18,867 results on '"pre‐exposure prophylaxis"'
Search Results
2. Preference for Long-Acting Injectable PrEP to Daily Oral PrEP Among Transgender Women in the U.S.: Findings From a Multisite Cohort
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Cooney, Erin E., Reisner, Sari L., Poteat, Tonia C., