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Running head: HIV/AIDS PREVENTION 0

PrEP Usage in HIV Prevention

There is a need for increased effective interventions to decrease HIV transmission because the global incidence of HIV exceeds 2 million new infections each year. HIV incidence among diverse at-risk populations can significantly be reduced by taking a prescribed pre-exposure chemoprophylaxis (PrEP) tablet, which contains emtricitabine and tenofovir disoproxil. These medications need to be taken orally on a daily basis, as shown by the randomized placebo-controlled research. PrEP's efficiency was correlated with levels of adherence in these studies. High adhesion and uptake levels are possible outside of controlled studies according to a suggestion by the demonstration projects with the recommendation by the official guidelines stating that PrEP should be provided to the individuals at the highest risk of HIV acquisition.

Nevertheless, there are various potential difficulties in implementing PrEP, such as adherence in "real-world" settings uncertainties and lack of affordable PrEP medications. The behaviors that would warrant PrEP usage, the stigma associated with its application, and long term use effects of tenofovir-emtricitabine are additional barriers. They have very little data about its usage adversity and low utilization and awareness of PrEP by those at risk are other possible restrictions that render its usage inefficient in HIV prevention. In spite of the above barriers, approaches like innovative pharmacologic chemoprophylactic could help provide solutions to some of these challenges. Adherence facilitation and pill burden reduction could be reduced through long-acting injectable medications and oral dosing regimens that are less-than-daily. Potential toxicities and systemic drug exposures may be the limitations to local delivery of PrEP medications to genital compartments through films, rings, and gels. There are high hopes that antiretroviral chemoprophylaxis could become highly competent, feasible, and acceptable, in addition to the current methods of preventing HIV. Such projections exist amid the delivery systems and chemoprophylactic agents portfolio of expansion to meet PrEP beneficiaries needs in their product preferences and sexual health that are diverse and challenging.

The elemental aim of the research was to figure out the importance of pre-exposure chemoprophylaxis (PrEP) in HIV prevention. To understand the vitality, benefits behaviors, perceptions, and medical best practices involving HIV prevention, the exploration of the prep usage is a crucial undertaking. The application and related studies on the effectiveness of PrEP will be analyzed based on previous reviews and published journals to assess and understand the attitudes of physicians toward the use of pre-exposure prophylaxis (PrEP) for HIV prevention. Besides, Prep integration into family planning service for high-risk populations to assist with prevention and interventions among female sex workers in urban clinics will be tested. Also, this study will look at the importance of implementing Prep within Family Planning clinics. Such implementation will be focused on reaching young women in high-risk settings and at-risk adolescent girls as well. In another perspective, this study aimed at testing interventions among female sex workers in two urban clinics and integrating Prep into family planning services for high-risk populations to assist with prevention (Eakle et al., 2017). HIV disproportionately affects young men who have sexual intercourse with other men. Pre-exposure prophylaxis (PrEP) can help prevent HIV acquisition; however, youth access to PrEP is limited by provider willingness to prescribe Prep. Studies also try to understand the attitudes of physicians towards the use of pre-exposure prophylaxis, popularly known as PrEP, for HIV prevention among youth is critical to improving access to PrEP. An examination of the PrEP-related attitudes among physicians who provide primary care to 13- to 21-year-old adolescents was crucial in this study. The evaluation of the utility of the risk score in predicting HIV incidence among a cohort of adolescent girls in rural regions has proved to be insightful in assessing its prevention strategies.

There is a need to determine whether specific subgroups of HIV providers were more likely to intend to prescribe PrEP than others to come up with a credible analysis of the prevention criterion. Besides, testing a multilevel package of interventions at the community and health system levels in Zambia to connect adolescent girls and young women, with a source of regular care. This could allow for sustainable, successful implementation of routine HIV testing and adherence to antiretroviral treatment. Moreover, women in high HIV burden settings offer a promising approach when PrEP is provided through child health and maternal and family planning clinics. In this sense, assessing the inner and outer context factors, which are the facilitators and barriers that might influence PrEP adoption prescription and treatment services in Title X clinics serving, could be useful (Sales n.d). It is crucial to be knowledgeable in differentiating HIV prevention awareness, health care access, and service utilization as well as investigating the associations between the perceived barriers and benefits of using HIV pre exposure prophylaxis medication.

