A Retrospective Comparison of HIV Pre-exposure Prophylaxis (PrEP) Outcomes Between a Pharmacist-led Telehealth Clinic and In-person Clinic in a Veteran Population.

Pre-exposure prophylaxis (PrEP) reduces human immunodeficiency virus (HIV) transmission through sexual contact by at least 90% when taken as prescribed. This retrospective cohort study evaluated differences in adherence to PrEP medication and monitoring between the physician- and nurse practitioner (NP)-led in-person setting and the pharmacist-led telehealth setting among patients followed by the infectious diseases clinic at the VA Eastern Colorado Health Care System from July 2012 to February 2021. The primary outcomes were PrEP tablets filled per person-year, serum creatinine (SCr) tests per person-year, and HIV screens per person-year. Secondary outcomes included sexually transmitted infection (STI) screens per person-year and patients lost to follow-up.149 patients were included in the study, with 167 person-years in the in-person cohort and 153 person-years in the telehealth cohort. Adherence to PrEP medications and monitoring was similar between in-person and telehealth clinics. PrEP tablets filled per person-year was 324 in the in-person cohort and 321 in the telehealth cohort (RR = 0.99; 95% CI, 0.98-1.00). SCr screens per person-year was 3.51 in the in-person cohort and 3.37 in the telehealth cohort (RR = 0.96; 95% CI, 0.85-1.07). HIV screens per person-year was 3.55 in the in-person cohort and 3.38 in the telehealth cohort (RR = 0.95; 95% CI, 0.85-1.07). There were no new HIV infections. Additionally, patients were less likely to be lost to follow-up when followed via telehealth (11.9% vs. 30.0%), Χ2 (1, N = 149) = 6.85, p = 0.009. These findings indicate that pharmacist-driven delivery of PrEP via telehealth can be used to increase access to PrEP without sacrificing quality of care.

Lopinavir and tenofovir interaction observed in non-pregnant adults altered during pregnancy.

WHAT IS KNOWN AND OBJECTIVE: Tenofovir exposure is increased in non-pregnant adults when tenofovir disoproxil fumarate is coadministered with lopinavir/ritonavir. In pregnant women, tenofovir exposure is decreased. Our objective is to describe the effect of lopinavir/ritonavir on tenofovir pharmacokinetics during pregnancy. METHODS: Data were collected through the International Maternal Pediatric and Adolescent AIDS Clinical Trials (IMPAACT) Network P1026s protocol. This was a nonrandomized, open-label, parallel-group and multicentre phase-IV prospective study in pregnant women with HIV. Intensive steady-state 24-h pharmacokinetic profiles were collected during the third trimester of pregnancy and postpartum. Tenofovir was measured in plasma using validated liquid chromatography-mass spectrometry method (quantification limit: 10 ng/ml). Statistical tests compared paired and between group pharmacokinetic data. RESULTS AND DISCUSSION: In women not receiving lopinavir/ritonavir (n = 28), tenofovir AUC0-24 was 27% lower (2.2 mcg·h/ml vs 2.8 mcg·h/ml, p = 0.002) and oral clearance was 27% higher (61 L/h vs 48 L/h, p = 0.001) during the third trimester compared to paired postpartum data. In women receiving lopinavir/ritonavir (n = 10), tenofovir AUC0-24 and oral clearance were not different antepartum compared to postpartum. Women with and women without concomitant lopinavir/ritonavir displayed no significant differences in postpartum tenofovir pharmacokinetics. WHAT IS NEW AND CONCLUSION: Tenofovir exposure during the third trimester was reduced compared to postpartum in pregnant women not receiving lopinavir/ritonavir, but not in pregnant women also receiving lopinavir/ritonavir. Our findings suggest that pregnancy confounds the expected decrease in tenofovir exposure with concomitant lopinavir/ritonavir in non-pregnant adults. These findings illustrate the need for drug-drug interaction studies in pregnant women as drug disposition differs significantly in pregnant women compared to non-pregnant adults.

