Oral HIV Pre-exposure Prophylaxis Research Articles

Expectations of preventative benefits and risk behaviors in a randomized trial evaluating oral HIV preexposure prophylaxis candidates

ABSTRACT When participants enrolled in an HIV prevention trial hold a preventive misconception (PM) – expectations that experimental interventions will confer protection from HIV infection – they may engage in behaviors that increase their risk of acquiring HIV. This can raise ethical concerns about whether those enrolled in the trial understand the nature of participation and their safety. Consequently, we systematically evaluated the prevalence of PM and its association with risk behaviors in a trial examining three candidate regimens for oral HIV pre-exposure prophylaxis in which all participants received at least one antiretroviral agent. Overall, trial participants exhibited relatively high preventive expectations that may be associated with an increase in risk behaviors among men who have sex with men. In addition, we identified substantial site variability in PM that necessitates future research to uncover its source. This will allow appropriate measures to be taken to mitigate PM and help ensure that participants have an accurate understanding of the potential risks and benefits of trial participation throughout the course of a trial.

Acceptance of digital phenotyping linked to a digital pill system to measure PrEP adherence among men who have sex with men with substance use.

Once-daily oral HIV pre-exposure prophylaxis (PrEP) is an effective strategy to prevent HIV, but is highly dependent on adherence. Men who have sex with men (MSM) who use substances face unique challenges maintaining PrEP adherence. Digital pill systems (DPS) allow for real-time adherence measurement through ingestible sensors. Integration of DPS technology with other digital health tools, such as digital phenotyping, may improve understanding of nonadherence triggers and development of personalized adherence interventions based on ingestion behavior. This study explored the willingness of MSM with substance use to share digital phenotypic data and interact with ancillary systems in the context of DPS-measured PrEP adherence. Adult MSM on PrEP with substance use were recruited through a social networking app. Participants were introduced to DPS technology and completed an assessment to measure willingness to participate in DPS-based PrEP adherence research, contribute digital phenotyping data, and interact with ancillary systems in the context of DPS-based research. Medical mistrust, daily worry about PrEP adherence, and substance use were also assessed. Participants who identified as cisgender male and were willing to participate in DPS-based research (N = 131) were included in this subsample analysis. Most were White (76.3%) and non-Hispanic (77.9%). Participants who reported daily PrEP adherence worry had 3.7 times greater odds (95% CI: 1.03, 13.4) of willingness to share biometric data via a wearable device paired to the DPS. Participants with daily PrEP adherence worry were more likely to be willing to share smartphone data (p = 0.006) and receive text messages surrounding their daily activities (p = 0.003), compared to those with less worry. MSM with substance use disorder, who worried about PrEP adherence, were willing to use DPS technology and share data required for digital phenotyping in the context of PrEP adherence measurement. Efforts to address medical mistrust can increase advantages of this technology for HIV prevention.

Feasibility of Implementing a Low-Barrier Long-Acting Injectable Antiretroviral Program for HIV Treatment and Prevention for People Experiencing Homelessness.

Long-acting (LA) antiretrovirals may provide meaningful benefit to people who use drugs and people experiencing homelessness (PEH) who face disproportionate structural and psychosocial barriers in adhering to daily oral HIV antiretroviral therapy or pre-exposure prophylaxis (PrEP), but their use in these populations has not been studied. The Maria X. Martinez Health Resource Center is a low-barrier (eg, no appointment) community-based clinic serving San Francisco PEH. A multidisciplinary care model with robust monitoring and outreach support was developed to provide LA antiretroviral therapy (ART) and LA-PrEP to eligible patients experiencing difficulties adhering to oral antiretrovirals. Feasibility was assessed by evaluating the rates of HIV viremia and on-time injections among patients receiving LA antiretrovirals over the first 24 months of program implementation. Between November 2021 and November 2023, 33 patients initiated LA-ART or LA-PrEP (median age, 37 years; 27% transgender/nonbinary; 73% non-White; 27% street homeless; 52% sheltered homeless; 30% with opioid use disorder; 82% with methamphetamine use disorder). Among 18 patients with HIV, 14 initiated LA-ART injections with detectable viremia (median CD4 count, 340 cells/mm 3 ; mean log 10 viral load, 3.53; SD, 1.62), 8 had never previously been virally suppressed, and all but 1 achieved or maintained virologic suppression (mean, 9.67 months; SD, 8.30). Among 15 LA-PrEP patients, all remained HIV negative (mean, 4.73 months; SD, 2.89). Of 224 total injections administered, 8% were delayed >7 days. The implementation of LA antiretrovirals is feasible in low-barrier, highly supportive clinical settings serving vulnerable PEH. Expansion of such programs will be critical in ending the HIV epidemic.

