Oral Pre-exposure Prophylaxis Research Articles

Willingness to take long-acting injectable pre-exposure prophylaxis among men who have sex with men who participated in the CROPrEP study: a cross-sectional online study

IntroductionEvidence on the willingness of men who have sex with men (MSM) with oral pre-exposure prophylaxis (PrEP) experience, especially those with suboptimal adherence, to take long-acting injectable PrEP (LAI-PrEP) is critical to guide future LAI-PrEP implementation.ObjectiveThe objective was to assess the willingness of MSM with oral PrEP experience to take LAI-PrEP.MethodsMSM who participated in the China Real-world Study of Oral PrEP (CROPrEP) were enrolled in this study. Information on the willingness of MSM to take LAI-PrEP and potential correlates was collected using a structured online questionnaire. The main outcomes were the willingness of MSM to take LAI-PrEP and its association with HIV-related behaviours, sexually transmitted infections, and oral PrEP history. Logistic regression was used to identify correlates of the willingness of MSM to take LAI-PrEP.ResultsA total of 612 former CROPrEP participants (FCPs) were included in this study. There were 315 (51.5%) daily oral PrEP (D-PrEP) users and 297 (48.5%) event-driven oral PrEP (ED-PrEP) users at the last follow-up. Most FCPs (77.8%) were willing to take free LAI-PrEP. FCPs with no less than two sexual male partners (aOR = 1.54, [95% CI: 1.04, 2.29], P = 0.031), those with male partners with unknown HIV statuses (aOR = 2.04, [95% CI: 1.31, 3.18], P = 0.002), those with recreational drug use (aOR = 1.58, [95% CI: 1.05, 2.40], P = 0.030), and those with HSV-2 positivity (aOR = 2.15, [95% CI: 1.30, 3.57], P = 0.003) were more willing to take LAI-PrEP, while ED-PrEP users (aOR = 0.66, [95% CI: 0.45, 0.98], P = 0.037) and FCPs with suboptimal oral PrEP adherence (aOR = 0.58, [95% CI: 0.36, 0.94], P = 0.026) were less willing to take LAI-PrEP.ConclusionLAI-PrEP has good prospects for expanding PrEP coverage. However, FCPs with suboptimal oral PrEP adherence are less likely to take LAI-PrEP. Further intervention and implementation efforts are needed to improve the willingness of MSM to use LAI-PrEP, and sexual health should be considered during the discussion about PrEP initiation.

Examination of Incidence of Sexually Transmitted Infections in the Ending the HIV Epidemic Priority Counties of the United States, 2005-2019.

The incidence of sexually transmitted infections (STIs) has been increasing in the United States, and this trend has continued alongside expanding/changing human immunodeficiency virus (HIV) prevention strategies, moving from reliance solely on behavioral interventions like condoms to biomedical methods like oral and injectable antiretroviral preexposure prophylaxis (PrEP). In 2019, the Ending the HIV Epidemic (EHE) initiative was released to prioritize resource allocation to the 50 jurisdictions in the United States with the highest HIV incidence, providing an opportunity to monitor STI incidence in a national group of discrete, geographic units and identify trends and differences across jurisdictions. Using existing data from the US CDC and Census Bureau, a retrospective analysis was conducted to examine the incidence of STIs in 49 of the 50 EHE priority counties between 2005 and 2019. This timeframe was divided into 2 periods representing a before and after entry into the biomedical era of HIV prevention: P1 (2005-2011) and P2 (2012-2019). A total of 49 EHE counties were included in this analysis, representing 27.4% of the total US population. Entry into the biomedical HIV prevention era was associated with an increase in STI incidence in 28 EHE counties and a decrease in 14 EHE counties. The greatest percent increase in total STI incidence was in the District of Columbia (+12.1%; incidence rate ratio = 1.121 [1.115, 1.127]; P < 0.001) and the greatest percent decrease was identified in Orleans Parish, LA (-8.7%; incidence rate ratio = 0.913 [0.908, 0.919]; P < 0.001). Rising STI rates in the biomedical era of HIV prevention represent missed opportunities for comprehensive sexual and preventive healthcare. County-level data provide actionable insight for reducing STI incidence. The EHE counties that have experienced decreases in STI incidence while being in the biomedical era may provide models of best practice, which may be scaled in other jurisdictions.

