Pre-exposure Prophylaxis Demonstration Project Research Articles

Uptake, Retention, and Adherence to Pre-exposure Prophylaxis (PrEP) in TRIUMPH: A Peer-Led PrEP Demonstration Project for Transgender Communities in Oakland and Sacramento, California.

Background:TRIUMPH (Trans Research–Informed communities United in Mobilization for the Prevention of HIV) was a community-led, transgender-specific pre-exposure prophylaxis (PrEP) demonstration project at 2 community-based clinical sites in California. TRIUMPH used peer health education, community mobilization, and clinical integration of PrEP with hormone therapy to promote PrEP knowledge and acceptability. The goal of this study was to evaluate PrEP uptake, retention, and adherence among TRIUMPH participants and examine site-based differences.Methods:Eligible participants were adult transgender and gender diverse people interested in PrEP. Participants were seen at baseline and at 1, 3, 6, 9, and 12 months for PrEP provision, clinical visits, and HIV testing. PrEP uptake was defined as dispensation of PrEP, PrEP retention was defined as proportion of expected visits completed among those who initiated PrEP, and PrEP adherence was assessed by measuring tenofovir diphosphate concentrations in dried blood spots. Logistic regression models quantified the association of variables with PrEP outcomes.Results:TRIUMPH enrolled 185 participants; the median age was 28 years (interquartile range: 23–35), 7% was Black, and 58% was Latinx. PrEP uptake was as follows: 78% in Oakland and 98% in Sacramento; 91% among trans women, 96% among trans men, and 70% among nonbinary participants. Almost half (47%) rarely/never believed about HIV, and 42% reported condomless sex act in the past 3 months. Participants who reported higher numbers of sex partners were more likely to be retained and adherent; other predictors of adherence included not having a primary partner and not experiencing violence in the past 3 months.Conclusions:This community-led, trans-specific PrEP demonstration project documents high levels of PrEP initiation in a young transgender and gender diverse cohort at risk of HIV acquisition.

Expanding the Pie-Differentiated PrEP Delivery Models to Improve PrEP Uptake in the San Francisco Bay Area.

Background:Pre-exposure prophylaxis (PrEP) uptake among trans people to date has been low. Recommendations implemented in San Francisco to offer PrEP with feminizing hormones have not led to improvement of PrEP uptake in trans communities. New delivery models may be needed. The aim of this study was to examine whether a PrEP-only clinic was more likely to serve trans people at highest risk of HIV than trans-affirming primary care clinics.Methods:Participants were recruited between 2017 and 2019 as part of a PrEP demonstration project in the San Francisco Bay Area. Survey data including sociodemographics, HIV-related risk behavior, barriers to PrEP, and self-reported PrEP adherence were collected at baseline, 3 months, and 6 months for all participants. Bivariable Poisson regression models were used to examine differences between participants in the primary care clinics and PrEP-only clinic delivered to participants.Results:Baseline survey data were collected from 153 participants. Those with a higher number of sexual partners were significantly more likely to use the PrEP-only clinic rather than the primary care clinics. Participants with higher perceived HIV risk and those who engaged in sex work were also more likely to use the PrEP-only clinic compared with the primary care clinic. Medical mistrust was higher at baseline among participants of the PrEP-only clinic. PrEP adherence was not significantly different by delivery model. Few participants identified PrEP barriers, such as interactions with feminizing hormones, to be determinants of PrEP uptake.Conclusions:A PrEP-only delivery model could improve PrEP uptake and may better meet the needs of trans people who could most benefit from PrEP.

Pre-exposure Prophylaxis Uptake, Adherence, and Persistence: A Narrative Review of Interventions in the U.S.