Qualitative focus group discussions exploring PrEP method and service delivery preferences among female sex workers and their managers in four Zambian provinces

ObjectivesTo describe the experiences of oral HIV pre-exposure prophylaxis (PrEP) use, preferences comparing oral PrEP to future long-acting PrEP products (the dapivirine vaginal ring (PrEP ring) and injectable cabotegravir (CAB...

Estimating The Impact Of Out-Of-Pocket Cost Changes On Abandonment Of HIV Pre-Exposure Prophylaxis.

Oral HIV pre-exposure prophylaxis (PrEP) is highly effective for preventing HIV. Several different developments in the US either threaten to increase or promise to decrease PrEP out-of-pocket costs and access in the coming years. In a sample of 58,529 people with a new insurer-approved PrEP prescription, we estimated risk-adjusted percentages of patients who abandoned (did not fill) their initial prescription across six out-of-pocket cost categories. We then simulated the percentage of patients who would abandon PrEP under hypothetical changes to out-of-pocket costs, ranging from $0 to more than $500. PrEP abandonment rates of 5.5percent at $0 rose to 42.6percent at more than $500; even a small increase from $0 to $10 doubled the rate of abandonment. Conversely, abandonment rates that were 48.0percent with out-of-pocket costs of more than $500 dropped to 7.3percent when those costs were cut to $0. HIV diagnoses were two to three times higher among patients who abandoned PrEP prescriptions than among those who filled them. These results imply that recent legal challenges to the provision of PrEP with no cost sharing could substantially increase PrEP abandonment and HIV rates, upending progress on the HIV/AIDS epidemic.

Knowledge, attitudes and practices of oral HIV pre-exposure prophylaxis (PrEP) among healthcare workers in the Ekurhuleni District, South Africa.

Prevention of new HIV infections is crucial for controlling the HIV epidemic. Despite HIV pre-exposure prophylaxis (PrEP) being one of the highly effective approaches to preventing HIV, and being freely available through primary healthcare clinics (PHCs), the uptake of HIV PrEP in South Africa (SA) is low. To understand knowledge, attitudes and practices (KAPs) of healthcare workers responsible for generating demand for HIV PrEP services, or identifying clients eligible for HIV PrEP services in PHCs in Ekurhuleni District, South Africa. We conducted a cross-sectional interviewer-administered survey among healthcare workers from 45 randomly selected PHCs in Ekurhuleni District. We collected information on participant characteristics and their KAPs regarding HIV PrEP service delivery. KAP scores were developed using a priori cut-off points and participants were categorised into binary levels of KAPs. We performed descriptive and multivariable logistic regression analysis in line with the study objectives. We enrolled 160 study participants from 1 May to 30 June 2022. About two-thirds of the participants (64.4%) were highly knowledgeable about HIV PrEP, and 58.1% self-reported practices that were considered to be good. Notably, 73.1% of participants had negative attitudes toward HIV PrEP delivery. Participants who were aged >50 years had poor HIV PrEP knowledge (adjusted odds ratio (aOR) 0.1; 95% confidence interval (CI) 0.0 - 0.4; p=0.01) compared with participants <30 years old. Participants aged 30 - 40 years had poor HIV knowledge although their association is not statistically significant. Nurses had higher HIV PrEP knowledge (aOR 11.1; 95% CI 3.8 - 32.4, p<0.001) compared with health promoters. Both nurses (aOR=0.2, 95% CI 0.1 - 0.6; p<0.001) and HIV testing service counsellors (aOR 0.3; 95% CI 0.1 - 0.9; p=0.02) had negative attitudes toward HIV PrEP, compared with health promoters. Nurses had better practices in HIV PrEP delivery compared with health promoters (aOR 2.5; 95% CI 1.0 - 5.9; p=0.04). Among the healthcare workers tasked with generating demand and identifying clients eligible for HIV PrEP services, low knowledge of HIV PrEP and negative attitudes towards HIV PrEP may be barriers to the uptake of HIV PrEP. Training healthcare workers on HIV PrEP is recommended.