High study participation but diverging adherence levels: qualitatively unpacking PrEP use among adolescent girls and young women over two years in Eastern Cape, South Africa

In Southern and Eastern Africa, initiation of daily oral pre-exposure prophylaxis (PrEP) for HIV prevention has been high among adolescent girls and young women (AGYW) offered PrEP. However, persistence and prevention-effective use of PrEP among this critical group continues to be a challenge. We conducted a qualitative sub-study of AGYW from the Community PrEP Study in Eastern Cape Province, South Africa who had high rates of pick up for monthly PrEP refills over two years, but differing levels of PrEP adherence based on tenofovir-diphosphate (TFV-DP) measurements in dried blood spots (DBS). Contrasting 22 AGYW with low versus high levels of TFV-DP in DBS, we qualitatively explored factors which influenced PrEP persistence vs. non-persistence, unique patterns of PrEP use (e.g., discarding or stockpiling), and participant recommendations for improving AGYW prevention-effective use of PrEP in the future. Results showed that PrEP misconceptions and mistrust among participants’ social networks negatively influenced adherence. In comparison, supportive families and/or partners and personal trust that PrEP works positively influenced adherence. Those with low adherence described being motivated to come to the site for other study benefits (e.g., reimbursement money, snacks, sanitary pads) and discarding PrEP to avoid stigma associated with being seen with pills. Future PrEP implementation strategies should focus on involving families and partners in PrEP support for AGYW and minimizing PrEP stigma at a community level.Trial registration NCT03977181. Retrospectively registered on June 6, 2019.

Low daily oral PrEP adherence and low validity of self-report in a randomized trial among PWID in Ukraine

BackgroundThe efficacy of daily oral pre-exposure prophylaxis (PrEP) in preventing HIV transmission among people who inject drugs (PWID) was demonstrated over a decade ago. However, only a few studies among PWID have since measured PrEP adherence using laboratory markers. MethodsIn this trial, we randomized recently injecting PWID in Kyiv, Ukraine, to receive daily oral TDF/FTC with or without SMS reminders. Enrollment and PrEP initiation took place at an HIV clinic. Subsequent visits at months 1, 3, and 6 were conducted at a community harm reduction center and included a structured interview, adherence counseling, PrEP dispensing, and dried blood spot collection. PrEP adherence was assessed using standard self-reported measures and TDF/FTC biomarkers. ResultsA total of 199 PWID (99 SMS, 100 No-SMS) were enrolled, of whom 24 % were women, with a median age of 37. At month 6, 79.4 % (158/199) of participants were retained, with 84 % (133/158) reporting opioid injection and 20 % (31/158) reporting stimulant injection in the past 30 days. 77 % (122/158) reported taking >95 % of PrEP doses in the past month, and 87 % reported taking the last dose within 2 days. Tenofovir diphosphate was detected in 17 % (28/158) of participants, and emtricitabine triphosphate was detected in 25 % (40/158). Only 3 % (5/158) had metabolite levels indicative of consistent PrEP uptake at 4+ doses per week. There was no association between the SMS intervention and TDF/FTC metabolite detection. ConclusionAdherence to daily oral PrEP among actively injecting PWID, without daily supervision or incentives, was extremely low, despite supportive counseling and SMS reminders. We also observed a high rate of discordance between self-report and classification by a validated biomarker of adherence. Given the scarcity of evidence and emerging data suggesting low oral PrEP adherence among PWID, additional implementation studies with TDF/FTC biomarkers are needed to study whether a sufficient level of adherence to daily PrEP is attainable among PWID, especially as long-acting injectable PrEP offers a promising alternative.

The potential benefits of long-acting injectable cabotegravir in pregnant and breastfeeding women and their infants.