Since 2012, HIV pre-exposure prophylaxis (PrEP) has been available to prevent HIV transmission; yet, uptake, adherence, and persistence to PrEP have been suboptimal. This narrative review examines the latest interventions and programs to improve all 3 stages of PrEP adherence and reviews ongoing studies to promote effective PrEP use. From 2017 to 2020, a total of 20 studies analyzed different individual- and structural-level approaches to increase PrEP adherence, including behavior change interventions, technology-based interventions (e.g., short message service messages and mobile applications), and alternate delivery strategies (e.g., pharmacy-based PrEP, integration with other services, and home delivery). Most published interventions involved men who have sex with men, although 3 assessed women (2 transgender, 1 cisgender). Randomized, controlled data support 3 behavioral change interventions and 1 technology-based intervention. Alternate delivery strategies seem promising, although more robust study designs are generally needed. In addition, data on the alignment of ongoing HIV risk and PrEP persistence (i.e., prevention-effective adherence) were limited. The authors also identified 20 ongoing studies that are promoting PrEP adherence. Future work should be inclusive of all at-risk groups in the U.S., including African American and Latinx heterosexual populations and people who inject drugs. Proven and promising approaches may work well in combination and may also need to be adapted with the introduction of long-acting pre-exposure prophylaxis formulations. Collectively, this body of work indicates considerable progress toward understanding the role PrEP adherence will play in Ending the HIV Epidemic in the U.S. that will be bolstered by the outcomes of ongoing trials.

PrEP for key populations: results from the first PrEP demonstration project in the Democratic Republic of the Congo

ABSTRACT Oral pre-exposure prophylaxis (PrEP) is recommended for persons at substantial risk for HIV, including female sex workers (FSW), men who have sex with men (MSM), people who inject drugs (PWID), and transgender women (TGW). We report on a PrEP demonstration project at seven clinics in the Democratic Republic of the Congo. Routinely collected data were abstracted to assess PrEP uptake, scheduled visit attendance, and self-reported adherence. Between February and May 2018, 469 eligible clients were offered daily oral PrEP; 75.1% accepted: 78.7% FSW, 20.5% MSM, and 0.9% TGW. Two percent also identified as PWID. Attendance was 64.5% at one-month visits; 82.1% at three-month visits; and among 47.7% of clients who initiated PrEP at least six months before data abstraction, 85.8% at six-month visits. Among 66.3% of clients with at least one adherence assessment, 39% self-reported low adherence. Results demonstrate the acceptability of PrEP delivered in healthcare settings serving FSW, MSM, PWID, and TGW.

The Costs of Creatinine Testing in the Context of a HIV Pre-Exposure Prophylaxis Demonstration Project in Eswatini

HIV treatment and prevention as well as other chronic disease care can require regular kidney function assessment based on a creatinine test. To assess the costs of creatinine testing in a public health care system, we conducted activity-based costing during a HIV pre-exposure prophylaxis (PrEP) demonstration project in the Hhohho region of Eswatini. Resource use was assessed by a laboratory technician and valued with government procurement prices, public sector salaries, and own cost estimates. Obtaining a blood sample in a clinic and performing a creatinine test in a high-throughput referral laboratory (> 660,000 blood tests, including > 120,000 creatinine tests, in 2018) were estimated to have cost, on average, $1.98 in 2018. Per test, $1.95 were variable costs ($1.38 personnel, ¢39 consumables, and ¢18 other costs) and ¢2.6 were allocated semi-fixed costs (¢1.1 laboratory equipment, ¢0.85 other, ¢0.45 consumables, and ¢1.3 personnel costs). Simulating different utilization of the laboratory indicated that semi-fixed costs of the laboratory (e.g., equipment purchase or daily calibration of the chemistry analyzer) contributed less than variable costs (e.g., per-test personnel time and test reagents) to the average creatinine test cost when certain minimum test numbers can be maintained. Our findings suggest, first, lower creatinine testing costs than previously used in cost and cost-effectiveness analyses of HIV services and, second, that investment in laboratory equipment imposed a relatively small additional cost on each performed test in the high-throughput referral laboratory.

