Pre-exposure Prophylaxis Discontinuation Research Articles

Navigating Patterns of Oral PrEP Use: A Qualitative Longitudinal Study of Gay, Bisexual, and Queer Men’s Dynamic Practices of Pausing, On-Demand, and Stopping PrEP in Canada

The Canadian HIV pre-exposure prophylaxis (PrEP) guidelines recommend both daily and on-demand dosing for gay, bisexual, and queer men (GBQM), meeting additional risk criteria. However, limited research explored how GBQM implement pausing, on-demand, discontinuation, and resumption of PrEP, including the contextual factors affecting decision-making. Using a relationally situated implementation science framework, we examined how GBQM tailor PrEP use to changing social and sexual circumstances. We conducted 109 longitudinal interviews with current and former PrEP users from Ontario (n=18) and British Columbia (n=20), Canada, at three time points between 2020 and 2022. We identified three dynamic PrEP use trajectories: pausing, on-demand, and stopping. Pausing involved brief breaks followed by a return to daily use during heightened sexual activity. Others followed the 2-1-1 on-demand schedule, while some stopped PrEP with plans to resume if social and sexual circumstances change. During the COVID-19 pandemic, participants paused PrEP when sexual activities decreased, restarting daily use when sexual engagements resumed. Others paused due to relationship changes or sexual inactivity, resuming PrEP in anticipation of sex. On-demand PrEP was adopted to manage side effects or save costs. Some stopped PrEP for sustained periods due to monogamy, private insurance loss, side effects, or low perceived HIV risk. Participants expressed concerns regarding lack of information on these strategies, relying on online sources or peers for guidance. Most participants obtained enough PrEP knowledge to adapt use appropriately. Comprehensive education campaigns on adaptable PrEP use effectiveness and strategies to discontinue and resume PrEP for clinicians, and GBQM should be implemented.

Experiences of oral pre-exposure prophylaxis use among heterosexual men accessing sexual and reproductive health services in South Africa: a qualitative study.

South African men face a substantial burden of HIV and are less likely to test for HIV and initiate antiretroviral therapy if tested positive and more likely to die from AIDS-related causes than women. In addition to condoms and circumcision, guidelines provide for the use of daily oral pre-exposure prophylaxis (PrEP) as an HIV prevention intervention for any men who recognize their need and request PrEP. However, heterosexual men have not been a focus of PrEP programmes, and since its introduction, there is limited literature on PrEP use among men in South Africa. This study explores the experiences, motivators and barriers to oral PrEP use among heterosexual men accessing primary healthcare services in South Africa. This study forms part of a mixed-methods implementation science study aimed at generating evidence for oral PrEP introduction and conducted in primary healthcare clinics in South Africa since 2018. Men aged ≥15 years who initiated oral PrEP and enrolled in a parent cohort study were purposefully invited to participate in an in-depth interview (IDI). Between March 2020 and May 2022, 30 men participated in IDIs exploring their motivators for PrEP use, and experiences with accessing health services. Interviews were audio recorded, transcribed and analysed thematically. The final analysis included 28 heterosexual men (18-56 years old). Motivations to initiate PrEP included fear of acquiring HIV, self-perceived vulnerability to HIV and mistrust in relationships; health systems factors which motivated PrEP use included the influence of healthcare providers, educational materials and mobile services. Perceived reduction in HIV vulnerability and changing proximity to partners were reasons for PrEP discontinuation. Side effects, daily-pill burden and stigma were noted as challenges to PrEP use. Health system barriers to PrEP use included limited PrEP availability, school and work demands, and inconsistent mobile clinic schedules. Our study reports on the experiences of heterosexual men accessing oral PrEP in real-world settings and contributes to the limited literature among this population. We highlight multiple levels which could be strengthened to improve men's PrEP use, including individual support, education among partners and communities, and addressing health system barriers to access.