Family influences on oral PrEP use among adolescent girls and young women in Kenya and South Africa.

Effective use of oral HIV pre-exposure prophylaxis (PrEP) has been lower among African adolescent girls and young women (AGYW) than among older women, young men who have sex with men, and serodiscordant heterosexual couples in the region. Efforts to build PrEP support have centered around peers and male partners, but the family may also play an important role. This qualitative study aimed to describe family influence on PrEP use among AGYW in in three African cities. POWER (Prevention Options for Women Evaluation Research) was a PrEP demonstration project among 2550 AGYW (16-25 years old) in Johannesburg and Cape Town, South Africa and Kisumu, Kenya conducted from 2017 to 2020. In-depth interviews and focus group discussions were conducted with 136 AGYW participants to explore their PrEP views and experiences, including awareness and interest in PrEP; barriers and facilitators to uptake and use; the influence of family, peers, intimate partners, and community; and the key types of support for their PrEP use. Transcripts were coded and analysed thematically. The decision to initiate PrEP was associated with fear and anxiety linked to anticipated stigma from family members, and with family's lived HIV experience. Family disclosure, especially to mothers, was important to participants, as most lived with their families and considered it essential for them to obtain their mother's approval to use PrEP. Most family members, particularly mothers, provided instrumental, emotional, informational and appraisal support to participants using PrEP, including reminders, encouragement, and problem-solving. Participants reported that family members with insufficient information about PrEP safety and efficacy and who voiced concerns were a substantial barrier to their use. However, they often became supportive after receiving more PrEP information. Families, particularly mothers, can play an important role in supporting PrEP use. PrEP programmes should leverage family support to help with PrEP persistence by providing basic information to families about PrEP safety and efficacy. AGYW using PrEP should be encouraged to selectively disclose PrEP use to build support and counseled on how to disclose and address family concerns.

Uptake of Oral HIV Pre-Exposure Prophylaxis (PrEP) and Associated Factors among Female Sex Workers in Tanga, Tanzania.

Pre-exposure prophylaxis (PrEP) prevents HIV infection among female sex workers (FSW). WHO recommends the use of Tenofovir disoproxil fumarate for use in oral PrEP regimens (TDF). Emtricitabine (FTC) 200 mg/Tenofovir Disoproxil Fumarate (TDF) 300 mg (Truvada) daily is the approved PrEP regimen in Tanzania. Evidence is limited on oral PrEP uptake and its associated factors in countries with a high burden of HIV, such as Tanzania. This study aimed to examine the uptake of oral PrEP and its associated factors among FSW in the Tanga region of Tanzania. This community-based cross-sectional study was conducted among 428 FSW. Data were collected through face-to-face interviews and analysed using STATA version 17 and RDSAT. Logistic regression was used to examine the associations of independent factors and PrEP uptake among study participants. About 55% of the recruited FSW used oral PrEP. FSW with three or more children were 2.41 times more likely to take oral PrEP (AOR 2.41, 95% CI: 1.08-4.25, p < 0.05). Moreover, those with a positive attitude were more likely to use oral PrEP (AOR 2.8, 95% CI: 1.88-4.17, p < 0.05). Poor belief was a barrier to PrEP use, and side effects of the drugs were a reason for the discontinuation of PrEP services. Most of the participants preferred PrEP services to be provided in the community. Oral PrEP uptake was 55%. Efforts to scale up PrEP for FSW should address misconceptions regarding PrEP, PrEP sensitization, and improving access through community-based intervention.

Preliminary feasibility of a wrist-worn receiver to measure medication adherence via an ingestible radiofrequency sensor.