Evaluation of a Multidrug Assay for Monitoring Adherence to a Regimen for HIV Preexposure Prophylaxis in a Clinical Study, HIV Prevention Trials Network 073.

Daily oral tenofovir disoproxil fumarate (TDF)-emtricitabine (FTC) is a safe and effective intervention for HIV preexposure prophylaxis (PrEP). We evaluated the performance of a qualitative assay that detects 20 antiretroviral (ARV) drugs (multidrug assay) in assessing recent PrEP exposure (detection limit, 2 to 20 ng/ml). Samples were obtained from 216 Black men who have sex with men (208 HIV-uninfected men and 8 seroconverters) who were enrolled in a study in the United States evaluating the acceptability of TDF-FTC PrEP (165 of the uninfected men and 5 of the seroconverters accepted PrEP). Samples from 163 of the 165 HIV-uninfected men who accepted PrEP and samples from all 8 seroconverters were also tested for tenofovir (TFV) and FTC using a quantitative assay (detection limit for both drugs, 0.31 ng/ml). HIV drug resistance was assessed in seroconverter samples. The multidrug assay detected TFV and/or FTC in 3 (1.4%) of the 208 uninfected men at enrollment, 84 (40.4%) of the 208 uninfected men at the last study visit, and 1 (12.5%) of the 8 seroconverters. No other ARV drugs were detected. The quantitative assay confirmed all positive results from the multidrug assay and detected TFV and/or FTC in 9 additional samples (TFV range, 0.65 to 16.5 ng/ml; FTC range, 0.33 to 14.6 ng/ml). Resistance mutations were detected in 4 of the 8 seroconverter samples. The multidrug assay had 100% sensitivity and specificity for detecting TFV and FTC at drug concentrations consistent with daily PrEP use. The quantitative assay detected TFV and FTC at lower levels, which also might have provided protection against HIV infection.

Urine assay for tenofovir to monitor adherence in real time to tenofovir disoproxil fumarate/emtricitabine as pre-exposure prophylaxis.

OBJECTIVES: Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) is approved for pre-exposure prophylaxis (PrEP) against HIV infection. Adherence is critical for the success of PrEP, but current adherence measurements are inadequate for real-time adherence monitoring. We developed and validated a urine assay to measure tenofovir (TFV) to objectively monitor adherence to PrEP. METHODS: We developed a urine assay using high-performance liquid chromatography coupled to tandem mass spectrometry with high sensitivity/specificity for TFV that allowed us to determine TFV concentrations in log10 categories between 0 and 10 000 ng/mL. We validated the assay in three cohorts: (1) HIV-positive subjects with undetectable viral loads on a TDF/FTC-based regimen, (2) healthy HIV-negative subjects who received a single dose of TDF/FTC, and (3) HIV-negative subjects receiving daily TDF/FTC as PrEP for 24 weeks. RESULTS: The urine assay detected TFV with greater sensitivity than plasma-based measures and with a window of measurements within 7 days of the last TDF/FTC dose. Based on the urine log-linear clearance after the last dose and its concordance with all detectable plasma levels, a urine TFV concentration > 1000 ng/mL was identified as highly predictive of the presence of TFV in plasma at > 10 ng/mL. The urine assay was able to distinguish high and low adherence patterns within the last 48 h (> 1000 ng/mL versus 10-1000 ng/mL), as well as nonadherence (< 10 ng/mL) extended over at least 1 week prior to measurement. CONCLUSIONS: We provide proof of concept that a semiquantitative urine assay measuring levels of TFV could be further developed into a point-of-care test and be a useful tool to monitor adherence to PrEP.

Combination Emtricitabine and Tenofovir Disoproxil Fumarate Prevents Vaginal Simian/Human Immunodeficiency Virus Infection in Macaques Harboring Chlamydia trachomatis and Trichomonas vaginalis.