Uptake and persistent use of HIV pre-exposure prophylaxis (PrEP) among key populations: Results from Ukraine’s scaled national PrEP program

Background: Ukraine has implemented ambitious HIV-prevention programs since 1999 and began offering pre-exposure prophylaxis (PrEP) in 2017. Little is known about PrEP uptake and persistence in this setting. Setting: We analyzed data from 40 facilities providing PrEP in 11 oblasts (regions) of Ukraine between October 2020-February 2022. Methods: We estimated the time between PrEP visits and conducted Kaplan-Meier analyses to estimate retention on PrEP stratified by sex, age, and key populations (KPs): men who have sex with men (MSM), people who inject drugs (PWID), sex workers (SW), discordant couples and others vulnerable to HIV acquisition (DC/Other). We used Cox regression to estimate risk of PrEP discontinuation by KP group and sex, adjusting for age. Results: Overall, 2,033 clients initiated PrEP across regions; the majority (51%) were DC/Other, 22% were MSM, 22% were PWID, and 5% were SW. The overall three-month persistence was 52.3% (95% confidence interval [CI]: 49.9-54.8%) and was lowest among MSM (46.7%; 95% CI: 41.9-52.2%) and SW (25.9%; 95% CI: 18.2-36.9%) (p<0.05 for differences by KP group). After adjusting for age, PrEP discontinuation was not statistically significantly different across groups, although female PWID tended to have the lowest discontinuation risk (adjusted hazard ratio [aHR] 0.59; 95% CI: 0.31-1.11 while male SW tended to have the highest risk (aHR 1.87, 95% CI: 0.57-6.11) compared with females in the DC/Other group). Conclusion: Three-month PrEP persistence was low across KP groups, especially in SW. Further research examining the barriers and enablers of persistence by KPs is needed.

Do we Still Need Eligibility Criteria to Recommend PrEP? Impact of National Prescribing Requirements on Retention in Care and Sexually Transmitted Infections Acquisition.

Italian guidelines recommend HIV pre-exposure prophylaxis (PrEP) only upon satisfying strict eligibility criteria. The objective of this study is to evaluate if PrEP candidates attending a community-based service comply with these criteria and whether these prescribing conditions affect retention in care and sexually transmitted infections (STIs) acquisition. A retrospective analysis was performed on PrEP candidates evaluated from January 2019 to June 2022. Data were collected from self-administered questionnaires and clinical files. The population was divided in subjects with 0/1 (0/1C) and ≥ 2 (≥ 2C) criteria. Descriptive statistics and non-parametric tests were employed to describe study population. Incidence of PrEP discontinuation and of STIs was estimated per 100 persons-year of follow up (PYFU), and incidence rate ratio (IRR) was calculated. Univariate and multivariable Cox regression analyses were used to evaluate the association strength between PrEP drop out and other variables. The analyses enrolled 659 individuals: 422 individuals were included in 0/1C, 237 in ≥ 2C group, respectively. Inconsistent condom use was the most reported prescribing criteria (399 individuals, 60.6%), followed by a previous STI (186 individuals, 28.2%). 0/1C exhibited lower STIs incidence. PrEP discontinuation was 29% in 0/1C and 38% in ≥ 2C (p = 0.031). Cox model revealed that inconsistent condom use was the only prescribing criteria associated to PrEP persistence. The majority of PrEP candidate did not comply with prescribing conditions. Eligibility criteria failed to identify individuals with better retention in care. Our results suggest that Italian guidelines should be updated removing barriers to prescription.

PrEP Discontinuation In A US National Cohort Of Sexual And Gender Minority Populations, 2017-22.

In the US, sexual and gender minority populations are disproportionately affected by HIV. Pre-exposure prophylaxis (PrEP) is a key prevention method, but its effectiveness relies on consistent usage. Our four-year national cohort study explored PrEP discontinuation among sexual and gender minority people who initiated PrEP. We found a high annual rate of discontinuation (35-40percent) after PrEP initiation. Multivariable analysis with 6,410 person-years identified housing instability and prior history of PrEP discontinuation as predictors of discontinuation. Conversely, older age, clinical indication for PrEP, and having health insurance were associated with ongoing PrEP use. To promote sustained PrEP use, strategies should focus on supporting those at high risk for discontinuation, such as younger people, those without stable housing or health insurance, and prior PrEP discontinuers.

PrEP initiation and discontinuation among transgender women in the United States: a longitudinal, mixed methods cohort study.