Adherence to medications is a complex task that requires complex biobehavioral support. To better provide tools to assist with medication adherence, digital pills provide an option to directly measure medication taking behaviors. These systems comprise a gelatin capsule with radiofrequency emitter, a wearable Reader that collects the radio signal and a smartphone app that collects ingestion data displays it for patients and clinicians. These systems are feasible in measuring adherence in the real-world, even in stigmatized diseases like HIV treatment adherence. While the current iteration of the digital pill system utilizes a wearable Reader worn like a necklace, preliminary feedback demonstrated that a miniaturized system that was worn on the wrist could be more functional in the real-world. This paper therefore describes the development and preliminary field testing of a wrist-borne wearable Reader to facilitate acquisition of oral HIV pre-exposure prophylaxis (PrEP) adherence data among individual prescribed PrEP.

Interrogating perceived relevance and feasibility of HIV pre-exposure prophylaxis: A novel model of PrEP acceptability among cisgender women who inject drugs

IntroductionUptake of daily oral HIV pre-exposure prophylaxis (PrEP) remains low among cisgender women who inject drugs (WWID) in the U.S., who experience elevated sexual- and injection-mediated HIV exposure risks. While anticipated barriers to PrEP uptake have been explored, further work is needed to situate PrEP acceptability (i.e., PrEP interest and willingness) within the context of WWID’s lives and the HIV risk environment. MethodsWe conducted semi-structured, in-depth interviews (N = 27) with cisgender WWID in Baltimore, Maryland, between April–September 2021. Interviews explored women’s daily survival needs, substance use practices, healthcare experiences, HIV risk perception, and PrEP perspectives. Thematic analysis revealed complex dimensions of WWID’s health perspectives and HIV risk conceptualization, from which a Psychosocial Model of PrEP Acceptability and a novel construct of ‘perceived PrEP relevance’ were developed using a grounded theory approach. ResultsIn our Psychosocial Model of PrEP Acceptability, anticipated PrEP feasibility and perceived PrEP relevance shape women’s interest in and willingness to initiate PrEP. Attending to PrEP-related healthcare tasks (e.g., medical appointments, bloodwork) and managing a daily medication regimen were anticipated as feasible but would likely be de-prioritized relative to women’s competing substance-related and survival needs. Women’s perceptions of both their locus of HIV risk and sufficiency of existing HIV prevention practices determined their perceived PrEP relevance. PrEP was least relevant for women perceiving their prevention practices as sufficient to mitigate self-controlled HIV risk and most relevant for women perceiving their prevention practices as insufficient to mitigate environmentally shaped HIV risk. ConclusionsOur models demonstrate how PrEP acceptability is influenced by WWID’s lived experiences and complex risk conceptualization. Effective multilevel interventions to enhance PrEP engagement should support women’s competing needs, affirm women’s existing prevention strategies, and address the harms of the HIV risk environment.

The use of oral HIV pre-exposure prophylaxis among people who inject drugs: barriers, and recommendations.

The use of oral HIV pre-exposure prophylaxis among people who inject drugs: barriers, and recommendations.

Exploring user and stakeholder perspectives from South Africa and Uganda to refine microarray patch development for HIV PrEP delivery and as a multipurpose prevention technology.