Genital inflammation associated with sexually transmitted infections increases susceptibility to human immunodeficiency virus (HIV), but it is unclear whether the increased risk can reduce the efficacy of pre-exposure prophylaxis (PrEP). We investigated whether coinfection of macaques with Chlamydia trachomatis and Trichomonas vaginalis decreases the prophylactic efficacy of oral emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF). Macaques were exposed to simian/human immunodeficiency virus (SHIV) vaginally each week for up to 16 weeks and received placebo or FTC/TDF pericoitally. All animals in the placebo group were infected with SHIV, while 4 of 6 PrEP recipients remained uninfected (P= .03). Oral FTC/TDF maintains efficacy in a macaque model of sexually transmitted coinfection, although the infection of 2 macaques signals a modest loss of PrEP activity.

Infection with the frequently transmitted HIV-1 M41L variant has no influence on selection of tenofovir resistance.

OBJECTIVES: In ∼10% of newly diagnosed HIV-1 patients, drug-resistant viral variants are detected. In such transmitted HIV-1 variants, the thymidine analogue mutation (TAM) M41L is frequently observed as a single resistance mutation and these viral variants often belong to phylogenetic transmission clusters. The presence of at least three TAMs, in particular patterns with M41L/L210W, impairs the efficacy of the extensively used drug tenofovir. We investigated whether the presence of a single M41L mutation at baseline influences the selection of resistance to tenofovir and emtricitabine in vitro and in vivo. METHODS: The impact of M41L on the development of drug resistance to tenofovir and emtricitabine was determined by extensive in vitro selection experiments and investigation of the virological outcome of patients on a first-line regimen. RESULTS: The presence of a single M41L mutation did not influence the selected mutational profile or the genetic barrier to resistance to tenofovir and/or emtricitabine during long-term in vitro selection experiments. In vivo, virological outcome of first-line regimens containing tenofovir and emtricitabine was comparable between patients diagnosed with HIV-1 harbouring M41L (n=17, 16 were part of one transmission cluster) and WT virus (n=248). CONCLUSIONS: Detection of a single M41L reverse transcriptase mutation at baseline did not influence the development of resistance in vitro or virological outcome on tenofovir-containing regimens in patients belonging to a large transmission cluster. Our results indicate that a high genetic barrier regimen may not be required when patients are diagnosed with HIV variants containing a single M41L mutation in reverse transcriptase.

Willingness to Take PrEP and Potential for Risk Compensation Among Highly Sexually Active Gay and Bisexual Men.

Once-daily Truvada (Emtricitabine/Tenofovir) as a method of pre-exposure prophylaxis (PrEP) is one of the most promising biomedical interventions to eliminate new HIV infections; however, uptake among gay, bisexual, and other men who have sex with men has been slow amidst growing concern in popular/social media that PrEP use will result in reduced condom use (i.e., risk compensation). We investigated demographic, behavioral, and psychosocial differences in willingness to use PrEP as well as the perceived impact of PrEP on participants' condom use in a sample of 206 highly sexually active HIV-negative gay and bisexual men. Nearly half (46.1 %) said they would be willing to take PrEP if it were provided at no cost. Although men willing to take PrEP (vs. others) reported similar numbers of recent casual male partners (<6 weeks), they had higher odds of recent receptive condomless anal sex (CAS)-i.e., those already at high risk of contracting HIV were more willing to take PrEP. Neither age, race/ethnicity, nor income were associated with willingness to take PrEP, suggesting equal acceptability among subpopulations that are experiencing disparities in HIV incidence. There was limited evidence to suggest men would risk compensate. Only 10 % of men who had not engaged in recent CAS felt that PrEP would result in them starting to have CAS. Men who had not tested for HIV recently were also significantly more likely than others to indicate willingness to take PrEP. Offering PrEP to men who test infrequently may serve to engage them more in routine HIV/STI testing and create a continued dialogue around sexual health between patient and provider in order to prevent HIV infection.