Transgender women in the United States experience high HIV incidence and suboptimal Pre-exposure prophylaxis (PrEP) engagement. We sought to estimate PrEP initiation and discontinuation rates and characterize PrEP discontinuation experiences among a prospective cohort of transgender women. Using a sequential, explanatory, mixed-methods design, 1312 transgender women at risk for HIV acquisition were enrolled from March 2018 to August 2020 and followed through July 2022 (median follow-up 24 months; interquartile range 15-36). Cox regression models assessed predictors of initiation and discontinuation. In-depth interviews were conducted among 18 participants, including life history calendars to explore key events and experiences surrounding discontinuations. Qualitative and quantitative data were integrated to generate typologies of discontinuation, inform meta-inferences and facilitate the interpretation of findings. 21.8% (n = 286) of participants reported taking PrEP at one or more study visits while under observation. We observed 139 PrEP initiations over 2127 person-years (6.5 initiations/100 person-years, 95% CI: 5.5-7.7). Predictors of initiation included identifying as Black and PrEP indication. The rate of initiation among those who were PrEP-indicated was 9.6 initiations/100 person-years (132/1372 person-years; 95% CI: 8.1-11.4). We observed 138 PrEP discontinuations over 368 person-years (37.5 discontinuations/100 person-years, 95% CI: 31.7-44.3). Predictors of discontinuation included high school education or less and initiating PrEP for the first time while under observation. Four discontinuation typologies emerged: (1) seroconversion following discontinuation; (2) ongoing HIV acquisition risk following discontinuation; (3) reassessment of HIV/STI prevention strategy following discontinuation; and (4) dynamic PrEP use coinciding with changes in HIV acquisition risk. PrEP initiation rates were low and discontinuation rates were high. Complex motivations to stop using PrEP did not consistently correspond with HIV acquisition risk reduction. Evidence-based interventions to increase PrEP persistence among transgender women with ongoing acquisition risk and provide HIV prevention support for those who discontinue PrEP are necessary to reduce HIV incidence in this population.

1535. Persistence With Human Immunodeficiency Virus Pre-exposure Prophylaxis in an Active-Duty Military Population

Abstract Background There is limited data on Human Immunodeficiency Virus Pre-exposure Prophylaxis (PrEP) use and persistence in the military. Despite universal access to care, there is concern that PrEP persistence may be lower in military populations due to frequent deployments, need for relocations, and perceived stigma. This study evaluated the persistence rates as well as reasons for PrEP discontinuation in a military cohort. Methods The Brooke Army Medical Center Infectious Diseases clinic provides PrEP to service members at Joint Base San Antonio. This study evaluated all active-duty service members who received PrEP between 2020-2022. All charts were examined to determine patient demographics and years on PrEP. If a patient stopped PrEP, they were contacted to determine etiology of discontinuation and invited to restart PrEP. Results In total, 112 service members received PrEP during the study period. The cohort was predominantly male (99%) with median age 30 [IQR: 26-34] and a median of 2 years [IQR: 0-3] receiving PrEP (Table 1). The most common indication was multiple sexual partners with less than 100% condom use (n=98, 88%). At the end of the study, most (n=88, 79%) patients were still receiving PrEP including 33 (37%) at other military or civilian facilities. Of the 24 service members who were no longer receiving PrEP, 18 (75%), were able to be contacted (Table 2). Two (1%) patients seroconverted while off PrEP with reasons for discontinuation being abstinence and difficulty making appointments. No patients contacted during this study were interested in restarting PrEP. Demographic Information of 112 Active-Duty Service Members Receiving PrEP at Brooke Army Medical Center 2020-2022 Reasons for PrEP Discontinuation at Brooke Army Medical Center 2020-2022 Conclusion This is the first study to evaluate PrEP persistence in an active-duty population. In this cohort with universal access to care, PrEP persistence rates and years receiving PrEP were greater than seen in other populations. While the most common reason for discontinuation was changes in sexual behavior, systemic factors still contributed to PrEP discontinuation. Future studies should elucidate the challenges to PrEP care in the military. Disclosures All Authors: No reported disclosures

Oral Pre-Exposure Prophylaxis for HIV Discontinuation in a Large Cohort of Adolescent Men Who Have Sex With Men and Transgender Women in Brazil

