Linking Women Experiencing Incarceration to Community-Based HIV Pre-Exposure Prophylaxis Care: A Qualitative Study.
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SUBMITTER: Ramsey SE
PROVIDER: S-EPMC8189628 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BACKGROUND:Women experiencing incarceration (WEI) engage in high rates of sex- and drug-related behavior that places them at risk for HIV. Pre-exposure prophylaxis (PrEP) is an efficacious means of reducing HIV acquisition. There is a general lack of knowledge regarding PrEP among women at elevated risk, and only a small percentage of at-risk women are currently engaged in PrEP care. The period of incarceration represents an opportunity to identify at-risk women, initiate PrEP during incarceration, and establish linkage to community-based PrEP care upon release from incarceration. Further, post-release is a time period that is particularly risky, and there are numerous barriers, including substance use, that may impede linkage to community-based care in the absence of intervention. The current protocol describes plans for the development and pilot randomized controlled trial (RCT) of an intervention to promote PrEP uptake during incarceration and facilitate linkage to community-based PrEP care post-release. METHODS/DESIGN:The motivational interviewing-navigation (MI-NAV) study intervention is being developed, refined, and tested over three phases within the framework of the social ecological model. All phases of the study are being conducted at a women's correctional facility and community-based PrEP provider located in the Northeastern region of the United States. Phase 1 consists of individual qualitative interviews to be conducted with key stakeholders (n?=?6-10) from the community-based PrEP care site and (n?=?6-10) from the women's correctional facility, as well as with (n?=?18-30) WEI. Recruitment for Phase 1 was initiated in November 2017. In Phase 2, MI-NAV will be piloted with a small cohort (n?=?8-12) of WEI and will be refined based upon participant feedback. During Phase 3, a pilot RCT of MI-NAV and a standard of care condition will be conducted with 80 WEI. RCT participants will complete baseline and follow-up assessments 1, 3, and 6 months post-release. The primary study outcome is linkage to community-based PrEP care, verified via medical records. DISCUSSION:This study will develop and evaluate a psychosocial intervention (MI-NAV) to promote PrEP uptake and facilitate linkage to community-based PrEP care among women at-risk for HIV. It is expected that, as a result of this project, the feasibility, acceptability, and preliminary efficacy of MI-NAV will be determined. If found to be efficacious, this intervention has the potential to reduce HIV acquisition in a high-need, underserved community. Clinical trial registration NCT03281343.
| S-EPMC6398222 | biostudies-literature
Project description:BackgroundDespite experiencing the second-highest rate of HIV incidence in the United States, pre-exposure prophylaxis (PrEP) use remains low among Black women due, in part, to a lack of patients' awareness and providers' knowledge.ObjectiveOur goal was to design animated educational tools informed by patients and women's health providers to address these barriers, specifically for women at risk for HIV.MethodsTwo animation storyboards about PrEP for women were created by academic stakeholders (eg, HIV clinical experts, educators, and HIV peer counselors), one for patients and one for providers. Four focus groups with community members from Baltimore, Maryland and four with women's health providers (eg, obstetrician/gynecologists, midwives, nurse practitioners, and peer counselors) at an academic center were conducted to discuss the storyboards. Transcripts were analyzed using conventional content analysis, and themes were incorporated into the final versions of the animations.ResultsAcademic stakeholders and 30 focus group participants (n=16 female community members and n=14 women's health providers) described important themes regarding PrEP. The themes most commonly discussed about the patient animation were understandability of side effects, HIV risk factors, messaging, PrEP access, and use confidence. Provider animation themes were indications for PrEP, side effects, and prescribing confidence.ConclusionsWe created two PrEP animations focused on women. Stakeholder feedback highlighted the importance of ensuring the understandability and applicability of PrEP educational materials while including necessary information to facilitate use or prescribing confidence. Both community members and women's health providers reported greater use confidence after viewing the animations.
