interval, 15.1-22.1) for the treatment group and 18.5 per 100 person-years (15.1-22.8) for the observation arm, a difference that was not statistically significant. CONCLUSIONS: Young women were very amenable to home screening for BV, gonorrhea, and chlamydia. Treatment of asymptomatic BV with 1 week of oral metronidazole did not decrease the incidence of gonorrhea and/or chlamydia. CLINICAL TRIALS REGISTRATION: NCT00667368.

Preexposure Prophylaxis for HIV Infection Integrated With Municipal- and Community-Based Sexual Health Services.

IMPORTANCE: Several randomized clinical trials have demonstrated the efficacy of preexposure prophylaxis (PrEP) in preventing human immunodeficiency virus (HIV) acquisition. Little is known about adherence to the regimen, sexual practices, and overall effectiveness when PrEP is implemented in clinics that treat sexually transmitted infections (STIs) and community-based clinics serving men who have sex with men (MSM). OBJECTIVE: To assess PrEP adherence, sexual behaviors, and the incidence of STIs and HIV infection in a cohort of MSM and transgender women initiating PrEP in the United States. DESIGN, SETTING, AND PARTICIPANTS: Demonstration project conducted from October 1, 2012, through February 10, 2015 (last date of follow-up), among 557 MSM and transgender women in 2 STI clinics in San Francisco, California, and Miami, Florida, and a community health center in Washington, DC. Data were analyzed from December 18, 2014, through August 8, 2015. INTERVENTIONS: A combination of daily, oral tenofovir disoproxil fumarate and emtricitabine was provided free of charge for 48 weeks. All participants received HIV testing, brief client-centered counseling, and clinical monitoring. MAIN OUTCOMES AND MEASURES: Concentrations of tenofovir diphosphate in dried blood spot samples, self-reported numbers of anal sex partners and episodes of condomless receptive anal sex, and incidence of STI and HIV acquisition. RESULTS: Overall, 557 participants initiated PrEP, and 437 of these (78.5%) were retained through 48 weeks. Based on the findings from the 294 participants who underwent measurement of tenofovir diphosphate levels, 80.0% to 85.6% had protective levels (consistent with ≥4 doses/wk) at follow-up visits. African American participants (56.8% of visits; P = .003) and those from the Miami site (65.1% of visits; P < .001) were less likely to have protective levels, whereas those with stable housing (86.8%; P = .02) and those reporting at least 2 condomless anal sex partners in the past 3 months (88.6%; P = .01) were more likely to have protective levels. The mean number of anal sex partners declined during follow-up from 10.9 to 9.3, whereas the proportion engaging in condomless receptive anal sex remained stable at 65.5% to 65.6%. Overall STI incidence was high (90 per 100 person-years) but did not increase over time. Two individuals became HIV infected during follow-up (HIV incidence, 0.43 [95% CI, 0.05-1.54] infections per 100 person-years); both had tenofovir diphosphate levels consistent with fewer than 2 doses/wk at seroconversion. CONCLUSIONS AND RELEVANCE: The incidence of HIV acquisition was extremely low despite a high incidence of STIs in a large US PrEP demonstration project. Adherence was higher among those participants who reported more risk behaviors. Interventions that address racial and geographic disparities and housing instability may increase the impact of PrEP.

High interest in preexposure prophylaxis among men who have sex with men at risk for HIV infection: baseline data from the US PrEP demonstration project.

BACKGROUND: Preexposure prophylaxis (PrEP) is the first biomedical intervention with proven efficacy to reduce HIV acquisition in men who have sex with men (MSM) and transgender women. Little is known about levels of interest and characteristics of individuals who elect to take PrEP in real-world clinical settings. METHODS: The US PrEP Demonstration Project is a prospective open-label cohort study assessing PrEP delivery in municipal sexually transmitted disease clinics in San Francisco and Miami and a community health center in Washington, DC. HIV-uninfected MSM and transgender women seeking sexual health services at participating clinics were assessed for eligibility and offered up to 48 weeks of emtricitabine/tenofovir for PrEP. Predictors of enrollment were assessed using a multivariable Poisson regression model, and characteristics of enrolled participants are described. RESULTS: Of 1069 clients assessed for participation, 921 were potentially eligible and 557 (60.5%) enrolled. In multivariable analyses, participants from Miami (adjusted Relative Risk [aRR]: 1.53; 95% confidence interval [CI]: 1.33 to 1.75) or DC (aRR: 1.33; 95% CI: 1.2 to 1.47), those who were self-referred (aRR: 1.48; 95% CI: 1.32 to 1.66), those with previous PrEP awareness (aRR: 1.56; 95% CI: 1.05 to 2.33), and those reporting >1 episode of anal sex with an HIV-infected partner in the last 12 months (aRR: 1.20; 95% CI: 1.09 to 1.33) were more likely to enroll. Almost all (98%) enrolled participants were MSM, and at baseline, 63.5% reported condomless receptive anal sex in the previous 3 months. CONCLUSIONS: Interest in PrEP is high among a diverse population of MSM at risk for HIV infection when offered in sexually transmitted disease and community health clinics.