Improved PrEP Awareness and Use among Trans Women in San Francisco, California

Transgender women face a serious risk of HIV infection. Despite this, there is limited knowledge and use of Pre-exposure prophylaxis (PrEP). We measured the continuity of prevention across services in the PrEP cascade and correlates of PrEP use among trans women in San Francisco enrolled in the 2019/20 National HIV Behavioral Surveillance Study. Knowledge and use of PrEP among trans women in San Francisco increased in recent years; almost all (94.0%) had heard about PrEP, 64.7% had discussed PrEP with a healthcare provider, and 44.8% had taken PrEP in the past 12 months. PrEP use was associated with participation in a PrEP demonstration project (aOR = 31.44, p = 0.001) and condomless receptive anal intercourse (aOR = 3.63, p = 0.024). Injection drug use was negatively associated (aOR = 0.19, p = 0.014). Efforts are needed to combat the gender-based stigma and discrimination faced by trans women, which can result in avoidance and mistrust of the medical system.

\u201cPrEP\u201ding for a PrEP demonstration project: understanding PrEP knowledge and attitudes among cisgender women

BackgroundPrior to implementing a pre-exposure prophylaxis (PrEP) demonstration study, we sought to explore cisgender women’s experiences with HIV prevention, PrEP knowledge and attitudes, and anticipated barriers and facilitators for PrEP uptake and adherence in Southern California.MethodsThree focus groups were held with cisgender women of mixed HIV serostatus in San Diego and Los Angeles between November 2015 and January 2016. Women were recruited through local testing sites, community-based organizations, and social media. Focus groups were audio-recorded and transcripts were analyzed using thematic analysis.ResultsTwenty-two women participated in focus groups, with median age 44 (IQR 30–53) and 6 identifying as non-Hispanic Black, 7 non-Hispanic White, 8 Latina and 1 mixed race. Despite limited prior PrEP knowledge and no PrEP experience, participants expressed interest in taking PrEP. Anticipated benefits were freedom from worry about HIV and control over sexual health; however, these were tempered by concerns including the possibility of increased HIV risk behaviors and potential side effects. Cisgender women reported potential barriers to PrEP uptake and adherence barriers, like competing priorities and poor PrEP access. Conversely, PrEP facilitators included utilizing practical tools such as phone apps and pill boxes as well as receiving encouragement from loved ones and support from other cisgender women on PrEP, women living with HIV and their medical providers.ConclusionsAlthough PrEP awareness was low, participants recognized the importance of PrEP and ways to facilitate adherence. Exploring perspectives of cisgender women is integral to developing effective interventions to support PrEP uptake and adherence for women at elevated risk for HIV.

Salient Constructs for the Development of Shared Decision-Making Tools for HIV Pre-Exposure Prophylaxis Uptake and Regimen Choice: Behaviors, Behavioral Skills, and Beliefs.

The availability of multiple pre-exposure prophylaxis (PrEP) regimens creates a preference-sensitive choice for individuals weighing alternative HIV prevention strategies. Investigating factors that are associated with PrEP uptake and regimen choice are key to developing tools to support that decision. A cross-sectional survey was offered to 536 participants in a PrEP demonstration project for gay, bisexual, and other men who have sex with men across 3 cities in China, of which 412 completed surveys and were included in the analysis. We conducted bivariable analyses followed by multi-variable logistic regressions to examine factors associated with overall PrEP uptake and PrEP regimen choice. Among the 412 participants, 36.9% were daily PrEP users, 28.4% were event-driven users, and 34.7% were non-PrEP users. Higher levels of education, lower PrEP use stigma, and higher perceived benefits of PrEP were associated with greater PrEP uptake. More frequent sex, higher PrEP adherence self-efficacy, higher endorsement of the belief in elevated efficacy of daily over on-demand PrEP, and lower endorsement of a desire for a PrEP method that is only taken when needed led to greater odds of choosing the daily PrEP regimen. As multiple HIV prevention modalities become available, there is a greater need for a shared decision-making approach to support this preference-sensitive choice of HIV prevention method. Our findings suggest salient constructs to inform the development of shared decision-making tools to support regimen choice.