| S-EPMC9308066 | biostudies-literature
Project description:Pre-exposure prophylaxis (PrEP) has emerged as a promising strategy for preventing the transmission of HIV. Although only one formulation is currently approved for PrEP, research into both new compounds and new delivery systems for PrEP regimens offer intriguing challenges from the perspective of pharmacokinetic and pharmacodynamic modeling. This review aims to provide an overview the current modeling landscape for HIV PrEP, focused on PK/PD and QSP models relating to antiretroviral agents. Both current PrEP treatments and new compounds that show promise as PrEP agents are highlighted, as well as models of uncommon administration routes, predictions based on models of mechanism of action and viral dynamics, and issues related to adherence to therapy. The spread of human immunodeficiency virus (HIV) remains one of the foremost global health concerns. In the absence of a vaccine, other prophylactic strategies have been developed to prevent HIV transmission. One approach, known as pre-exposure prophylaxis (PrEP), allows HIV-negative individuals who are at high risk of exposure to the virus, be it through an HIV-positive sexual partner or through the shared use of drug injection equipment, to substantially reduce the risk of developing an HIV infection. PrEP is a relatively recent approach to combating the HIV epidemic, with the only currently approved treatment being Truvada, a daily oral antiretroviral (ARV) therapy initially indicated in the treatment of active HIV-1 infections, but approved for HIV PrEP in 2012. Although PrEP therapy has consistently demonstrated high efficacy in preventing HIV infection, this efficacy is dependent on patient adherence to the prescribed treatment regimen. This can present a significant problem in low- and middle-income countries, which may lack the infrastructure to provide sufficient access to PrEP medication to maintain daily dosing regimens. Furthermore, while the conventional approach has generally been to advocate for continuous administration akin to regimens used for viral suppression in infected patients, there has been some discussion of whether a better treatment paradigm might be to push for PrEP therapy primarily during those known periods of heightened exposure risk, while relying on post-exposure prophylaxis regimens to prevent infection after unanticipated exposures during low-risk periods. These considerations have led to a push for the development of long-duration and on-demand PrEP formulations, including subdermal and subcutaneous implants, slow-release intramuscular depot injections, vaginal and rectal antimicrobial gels, and intravaginal rings and dissolving films. PrEP therapy is a quickly evolving field, with a variety of antiretroviral compounds and formulations under investigation. This review aims to report on notable drugs and formulations from a pharmacokinetic/pharmacodynamic (PK/PD) modeling perspective. Given the nature of PrEP as a preventive therapy designed for long-term use, clinical trials for PrEP therapies can last for months or even years, particularly in the case of long-duration formulations. Furthermore, in contrast to antiretroviral trials in infected patients, pharmacodynamic endpoints in PrEP therapies are difficult to quantify, as the primary endpoint for efficacy is generally the rate of seroconversion. Computational modeling approaches offer flexible and powerful tools to provide insight into drug behavior in clinical settings, and can ultimately reduce the time, expense, and patient burden incurred in the development of PrEP therapies.
| S-EPMC7005100 | biostudies-literature
Project description:Purpose: In Argentina, transgender women face a disproportionately high prevalence of HIV infection (34%). Although not currently approved in Argentina, pre-exposure prophylaxis (PrEP) may offer a potential effective HIV prevention tool for this population. In this study, we assessed the willingness to use PrEP among transgender women in Argentina. Methods: Data were drawn from a nationwide cross-sectional survey conducted among transgender women in 2013. Using multivariable logistic regression, we assessed the prevalence of and factors associated with willingness to use PrEP among transgender women with negative or unknown HIV status. Results: This study included 337 transgender women (278 HIV negative and 59 with unknown HIV status), most of whom had a history of sex work involvement (81.8%). Overall, 301 (89.3%) expressed willingness to use PrEP. In a multivariable analysis, having casual sexual partners was positively associated with willingness to use PrEP (adjusted odds ratio [AOR]=4.26, 95% confidence interval [CI] 1.73-10.51), while discrimination by healthcare workers was negatively associated (AOR=0.33, 95% CI 0.12-0.88). Conclusion: We found high levels of willingness to use PrEP among transgender women in Argentina, suggesting that there is high perception of HIV risk in this population. However, discrimination by healthcare workers was a strong negative correlate of willingness to use PrEP, suggesting that multilevel interventions that address gender-based stigma in healthcare settings will be critical for the success of PrEP as an HIV prevention strategy in this population.