Pregnant and breastfeeding women (PBW) in sub-Saharan Africa have high HIV incidence rates and associated risk of vertical transmission to their infants. Oral preexposure prophylaxis (PrEP) and injectable PrEP (long-acting cabotegravir, or CAB-LA) can potentially reduce this HIV transmission, but population-level impacts are uncertain. We extended a previously developed model of HIV and PrEP in South Africa to allow for variable PrEP duration and preference in PBW. We considered three potential scenarios for PrEP provision to PBW: oral PrEP only, CAB-LA only, and allowing oral/CAB-LA choice, with uptake and retention assumptions informed by South African data, each compared with a 'base' scenario without PrEP for PBW. Without PrEP for PBW, the model estimates 1.31 million new infections will occur between 2025 and 2035 in South African adults and children, including 100 000 in PBW, 16 800 in infants at/before birth, and 35 200 in children through breastmilk. In the oral PrEP-only scenario, these numbers would reduce by 1.2% (95% CI: 0.7-1.7%), 8.6% (4.8-12.9%), 4.0% (2.1-5.8%), and 5.3% (3.0-8.2%) respectively. In the CAB-LA-only scenario, the corresponding reductions would be 6.1% (2.9-9.6%), 41.2% (19.8-65.0%), 12.6% (6.0-19.4%), and 29.5% (13.9-46.8%), respectively, and in the oral/CAB-LA choice scenario, similar reductions would be achieved [5.6% (3.4-8.0%), 39% (23.4-55.9%), 12.4% (7.4-16.8%) and 27.6% (16.5-39.9%) respectively]. CAB-LA has the potential to be substantially more effective than oral PrEP in preventing HIV acquisition in PBW and vertical transmission, and can also modestly reduce HIV incidence at a population level.

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.

Effect of implementation strategies on pre-exposure prophylaxis persistence among female sex workers in South Africa: an interrupted time series study

A disproportionate number of new HIV infections in South Africa are among female sex workers; pre-exposure prophylaxis (PrEP) for HIV prevention is freely available to female sex workers in the country, but unique barriers challenge PrEP persistence. TB HIV Care, a large South African non-profit organisation that provides daily oral PrEP (tenofovir disoproxil fumarate and emtricitabine), has implemented multiple strategies to improve PrEP persistence. We aimed to evaluate the effect of different implementation strategies on PrEP persistence in a large-scale real-world setting. In this interrupted time series study, we estimated level changes in 1-month oral PrEP persistence associated with roll-out of various implementation strategies among female sex workers across nine districts in South Africa. We used routinely collected data from TB HIV Care programme files from June 7, 2016, to April 30, 2021. Poisson regression of 1-month persistence was used to assess the effect of these strategies. In secondary analyses, we tested the association between each of the strategies and 4-month persistence. The median 1-month PrEP persistence for female sex workers was 33% (IQR 27-40). SMS support and refill reminders were associated with an 11% relative increase in 1-month persistence (risk ratio [RR] 1·11, 95% CI 1·02-1·26) and clinical mentoring for PrEP providers was associated with a 127% relative increase (RR 2·27, 95% CI 1·94-2·66) among female sex workers. The loyalty rewards programme was negatively associated with 1-month persistence (RR 0·71, 95% CI 0·67-0·83). Although clinical mentoring improved 4-month persistence, SMS support text messages had no significant effect. Identification and subsequent use of clinical mentoring for PrEP providers and SMS support and refill reminders might improve the usefulness of PrEP overall to prevent new HIV infections among female sex workers. PrEP persistence remains an important issue, and strategies to build on our findings are needed. National Institute of Mental Health and National Institute of Allergy and Infectious Diseases.

HIV pre-exposure prophylaxis and its implementation in the PrEP Impact Trial in England: a pragmatic health technology assessment