The Influence of PrEP-Related Stigma and Social Support on PrEP-Use Disclosure among Women Who Inject Drugs and Social Network Members.

Pre-exposure prophylaxis (PrEP) is a promising but underutilized HIV prevention strategy for Women who Inject Drugs (WWID). Stigma and disclosure concerns have been key barriers to PrEP use among women in PrEP efficacy trials. Social support has been found to buffer against some PrEP stigma, though these factors have been largely unexplored among WWID. Investigating how WWID disclose PrEP use is important given evidence that disclosure is associated with higher adherence. We aimed to identify the impact of stigma and support on PrEP disclosure within social networks of WWID participating in a PrEP demonstration project in Philadelphia, PA, USA. PrEP-using WWID ≥ 18years completed social network surveys. Generalized estimating equations were used to account for the correlation of network structure. Thirty-nine WWID (i.e. egos) named an average of 9.5 ± 3.3 network members (i.e. alters), for a total sample of 371 unique relationships. Egos disclosed their PrEP use to an average of 4.0 alters (SD = 2.8). Related to PrEP stigma, participants had 0.4 times decreased odds of PrEP disclosure with alters who would disapprove of them taking PrEP (95% CI: 0.1-0.9). Related to support, participants had 2.5 times higher odds of disclosure among peers who could provide PrEP advice (95% CI: 1.0-6.0). Interventions that increase social support and decrease stigma are pivotal for increasing PrEP use disclosure among WWID.

The social meanings of PrEP use - A mixed-method study of PrEP use disclosure in Antwerp and Amsterdam.

Pre-Exposure Prophylaxis (PrEP) is a novel HIV prevention tool. PrEP stigma is a frequently reported barrier, while social disclosure of PrEP use may be an important facilitator. We explored how PrEP users managed PrEP use disclosure using a symbolic interactionist approach. We interviewed 32 participants from two PrEP demonstration projects (Be-PrEP-ared, Antwerp; AMPrEP, Amsterdam). We validated qualitative findings through Be-PrEP-ared questionnaire data. A minority of participants had received negative reactions on PrEP. The way PrEP use was disclosed was highly dependent on the social situation. In a sexual context among MSM, PrEP use was associated with condomless sex. Friends endorsed PrEP use as a healthy choice, but also related it to carelessness and promiscuity. It was seldom disclosed to colleagues and family, which is mostly related to social norms dictating when it is acceptable to talk about sex. The study findings reveal that PrEP stigma experiences were not frequent in this population, and that PrEP users actively manage disclosure of their PrEP user status. Frequent disclosure and increased use may have helped PrEP becoming normalised in these MSM communities. To increase uptake, peer communication, community activism and framing PrEP as health promotion rather than a risk-reduction intervention may be crucial.

Improving adherence to daily preexposure prophylaxis among MSM in Amsterdam by providing feedback via a mobile application.

Improving adherence to preexposure prophylaxis (PrEP) by providing automated feedback on self-reported PrEP use via a mobile application (app). Randomized clinical trial among MSM participating in the Amsterdam PrEP demonstration project (AMPrEP). Eligible participants were randomized 1 : 1 to the control or intervention app. Both allowed daily reporting of sexual behaviour and medication intake; the intervention app also provided visual feedback. Dried blood spots collected at 12 and 24 months yielded intracellular tenofovir diphosphate concentrations (TFV-DP). We assessed proportions of participants with poor (TFV-DP <700 fmol/punch; primary outcome), good (TFV-DP ≥700 fmol/punch) and excellent (TFV-DP ≥1250 fmol/punch; secondary outcome) adherence at both time-points, and the association with the control or intervention app. We randomized 229 participants, 118 to the intervention and 111 to the control arm. The primary, per-protocol, analysis included 83 participants per arm. In total, 22/166 (13%) of participants adhered poorly, 144/166 (87%) good and 66/166 (40%) excellently. App feedback did not result in a lower proportion of participants with poor adherence [control: 9 of 83 (11%); intervention: 13 of 83 (16%); P = 0.36]. App feedback did result in a larger proportion of participants with excellent adherence [control: 26/83 (31%); intervention: 40/83 (48%); P = 0.026]. In this highly adherent population, app feedback did not improve the proportion of participants with poor adherence to PrEP.Clinical Trial Number Netherlands Trial Register: NL5413.