| S-EPMC5367484 | biostudies-other
Project description:BackgroundPre-exposure prophylaxis (PrEP) has the potential to reduce HIV transmission and stem the HIV epidemic. Unfortunately, PrEP uptake in rural sub-Saharan Africa has been slow and medication adherence has been suboptimal.ObjectiveTo explore the perspectives, attitudes, and experiences of HIV serodiscordant partners taking PrEP and develop a messaging campaign to improve PrEP uptake in rural Mozambique to reduce HIV transmission among serodiscordant partners.MethodsIn this qualitative study, we interviewed 20 people in serodiscordant relationships using PrEP at a rural health center in Zambézia province, Mozambique and employed inductive and deductive coding to elicit their perspectives, attitudes, and experiences related to learning their partner's HIV status, barriers to PrEP uptake, obstacles to PrEP adherence, and decisions to disclose their PrEP use with family and friends using thematic analysis.ResultsOur analysis generated nine themes across various levels of the socioecological model. Participants reported a strong desire to stay in the discordant relationship and highlighted the importance of working together to ensure PrEP and antiretroviral therapy adherence, with the majority skeptical that adherence could be achieved without both partners' support (individual and interpersonal). Although most participants were reticent about sharing their serodiscordant status with family and friends (individual and interpersonal), those who did found their family and friends supportive (interpersonal). Participants suggested increasing community health agent availability to help people navigate HIV prevention and treatment (organizational). We then created three oral stories, using themes from the interviews, with examples from various levels of the socioecological model that will be used to generate support for PrEP use among community members.ConclusionsOur findings informed oral template stories that will be used to emphasize how couples can work together to improve PrEP uptake and reduce incident HIV infections in serodiscordant couples elsewhere in rural Mozambique.
| S-EPMC8266225 | biostudies-literature
Project description:BackgroundIn the United States, women represent less than 5% of all pre-exposure prophylaxis (PrEP) users. Social networks may promote and/or inhibit women's PrEP awareness, which could influence PrEP intentions. Furthermore, women experiencing intimate partner violence (IPV) may have smaller, less supportive networks, which could deter or have no impact on PrEP care engagement. This study examined associations between network characteristics and women's PrEP awareness, interest, uptake, and perceived candidacy and analyzed IPV as an effect modifier.Setting/methodsFrom 2017 to 2018, data were collected from a prospective cohort study of 218 PrEP-eligible women with (n = 94) and without (n = 124) IPV experiences in Connecticut. Women completed surveys on demographics, IPV, social networks, and PrEP care continuum outcomes.ResultsAdjusted analyses showed that PrEP awareness related to having more PrEP-aware alters. PrEP intentions related to having more alters with favorable opinions of women's potential PrEP use and a smaller network size. Viewing oneself as an appropriate PrEP candidate related to having more PrEP-aware alters and more alters with favorable opinions of women's potential PrEP use. IPV modified associations between network characteristics and PrEP care. Having members who were aware of and/or used PrEP was positively associated with PrEP care engagement for women without IPV experiences but had either no effect or the opposite effect for women experiencing IPV.ConclusionImproving PrEP attitudes might improve its utilization among women. Social network interventions might be one way to increase PrEP uptake among many US women but may not be as effective for women experiencing IPV.
| S-EPMC6408934 | biostudies-literature
Project description:There is increasing evidence that the use of antiretroviral agents (ARVs) can be a safe and effective means of preventing HIV infection. In fact, a combination of ARVs, tenofovir-emtricitabine, was recently approved by the US Food and Drug Administration (FDA) for use as "pre-exposure prophylaxis"(PrEP), and the US Centers for Disease Control and other regulatory authorities have issued guidance concerning PrEP use. Clinicians and policy makers are now faced with questions about the appropriateness of prescribing ARVs to healthy persons who are at risk of becoming infected with HIV, and those at risk of being infected must decide whether to use PrEP. In addition, researcher stakeholders must grapple with determining whether and how PrEP should be included in future HIV prevention research. In addressing such issues, it is important that their ethical dimensions are identified. When using PrEP, 2 broad ethical domains are of special relevance: well-being and justice. Ethical issues related to well-being include safety, parameters of use, risk behaviors, resistance, stigma, and diversion. Those related to justice include access and competing priorities. In research involving PrEP, ethical issues include determining the appropriate control arm and whether PrEP should be included as a part of the prevention package provided to all at risk participants. Although PrEP could play an important role in HIV prevention, understanding and addressing the related ethical issues is critical to its safe, effective, and appropriate use in practice and future research.
| S-EPMC3728665 | biostudies-other
Project description:INTRODUCTION:Pre-exposure prophylaxis (PrEP) is recommended by the World Health Organization as an effective method of HIV prevention for individuals at risk for infection. In this paper, we describe the unique role that Thailand has played in the global effort to combat the HIV epidemic, including its role in proving the efficacy of PrEP, and discuss the opportunities and challenges of implementing PrEP in a middle-income country. DISCUSSION:Thailand was one of the first countries in the world to successfully reverse a generalized HIV epidemic. Despite this early success, HIV prevalence has remained high among people who inject drugs and has surged among men who have sex with men (MSM) and transgender women (TGW). Two pivotal trials that showed that the use of oral antiretroviral medication as PrEP can reduce HIV transmission were conducted partially or entirely at Thai sites. Demonstration projects of PrEP, as well as clinical trials of alternative PrEP regimens, began or will begin in 2014-2015 in Thailand and will provide additional data and experience on how to best implement PrEP for high-risk individuals in the community. Financing of drug costs, the need for routine laboratory monitoring and lack of awareness about PrEP among at-risk groups all present challenges to the wider implementation of PrEP for HIV prevention in Thailand. CONCLUSIONS:Although significant challenges to wider use remain, PrEP holds promise as a safe and highly effective method to be used as part of a combined HIV prevention strategy for MSM and TGW in Thailand.