PurposeThis study aimed to describe pre-exposure prophylaxis (PrEP) for HIV discontinuation in adolescent men who have sex with men (aMSM) and adolescent transgender women (aTGW) and to identify factors associated with discontinuation. MethodsThe PrEP1519 study included a cohort of aMSM and aTGW aged 15–19 years old, and it was conducted in three large Brazilian capital cities. For this analysis, we included adolescents who initiated PrEP. PrEP discontinuation was defined as no possession of PrEP pills for >90 days. Kaplan-Meier curves were used to analyze the probabilities of discontinuation, and survival distributions stratified by covariates were compared using log-rank or Wilcoxon tests. Cox regression models were used to estimate the adjusted hazard ratio (aHR) with a 95% confidence interval (95% CI). ResultsWe included 908 adolescents, 829 (91.30%) aMSM and 79 (8.70%) aTGW, most of whom were 18–19 years (80.29%). The incidence rate of discontinuation was 75.6 per 100 person-years. The probability of discontinuation was 52.61% in the first year. The multivariate analysis demonstrated that the aTGW (aHR = 1.63; 95% CI: 1.02–1.64) and adolescents with a medium (aHR = 1.29; 95% CI: 1.02–1.64) or low (aHR = 1.65; 95% CI: 1.29–2.12) perceived risk of HIV infection had an increased risk of discontinuation, whereas the adolescents with a partner living with HIV had a lower risk of discontinuation (aHR = 0.57; 95% CI: 0.35–0.91). DiscussionAdolescents with a high risk for discontinuation may need additional support that emphasizes the value of PrEP as a tool for HIV prevention because PrEP discontinuation was associated with a disconnect between HIV risk perception and HIV prevention.

Mental Health Needs of Adolescent and Young Adult PrEP Users in South Africa: Implications for Sexual and Reproductive Health Programming

PurposePoor mental health is associated with sexual and reproductive health (SRH) risks, including human immunodeficiency virus (HIV) and pre-exposure prophylaxis discontinuation. Adolescents and young people (AYP) are vulnerable to HIV and depression. This paper describes the prevalence and severity of depression and associated factors in AYP accessing SRH services in South Africa. MethodsA cross-sectional analysis of enrollment data (January 2019 to December 2021) from a cohort of individuals receiving pre-exposure prophylaxis services at eight clinics in three provinces in South Africa was conducted. Females (n = 1,074) and males (n = 231) aged 15–24 years were included. Interviewer-administered questionnaires were conducted, and the prevalence and severity of depression assessed using the Patient Health Questionnaire-9. Multivariate analysis was used to identify factors associated with depression. ResultsOver 40% of participants had experienced any depression symptoms (43.7% of females, 38.5% of males). For males, experiencing intimate partner violence was the only predictor of depression symptoms (adjusted odds ratio (AOR) 8.81, 95% confidence intervals (CI) 1.03–75.44). For females, living with both parents (AOR 1.70, 95% CI 1.15–2.51), having transactional sex (AOR 1.63, 95% CI 1.00–2.65), experiencing any intimate partner violence (AOR 1.96, 95% CI 1.34–2.89), and using drugs (AOR 1.78, 95% CI 1.03–3.11) were all positively associated with depression symptoms. Resilience was a protective factor against depression symptoms for both sexes (males: AOR 0.96, 95% CI 0.93–0.98; females: AOR 0.96, 95% CI 0.95–0.97). DiscussionThere is a high burden of depression among AYP accessing SRH services in South Africa. Mental health screening should be integrated into SRH and HIV prevention programs for AYP.

Patterns of HIV Pre-exposure Prophylaxis use Among Adolescent Girls and Young Women Accessing Routine Sexual and Reproductive Health services in South Africa