Results from a Pre-exposure Prophylaxis Demonstration Project for At-risk Cisgender Women in the United States.

Daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) is effective for reducing human immunodeficiency virus (HIV) acquisition among cisgender women. We report results from the first US observational open-label demonstration project of pre-exposure prophylaxis (PrEP) among at-risk cisgender women. Adherence Enhancement Guided by Individualized Texting and Drug Levels was a 48-week, single-arm, open-label demonstration study of daily oral TDF/FTC in cisgender women ≥18 years old at risk for HIV. Adherence was supported using 2-way text messaging and titrated adherence counseling based on rapid-turnaround tenofovir diphosphate concentrations from dried blood spots. Study visits occurred at baseline, weeks 4 and 12, and quarterly through week 48. Outcomes included TDF/FTC adherence, retention, and persistence. From June 2016 to October 2018, 136 cisgender women enrolled (mean age, 40 years (standard deviation, 11); 38% non-Hispanic Black and 19% Latina). At 48 weeks, 84 (62%) participants were retained and 62 (46%) remained on PrEP. More than one-third (12/31) of those on study but off PrEP throughout the study discontinued TDF/FTC because of side effects, and 1 adverse event led to study discontinuation. Of 120 participants with drug concentrations measured, 67 (56%) had at least 1 concentration consistent with 6 doses/week; 22 (18%) had consistent ≥6 doses/week across all study visits attended. There were no incident HIV infections and 4 incident bacterial sexually transmitted infections. Adequate PrEP adherence for protective drug concentrations was not achieved for most study participants. More work needs to be done to fully explicate the reasons for nonadherence and low retention in cisgender women.

Offering a choice of daily and event-driven preexposure prophylaxis for men who have sex with men in the Netherlands: a cost-effectiveness analysis.

To assess the cost-effectiveness of a preexposure prophylaxis (PrEP) programme offering a choice of daily and event-driven PrEP for men who have sex with men (MSM) in the Netherlands. We used an agent-based transmission model and an economic model to simulate a programme offering only daily PrEP and a programme offering daily and event-driven PrEP. Use of PrEP medication and preference for daily versus event-driven PrEP were estimated from the Amsterdam PrEP Demonstration Project (AMPrEP). We calculated costs, quality-adjusted life-years (QALY), and incremental cost-effectiveness ratios (ICER), over 2018-2027. An ICER less than €20 000 per QALY gained was considered cost-effective. Using AMPrEP data, we estimated that 27% of PrEP users chose event-driven PrEP with a median of 12 pills per month; daily PrEP users used a median of 30 pills per month. With PrEP, 3740 HIV infections were averted and 1482 QALYs were gained over 2018-2027, compared to the scenario without PrEP. The probability of the PrEP programme being cost-effective (compared to not having a PrEP programme) increased from 91% with daily PrEP to 94% with a choice of daily and event-driven PrEP. The probability of being cost-saving increased from 42% with only daily PrEP to 48% with choice of daily and event-driven PrEP. A daily PrEP programme for MSM would be cost-effective. Providing a choice of daily and event-driven PrEP can result in savings and is more likely to be cost-effective and cost-saving, compared to a programme offering only daily PrEP.

"PrEP just isn't my priority": Adherence challenges among women who inject drugs participating in a pre-exposure prophylaxis (PrEP) demonstration project in Philadelphia, PA USA.