Oral HIV pre-exposure prophylaxis (PrEP) is highly effective, but alternative delivery options are needed to reach more users. Microarray patches (MAPs), a novel drug-delivery system containing micron-scale projections or "microneedles" that deliver drugs via skin, are being developed to deliver long-acting HIV PrEP and as a multipurpose prevention technology to protect from HIV and unintended pregnancy. We explored whether MAP technology could meet user and health system needs in two African countries. Researchers in South Africa and Uganda conducted 27 focus group discussions, 76 mock-use exercises, and 31 key informant interviews to explore perceptions about MAPs and specific features such as MAP size, duration of protection, delivery indicator, and health system fit. Participants included young women and men from key populations and vulnerable groups at high risk of HIV and/or unintended pregnancy, including adolescent girls and young women; female sex workers and men who have sex with these women; and men who have sex with men. In Uganda, researchers also recruited young women and men from universities and the community as vulnerable groups. Key stakeholders included health care providers, sexual and reproductive health experts, policymakers, and youth activists. Qualitative data were transcribed, translated, coded, and analyzed to explore perspectives and preferences about MAPs. Survey responses after mock-use in Uganda were tabulated to assess satisfaction with MAP features and highlight areas for additional refinement. All groups expressed interest in MAP technology, reporting perceived advantages over other methods. Most participants preferred the smallest MAP size for ease of use and discreetness. Some would accept a larger MAP if it provided longer protection. Most preferred a protection duration of 1 to 3 months or longer; others preferred 1-week protection. Upper arm and thigh were the most preferred application sites. Up to 30 minutes of wear time was considered acceptable; some wanted longer to ensure the drug was fully delivered. Self-administration was valued by all groups; most preferred initial training by a provider. Potential users and stakeholders showed strong interest in/acceptance of MAP technology, and their feedback identified key improvements for MAP design. If a MAP containing a high-potency antiretroviral or a MAP containing both an antiretroviral and hormonal contraceptive is developed, these products could improve acceptability/uptake of protection options in sub-Saharan Africa.

The Fidelity of a Pharmacy-Based Oral HIV Pre-Exposure Prophylaxis Delivery Model in Kenya.

HIV pre-exposure prophylaxis (PrEP) delivery at private pharmacies is a promising new differentiated service delivery model that may address barriers to PrEP delivery at public health care facilities. We measured the fidelity of this model (ie, delivery as intended) in a pilot study in Kenya. Five private, retail pharmacies in Kisumu and Thika Counties. Trained pharmacy providers delivered PrEP services, including identifying eligible clients, counseling on HIV risk, assessing PrEP safety, testing for HIV, and dispensing PrEP. Pharmacy clients completed surveys that assessed the fidelity of the services received after each visit. Standardized client actors (ie, mystery shoppers) were trained on 4 different case scripts, then made unannounced pharmacy visits, and then completed a 40-item checklist that assessed the fidelity and quality of service delivery components. From November 2020 to December 2021, 287 clients initiated and 159 (55%) refilled PrEP. At initiation, most clients were counseled on PrEP adherence (99%, 284 of 287) and potential side effects (97%, 279 of 287) and all received provider-assisted HIV self-testing before PrEP dispensing (findings consistent across refill visits). Nine standardized client actors completed 15 pharmacy visits. At each visit, most actors were asked about their behaviors associated with HIV risk (80%, 12/15) and all were counseled on PrEP safety and side effects. All actors reported that pharmacy providers treated them with respect. In this first pilot study of pharmacy-delivered PrEP services in Africa, the fidelity of service delivery was high, suggesting that trained providers at private pharmacies can deliver quality PrEP services.

Psychological and Behavioural Within-participant Predictors of Adherence to Oral HIV Pre-Exposure Prophylaxis (PrEP).

Oral PrEP's effectiveness relies on adequate adherence during periods of substantial HIV risk. Since most PrEP users will miss doses, understanding predictors within participants can help to explain adherence. We used a cross-sectional, within-participant design with 67 gay, bisexual, and other men who have sex with men taking PrEP daily. Using a questionnaire, informed by the Information Motivation Behavioral Skills Model, participants were asked about an adherent and a non-adherent episode. PrEP non-adherence was associated with non-normality of the day (p < .001), being out of the home (p < .001), weekend days (p = .01), having company (p = .02), using substances (p = 0.02), not using reminders (p = .03), lower PrEP information (p = .04), lower behavioural skills (p < .001) and less positive affect (p = .002). PrEP adherence assessment could focus on situational variations, supporting the construction of alternative strategies to facilitate adherence in these situations.

Oral HIV pre-exposure prophylaxis use among pregnant and postpartum women: results from real-world implementation in Lesotho.

