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      Attitudes towards participating in research involving digital pill systems to measure oral HIV pre-exposure chemoprophylaxis: a cross-sectional study among men who have sex with men with substance use in the USA

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          Abstract

          Objectives

          This quantitative survey sought to understand, among men who have sex with men (MSM) with potentially problematic substance use, the attitudes towards participation in research involving digital pill systems (DPS) for HIV pre-exposure prophylaxis (PrEP) adherence measurement, and the barriers and facilitators to research participation.

          Design

          One-time, cross-sectional, online sampling-based survey.

          Setting

          US social networking app predominantly focused on MSM.

          Participants

          MSM without HIV who reported current use of oral PrEP, potentially problematic substance use and sexual activity in the past 3 months. A total of 157 participants were eligible, passed validity checks and enrolled.

          Outcome measures

          Perceptions of DPS usefulness, accuracy and usability (System Usability Scale (SUS)); willingness and motivations to participate in DPS research; preferences for access to and feedback on DPS adherence data; data sharing considerations; and medical mistrust (Group-Based Medical Mistrust Scale (GBMMS)).

          Results

          Most of the sample (N=157) was white (n=119, 75.8%), gay (n=124, 79.0%) and cisgender (n=150, 95.5%). The median age was 33 years (IQR: 14). The mean GBMMS score was 13.5 (SD=5.2), and the median SUS score was 70 (IQR: 27.5). In the past 3 months, 36.3% (n=57) reported frequent use of substances before or during sex, and 62.4% (n=98) engaged in condomless sex. While most were adherent to PrEP, approximately 34.4% (n=54) expressed significant worry about daily adherence. Participants wished to monitor their PrEP adherence daily (n=66, 42.0%) and 52% (n=82) were very willing to participate in DPS-based research. The majority were minimally concerned about sharing DPS-detected adherence data with research teams (n=126, 80.3%), and were extremely willing to share these data with healthcare providers (n=109, 69.4%).

          Conclusions

          In this sample, MSM without HIV who use substances reported willingness to use DPS to measure PrEP adherence in a research context, and identified benefits to accessing real-time, DPS-detected adherence data.

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          Most cited references37

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          Preexposure Chemoprophylaxis for HIV Prevention in Men Who Have Sex with Men

          Antiretroviral chemoprophylaxis before exposure is a promising approach for the prevention of human immunodeficiency virus (HIV) acquisition. We randomly assigned 2499 HIV-seronegative men or transgender women who have sex with men to receive a combination of two oral antiretroviral drugs, emtricitabine and tenofovir disoproxil fumarate (FTC-TDF), or placebo once daily. All subjects received HIV testing, risk-reduction counseling, condoms, and management of sexually transmitted infections. The study subjects were followed for 3324 person-years (median, 1.2 years; maximum, 2.8 years). Of these subjects, 10 were found to have been infected with HIV at enrollment, and 100 became infected during follow-up (36 in the FTC-TDF group and 64 in the placebo group), indicating a 44% reduction in the incidence of HIV (95% confidence interval, 15 to 63; P=0.005). In the FTC-TDF group, the study drug was detected in 22 of 43 of seronegative subjects (51%) and in 3 of 34 HIV-infected subjects (9%) (P<0.001). Nausea was reported more frequently during the first 4 weeks in the FTC-TDF group than in the placebo group (P<0.001). The two groups had similar rates of serious adverse events (P=0.57). Oral FTC-TDF provided protection against the acquisition of HIV infection among the subjects. Detectable blood levels strongly correlated with the prophylactic effect. (Funded by the National Institutes of Health and the Bill and Melinda Gates Foundation; ClinicalTrials.gov number, NCT00458393.).
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            Antiretroviral Prophylaxis for HIV Prevention in Heterosexual Men and Women

            New England Journal of Medicine, 367(5), 399-410
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              The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST): development, reliability and feasibility

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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2023
                30 January 2023
                : 13
                : 1
                : e067549
                Affiliations
                [1 ]departmentDepartment of Emergency Medicine , Brigham and Women’s Hospital , Boston, Massachusetts, USA
                [2 ]Fenway Institute , Boston, Massachusetts, USA
                [3 ]departmentThe Koch Institute for Integrated Cancer Research , Massachusetts Institute of Technology , Cambridge, MA, USA
                [4 ]departmentDepartment of Psychosocial Oncology and Palliative Care , Dana Farber Cancer Institute , Boston, MA, USA
                [5 ]Boston University School of Public Health , Boston, Massachusetts, USA
                [6 ]departmentDepartment of Psychiatry , Massachusetts General Hospital , Boston, Massachusetts, USA
                [7 ]departmentDepartment of Medicine , Beth Israel Deaconess Medical Center , Boston, Massachusetts, USA
                [8 ]departmentCenter for Ethics Education , Fordham University , New York, New York, USA
                Author notes
                [Correspondence to ] Dr Peter Chai; pchai@ 123456bwh.harvard.edu
                Author information
                http://orcid.org/0000-0003-0955-4117
                http://orcid.org/0000-0002-7170-6014
                Article
                bmjopen-2022-067549
                10.1136/bmjopen-2022-067549
                9887701
                36717151
                a7bc215d-ff11-4272-8ece-e442510028e8
                © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 17 August 2022
                : 19 January 2023
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100000002, National Institutes of Health;
                Award ID: K23DA044874
                Award ID: R25DA031608
                Funded by: Harvard Center for AIDS Research;
                Award ID: P30AI060354
                Funded by: FundRef http://dx.doi.org/10.13039/100000060, National Institute of Allergy and Infectious Diseases;
                Award ID: T32 AI007433
                Categories
                HIV/AIDS
                1506
                Original research
                Custom metadata
                unlocked

                Medicine
                hiv & aids,preventive medicine,substance misuse,health informatics
                Medicine
                hiv & aids, preventive medicine, substance misuse, health informatics

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