Pre-exposure prophylaxis (PrEP) has the ability to curb HIV transmission among women if they are highly adherent (e.g. 6/7 weekly doses). In a recent PrEP demonstration project with 95 women who inject drugs (WWID) in Philadelphia, PA, USA, PrEP uptake was high but adherence was low. This qualitative study draws upon the Behavioral Model for Vulnerable Populations (BMVP) to describe how the context of 23 WWID's lives challenged PrEP adherence using narrative data from in-depth interviews. Content analysis suggests that women's need to organize their day around predisposing survival needs made it difficult to prioritize PrEP. Adherence was further challenged by dis-enabling structural forces such as entry into institutions that do not provide PrEP (e.g., drug treatment and correctional facilities) and medication diversion to illicit marketplaces. Overtime, women's perceived need for PrEP was dynamic: in periods they characterized as risky, women considered PrEP highly beneficial and described enhanced motivation to adhere. In periods of low perceived risk, women were less committed to continuing daily PrEP in the context of their competing survival needs. In sum, WWID faced challenges to PrEP adherence that correspond to all of the BMVP domains. To optimize PrEP for WWID, multi-level programs are needed that address the determinants that both increase HIV susceptibility and undermine adherence.

Multilevel Barriers to HIVPrEP Uptake and Adherence Among Black and Hispanic/Latinx Transgender Women in Southern California.

Black and Hispanic/Latinx transgender women in the United States (U.S.) are disproportionately affected by HIV. Pre-exposure prophylaxis (PrEP) reduces risk of HIV infection but PrEP uptake remains low among Black and Hispanic/Latinx transgender women. Between July 2018 and August 2019, we conducted individual interviews with 30 Black and Hispanic/Latinx transgender women who were prescribed PrEP through a PrEP demonstration project and 10 healthcare providers who provide PrEP services to transgender women in Los Angeles and San Diego, California. The interviews assessed general attitudes, experiences, and beliefs about PrEP as well as individual-, interpersonal-, community-, and structural-level barriers to PrEP uptake and adherence. PrEP adherence was assessed by collecting quantitative intracellular tenofovir-diphosphate (TFV-DP) levels in retrospect on batched, banked dried blood spot (DBS) samples. We utilized qualitative content analysis to identify themes from the interviews. Findings indicated the presence of individual-level barriers including cost concerns, mental health issues, substance use, and concerns about PrEP side effects including hormone interaction. Interpersonal-level barriers included the influence of intimate/romantic partners and the impact of patient-provider communication. Community-level barriers consisted of experiencing stigma and negative community opinions about PrEP use as well as having negative experiences in healthcare settings. Structural-level barriers included unreliable transportation, employment, and housing insecurity. Interventions aiming to increase PrEP uptake and adherence among Black and Hispanic/Latinx transgender women in the U.S. should employ a multilevel approach to addressing the needs of transgender women, especially the structural barriers that have greatly limited the use of PrEP.

Determinants of HIV Preexposure Prophylaxis Adherence Among Female Sex Workers in a Demonstration Study in Cotonou, Benin: A Study of Behavioral and Demographic Factors.

HIV preexposure prophylaxis (PrEP) efficacy is closely linked to adherence, and factors associated with PrEP adherence are not well understood and may differ across populations. As PrEP demonstration projects and implementation are ongoing, it is essential to understand factors associated with adherence to oral PrEP to design effective adherence interventions and maximize the public health impact of PrEP. We thus aimed to assess demographic and behavioral factors associated with optimal PrEP adherence (100%) among female sex workers (FSWs) participating in a demonstration project in Cotonou, Benin. Female sex workers were provided with daily Truvada and followed quarterly for 1 to 2 years. Sociodemographics, partners, and behaviors were collected through face-to-face questionnaires. Another questionnaire based on sexual the theory of planned behavior and the theory of interpersonal behavior was also administered. Generalized estimating equations were used to identify factors associated with optimal daily adherence. At baseline, 255 FSWs were followed up. One-year increase in age of FSWs was associated with a 3% increase in optimal adherence (prevalence ratio, 1.03; 95% confidence interval, 1.01-1.05; P for trend = 0.0003), and optimal adherence decreased by 31% for every 6 months of follow-up (prevalence ratio, 0.69; 95% confidence interval, 0.59-0.79; P for trend < 0.0001). For the participants who have completed the behavioral questionnaires, high intention to adhere to the treatment was also a predictor of optimal adherence. Efforts should be geared toward FSWs intending to use PrEP to help them reach adequate adherence levels for effective HIV protection.