Lesotho has reached epidemic control, PrEP is an important component in maintaining that and in reaching the goal of eliminating mother-to-child transmission. We conducted a retrospective review of existing, routine PrEP health records in 26 health facilities in Lesotho. PrEP visit data were collected for pregnant and postpartum women screened for PrEP and/or enrolled in PrEP programs from 1 January 2019 through 30 June 2021 with follow-up data collected up to the date of data abstraction per site between October 2021 and May 2022. Poisson regression with robust variance was used to evaluate the association between patient characteristics and continuation of PrEP. Indications for starting PrEP were significantly associated with continuation in PrEP use. Women starting PrEP due to having a partner known to be living with HIV were the most likely to return for follow-up. In all age groups, the most common reason for starting PrEP was being in a serodiscordant relationship, though the proportion varies by age. As Lesotho is now in the process of optimizing PrEP use among pregnant and postpartum women, it is critical to revise data sources to capture information that will link PrEP records and ANC/PNC records and document pregnancy/postpartum status in order to better understand PrEP use and gaps in this population.

Effect of 6-Month HIV Preexposure Prophylaxis Dispensing With Interim Self-testing on Preexposure Prophylaxis Continuation at 12 Months

Daily oral HIV preexposure prophylaxis (PrEP) delivery requires quarterly clinic visits for HIV testing and drug refilling that are costly to health systems and clients. To evaluate whether 6-month PrEP dispensing supported with interim HIV self-testing (HIVST) results in noninferior PrEP continuation outcomes at 12 months compared with standard quarterly clinic visits. This randomized noninferiority trial was conducted from May 2018 to May 2021 with 12 months of follow-up among PrEP clients aged 18 years or older who were returning for their first refill at a research clinic in Kiambu County, Kenya. Participants were randomized 2:1 to (1) 6-month PrEP dispensing with semiannual clinic visits and interim HIVST at 3 months or (2) standard-of-care (SOC) PrEP delivery with 3-month dispensing, quarterly clinic visits, and clinic-based HIV testing. Prespecified 12-month outcomes included recent HIV testing (any in past 6 months), PrEP refilling, and PrEP adherence (detectable tenofovir-diphosphate concentrations in dried blood spots). Binomial regression models were used to estimate risk differences (RDs), and a 1-sided 95% CI lower bound (LB) of -10% or greater was interpreted as noninferior. A total of 495 participants were enrolled, with 329 enrolled in the intervention group and 166 enrolled in the SOC group; 330 (66.7%) were women, 295 (59.6%) were in serodifferent relationships, and the median (IQR) age was 33 (27-40) years. At 12 months, 241 individuals in the intervention group (73.3%) and 120 in the SOC group (72.3%) returned to clinic. In the intervention group, recent HIV testing was noninferior (230 individuals [69.9%]) compared with the SOC group (116 [69.9%]; RD, -0.33%, 95% CI LB, -7.44%). PrEP refilling in the intervention group (196 [59.6%]) was inconclusive compared with the SOC group (104 [62.7%]; RD, -3.25%; 95% CI LB, -10.84%), and PrEP adherence was noninferior in the intervention group (151 [45.9%]) compared with the SOC group (70 [42.2%]; RD, 4.96%; 95% CI LB, -2.46%). No HIV seroconversions were observed over the follow-up period. In this analysis of secondary trial end points at 1 year, semiannual PrEP dispensing with interim HIVST resulted in noninferior recent HIV testing and PrEP adherence compared with SOC quarterly PrEP dispensing. This novel model has the potential to optimize PrEP delivery. ClinicalTrials.gov Identifier: NCT03593629.

Characteristics of Kenyan women using HIV PrEP enrolled in a randomized trial on doxycycline postexposure prophylaxis for sexually transmitted infection prevention