Importance of PrEP Implementation within family planning

Method

In their quest to study the usefulness of implementing Prep within Family Planning clinics to reach at-risk adolescent’s girls and young women in high-risk settings, Mugwanya et al., (2019) found useful insights. They found that the continuation of PrEP use at 1, 3, and 6 months post-initiation was 41%, 24%, and 15% and that low perceived risk of HIV were the reasons for discontinuing Prep. Program retention at 12 months was another measure in the research, also reported male partner HIV status as a result of the new continuation of Prep.

Moreover, additional measures involved women in intervention clinics having monthly visits for the first three months post‐enrollment. After that, gel provision and monitoring were scheduled to coincide with each woman's routine FP visit. They were assigned to control clinics and the received gel. Applicators monthly, irrespective of frequency or formulation of contraception. In its quantitative data research, which involved a sample of women aged 15 to 45 from the general population seeking FP services at eight public health clinics were universally screened for HIV behavioral risk factors before they were offered PrEP. School-attending young women aged between 13 to 20 years were enrolled in the trial from 2011 to 2012 and were followed for up to three years. The study developed a risk score based on the individual-level risk factors measured during enrollment was calculated for the participants who completed a one-year follow-up visit and were HIV seronegative at registration. Composite scores were developed to measure PrEP knowledge, experience, and the likelihood of prescribing. Performing formative research including focus groups and in-depth interviews among the adolescent girls and young women, stakeholders, and caregivers to help inform the development and tailoring of the interventions (Subramanian et al., n.d). Surveys and in-depth interviews were the methods used to collect staff and stakeholder feedback after the trial. Additional measures in the research found that the approximated changes in costs of creatinine testing were postponed from initiation to the first follow-up visit. Also, PrEP was prioritized to clients who were at a high HIV risk using a behavioral risk assessment tool.

The screening was conducted in 1,271 of uninfected women in which only 278 started Prep. Those that went back for refill were only 114 women in a month, which were used as a measure through a monthly follow up for refills in clinic measures. In this study, the intervention involved women initiating on PrEP being followed as per the Kenya national guidelines for PrEP, including initiation, month 1, and then three monthly visits for clinical review. The focus was given to girls and young women. Interviews conducted assessed familiarity with PrEP, the perceived benefits, and barriers to providing PrEP to adolescents, facilitating factors for prescribing PrEP, and the likelihood of recommending and prescribing PrEP to adolescents (Mullins et al., n.d). Multivariate logistic regression was used to assess provider beliefs associated with willingness to provide PrEP. A proportional hazards model was then adopted to determine if the risk score at enrollment was predictive of incident HIV infection at follow-up. An area under the curve analysis was then used to examine the predictive ability of the score. Also, the latent class analysis was used to stratify provider attitudes toward PrEP.

Further intervention includes adapting prior tools to create the Support for HIV integrated education, linkages to care, and destigmatization (SHIELD), intervention to educate and empower Zambian adolescent young girls and women (Castel et al., 2015). Another method involved a cluster-randomized controlled trial that was implemented in Lusaka included six clinic catchment areas that were randomized into three groups: zones with only SHIELD intervention, zones with integrated wellness care clinics, and control zones with no response (Castel et al., 2015). HIV testing among the unknown (HIV-/u) or HIV-negative cohort and retention in care, in addition to viral load suppression, will be evaluated in the HIV-positive (HIV+) cohort. Informant interviews that were conducted among a purposively selected subset of responders were used to comprehensively assess the inner and outer context factors that might influence the adoption and implementation of PrEP in Title X Family Planning clinics in the South (Castel et al., 2015). Participants completed an in-person computer-assisted self-interview every six months, up to February 2017, with questions on sociodemographic factors, awareness of biomedical HIV prevention strategies, and an HIV treatment optimism-skepticism scale. Oral tenofovir (TDF) was administered daily and followed up every 12 weeks for two years (Roberts et al., 2019). Women received monthly visits throughout the study for the first three months while in the intervention clinic, and the control clinic received monthly follow up. The authors conducted a costing study from the provider perspective within the PrEP Implementation for young women and adolescent’s program in western Kenya.

