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      Considerations for the Design of Pre-exposure Prophylaxis (PrEP) Interventions for Women: Lessons Learned from the Implementation of a Novel PrEP Intervention

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          Abstract

          Pre-exposure prophylaxis (PrEP) uptake among women in the United States has been low. To increase uptake, we developed a peer outreach and navigation PrEP intervention. Semi-structured qualitative interviews with 32 cisgender women and 3 transgender women were conducted to assess the intervention. We used a thematic approach to identify barriers to, and facilitators of the intervention. Facilitators included interest in PrEP, offer of health and social services, the intervention’s women-focused approach, and peer outreach and navigation. Barriers were perceived HIV risk, concerns about medication side effects or interactions, housing insecurity and travel, co-occurring health-related conditions, and caregiving responsibilities. We recommend that future interventions consider packaging PrEP in local community settings, such as syringe exchange programs; include services such as food and housing assistance; use peers to recruit and educate women; integrate a culturally appropriate women’s focus; and consider providing same-day PrEP.

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          Most cited references86

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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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              Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana.

              Preexposure prophylaxis with antiretroviral agents has been shown to reduce the transmission of human immunodeficiency virus (HIV) among men who have sex with men; however, the efficacy among heterosexuals is uncertain. We randomly assigned HIV-seronegative men and women to receive either tenofovir disoproxil fumarate and emtricitabine (TDF-FTC) or matching placebo once daily. Monthly study visits were scheduled, and participants received a comprehensive package of prevention services, including HIV testing, counseling on adherence to medication, management of sexually transmitted infections, monitoring for adverse events, and individualized counseling on risk reduction; bone mineral density testing was performed semiannually in a subgroup of participants. A total of 1219 men and women underwent randomization (45.7% women) and were followed for 1563 person-years (median, 1.1 years; maximum, 3.7 years). Because of low retention and logistic limitations, we concluded the study early and followed enrolled participants through an orderly study closure rather than expanding enrollment. The TDF-FTC group had higher rates of nausea (18.5% vs. 7.1%, P<0.001), vomiting (11.3% vs. 7.1%, P=0.008), and dizziness (15.1% vs. 11.0%, P=0.03) than the placebo group, but the rates of serious adverse events were similar (P=0.90). Participants who received TDF-FTC, as compared with those who received placebo, had a significant decline in bone mineral density. K65R, M184V, and A62V resistance mutations developed in 1 participant in the TDF-FTC group who had had an unrecognized acute HIV infection at enrollment. In a modified intention-to-treat analysis that included the 33 participants who became infected during the study (9 in the TDF-FTC group and 24 in the placebo group; 1.2 and 3.1 infections per 100 person-years, respectively), the efficacy of TDF-FTC was 62.2% (95% confidence interval, 21.5 to 83.4; P=0.03). Daily TDF-FTC prophylaxis prevented HIV infection in sexually active heterosexual adults. The long-term safety of daily TDF-FTC prophylaxis, including the effect on bone mineral density, remains unknown. (Funded by the Centers for Disease Control and Prevention and the National Institutes of Health; TDF2 ClinicalTrials.gov number, NCT00448669.).
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                Author and article information

                Contributors
                smk556@nyu.edu
                Journal
                AIDS Behav
                AIDS Behav
                AIDS and Behavior
                Springer US (New York )
                1090-7165
                1573-3254
                17 June 2021
                : 1-13
                Affiliations
                [1 ]GRID grid.137628.9, ISNI 0000 0004 1936 8753, School of Global Public Health, , New York University, ; New York, NY USA
                [2 ]GRID grid.240283.f, ISNI 0000 0001 2152 0791, Division of General Internal Medicine, Department of Medicine, , Montefiore Medical Center/Albert Einstein College of Medicine, ; 3300 Kossuth Avenue, Bronx, NY 10467 USA
                [3 ]GRID grid.212340.6, ISNI 0000000122985718, Department of Psychology, Hunter College, , City University of New York, ; New York, NY USA
                [4 ]GRID grid.266102.1, ISNI 0000 0001 2297 6811, Department of Medicine, , University of California San Francisco, ; San Francisco, CA USA
                Author information
                http://orcid.org/0000-0002-2975-2893
                Article
                3353
                10.1007/s10461-021-03353-2
                8210500
                34138377
                b2be5ee8-d80a-4924-86b1-78f5bbf90b31
                © The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature 2021

                This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.

                History
                : 11 June 2021
                Funding
                Funded by: Centers for Disease Control and Prevention Minority HIV/AIDS Research Initiative Grant
                Award ID: 1U01PS005111-01
                Award Recipient :
                Funded by: FundRef http://dx.doi.org/10.13039/100000026, National Institute on Drug Abuse;
                Award ID: T32 DA007233-31
                Award ID: R25DA026401
                Award Recipient :
                Categories
                Original Paper

                Infectious disease & Microbiology
                cisgender women,transgender women,pre-exposure prophylaxis,hiv,syringe service program,drug use,exchange sex

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