The acyclic nucleoside phosphonates (ANPs): Antonín Holý's legacy.

The name of Antonín Holý has become synonymous for the era of acyclic nucleoside phosphonates (ANPs), which started with (S)-HPMPA as the prototype and (S)-HPMPC (cidofovir) as the first marketed compound. It has now evolved to a number of compounds clinically used in the treatment of HIV and hepatitis B virus infections, either as such [tenofovir disoproxil fumarate (TDF, Viread®)] or in combination [Truvada®, Atripla®, Complera®, Stribild®]. Truvada has also been approved for the prevention of HIV infections. Forthcoming is a new formulation of tenofovir (TAF: tenofovir alafenamide). Also forthcoming are several "quad" drug combinations containing either TDF or TAF. Other ANPs, based on either an alkoxy side chain or 5-azacytosine heterocycle seem highly promising and worth further pursuing.

Efficacy and Safety of Pre-Exposure Prophylaxis to Control HIV and Sexually Transmitted Infection Among Men Who Have Sex With Men: Protocol for a Single-Arm Interventional Study.

BACKGROUND: Pre-exposure prophylaxis (PrEP) against HIV infection is a new approach that involves the prophylactic use of the anti-HIV drug Truvada (tenofovir disoproxil fumarate [TDF] and emtricitabine [FTC]) by people not infected with HIV. OBJECTIVE: The objective of this investigator-initiated clinical study of PrEP was to evaluate the incidence of HIV and sexually transmitted infection (STI), safety and efficacy of PrEP in PrEP users, and their compliance with PrEP medication. The social, medical, and economic benefits of PrEP in Japan was assessed. METHODS: This single-center feasibility study of PrEP was conducted at the National Center for Global Health and Medicine, Tokyo, Japan, where a cohort of men who have sex with men without HIV was established in January 2017. This single-arm interventional study compared the efficacy and safety of PrEP in a single group of men who have sex with men who participated in PrEP cohort studies. For reference, the cohort study participants who did not participate in the PrEP study were included for comparison. Blood samples were collected for storage at baseline and clinic visits at 1, 3, and 6 months after starting PrEP and every 3 months thereafter. The participants were administered with 1 tablet of Truvada once daily as PrEP. They underwent blood and anal swab tests 1 and 3 months after starting PrEP and then HIV and STI infection assessments at 3-month intervals. Blood samples were centrifuged at the AIDS Clinical Center Laboratory. PrEP safety was evaluated by monitoring serum creatinine levels for symptoms of renal function disorders. The primary end point was the incidence of HIV in PrEP users (100 person-years). The secondary end points were the incidence of STI in PrEP users (100 person-years), incidence of adverse events caused by Truvada, frequency of high-risk sexual activity, and adherence to periodic visits and medication. RESULTS: The study protocol was reviewed and approved by the certified review board of the National Center for Global Health and Medicine (NCGM-C-003129-03) on April 20, 2020. Changes to the study plan were submitted for review by the certified review board and approved before implementation. Recruitment was completed on March 28, 2019, and the study was completed (last adult participant and last time point) on March 31, 2021. The data were analyzed, and the main results of the study have been published in a peer-reviewed journal. CONCLUSIONS: The findings indicated that PrEP is a highly effective and feasible strategy against HIV infection in terms of prophylactic response, retention, and compliance. TRIAL REGISTRATION: UMIN Clinical Trials Registry UMIN000031040; https://tinyurl.com/3msdkeb8 and Japan Registry of Clinical Trials jRCTs031180134; https://tinyurl.com/2p88mhyr. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/50919.

Pre-exposure prophylaxis in real life: experience from a prospective, observational and demonstration project among men who have sex with men in Benin, West Africa.