PurposeThis study describes the patterns of pre-exposure prophylaxis (PrEP) use among adolescent girls and young women (AGYW) initiated on daily oral PrEP for the prevention of HIV, within routine sexual and reproductive health services in South Africa. MethodsWe analysed clinical and survey data from a nested cohort of 967 AGYW initiated on oral PrEP between January 2019 and December 2021 in four geographical clusters in South Africa. We describe the periods of PrEP use, and the proportion who discontinued and subsequently restarted PrEP. Logistic regression analyses were conducted to determine factors associated with early PrEP discontinuation, PrEP use for ≥4 months and PrEP restart. ResultsPrEP use for ≤1 month was high (68.6%), although 27% returned and restarted PrEP; and 9% restarted more than once. Initiating PrEP at a mobile clinic (AOR 2.10, 95% CI 1.51 – 2.93) and having a partner known to be HIV negative or whose HIV status was unknown (AOR 7.11, 95% CI 1.45 – 34.23; AOR 6.90, 95% CI 1.44 – 33.09) were associated with PrEP use for ≤1 month. AGYW receiving injectable contraceptives were more likely to restart PrEP (AOR 1.61, 95% CI 1.10 – 2.35). Compared to those aged 15–17 years, participants 18 – 20 and 21 – 24 years were less likely to restart PrEP (AOR 0.51, 95% CI 0.35 – 0.74; AOR 0.60, 95%, CI 0.41 – 0.87), as were those initiating PrEP at a mobile clinic compared to a fixed facility (AOR 0.66, 95% CI 0.47 – 0.92). DiscussionAlthough early PrEP discontinuation was high, it appears that PrEP use is frequently cyclical in nature. Further research is needed to determine if these cycles of PrEP correlate to periods of perceived or actual vulnerability to HIV, which may also be cyclical. PrEP delivery presents a unique opportunity to address multiple unmet health needs of young people.

The Use of HIV Pre-exposure Prophylaxis Among Men Accessing Routine Sexual and Reproductive Health Services in South Africa

PurposeThis study describes a cohort of men seeking oral pre-exposure prophylaxis (PrEP) services and explores their patterns of PrEP use within an implementation project seeking to integrate PrEP provision within sexual and reproductive health services in public health clinics in South Africa. MethodsRoutine program and survey data from 364 males initiated on oral PrEP between July 2020 and May 2022 were analyzed. PrEP use was examined, including time to first discontinuation and restart patterns. Factors associated with early PrEP discontinuation and PrEP restart were analyzed. ResultsDespite primarily focusing on access for adolescent girls and young women, PrEP services reached males with HIV prevention needs. PrEP use for ≤1 month (early discontinuation) was high at 58%; however, 18% restarted on PrEP, with 4% restarting repeatedly. Having depression symptoms was associated with early PrEP discontinuation (adjusted odds ratio [AOR]: 1.71, 95% CI [confidence interval]: 1.06–2.78). Those ≥25 years were less likely to discontinue early, as were those with a partner treated for a sexually transmitted infection in the preceding three months (AOR: 0.33, 95% CI: 0.13–0.84) and those who had been circumcised (AOR: 0.59, 95% CI: 0.36–0.96). Those 18–20 years old were less likely to restart PrEP than those ≥25 years (AOR: 0.43, 95% CI: 0.19–0.97), as were those whose partner's HIV status was unknown (AOR: 0.33, 95% CI: 0.12–0.88). DiscussionThis study identified interest and uptake of oral PrEP among an underrepresented population of predominantly heterosexual males seeking sexual and reproductive health services. It found high rates of early PrEP discontinuation, with a subset returning to restart PrEP. Further research is needed to determine whether these periods of PrEP use are associated with periods of HIV risk.

Uptake and Discontinuation of Pre-Exposure Prophylaxis Among Uninsured Transgender and Cisgender Women: A Public-Private Partnership Model in North Carolina.

HIV pre-exposure prophylaxis (PrEP) remains underutilized among cis and trans women. The PrEP Initiative Program (PIP) is a novel public-private partnership implemented at 12 local clinics in North Carolina. PIP provides HIV/sexually transmitted infection (STI) testing and clinical and laboratory monitoring for PrEP to uninsured/underinsured clients. We sought to understand service-related differences among both cis and trans women enrolled in PIP, including STIs diagnoses, clinic type, sources of referral, services needed, and reasons for PrEP discontinuation. The Kaplan-Meier curves display retention on PrEP over the duration of the program. Since 2018, 142 women (cis n = 113; trans n = 29) enrolled, and 136 started PrEP. The majority were ages 25-34 years (31.7%) or 18-24 years (29.6%), Black (57.8%) or Latinx (24.7%). Approximately 20.6% of recipients reported at least one STI while enrolled. Overall, trans women requested fewer services than cis women. After accounting for the amount of time each patient was taking PrEP, there were higher rates of trans women diagnosed with syphilis than cis women. Rates of persons with other STIs were not notably different between trans and cis women. Clinic access varied by gender: 69% of trans women were enrolled at only one site. Trans women were retained significantly longer: The Kaplan-Meier adjusted median time to discontinuation was 560 and 238 days for trans and cis women, respectively. PIP successfully reached historically marginalized and uninsured cis and trans women who may benefit from PrEP. Further investigations into factors contributing to recruitment and retention of women in HIV prevention programs are needed.