HIV pre-exposure prophylaxis (PrEP) is highly effective in preventing HIV acquisition. To enable routine commissioning of PrEP in England, we aimed to establish population need, duration of need, PrEP uptake, and duration of use in attendees of sexual health services (SHS) in England. The Impact Trial was a prospective, open-label, single-arm, multicentre trial conducted at 157 SHS across England between Oct 13, 2017, and July 12, 2020. Clinicians assessed HIV-negative attendees for their risk of HIV acquisition to identify those who were eligible to participate and receive either daily or event-based oral PrEP (tenofovir disoproxil maleate with emtricitabine), as appropriate. Eligible participants were aged 16 years or older, considered HIV-negative on the day of enrolment, and willing to adhere to the trial procedures. Non-trial attendees are mutually exclusive of trial participants and included SHS attendees who were not recruited to the Impact Trial at any point. They include HIV-negative individuals aged 16 years or older who attended a participating SHS at least once after recruitment at that SHS had begun and before Feb 29, 2020. The main outcomes assessed were PrEP need, uptake, and use, and HIV and sexually transmitted infection (STI) incidence. Data are presented up to Feb 29, 2020, before the introduction of COVID-19 control measures. The study is registered with ClinicalTrials.gov, NCT03253757. In this analysis, we include 21 356 of 24 268 participants enrolled before Feb 29, 2020. 20 403 participants (95·5%) were men who have sex with men (MSM). Uptake of PrEP among SHS attendees clinically assessed and coded as eligible was 21 292 (57·1%) of 37 289. 18 400 trial participants had at least one post-enrolment visit and a median of 361 days of follow-up (IQR 143-638); 14 039 (75·9%) of these had enough PrEP prescribed to provide protection for 75% of their follow-up time. Among MSM, HIV incidence was 0·13 (95% CI 0·08-0·19) per 100 person-years in trial participants (27 seroconversions) and 0·95 (95% CI 0·88-1·03) per 100 person-years in non-trial attendees (587 seroconversions; proportionate reduction of 86·8%, 95% CI 80·2-91·6). 18 607 bacterial STIs were recorded (incidence 68·1 per 100 person-years in trial participants who were MSM). 4343 (24·4%) MSM participants were diagnosed with two or more STIs, accounting for 14 800 (79·5%) of all 18 607 diagnoses. PrEP need was higher than initially estimated by an expert stakeholder group. The high proportion of follow-up time protected by PrEP suggests that the need for protection persisted throughout trial participation for most participants. HIV incidence among MSM trial participants was low. The large unmet need for PrEP suggests that greater provision is required to maximise the potential of a national programme. The high incidence of bacterial STIs among participants, concentrated within a subgroup of PrEP users, presents an opportunity for tailored STI control measures. NHS England.

Oral Pre-Exposure Prophylaxis (PrEP) for HIV Prevention, Clinical Effectiveness, Safety, Adherence, and Risk Compensation in all Populations

Based on WHO and UNAIDS reports in 2021, 38.4 million (33.9-43.8 million) HIV cases in the world, in Indonesia reported by 34 provinces, the number of people living with HIV found in the January-March 2022 period was 10,525 941,973 people have HIV, and 8,784 people are receiving ARV treatment. The aim of this study is to observe the literature on the clinical efficacy, safety, compliance and risk compliance of oral pre-exposure prophylaxis (PrEP) for HIV prevention in all population groups. A literature review was carried out by identifying national and international articles regarding pre-exposure prophylaxis (PrEP) for preventing HIV transmission. The database used was Google Scholar, Pubmed, Science Direct, The Lancet. There were 331 articles searched from the Pubmed online database, 14 articles, Proquest 134, Science Direct 105, The Lancet 2, Google Scholar 105. There were 20 articles that met the inclusion criteria and were processed.

Adults on pre-exposure prophylaxis (tenofovir-emtricitabine) have faster clearance of anti-HIV monoclonal antibody VRC01

Broadly neutralizing monoclonal antibodies (mAbs) are being developed for HIV-1 prevention. Hence, these mAbs and licensed oral pre-exposure prophylaxis (PrEP) (tenofovir-emtricitabine) can be concomitantly administered in clinical trials. In 48 US participants (men and transgender persons who have sex with men) who received the HIV-1 mAb VRC01 and remained HIV-free in an antibody-mediated-prevention trial (ClinicalTrials.gov #NCT02716675), we conduct a post-hoc analysis and find that VRC01 clearance is 0.08 L/day faster (p = 0.005), and dose-normalized area-under-the-curve of VRC01 serum concentration over-time is 0.29 day/mL lower (p < 0.001) in PrEP users (n = 24) vs. non-PrEP users (n = 24). Consequently, PrEP users are predicted to have 14% lower VRC01 neutralization-mediated prevention efficacy against circulating HIV-1 strains. VRC01 clearance is positively associated (r = 0.33, p = 0.03) with levels of serum intestinal Fatty Acid Binding protein (I-FABP), a marker of epithelial intestinal permeability, which is elevated upon starting PrEP (p = 0.04) and after months of self-reported use (p = 0.001). These findings have implications for the evaluation of future HIV-1 mAbs and postulate a potential mechanism for mAb clearance in the context of PrEP.