| S-EPMC4509899 | biostudies-other
Project description:The RV144 HIV-vaccine trial highlighted the importance of envelope-specific non-neutralizing antibody (nNAb) Fc-mediated functions as immune correlates of reduced risk of infection. Since pre-exposure prophylaxis (PrEP) and HIV-vaccines are being used as a combination prevention strategy in at risk populations, the effects of PrEP on nNAb functions both mucosally and systemically remain undefined. Previous animal and human studies demonstrated reduced HIV-specific antibody binding avidity post-HIV seroconversion with PrEP, which in turn may affect antibody functionality. In seroconverters from the CAPRISA 004 tenofovir gel trial, we previously reported significantly higher detection and titres of HIV-specific binding antibodies in the plasma and genital tract (GT) that distinguished the tenofovir from the placebo arm. We hypothesized that higher HIV-specific antibody titres and detection reflected corresponding increased antibody-dependent neutrophil-mediated phagocytosis (ADNP) and NK-cell-activated antibody-dependent cellular cytotoxic (ADCC) activities. HIV-specific V1V2-gp70, gp120, gp41, p66, and p24 antibodies in GT and plasma samples of 48 seroconverters from the CAPRISA 004 tenofovir gel trial were tested for ADCP and ADCC at 3, 6- and 12-months post-HIV-infection. GT gp41- and p24-specific ADNP were significantly higher in the tenofovir than the placebo arm at 6 and 12 months respectively (p < 0.05). Plasma gp120-, gp41-, and p66-specific ADNP, and GT gp41-specific ADCC increased significantly over time (p < 0.05) in the tenofovir arm. In the tenofovir arm only, significant inverse correlations were observed between gp120-specific ADCC and gp120-antibody titres (r = -0.54; p = 0.009), and gp41-specific ADNP and gp41-specific antibody titres at 6 months post-infection (r = -0.50; p = 0.015). In addition, in the tenofovir arm, gp41-specific ADCC showed significant direct correlations between the compartments (r = 0.53; p = 0.045). Certain HIV-specific nNAb activities not only dominate specific immunological compartments but can also exhibit diverse functions within the same compartment. Our previous findings of increased HIV specific antibody detection and titres in women who used tenofovir gel, and the limited differences in nNAb activities between the arms, suggest that prior PrEP did not modulate these nNAb functions post-HIV seroconversion. Together these data provide insight into envelope-specific-nNAb Fc-mediated functions at the site of exposure which may inform on ensuing immunity during combination HIV prevention strategies including PrEP and HIV vaccines.
| S-EPMC7357346 | biostudies-literature
Project description:When taken consistently, pre-exposure prophylaxis (PrEP) against human immunodeficiency virus (HIV) with once daily tenofovir disoproxil fumarate-emtricitabine (TDF-FTC) has been shown to safely reduce the incidence of HIV infection in high-risk individuals by more than 90%. Yet, according to the Centers for Disease Control and Prevention, there were about 2.1 million new cases of HIV reported worldwide in 2015. Undoubtedly, there is significant room for improvement to prevent the transmission of HIV. Research to date has been heavily focused on the high-risk men who have sex with men (MSM) population, yet, many women worldwide remain at high risk of HIV transmission. PrEP offers women a protection method that is discrete, does not require partner consent, and may be compatible with both contraception or conception as desired. However, women often remain under-represented in HIV prevention literature and are reported to have lower real-world uptake in comparison to men. Furthermore, clinical trials that do focus on the female population demonstrate mixed efficacy results that highlight the adherence challenges in this population. It is essential to identify factors that contribute to PrEP non-adherence as well as barriers to preventative treatment. This review will discuss the clinical evidence behind PrEP in women, current barriers to use afflicting this population, pharmacotherapy considerations for the female patient, alternative and future agents, and the current real-world application of PrEP.
| S-EPMC5595773 | biostudies-other