INTRODUCTION: Since many countries in sub-Saharan Africa are willing to implement HIV oral pre-exposure prophylaxis (PrEP) for men who have sex with men (MSM), data are needed to assess its feasibility and relevance in real life. The study objectives were to assess drug uptake, adherence, condom use and number of sexual partners, HIV incidence and trends in the prevalence of gonorrhoea and chlamydia. METHODS: In this oral PrEP demonstration study conducted prospectively in Benin, a combination of tenofovir disoproxil fumarate-TDF 300 mg and emtricitabine-FTC 200 mg (TDF-FTC) was offered daily or on-demand to MSM. Participants were recruited from 24 August to 24 November 2020 and followed over 12 months. At enrolment, month-6 and month-12, participants answered to a face-to-face questionnaire, underwent a physical examination and provided blood samples for HIV, gonorrhoea and chlamydia. RESULTS: Overall, 204 HIV-negative men initiated PrEP. The majority of them (80%) started with daily PrEP. Retention rates at month-3, 6, 9 and 12 were 96%, 88%, 86% and 85%, respectively. At month-6 and month-12, respectively, 49% and 51% of the men on daily PrEP achieved perfect adherence (self-reported), that is seven pills taken during the last week. For event-driven PrEP, the corresponding proportions for perfect adherence (last seven at-risk sexual episodes covered) were 81% and 80%, respectively. The mean number (standard deviation) of male sexual partners over the last 6 months was 2.1 (1.70) at baseline and 1.5 (1.27) at month-12 (p-value for trend <0.001). Consistent condom use during the last 6 months was 34% (enrolment), 37% (month-6) and 36% (month-12). Three HIV seroconversions (2-daily and 1-event-driven) were recorded. Crude HIV incidence (95% confidence interval) was 1.53 (0.31-4.50)/100 person-years. Neisseria gonorrhoeae and/or Chlamydia trachomatis prevalence at the anal and/or pharyngeal and/or urethral sites was 28% at baseline and 18% at month-12 (p-value = 0.017). CONCLUSIONS: In West Africa, oral PrEP introduction in routine practice as a component of a holistic HIV prevention package is feasible and may not result in a significant increase in condomless sex among MSM. Since HIV incidence was still higher, additional interventions, such as culturally tailored adherence counselling, may be needed to optimize the benefits of PrEP.

Single-nucleotide polymorphisms in ABC drug transporters alter expression and circulating tenofovir in healthy South African women exposed to pre-exposure prophylaxis.

Aim: We investigated if single-nucleotide polymorphisms (SNPs) in ATP-binding cassette (ABC) drug transporters alter gene expression and tenofovir disposition in South African women taking Truvada® for HIV prevention. Materials & methods: In 393 women, real-time PCR was used to determine the associations between six SNPs in ABC transporter genes, mRNA expression and circulating-tenofovir. Results: Univariable and multivariable analyses showed that CT and TT relative to CC genotypes for the ABCC4(3463C/T) SNP had significantly higher tenofovir levels. In contrast, the AA genotype for the ABCC4(4976A/G) SNP showed significantly less tenofovir, while mRNA expression was increased. Conclusion: SNPs in the ABCC4 gene may differentially affect gene expression and circulating tenofovir. Their impact may inform on low pre-exposure prophylaxis efficacy and discern effective drugs in clinical trials of African women enriched for certain genotypes.

Acknowledging and addressing the gender disparity in pre-exposure prophylaxis use for HIV prevention.

