Dataset Information

Online Navigation for Pre-Exposure Prophylaxis via PleasePrEPMe Chat for HIV Prevention: Protocol for a Development and Use Study.

ABSTRACT: BACKGROUND:Pre-exposure prophylaxis is an HIV medication taken by an individual who is HIV-negative to prevent infection before exposure to the virus. Numerous clinical studies in various communities have shown high rates of effectiveness when pre-exposure prophylaxis is taken as prescribed. Since FDA (US Food and Drug Administration) approval of the first product for pre-exposure prophylaxis in 2012, uptake has been lower than the estimated 1.1 million US adults who could benefit from its use, with an estimated 70,394 individuals on pre-exposure prophylaxis in 2017. Of these, only 11% were Black and 13% were Hispanic despite Black and Hispanic individuals comprising two-thirds of individuals who could benefit, highlighting racial and ethnic disparities in pre-exposure prophylaxis uptake. Patient navigators have been shown to be effective in improving the linkage and retention in care outcomes of people living with HIV across the HIV treatment cascade and can be used throughout the pre-exposure prophylaxis care continuum to assist decision making and connect potential users to pre-exposure prophylaxis services. OBJECTIVE:PleasePrEPMe Chat was designed as a novel online strategy aimed at improving engagement in pre-exposure prophylaxis care services with pre-exposure prophylaxis-eligible populations in California via free HIV-prevention information and health care navigation services. METHODS:Visitors connected with navigators via online bilingual (English, Spanish) chat. During the chat, navigators helped locate pre-exposure prophylaxis services through the PleasePrEPMe provider directory, provided links to HIV-prevention resources, and supported uninsured, insured, and undocumented visitors with benefits navigation. Data such as date, time, type of encounter, visitor type, key demographics, discussion topics, insurance, and other relevant information were collected via a chat log and through the HealthEngage chat platform. RESULTS:From April 2017 to December 2019, PleasePrEPMe completed 2191 online chats. Mean interaction time was 16 minutes, with 68% of chats covering more than one topic. Conversation topics included health care navigation (1104/2191, 50.39%), provider identification (954/2191, 43.54%), pre-exposure prophylaxis information (773/2191, 35.28%), post-exposure prophylaxis information (318/2191, 14.91%), and the California Pre-Exposure Prophylaxis Assistance Program (232/2191, 10.59%). Referrals to pre-exposure prophylaxis- or non pre-exposure prophylaxis-related resources included directory updates, HIV testing and treatment, undetectable=untransmittable, reproductive health, sexually transmitted infections, and other prevention methods. A total of 368 chat visitors completed a voluntary satisfaction scale rating the quality and helpfulness of the service provided, producing a mean rating of 4.7 out of 5. CONCLUSIONS:Online chat is a method for reaching people not already engaged in HIV-prevention services, supporting HIV-prevention decision making, and linking people seeking information online with in-person services. Additional research to evaluate online sexual health information services and understand how social determinants of health influence online engagement is needed to better understand how to reach priority populations not well served by current HIV-prevention services. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):RR1-10.2196/20187.

SUBMITTER: Weber S

PROVIDER: S-EPMC7539157 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Online Navigation for Pre-Exposure Prophylaxis via PleasePrEPMe Chat for HIV Prevention: Protocol for a Development and Use Study.

Weber Shannon S Lazar Laura L McCord Alan A Romero Charlie C Tan Judy J

JMIR research protocols 20200922 9

<h4>Background</h4>Pre-exposure prophylaxis is an HIV medication taken by an individual who is HIV-negative to prevent infection before exposure to the virus. Numerous clinical studies in various communities have shown high rates of effectiveness when pre-exposure prophylaxis is taken as prescribed. Since FDA (US Food and Drug Administration) approval of the first product for pre-exposure prophylaxis in 2012, uptake has been lower than the estimated 1.1 million US adults who could benefit from i ...[more]

PMID: 32960183

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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.

Project description:Women in Africa face disproportionate risk of human immunodeficiency virus (HIV) acquisition, accounting for more than half of new infections in Africa and similarly face a disproportionate burden of sexually transmitted infections (STIs). Very high STI prevalence is being observed globally, especially among people taking pre-exposure prophylaxis (PrEP) for HIV prevention. Doxycycline post-exposure prophylaxis (dPEP) has been proposed as an STI prevention strategy to reduce chlamydia, syphilis, and possibly gonorrhea, and trials are ongoing among cisgender men who have sex with men (MSM) and transgender women who are taking PrEP in high-income settings. We designed and describe here the first open-label trial to determine the effectiveness of dPEP to reduce STI incidence among cisgender women. We are conducting an open-label 1:1 randomized trial of dPEP versus standard of care (STI screening and treatment and risk-reduction counseling without dPEP) among 446 Kenyan women aged ≥ 18 and ≤ 30 years old women taking PrEP. Women are followed for 12 months, with quarterly STI testing, treatment, and adherence counseling. The primary trial outcome will be the combined incidence of Chlamydia trachomatis, Neisseria gonorrhoeae, and Treponema pallidum, compared between the randomized groups. We will also assess dPEP acceptability, tolerability, safety, impact on sexual behavior, adherence, and occurrence of antimicrobial resistance (AMR) in N. gonorrhoeae and C. trachomatis isolates. Finally, we will estimate cost per incident STI case and complications averted accounting for nonadherence and benefits relative AMR or side effects. The results of this trial may have immediate implications for the global epidemic of STIs and sexual health. If effective, dPEP could put STI prevention into women's hands. While dPEP may be able to prevent STIs, it carries important risks that could counter its benefits; global debate about the balance of these potential risks and benefits requires data to inform policy and implementation and our study aims to fill this gap. ClinicalTrials.gov NCT04050540 .

Dataset Information

Online Navigation for Pre-Exposure Prophylaxis via PleasePrEPMe Chat for HIV Prevention: Protocol for a Development and Use Study.

Publications

Online Navigation for Pre-Exposure Prophylaxis via PleasePrEPMe Chat for HIV Prevention: Protocol for a Development and Use Study.

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