Findings

Various outcomes were collected in the research concerning PrEP use and related medication. Of those enrolled, 22% on PrEP and 60% on early ART were seen at 12 months; observed high rates of loss to follow-up women in intervention and control clinics were comparable, and retention rates were 92.1% and 92.3% respectively. Women in intervention clinics and control clinics returned on average 5.2 (95% confidence interval (CI): 4.7 to 5.7), and 5.7 (CI: 5.2 to 6.2) used gel applicators per month, respectively, with a mean difference of -0.47. Nearly all providers had heard of PrEP, while 35.2% had prescribed PrEP. While almost all providers agreed that PrEP prevents HIV, fewer were willing to prescribe to young adults or adolescents. The willingness to prescribe PrEP was strongly associated with beliefs that providers had enough knowledge to provide PrEP to adolescents safely and that adolescents would be adherent. The mean age was 44.6 years, fourteen physicians (37%) reported being somewhat or very familiar with PrEP (Hart-Cooper et al., n.d). The perceived benefits of prescribing PrEP included decreased acquisition/rates of HIV, improved provision of sexual health services, and enhanced patient awareness of HIV risk. Barriers to the use and access to PrEP were reported at the patient (like the lack of acceptability to patients), provider (for example concerns about safe patient adherence, safety/side effects, parents as a barrier to PrEP use), and system (e.g., high cost) levels. Facilitating factors for prescribing PrEP included low cost/coverage by insurance, physician education about PrEP, patient educational materials, and clinical guidelines for PrEP use in youth. A higher proportion of physicians reported being highly or somewhat likely to recommend (N = 16, 42%) than prescribe PrEP (N = 13, 34%). The risk score had a limited variability in the HPTN 068 sample. The risk score did not automatically predict HIV incidence after one year of follow-up and showed poor predictive ability. Among 142 HIV providers, 73.2% had cared for more than 20 HIV-infected patients in the previous three months; 17% had ever prescribed PrEP.

The latent class analysis identified two classes of providers found PrEP less useful and perceived barriers to prescribing it; Class 2 observed PrEP as moderately active and perceived fewer barriers to prescribing it. Compared with class 2, class 1 had significantly less experience with PrEP delivery and was considerably less likely to have the intent to prescribe PrEP to patients who had multiple sex partners.

Interim results are expected in 2021, while the final results are expected later in 2022. Incase this multilevel intervention strategy is successful in establishing a comprehensive care continuum for HIV-affected adolescent girls and young women, AGYW, the Zambian Ministry of Health may advocate for the expansion to additional settings to support national scale-up. For an annual program output of the 24,005 screenings, 4198 PrEP initiations, and the 4427 follow-up visits, the study shows that the average cost per client-month of PrEP dispensed was approximately $26.52. Drugs, personnel, and laboratory tests comprised 25%, 43%, and 14% of program costs, respectively. The study further reveals that postponing creatinine testing and prioritizing PrEP delivery to clients at high HIV risk reduced total program costs by 8% and 14%, respectively. In the Ministry of Health scenario, assuming no changes in outputs occurred, the projected cost per client-month of PrEP dispensed decreased to approximately $16.54, and total program costs decreased by 38%. Phase 1 of planning for PrEP research activities began in October 2017 and is ongoing. To date, survey and essential informant interview administration are near completion, with quantitative and qualitative data analysis scheduled to start soon after data collection completion. Of 698 GBM who enrolled in the longitudinal study, 36.8% were less than 30 years old at the first study visit (Closson et al., 2019). After controlling for gender identification, sexual orientation, HIV status, and income in the past six months, younger GBM (n = 257/698) had lower awareness of biomedical HIV prevention strategies and less HIV treatment optimism compared with older GBM (n = 441/698). A total of 411 participants were enrolled in this study, and 1561 follow-up observation points were obtained. The average medication rate was 0.62 ± 0.37, and the medication rate increased with longer follow-up (P < 0.05) (Huang et al., 2018). The medication rate was higher among MSM who were divorced (compared to those who were unmarried, P < 0.0001).