Online distribution of HIV self-testing kits to promote HIV testing among men who have sex with men discontinuing pre-exposure prophylaxis after demonstration project completion in China: a multicentre open-label randomized controlled trial

HIV self-testing (HIVST) offers potential solutions to challenges associated with site-based HIV testing (SBHT). However, the effectiveness of HIVST as an HIV prevention strategy for men who have sex with men (MSM) discontinuing pre-exposure prophylaxis (PrEP) after the completion of PrEP demonstration project has rarely been assessed. The China Real-world Study of Oral PrEP (CROPrEP) project was conducted in four cities in China. Participants were directed to community resources to continue their PrEP medication after the discontinuation of project-provided PrEP at the last CROPrEP visit. We conducted a multicentre open-label randomized controlled trial among MSM who had discontinued PrEP induced by the completion of CROPrEP. Eligible participants were randomly assigned to either the intervention group or the control group (1:1). Participants received regular health education and behavioural interventions throughout the trial. The intervention group was given a link to order free HIVST kits online, while the control group received information about free SBHT. Both groups completed internet-based follow-up surveys at three and six months. The primary outcome was the proportion of participants who underwent HIV testing during the six-month follow-up period. This trial was registered at chictr.org.cn (ChiCTR2000038416). Between November 2020 and January 2021, we recruited a total of 620 participants (300 in the intervention group and 320 in the control group). The follow-up completion rates were 99·0% and 95·0% in the intervention and control groups, respectively. At baseline, the median age of participants was 32 (interquartile range: 26-37), and 77·7% underwent HIV testing in the past three months. The proportion of participants who underwent HIV testing in the past three months was higher in the intervention group than in the control group at both the three-month (adjusted risk difference [RD]: 36·7, 95% confidence interval [CI]: 35·1-38·5, p<0·001) and six-month (RD: 26·7, 95% CI: 24·6-28·7 p<0·001) follow-up periods. Our study suggests that providing online distribution of HIVST kits for MSM with PrEP discontinuation induced by completion of the PrEP project effectively promoted HIV testing. This digital approach improves access to HIV testing for MSM and can be applicable to other settings where MSM turn to online public health services. The study was funded by the Fund of National Natural Science Foundation of China; the Mega-Projects of National Science Research for the 13th Five-Year Plan; and the Liaoning Revitalization Talents Program, China.

Pre-exposure Prophylaxis Use and Discontinuation in a Federally Qualified Health Center in a Mexico-US Border City.

Latino men who have sex with men (MSM) experience disproportionately high rates of HIV diagnoses in the United States. Pre-exposure prophylaxis (PrEP) use is critical to reduce this inequity, but PrEP awareness, access, and use are low among Latino MSM. This study aims to describe patterns of PrEP persistence and discontinuation among predominately Latino MSM accessing PrEP in a federally qualified health center (FQHC) in El Paso, Texas. This retrospective cohort comprised individuals who were eligible for PrEP at a FQHC in El Paso, Texas, between January 30, 2019, and August 15, 2021. We defined hierarchical categories of PrEP use and discontinuation, which was defined as more than 120days between PrEP visits. We used Kaplan-Meier survival plots to estimate median time to first PrEP discontinuation. There were 292 patients evaluated for PrEP; 91% were Latino. The majority of PrEP patients (70%, 205/292) experienced any PrEP discontinuation, and the median time to first PrEP discontinuation was 202days (95% CI: 179-266). The proportion of patients who remained on PrEP at 3months after initiation was 82% (95% CI: 76%, 87%) and at 6months after initiation was 55% (95% CI: 46%, 62%). While 3-month PrEP retention was high in this predominately Latino MSM patient population, PrEP discontinuation was common. Interventions that enhance longer-term persistence and support for restarting PrEP are needed to reduce the persistent ethnoracial disparities in HIV incidence.