Transient Changes in Pre-Exposure Prophylaxis Use and Daily Sexual Behaviour after the Implementation of COVID-19 Restrictions Among Men Who Have Sex with Men

Introduction: We assessed how the Dutch restrictions of 15-March-2020 affected sexual behaviour, pre-exposure prophylaxis (PrEP) and condom use among PrEP-users from the Amsterdam PrEP demonstration project.Methods: We used data on (1) PrEP use, (2) anal sex acts and (3) condom use, per partner type (steady [SP], known casual [KCP], unknown casual [UCP]), collected daily through a mobile application used between 1-December-2019 and 30-June-2020. We compared the period before versus after 15-March-2020 with respect to average proportion of days per week at which each endpoint was reported (multilevel logistic regression) and average proportion of anal sex acts covered by PrEP and/or condoms (bivariate probit regression). We evaluated whether the difference in sex acts were also observed before versus after the same date in the previous year.Findings: We included data from 136 MSM. After 15-March-2020, the proportion of days with anal sex increased with SP (OR=1·26;95%CI=1·10-1·44) and decreased with KCP (OR=0·73;95%CI=0·64-0·82) and UCP (OR=0·54;95%C=0·48-0·61), while these changes were not seen (SP/KCP) or less apparent (UCP) during the previous year. Shifts in partner types were most profound immediately after 15-March-2020, while returning to pre-restriction levels mid-May-2020. The proportion of days with PrEP use decreased from 74% before to 58% after 15-March-2020 (pInterpretation: MSM decreased sex acts with casual partners and increased sex acts with SP, but changes were transient. Decreases in sex with casual partners paralleled decreases in PrEP use. However, condom use during sex with casual partners decreased, indicating the importance of continued sexual health services, including STI screening and PrEP care, during COVID-19 restrictions.Trial Registration: Netherlands Trial Registry, number NL5302Funding: ZonMw, RIVM, GGD, Gilead Sciences, H-TEAM.Declaration of Interests: The study drug was donated by Gilead Sciences. EH obtained advisory board fees from Gilead Sciences, which were paid to her institute. UD obtained unrestricted research grants and speaker’s fees from Gilead Sciences, which were paid to his institution. HdV obtained a research grant from Medigene and advisory board and speaker fees from Gilead Sciences, Medigene, Abbvie, Janssen- Cilag and Willpharma, all of which were paid to his institution. MP obtained unrestricted research grants and speaker fees from Gilead Sciences, Roche, Abbvie and MSD, all of which were paid to her institution. All other authors declare no conflicts of interests.Ethics Approval Statement: The study was approved by the ethics board of the Amsterdam University Medical Centres, location Academic Medical Center (Amsterdam, the Netherlands; NL49504.018.14).

PrEP Demonstration Project Showed Superior Adherence with Tenofovir Alafenamide/Emtricitabine Compared to Tenofovir Disoproxil Fumarate/Emtricitabine in a Sample of Partnered Sexual Minority Men.