Objective: One in four persons living with HIV in the USA is a woman. While the annual HIV diagnoses for 2019 decreased by approximately 9% when compared with 2015, this decrease was seen in men, while the rates remained stable for women. Pre-exposure prophylaxis (PrEP) is one major biomedical tool that could benefit women at risk of HIV. However, women only account for approximately 5% of PrEP users annually. The objective of this study is to identify and address the gender disparity in PrEP use. Methods: This study used epidemiological data from the AIDSVu database to confirm the presence of a gender disparity in PrEP use across the USA. Cross-sectional data from 2019 showed that PrEP use was significantly higher in men, which suggested the existence of a disparity. The PrEP-to-Need ratio was then used to examine the trends in PrEP use relative to the rate of HIV infections, from 2012 to 2019, and to confirm the existence of the gender disparity in PrEP use. Key findings: There is a marked gender disparity in PrEP use. This disparity is widening and therefore demands more attention to women at risk of HIV. Some recommendations for addressing the disparity include the following: raising awareness, capacity building for providers, scaling up efforts to better reach women at risk of HIV and additional research to understand the drivers of the disparity. Conclusions: Policy makers could therefore prioritize the health outcomes of women by promoting research and education aimed at extending PrEP offerings to effectively reach women.

Employer-sponsored health insurance and labor market outcomes for men in same-sex couples: Evidence from the advent of pre-exposure prophylaxis.

In the United States, the cost of providing employer-sponsored health insurance (ESI) varies for employers based on the medical expenditures of their employees, a practice known as "experience rating". Experience rating increases the cost of employing workers who have greater medical expenditures, one example being men in same-sex couples. To study whether ESI affects labor market outcomes for men in same-sex couples, I use the 2012 advent of Pre-Exposure Prophylaxis (PrEP), a $24,000 per year drug that effectively prevents Human Immunodeficiency Virus (HIV) acquisition. Using American Community Survey data and a difference-in-difference empirical approach - comparing post-PrEP changes in earnings among men who have ESI - I find that annual earnings for men in same-sex couples decline by $2,650 (approximately 3.9%) relative to comparable men after PrEP becomes available. For those who are most likely to be taking Truvada (the brand name for PrEP), such as young men and white men, effects on earnings are considerably larger. I also observe a 3.7 percentage point (4.6%) decline in ESI prevalence and a 0.8 percentage point (10.7%) increase in part-time employment among men in same-sex couples. Event studies provide support for a causal interpretation for my findings. My estimates are also robust to placebo analyses, various specification permutations, and a range of sensitivity checks.

HIV Post Exposure Prophylaxis and Risk of Relapse in Adolescent With Bipolar Illness and Psychopharmacologic Challenges.

Bipolar disorder (BD) in adolescents is associated with risky behaviors, including high risk for sexually transmitted infections. When exposed, post exposure prophylaxis (PEP) is recommended within 72 hours for a period of 28 days. The medications used for PEP are known to have common neuropsychiatric side effects, renal toxicity and risk of hepatic injury. The concomitant use of PEP and bipolar medications may have serious additive adverse effects which needs careful assessment and monitoring. PEP medications, in particular raltegravir, are known to have a common side effect of insomnia. The medication options may be more limited during this period and since insomnia is also known to precipitate mania it needs to be addressed. The knowledge of these side effects of PEP medications, understanding its interactions with mood stabilizers like lithium and valproic acid is important when caring for these individuals. The medication options of monotherapy or combination regimen for BD must be discussed with the patient and informed choices would yield better clinical outcomes. Although there is no established standard, but weekly monitoring of complete blood counts and liver functions until PEP is completed would be highly recommended to prevent serious negative events.

The effectiveness of tenofovir-based pre-exposure prophylaxis for prevention of HIV acquisition among sub-Saharan African women at high risk: a systematic review.