IntroductionThe global incidence of sexually transmitted infections (STIs) has been rapidly increasing over the past decade, with more than one million curable STIs being acquired daily. Young women in sub-Saharan Africa have a high prevalence and incidence of both curable STIs and HIV. The use of doxycycline as a prophylaxis to prevent STIs is promising; however, clinical trials, to date, have only been conducted among men who have sex with men (MSM) in high-income settings. We describe the characteristics of participants enrolled in the first trial to determine the efficacy of doxycycline post-exposure prophylaxis (PEP) to reduce STI incidence among women taking daily, oral HIV pre-exposure prophylaxis (PrEP).MethodsThis is an open-label 1:1 randomized clinical trial on the efficacy of doxycycline PEP compared with standard of care (e.g., quarterly STI screening and treatment) to reduce incident bacterial STIs – Neisseria gonorrhoeae, Chlamydia trachomatis, and Treponema pallidum – among Kenyan women aged ≥18 and ≤30 years. All were also taking HIV pre-exposure prophylaxis (PrEP). We describe the baseline characteristics, STI prevalence, and STI risk perception of participants.ResultsBetween February 2020 and November 2021, 449 women were enrolled. The median age was 24 years (IQR 21–27), the majority were never married (66.1%), 370 women (82.4%) reported having a primary sex partner, and 33% had sex with new partners in the three months prior to enrolment. Two-thirds (67.5%, 268 women) did not use condoms, 36.7% reported transactional sex, and 43.2% suspected their male partners of having sex with other women. Slightly less than half (45.9%, 206 women) were recently concerned about being exposed to an STI. The prevalence of STIs was 17.9%, with C. trachomatis accounting for the majority of infections. Perceived risk of STIs was not associated with the detection of an STI.ConclusionYoung cisgender women using HIV PrEP in Kenya and enrolled in a trial of doxycycline postexposure prophylaxis had a high prevalence of curable STIs and represent a target population for an STI prevention intervention.

Stand-alone model for delivery of oral HIV pre-exposure prophylaxis in Kenya: a single-arm, prospective pilot evaluation.

The delivery of daily, oral HIV pre-exposure prophylaxis (PrEP) at private pharmacies may overcome barriers to PrEP delivery at public healthcare facilities, including HIV-associated stigma, long wait times and overcrowding. At five private, community-based pharmacies in Kenya, a care pathway for PrEP delivery (ClinicalTrials.gov: NCT04558554) was piloted-the first of its kind in Africa. Pharmacy providers screened clients interested in PrEP for HIV risk, then used a prescribing checklist to identify clients without medical conditions that might contraindicate PrEP safety, counsel them on PrEP use and safety, conduct provider-assisted HIV self-testing and dispense PrEP. For complex clinical cases, a remote clinician was available for consultation. Clients who did not meet the checklist criteria were referred to public facilities for free services delivered by clinicians. Pharmacy providers dispensed a 1-month PrEP supply at initiation and a 3-month supply thereafter at a client fee of 300 KES (∼$3 USD) per visit. From November 2020 to October 2021, pharmacy providers screened 575 clients, identified 476 who met the prescribing checklist criteria and initiated 287 (60%) on PrEP. Among pharmacy PrEP clients, the median age was 26 years (IQR 22-33) and 57% (163/287) were male. The prevalence of behaviours associated with HIV risk among clients was high; 84% (240/287) reported sexual partners with unknown HIV status and 53% (151/287) reported multiple sexual partners (past 6 months). PrEP continuation among clients was 53% (153/287) at 1 month, 36% (103/287) at 4 months and 21% (51/242) at 7 months. During the pilot observation period, 21% (61/287) of clients stopped and restarted PrEP and overall pill coverage was 40% (IQR 10%-70%). Nearly, all pharmacy PrEP clients (≥96%) agreed or strongly agreed with statements regarding the acceptability and appropriateness of pharmacy-delivered PrEP services. Findings from this pilot suggest that populations at HIV risk frequently visit private pharmacies and PrEP initiation and continuation at pharmacies is similar to or exceeds that at public healthcare facilities. Private pharmacy-based PrEP delivery, conducted entirely by private-sector pharmacy staff, is a promising new delivery model that has the potential to expand PrEP reach in Kenya and similar settings.

Correlates of self-reported and biomarker based adherence to daily oral HIV pre-exposure prophylaxis among a cohort of predominantly men who have sex with men in Nigeria.