Sexual minority men (SMM) remain at high risk of HIV infection in the United States, and for those in relationships, dyadic functioning may contextualize prevention decisions. Pre-exposure prophylaxis (PrEP) for HIV prevention was previously limited to tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) until the FDA approved tenofovir alafenamide/FTC (TAF/FTC) for PrEP in 2019. Data regarding substance use, sexual behavior, holding an active PrEP prescription, and type of PrEP regimen (TDF/FTC versus TAF/FTC) were analyzed from a sample of 421 partnered SMM. The majority of the sample on PrEP reported a TDF/FTC prescription as opposed to TAF/FTC. However, SMM reported significantlybetter adherence to TAF/FTC than TDF/FTC in multivariable models. Novelty of TAF/FTC, treatment fatigue with TDF/FTC, and/or a belief in TAF/FTC's superior efficacy and mitigated side effects may be plausiblecontributingfactors. More studies using objective adherence metrics and surveys are needed.

Decision-making regarding condom use among daily and event-driven users of preexposure prophylaxis in the Netherlands.

To explore the frequency of and reasons for using condoms among men who have sex with men (MSM) on preexposure prophylaxis (PrEP). We analyzed quantitative app-based diary data on daily sexual practices (August 2015-February 2019) and qualitative in-depth interviews among MSM using daily PrEP and event-driven PrEP (edPrEP) in the Amsterdam PrEP demonstration project. Participants could report daily about sex acts, PrEP use and condom use per partner type (steady and casual partners). We examined four strategies of PrEP and condom use: PrEP only, PrEP and condoms, condoms only, and neither strategy. We compared the proportions of sex acts per strategy between PrEP regimens. In 43 in-depth interviews, we explored motives for implementing each strategy. Three hundred and fifty-two participants reported 48 949 anal sex acts. PrEP only was the most common strategy employed with any partner type (81%, n = 39 650/48 949) and was motivated by anticipating more pleasurable sex, sexually transmitted infection's perceived curability, and habituation to condomless sex. Combining PrEP and condoms was more often chosen for sex acts with casual partners (18%, n = 6829/37 317) than with steady partners (5%, n = 614/11 632) and was linked to, for example, higher perceived vulnerability for sexually transmitted infections or HIV and avoidance of PrEP disclosure. Condoms only was uncommon but occurred particularly among edPrEP users (4%, n = 379/8695). Applying neither strategy was common among edPrEP users with steady partners (25%, n = 538/2122) and was motivated by low perceived HIV risk. Condoms remain a viable option for PrEP users in certain settings. Condoms were applied in higher risk settings, to avoid PrEP disclosure, or as substitute for PrEP, especially among edPrEP users.

A stepped-wedge randomized trial and qualitative survey of HIV pre-exposure prophylaxis uptake in the Eswatini population.

Clinical trials have shown that antiretroviral drugs used as pre-exposure prophylaxis (PrEP) are highly effective for preventing HIV acquisition. PrEP efforts, including in sub-Saharan Africa, have almost exclusively focused on certain priority groups, particularly female sex workers, men having sex with men, pregnant women, serodiscordant couples, and young women. As part of a PrEP demonstration project involving the general population at six primary health care facilities in Eswatini (formerly Swaziland), we conducted a randomized trial of a health care facility-based PrEP promotion package designed to increase PrEP uptake. Over the 18-month study duration, 33.6% (517 of 1538) of adults identified by health care workers as being at risk of acquiring HIV took up PrEP, and 30.0% of these individuals attended all scheduled appointments during the first 6 months after initiation of PrEP. The PrEP promotion package was associated with a 55% (95% confidence interval, 15 to 110%; P = 0.036) relative increase in the number of individuals taking up PrEP, with an absolute increase of 2.2 individuals per month per health care facility. When asked how PrEP uptake could be improved in 217 accompanying in-depth qualitative interviews, interviewees recommended an expansion of PrEP promotion activities beyond health care facilities to communities. Although a health care facility-based promotion package improved PrEP uptake, both uptake and retention remained low. Expanding promotion activities to the community is needed to achieve greater PrEP coverage among adults at risk of HIV infection in Eswatini and similar settings.