Pre‐exposure prophylaxis adherence and discontinuation at an urban pre‐exposure prophylaxis program in Atlanta, Georgia

AbstractOral pre‐exposure prophylaxis (PrEP) effectiveness is directly correlated with medication adherence. Grady Health System (GHS) developed a PrEP program to optimize PrEP uptake in Atlanta, Georgia. The purpose of this study is to determine PrEP medication adherence and its associated factors during the first 18 months of the program's implementation. A single‐center, retrospective chart review was conducted on patients enrolled in a PrEP program in Atlanta, Georgia, between June 1, 2018 and February 29, 2020, who received more than one PrEP prescription. The primary outcome was mean adherence to PrEP, using the medication possession ratio (MPR). This study included 154 primarily young patients (mean 34 years of age), Black (70.8%), uninsured (59.1%), and cisgender men (62.3%). Mean PrEP adherence was 89.2%; 77.3% of patients had an MPR ≥ 80% (high adherence). Of all patients, 71 (46%) met PrEP discontinuation criteria. This PrEP program demonstrated high levels of PrEP adherence with discontinuation rates similar to other PrEP programs nationwide, despite a higher index of social vulnerability in the area. Future areas of research include identifying the specific program‐related factors that may optimize PrEP adherence in areas with high indices of social vulnerability.

Understanding Retention in the HIV Pre-Exposure Prophylaxis Cascade Among Cisgender Women.

HIV remains a significant public health concern in the United States, with 34,800 new cases diagnosed in 2019; of those, 18% were among women. Oral pre-exposure prophylaxis (PrEP) with daily tenofovir disoproxil fumarate/emtricitabine is effective and safe, reducing HIV transmission by up to 92% in women. Though studies demonstrate low rates of PrEP adherence among cisgender women prescribed oral PrEP, little is known about the factors that shape PrEP continuation among them. This study focuses on understanding the experiences of cisgender women who have initiated PrEP to gain insight into the factors that shape PrEP continuation. We conducted semi-structured interviews with (N = 20) women who had been prescribed oral PrEP. Interviews were guided by the social-ecological framework to identify multilevel factors affecting PrEP continuation; we specifically examined the experience of engagement and retention in the PrEP cascade. We recruited women who had been prescribed oral PrEP by a government-sponsored sexual health center or a hospital-based family planning clinic in Washington, DC. Factors facilitating PrEP continuation included a positive emotional experience associated with PrEP use, high perceived risk of HIV acquisition, and high-quality communication with health care providers. The most common reason for PrEP discontinuation was low perceived HIV risk (n = 11). Other factors influencing discontinuation were side effects, a negative emotional experience while using PrEP, and negative interactions with the health care system. This study underscores the importance of specific multi-level factors, including the provision of high-quality communication designed to resonate with women and shared decision making between women and their health care providers.

Psychosocial determinants of pre-exposure prophylaxis use among pregnant adolescent girls and young women in Cape Town, South Africa: A qualitative study.

In South Africa, at least 7.5million people (age ≥15years) are living with Human Immunodeficiency Virus (HIV). In 2020, 220,000 new infections occurred, approximately one-third of which were among cisgender adolescent girls and women (age ≥15years). The perspectives of pregnant adolescent girls and young women (AGYW) as key, targeted end-users of pre-exposure prophylaxis (PrEP) in this setting are not well known. We purposively recruited participants enrolled in an ongoing cohort study at an urban antenatal clinic in Cape Town, South Africa for in-depth interviews between July-September 2020. We restricted our analysis to pregnant AGYW (age: 16-25years) who initiated daily oral PrEP (Tenofovir/Emtricitabine) antenatally and self-reported either high PrEP persistence (≥25days in the past 30days and no missed PrEP collection), or low PrEP persistence and/or discontinuation (missing >5days in the last 30days or missed PrEP collection). The findings were organized thematically, per the adapted Health Behavior Model (2000), using Nvivo-v.1.5. We interviewed 18 AGYW (mean age = 22years), at a mean of 14weeks postpartum. Higher self-esteem and high-quality study provider-client relationships, including empathic psychosocial support, facilitated PrEP continuation. Reported barriers included unstable social structure characteristics (i.e., financial hardship) and individual factors (i.e., unintended pregnancy, parental rejection, and inadequate peer- and [non-cohabiting] partner support). Participants self-perceived a need for PrEP, feeling susceptible to non-consensual, forced sex, or considering partners' (presumed) sexual risk-taking. Limited community awareness regarding PrEP availability and/or perceived complexity in navigating health system access to PrEP, impede continuation. PrEP-focused healthcare access pathways for pregnant and postpartum AGYW need to be simplified. Further research is needed on health system determinants (i.e., structural barriers, provider-client interactions, and related outcomes) of oral PrEP utilization. In 2022, South Africa announced regulatory approval of long-acting PrEP options (i.e., the dapivirine ring for non-pregnant women and injectable cabotegravir, respectively); these may mitigate implementation barriers reported in this study. However, the safety and efficacy of long-acting PrEP (e.g., injectables, implants) among pregnant or breastfeeding women, specifically, remains to be confirmed in this setting.