INTRODUCTION: women in sub-Saharan Africa (SSA) are disproportionately affected by the HIV epidemic. In 2019, they constituted 59% of new infections; thus, they remain a key population for control. Public health interventions to prevent acquisition of HIV in this high-risk population are urgently needed. Tenofovir-based pre-exposure prophylaxis (TFV-PrEP) has been shown to reduce HIV infections in other key populations. However, comprehensive evidence regarding TFV-PrEP effectiveness in women living in SSA has not been determined. Therefore, we undertook a systematic review to determine the effectiveness of tenofovir-1% (TFV-1%) vaginal gel, oral tenofovir (TFV) and tenofovir-emtricitabine (TDF-FTC) pre-exposure prophylaxis for primary acquisition of HIV in at-risk women living in SSA. METHODS: OVID Medline, Embase, CENTRAL, Web of Science and Clinical Trials.gov were searched for eligible studies from 1st January 2020 to 31st July 2020. Only randomised controlled trials (RCTs) conducted in women living in SSA were included. Measures of effectiveness (hazard ratios (HR), incidence rate ratios (IRR)) were extracted from individual studies to determine the effectiveness of TFV-PrEP in preventing HIV infection among at-risk women living in SSA. RESULTS: from 2002 non-duplicate articles, four RCTs evaluating the effectiveness of one or more of the interventions against placebos were included. TFV-1% vaginal gel, oral TDF or TDF-FTC were not effective in preventing the acquisition of HIV infection in women living in SSA. However, poor adherence by study participants could have confounded the true effectiveness of TFV-PrEP in this high risk population. Meta-analysis was not conducted given the limited number of eligible studies identified from the search. CONCLUSION: the current evidence does not support the effectiveness of TFV-PrEP for HIV in SSA women. More studies aimed at addressing factors driving low adherence to HIV interventions in this high risk population are urgently needed in order to improve the design of future RCTs leading to the determination of more reliable estimates of TFV-1% vaginal gel or oral TDF or TDF-FTC effectiveness. Protocol registration: this systematic review was not registered in PROSPERO.

Perspectives on oral pre-exposure prophylaxis use amongst female sex workers in Harare, Zimbabwe.

BACKGROUND: Pre-exposure prophylaxis (PrEP) could provide protection from human immunodeficiency virus (HIV) infection in sexually active persons at risk. Limited data are available in Zimbabwe with regard to the perceptions about PrEP amongst female sex workers (FSWs). OBJECTIVES: The aim of this study was to evaluate the knowledge levels of oral PrEP and the likelihood of its use amongst FSWs. METHOD: This was a cross-sectional study in the peri-urban areas of Harare, Zimbabwe. Human immunodeficiency virus-negative FSWs were interviewed to assess their awareness of and likelihood to use PrEP. The relative importance index was used to evaluate the levels of knowledge and the likelihood of, and barriers to, PrEP use. A set of 10 questions was designed and validated that evaluated participants' understanding of PrEP. A bivariate logistic regression model was utilised to identify predictors of PrEP use. RESULTS: A total of 131 FSWs with a median age of 25 years (interquartile range: 21-31) participated in this study. Of the 71 (54%) FSWs who had heard about PrEP, 46 (35%) participants had adequate knowledge of its use. A total of 102 (78%) participants revealed that they would be willing to continuously use PrEP if it was provided free of cost. Increasing age of the participants was associated with an increase in the likelihood of using PrEP (r = 0.0033, p = 0.038). More knowledge about PrEP increased the likelihood of its use (r = 0.21, p = 0.0153). This likelihood increased amongst participants with an unprotected sexual intercourse encounter in the preceding 3 months (r = 0.0448, p = 0.026). CONCLUSION: Knowledge of PrEP amongst FSWs was low. To increase the uptake of PrEP, there is a need to further sensitise FSWs about this intervention. Programmes should also promote awareness training in FSW subgroups that are less likely to use PrEP.

Homo adhaerens: Risk and adherence in biomedical HIV prevention research.