Stability and bifurcation analysis of an HIV model with pre-exposure prophylaxis and treatment interventions

Oral pre-exposure prophylaxis (PrEP) is a highly effective method of HIV prevention. However, despite its effectiveness, the use of PrEP is not without challenges. These challenges include issues such as adherence, societal stigma, as well as accessibility and cost. PrEP effectiveness measures the drug’s performance in the real world while efficacy measures the degree to which PrEP inhibits HIV infection and its transmission. In this paper, we address the problem of reduced effectiveness of PrEP, primarily due to non-adherence, and the impact on the dynamics of HIV infection. The study aims to determine the critical threshold of PrEP effectiveness required to avoid the occurrence of a backward bifurcation. The conditions for a stable infection-free equilibrium are stated. Through a rigorous analysis of the proposed mathematical model using Castillo-Chavez and Song’s bifurcation theorem, it was found that backward bifurcation occurs when PrEP effectiveness falls below 100%. In contrast, if the effectiveness is 100%, which implies full adherence to PrEP, the model undergoes forward bifurcation. The existence of a backward bifurcation bears significant consequences, most notably the co-existence of the infection-free equilibrium and the endemic equilibrium. Under these circumstances, the eradication of HIV within a particular community becomes very difficult. The results of the numerical analysis demonstrate the important role of proper adherence in augmenting the effectiveness of PrEP and, consequently, curbing HIV transmission within communities. Nevertheless, intensive efforts are required to boost adherence to PrEP. Therefore, other HIV control measures need to be promoted to further reduce transmission.

Preferences for Long-Acting PrEP Products Among Women and Girls: A Quantitative Survey and Discrete Choice Experiment in Eswatini, Kenya, and South Africa

While oral pre-exposure prophylaxis (PrEP) can substantially reduce HIV risk, there are important barriers to uptake and adherence. We explored preferences for long-acting injectable and implantable PrEP among women and girls in Eswatini, Kenya, and South Africa. We conducted an online quantitative survey and discrete choice experiment (DCE) among adolescent girls (15–17), young women (18–29), and adult women (30–49). Participants completed a survey about their demographics and behavior and a DCE with 5 attributes (format, insertion location, number of insertions, dual-protection, and palpability). We recruited 1236 respondents (Eswatini = 420; Kenya = 350; South Africa = 493) in May 2022. Most participants were sexually active (72%), nearly 29% of whom reported recently engaging in transactional sex. 46% had heard of oral PrEP, but of those, only 16% reported having ever used it. Product format and dual-protection were significant predictors of product choice. Relative to a 2-month injection, participants had 1.76 times the odds (95% CI 1.08–2.04) of choosing a 6-month injectable, and 1.70 the odds (95% CI 1.06–1.92) of choosing a 12-month removable implant. Compared to a single-indication product, respondents had 2.46 times the odds (95% CI 1.04–2.68) of preferring a product also protecting against pregnancy, and 2.81 the odds (95% CI 1.04–3.05) of choosing a product that also protected against STIs. Adolescent girls and women in these countries showed strong preferences for longer-acting PrEP product formats, as well as those offering dual-protection. Introduction of long-acting options could improve PrEP uptake and reduce HIV burdens in east and southern African settings.

Ex-vivo rectal tissue infection with HIV-1 to assess time to protection following oral preexposure prophylaxis with tenofovir disoproxil/emtricitabine.

We wished to assess time to protection from HIV-1 infection following oral tenofovir disoproxil and emtricitabine (TDF/FTC) as preexposure prophylaxis (PrEP), using ex-vivo rectal tissue infections and drug concentration measures in blood and rectal tissue. Participants from the ANRS PREVENIR study (NCT03113123) were offered this sub-study after a 14-day wash-out. We used an ex-vivo model to evaluate rectal tissue HIV-1 susceptibility before and after PrEP, 2 h after two pills or 7 days of a daily pill of TDF/FTC. PrEP efficacy was expressed by the difference (after-before) of 14-day cumulative p24 antigen levels. TFV-DP and FTC-TP levels were measured in rectal tissue and PBMCs and correlated with HIV-1 infection. Twelve and 11 men were analyzed in the 2 h-double dose and 7 days-single dose groups, respectively. Cumulative p24 differences after-before PrEP were -144 pg/ml/mg (IQR[-259;-108]) for the 2 h-double dose group ( P = 0.0005) and -179 pg/ml/mg (IQR [-253;-86]) for the 7 days-single dose group ( P = 0.001), with no differences between groups ( P = 0.93). Rectal TFV-DP was below quantification after a double dose, but FTC-TP levels were similar to levels at 7 days. There was a significant correlation between rectal FTC-TP levels and p24 changes after a double dose ( R = -0.84; P = 0.0001). Oral TDF/FTC provided similar protection against HIV-1 infection of rectal tissue 2 h after a double dose or 7 days of a daily dose. At 2 h, this protection seems driven by high FTC-TP concentrations in rectal tissue. This confirms the importance of combining TDF and FTC to achieve early protection.