Strengths

There were various strengths in this study, such as the feasibility in the integration of universal screening and counseling for PrEP in Family Planning clinics. It was because of the possibility that this platform was made a potential "one-stop" location for PrEP and Family Planning. The research revealed the need for more significant efforts to support PrEP persistence and normalization for African women. These were needed to help women navigate their decisions about HIV prevention. How to obtain as well as the maintenance of high medication adherence among MSM, was crucial for the PrEP intervention strategy for effective reduction of HIV infection. There are widespread benefits of the data gained from this study, including informing a type 1 hybrid effectiveness implementation study. The implementation would be useful in the evaluation of multilevel factors associated with successful PrEP implementation while evaluating the degree of PrEP adherence among women seen in Title X clinics, their continuation and uptake as well. The attendance of peer-based HIV-leadership programs has enhanced age-disparities in treatment optimism and HIV-prevention knowledge. Another strength of this research entails the incremental PrEP costs, which are sensitive to the service delivery strategy used to engage priority populations. Prices might also be reduced through prioritization of PrEP delivery to clients at high HIV risk as well as postponing creatinine testing. The multilevel model interventions of the healthcare system at various levels can be useful in integrating the service delivery model, which can be a platform to implement additional preventive services further so that the HIV-/u and HIV+ AGYW could receive comprehensive, integrated services. Complementary strengths of the research involve HIV providers finding PrEP to be effective. Addressing these barriers may increase adolescent’s access to PrEP, maybe enhanced through addressing such issues as changing attitudes toward PrEP prescribing physicians when treating or prescribing for adolescents.

Moreover, almost all the providers had heard of PrEP and most of the providers were willing to prescribe PrEP to their clients. Provider tools and education to promote provider self-efficacy and adolescent adherence might improve provider willingness to provide PrEP. In the stratification of provider attitudes toward PrEP, the latent class analysis was utilized. A proportional hazards model was then used to determine if the risk score at enrollment was predictive of incident HIV infection at follow-up, and an area under the curve analysis was used to examine the predictive ability of the score.

Limitations

However, limitations existed in the study, such as the lack of qualitative work that could provide insights into the women's decision-making on PrEP uptake and continuation. Also, definitive ascertainment of the robustness of a PrEP-dedicated nurse-led implementation strategy may be limited by the study, which was a non-randomized design. Another limitation or imposing clinical study requirements was the lack of a control group when PrEP was not approved through the prospective regulatory system. Such imposition could have assuredly affected the timing as well as the uptake of the Implementation of a national sex worker HIV program, which could, in return, have influenced retention and absorption. Also, that there existed the burden perceived during the medication as well as a dislike of taking the drugs which had no effects on the actual medication rate of taking TDF limited the accuracy of the study outcome and even the subsequent analysis. Besides, in the HPTN 068 sample, it was found that the VOICE risk score demonstrated low utility to predict HIV incidence (Giovenco et al., 2019). The findings highlighted the need for developmentally and age-appropriate tools for assessing risk for HIV infection among adolescents. Holding interviews that were not in-depth with providers and opting for the semi-structured interviews only and involving an imbalanced age group because the participants were only 18 years and younger also was noted in the research. Further limitations included the lack of a specific timeline for the duration of the survey as well as the number of clinicians not indicated who participated in the study nor were the number of participants in the age groups indicated

In summary, it is tough to singular the goal of revolutionizing HIV prevention and ultimately "getting to zero" new HIV infections worldwide. However, the importance of pre-exposure chemoprophylaxis (PrEP) in HIV prevention is critical. To understand the vitality, benefits behaviors, perceptions, and medical best practices involving HIV prevention, the exploration of the prep usage is a crucial undertaking. The application and related studies on the effectiveness of PrEP will be analyzed based on previous reviews and published journals to assess and understand the attitudes of physicians toward the use of pre-exposure prophylaxis (PrEP) for HIV prevention.