After the turn of the millennium, HIV clinical researchers pivoted from developing and testing new antiretrovirals (ARVs) for treatment, to reconfiguring the same molecules for pre-exposure prophylaxis (PrEP). In 2012, Truvada became the first HIV therapy to also be approved by the FDA for PrEP, regarded as a magic bullet that promised to end the epidemic. However, six years after its approval, it continues to be inaccessible to those who are most vulnerable. In this article, I critically analyze HIV PrEP clinical trials, dissecting the novel techniques researchers use to demonstrate efficacy. I argue that in making sense of the interplay between adherence to a prophylactic regimen and risk for HIV, biomedical HIV prevention research has revealed a new subject of biopolitics, Homo adhaerens. In the early 2000s, clinical researchers operating in the Global South identified Homo adhaerens as the ideal subject, one who embodies both high-risk behavior and diligent adherence to a daily oral regimen. I trace the construction of Homo adhaerens to the United States, where I listen closely to activists engaged with the ongoing DISCOVER trial of PrEP. Activists either aspire for Homo adhaerens as a standard, making the liberal argument that expanding access could make PrEP successful, or they rebuke the framework of clinical research that produces narrow understandings of adherence, efficacy, and universality. Ultimately, I argue that by failing to grapple with the social realities that underlie poor adherence, PrEP clinical trials produce knowledge that is not useful for those who are most vulnerable.

Influences on willingness to use vaginal or oral HIV PrEP during pregnancy and breastfeeding in Africa: the multisite MAMMA study.

INTRODUCTION: Women in sub-Saharan Africa spend a substantial portion of their reproductive lives pregnant and/or breastfeeding (P/BF), yet they have limited options to prevent HIV during these maternal stages. In preparation for phase 3b prevention trials in P/BF women, we explored attitudes about using a vaginal ring or oral pills for pre-exposure prophylaxis (PrEP), perceptions of HIV risk during P/BF and key influences on future PrEP use. METHODS: In 2018, we conducted 16 single-sex focus group discussions (FGDs) with community- and clinic-recruited HIV-uninfected women, currently or recently P/BF, aged 18 to 40, and men with (currently or recently) P/BF partners, aged 18+. Participants completed a behavioural questionnaire, viewed an educational video and handled prototype placebo products. FGDs were conducted in local languages and transcribed, coded and analysed, using a socio-ecological framework, for key influences on willingness to use products, HIV risk perceptions and opinions on product attributes. RESULTS: Of the 128 participants (65 women, 63 men) 75% lived with their partner and 84% had a child. Women reported the most important influencers when P/BF were partners, and all stated that health decisions when P/BF are typically made jointly (e.g. medication use; ante/postnatal and baby care). There was consensus that P/BF women are at high risk for HIV, primarily because of their partner's infidelities, and new prevention options were welcomed. Participants valued multiple options and stated that woman's personal preference would be key to product choice. Anticipated concerns about products included risk of miscarriage, impact on infant development, complications during delivery and adequate production or taste of breastmilk. Specific perceived disadvantages emerged for the ring (e.g. vaginal discomfort, difficulty inserting/removing) and for pills (e.g. nausea/vomiting) that may be exacerbated during pregnancy. Health care providers' (HCPs) knowledge and approval of product use during P/BF was needed to mitigate anticipated fears. CONCLUSIONS: Participants perceived pregnancy and breastfeeding as high HIV risk periods and valued new prevention options. HIV protection of the mother-child dyad, safety of the baby, and ultimately, health of the family were paramount. Endorsement by HCPs and support from partners were key to future product acceptance. Participants recommended involving partners and HCPs in sensitization efforts for future trials.

"It's Like Birth Control for HIV": Communication and Stigma for Gay Men on PrEP.

This study focuses on how gay men communicate about pre-exposure prophylaxis (PrEP), focusing on how they learned about PrEP, how they discussed adoption with health care providers, and to what extent they have encountered stigma on social networks. In this qualitative study, 39 gay PrEP users were interviewed about PrEP. A majority of the participants learned about PrEP via friends and potential sex partners, and a majority of the participants experienced stigma from their health care provider and from other gay men online, mainly referring to promiscuity and risks of STIs. The authors recommend that health care providers should be trained in minimizing the expression of stigmatizing attitudes and should increase their knowledge of PrEP.