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.

Demand creation and retention strategies for oral pre-exposure prophylaxis for HIV prevention among men who have sex with men and transgender women: a systematic review and meta-analysis

BackgroundMen who have sex with men (MSM) and transgender women (TGW) have a disproportionately higher risk of human immunodeficiency virus (HIV) infection than other groups. Oral HIV pre-exposure prophylaxis (PrEP) is an effective prevention tool and should be offered to those at higher risk. Identifying demand creation strategies (DCS) and retention strategies (RS) to improve PrEP persistence is essential to control the HIV epidemic.AimWe aimed to identify the (DCS and RS with higher proportions among MSM and TGW.MethodsA systematic review and meta-analysis of prospective studies were conducted, with studies retrieved from five databases until November, 2022 following the Cochrane and PRISMA guidelines. The study protocol was registered in PROSPERO (CRD42022323220). The outcomes were DCS and RS for PrEP use among MSM and TGW. Strategies used for users enrolled in the PrEP-recruited (DCS) were classified as face-to-face (peer educator recruitment at social venues, nongovernmental organizations, and parties; direct referrals by health services; friends and/or sexual partners); online (chatbot or peer educator recruitment on social media [e.g., , Instagram or Facebook] or dating/hook-up apps [e.g., Grindr, Tinder, Badoo, and Scruff]); and mixed (face-to-face and online). RS was classified as provider counseling (face-to-face by a health professional; prevention of HIV risk counseling, distribution of condoms, lubricants, and testing for HIV or other sexually transmitted infections); online counseling (text messages, chatbots, telephone calls, social media, and peer educators); and mixed (all previous strategies). Subgroup analyses were conducted for each treatment strategy. Meta-analyses were performed using the R software version 4.2.1.ResultsA total of 1, 129 studies were retrieved from the five databases. After eligibility, 46 studies were included. For MSM, most DCS and RS were online at 91% (95% CI: 0.85–0.97; I2=53%), and 83% (95% CI: 0.80–0.85; I2=17%) respectively. For TGW, mixed DCS and RS were the most frequent at85% (95% CI: 0.60–1.00; I2=91%) and online counseling at 84% (95% CI: 0.64–0.95) compared to other strategies.ConclusionCritical issues play. Pivotal role in increasing PrEP awareness among MSM and TGW, minimizing access gaps, and ensuring retention of PrEP services. Offering oral PrEP using online DCS and RS can reach and retain high numbers of MSM and TGW, and reduce HIV incidence in these populations.

Efficient regulatory approval of two novel HIV prevention interventions in a resource-limited setting: experiences from Zimbabwe.

The global burden of HIV remains unacceptably high despite significant progress made in HIV treatment and prevention. There is an urgent need to scale up the comprehensive HIV prevention strategies that include pre-exposure prophylaxis (PrEP). Oral PrEP is highly effective in preventing HIV acquisition when taken regularly, but this remains a challenge for some at-risk individuals. Therefore, there is a need for other HIV prevention options. The dapivirine vaginal ring (DVR) and long-acting injectable cabotegravir (CAB-LA) are novel biomedical interventions that are safe and efficacious for HIV pre-exposure prophylaxis, as demonstrated in recently completed clinical trials. Timely roll-out and scalability of efficacious interventions depend on the registration process with the national medicine regulatory authorities (NMRAs). The Medicines Control Authority of Zimbabwe (MCAZ) was the first NMRA globally to approve the DVR in July 2021 and the first in Africa to approve CAB-LA for HIV prevention in July 2022. The regulatory review process for DVR and CAB-LA by MCAZ took 4.5 and 5.5 months, respectively. This efficient review process of the two interventions by MCAZ, a regulatory body in a resource-limited setting, provides important lessons to shorten timelines between the completion of the clinical development process and the registration of essential medicines.