References

*Eakle, R., Gomez, G. B., Naicker, N., Bothma, R., Mbogua, J., Cabrera Escobar, M. A., … Rees, H. (2017). HIV pre-exposure prophylaxis and early antiretroviral treatment among female sex workers in South Africa: Results from a prospective observational demonstration project. PLoS Medicine, 14(11). https://doi.org/10.1371/journal.pmed.1002444

Hart-Cooper, Geoffrey D. et al.Journal of Adolescent Health, Volume 63, Issue 2, 242 – 244

Primary Care Physician Attitudes and Intentions toward the Use of HIV PrEP in Adolescents in One Metropolitan Region

*Castel, A. D., Feaster, D. J., Tang, W., Willis, S., Jordan, H., Villamizar, K., … Metsch, L. R. (2015). Understanding HIV Care Provider Attitudes Regarding Intentions to Prescribe PrEP. Journal of acquired immune deficiency syndromes (1999), 70(5), 520–528.

*Closson, K., Chown, S., Armstrong, H. L., Wang, L., Bacani, N., Ho, D., … Lachowsky, N. J. (2019). HIV leadership programming attendance is associated with PrEP and PEP awareness among young, gay, bisexual, and other men who have sex with men in Vancouver, Canada. BMC public health, 19(1), 429.

*Giovenco, D., Pettifor, A., MacPhail, C., Kahn, K., Wagner, R., Piwowar-Manning, E., … Hughes, J. P. (2019). Assessing the risk for HIV infection among adolescent girls in South Africa: an evaluation of the VOICE risk score (HPTN 068). Journal of the International AIDS Society, 22(7), e25359. doi:10.1002/jia2.25359

Hu, Y., Zhong, X. N., Peng, B., Zhang, Y., Liang, H., Dai, J. H., … Huang, A. L. (2018). Associations between perceived barriers and benefits of using HIV pre-exposure prophylaxis and medication adherence among men who have sex with men in Western China. BMC infectious diseases, 18(1), 575. doi:10.1186/s12879-018-3497-7

Mansoor, L. E., Yende‐Zuma, N., Baxter, C., Mngadi, K. T., Dawood, H., Gengiah, T. N., Samsunder, N., Schwartz, J. L., Doncel, G. F. and Abdool Karim, Q. Integrated provision of topical pre‐exposure prophylaxis in routine family planning services in South Africa: a non‐inferiority randomized controlled trial. J Int AIDS Soc. 2019; 22( 9):e25381

Mullins, Tanya L. Kowalczyk et al.Journal of Adolescent Health, Volume 64, Issue 5, 581 - 588

*Mugwanya KK, Pintye J, Kinuthia J, Abuna F, Lagat H, Begnel ER, et al. (2019) Integrating preexposure prophylaxis delivery in routine family planning clinics: A feasibility programmatic evaluation in Kenya. PLoS Med 16(9): e1002885. https://doi.org/10.1371/journal.pmed.1002885

Roberts, D. A., Barnabas, R. V., Abuna, F., Lagat, H., Kinuthia, J., Pintye, J., … Levin, C. (2019). The role of costing in the introduction and scale-up of HIV pre-exposure prophylaxis: evidence from integrating PrEP into routine maternal and child health and family planning clinics in western Kenya. Journal of the International AIDS Society, 22 Suppl 4(Suppl Suppl 4), e25296. doi:10.1002/jia2.25296

*Sales JM, Escoffery C, Hussen SA, Haddad LB, Phillips A, Filipowicz T, Sanchez M, McCumber M, Rupp B, Kwiatkowski E, Psioda MA, Sheth AN Pre-Exposure Prophylaxis Integration into Family Planning Services at Title X Clinics in the Southeastern United States: A Geographically-Targeted Mixed Methods Study

*Subramanian S, Edwards P, Roberts ST, Musheke M, Mbizvo M Integrated Care Delivery for HIV Prevention and Treatment in Adolescent Girls and Young Women in Zambia: Protocol for a Cluster-Randomized Controlled Trial

*Literature reviewed articles