HIV pre-exposure prophylaxis (PrEP) significantly reduces the risk of HIV acquisition. However, studies have demonstrated discordance between self-reported measures and biomedical benchmarks of PrEP adherence. We estimated the correlation between self-reported PrEP adherence and PrEP biomarkers and explored factors associated with adherence among men who have sex with men (MSM) in Nigeria. TRUST-PrEP, an open-label, prospective study; conducted in Abuja between April 2018 and May 2019. MSM ≥ 18 years with substantial HIV risk were enrolled. Participants reported PrEP adherence in the last month using a 4-point scale from "poor" to "perfect" and serum samples for PrEP biomarkers were collected at months 3 and 9. Serum tenofovir concentration was measured by liquid chromatography-tandem mass spectrometry and considered protective for adherence if ≥ 4.2 ng/ml. Spearman's rank correlation was used to estimate correlation between self-reported adherence and measured tenofovir levels. Generalized estimating equations with a logit link was used to estimate adjusted odds ratios (aORs) and 95% confidence intervals (CIs) for associations between self-reported adherence and laboratory-measured adherence. A total of 219 MSM with median age 23 (interquartile range 20-27) years had at least one PrEP biomarker assay. Only 66/219 (30%) had at least one record of protective tenofovir concentration. Correlation between tenofovir and self-reported adherence at 3 and 9 months were 0.1 and 0.02 respectively. Furthermore, 17/219 (8%,) and 49/219 (22%) had serum tenofovir of 4.2-35.4 ng/mL and ≥ 35.5 ng/mL, corresponding to at least 4 and 7 days' PrEP use in a week, respectively. PrEP adherence was higher among participants introduced to PrEP in the clinics compared with communities (aOR: 8.35, 95%CI: [3.24, 21.5]) and those with same-sex practices family disclosure (aOR: 3.60 95% CI: [1.73, 7.51]). Self-reported PrEP adherence poorly correlated with biomarkers. Facilitating clinic-based PrEP introduction and disclosure of same-sex practices to family among MSM may improve PrEP adherence.

Roll-out and effectiveness of HIV pre-exposure prophylaxis in France: An overview

Oral HIV pre-exposure prophylaxis (PrEP) has been available and fully reimbursed for people at high risk of sexually acquired HIV infection in France since January 2016. To evaluate the roll-out of PrEP use in France and its real-life effectiveness. The main results of two previously published studies were presented at the second e-congress of the EPI-PHARE scientific interest group on pharmacoepidemiology and public decision support held in June 2022, and are reported in this article. Two studies were carried out using the French National Health Data System (SNDS) covering 99% of the French population. A first study aimed to evaluate the roll-out of PrEP use in France from its implementation until June 2021, globally over the entire study period, including an assessment of the impact of the coronavirus disease 2019 (COVID-19) pandemic that started in February 2020 in France. A second study using a nested case-control design was conducted in a cohort of men at high risk of HIV acquisition included between January 2016 and June 2020 to assess the effectiveness of PrEP in the real world. As of 30 June 2021, a total of 42159 people had initiated PrEP in France. Initiations increased steadily until February 2020, then slowed down sharply from the start of the COVID-19 pandemic and resumed from the first half of 2021. PrEP users were overwhelmingly men (98%), with an average age of 36 years, living in a large urban area (74%), and of whom a minority (7%) were socioeconomically disadvantaged. Throughout the study period, the level of PrEP maintenance from one semester to the next was high (80-90%). However, for 20% of PrEP initiators, no prescription renewals were recorded during the first six months, suggesting a substantial proportion of early treatment discontinuation. A minority (21%) of PrEP renewal prescriptions were made by private practitioners. Among 46706 men at high risk of HIV infection, 256 patients identified with HIV infection were matched with 1213 controls. PrEP was used by 29% of cases and 49% of controls. Overall, PrEP effectiveness reached 60% (95% confidence interval 46% to 71%), and was increased in people with high PrEP use (93% (84% to 97%)), or after excluding periods of treatment discontinuation (86% (79% to 92%)). PrEP effectiveness was significantly reduced in people under 30 years of age (26% (-21% to 54%)) and in socioeconomically disadvantaged people (-64% (-392% to 45%)), for whom low PrEP uptake rates or high PrEP discontinuation rates were frequently observed. PrEP roll-out has been strongly impacted by the COVID-19 pandemic in France. Although it has been substantial among men who have sex with men, additional measures are needed to expand access to PrEP to all other population groups that could benefit from it. Promoting adherence to PrEP (especially among young people and the socioeconomically disadvantaged) will be essential to ensure a higher level of PrEP effectiveness, which has been shown to be lower in real-life settings than in clinical trials.