“Sex without fear”: exploring the psychosocial impact of oral HIV pre-exposure prophylaxis on gay men in England

Gay, bisexual, and other men who have sex with men (GBMSM) experience a high prevalence of psychosocial health problems, such as harmful substance use and depression, as well as being disproportionately affected by HIV. HIV Pre-Exposure Prophylaxis (PrEP) may provide psychosocial benefits beyond its intended purpose of reducing HIV infection. We explore the psychosocial impact of oral PrEP use on gay men in England using qualitative data from the PROUD study. From February 2014 to January 2016, semi-structured in-depth interviews were conducted with 40 gay men and one trans woman. Participants were purposively recruited based on trial arm allocation, adherence, and sexual risk behaviours. By removing HIV risk from sex, PrEP improves users’ wellbeing by reducing HIV-related anxiety and internalised stigma and increasing HIV prevention self-efficacy, sexual pleasure, and intimacy. In turn, these psychological changes may influence behaviour in the form of greater sexual freedom, reduced harmful drug use, and more protective sexual health behaviours. However, PrEP may create internal conflict for some gay men, due to its disruption of social norms around condom use and its perceived influence on their sexual behaviour leading to reduced condom self-efficacy. These findings provide a baseline of PrEP’s psychosocial impact amongst some of the first PrEP users in England and supports calls to consider the psychosocial impact of PrEP in prescribing guidelines.

Implementing Differentiated and Integrated HIV Prevention Services for Adolescent Girls and Young Women: Experiences From Oral PrEP Rollout in Primary Care Services in South Africa

PurposeIn South Africa, adolescent girls and young women (AGYW, aged 15–24 years) are disproportionately affected by human immunodeficiency viruses (HIV). Oral pre-exposure prophylaxis (PrEP) has been available in South Africa since 2016; however, there is limited evidence on oral PrEP implementation and integration in real-world settings, particularly among AGYW. Project PrEP is an implementation science project that sought to inform the introduction and integration of oral PrEP as part of combination HIV prevention and sexual and reproductive health services (SRH) in South Africa. The project focused on AGYW, as a priority population in need of HIV prevention. This paper presents strategies Project PrEP employed to increase oral PrEP and SRH service access and utilization. MethodsWe present strategies employed to increase oral PrEP and SRH services uptake. Using routine monitoring data, facility assessments, stakeholder engagement, training and progress reports, and observations, we share implementation lessons learned and describe how strategies can be adapted by HIV prevention programs in different contexts. ResultsApproximately 22, 000 people initiated on oral PrEP (December 2018–December 2021) across eight facilities and four mobile clinics. Two-thirds (67%) of initiated clients were AGYW. DiscussionLessons are to be learned from the introduction of oral PrEP as implementers prepare for the introduction of new PrEP methods. Stakeholders must be continuously engaged to ensure buy-in, and social mobilization and demand creation should be contextual, focused, and innovative. Continuous staff training is needed to reinforce knowledge, and AGYW service delivery models must be local context relevant.

Same-Day Initiation of Oral Pre-Exposure Prophylaxis is High Among Adolescent Men Who Have Sex With Men and Transgender Women in Brazil

PurposeThis study analyzed the sociodemographic and behavioral characteristics of adolescent men who have sex with men (aMSM) and transgender women (aTGW) initiating oral pre-exposure prophylaxis (PrEP) in human immunodeficiency virus (HIV) prevention clinics. MethodsPrEP1519 is a prospective, multicenter, open-label PrEP demonstration cohort study of aMSM and aTGW aged 15–19 years living in three large Brazilian capital cities. For this analysis, we included adolescents who enrolled in PrEP1519 from February 2019 to August 2021. Adolescents who visited PrEP clinics were classified into four groups based on PrEP eligibility and on their decision to use PrEP: (1) ineligible for same-day PrEP initiation; (2) eligible for same-day PrEP initiation, initiated PrEP at first visit; (3) eligible for PrEP initiation, initiated PrEP after the first visit; and (4) eligible for same-day PrEP initiation but declined. The groups that were eligible for same-day PrEP initiation were compared using the Chi-square and Fisher’s exact tests. ResultsOf the 1,254 adolescents enrolled in the PrEP1519 study, 61 (4.9%) were considered ineligible for same-day PrEP initiation. Of the 1,193 eligible for same-day PrEP initiation, 1,113 (93.3%) initiated PrEP [1,054 initiated PrEP in the first visit (88.3%) and 59 in subsequent visits (4.9%)] and 80 (6.7%) did not. Despite 90% of the PrEP decliners reporting a low risk of HIV infection, most reported condomless anal sex in the past six months (70%). DiscussionSame-day PrEP initiation among aMSM and aTGW was high, highlighting that this strategy was important to promote PrEP initiation among adolescents with increased vulnerability to HIV in Brazil.

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.