Uptake and continuation of HIV pre-exposure prophylaxis among women of reproductive age in two health facilities in Kisumu County, Kenya.

In 2020, Kenya had 19,000 new HIV infections among women aged 15+ years. Studies have shown sub-optimal oral pre-exposure prophylaxis (PrEP) use among sub-populations of women. We assessed the uptake and continuation of oral PrEP among women 15-49 years in two health facilities in Kisumu County, Kenya. A retrospective cohort of 262 women aged 15-49 years, initiated into oral PrEP between 12 November 2019 and 31 March 2021, was identified from two health facilities in the urban setting of Kisumu County, Kenya. Data on baseline characteristics and oral PrEP continuation at months 1, 3 and 6 were abstracted from patient records and summarized using descriptive statistics. Missing data in the predictor variables were imputed within the joint modelling multiple imputation framework. Using logistic regression, we evaluated factors associated with the discontinuation of oral PrEP at month 1. Of the 66,054 women screened, 320 (0.5%) were eligible and 262 (82%) were initiated on oral PrEP. Uptake was higher among women 25-29 years as compared to those 15-24 years (77% vs. 33%). Oral PrEP continuation declined significantly with increasing duration of follow-up; 37% at month 1, 21% at month 3 and 12% at month 6 (p<0.05). In the adjusted analysis, women 15-24 years had lower adjusted odds of continuing at month 1 than women ≥25 years (adjusted odds ratio [aOR]: 0.41, 95% CI: 0.21-0.82). There was no association between being sero-discordant and continuation of oral PrEP at month 1 (aOR; 1.21, 95% CI 0.59-2.50). Women from the sub-county hospital were more likely to continue at month 1 of follow-up compared to women enrolled in the county referral hospital (aOR 5.11; 95% CI 2.24-11.70). The low eligibility for oral PrEP observed among women 15-49 years in an urban setting with high HIV prevalence calls for a review of the screening process to validate the sensitivity of the screening tool and its proper application. The low uptake and continuation among adolescent girls and young women underscores the need to identify and address specific patient- and facility-level barriers affecting different sub-populations at risk for HIV acquisition.

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.

Identifying Patterns of Discontinuing and Recommencing Pre-exposure Prophylaxis in the Context of Sexual Behavior Among Gay and Bisexual Men in Australia

We mapped gay and bisexual men’s (GBM) patterns of using pre-exposure prophylaxis (PrEP) over time and explored sexual behavior as PrEP use changed. We conducted semi-structured interviews between June 2020 and February 2021 with 40 GBM living in Australia who had changed their PrEP use since initiating. There was considerable diversity in patterns of discontinuation, suspension, and recommencement of PrEP. Reasons for changing PrEP use mostly centered on accurate perceived changes to HIV risk. Twelve participants reported condomless anal intercourse with casual or fuckbuddy partners after discontinuing PrEP. These sex events were unanticipated, condoms were not a preferred option, and other risk reduction strategies were applied inconsistently. Service delivery and health promotion can support safer sex among GBM when PrEP use fluctuates by promoting event-driven PrEP and/or non-condom-based risk reduction methods during periods off daily PrEP, and guiding GBM to better recognize changing circumstances of risk and when to recommence PrEP.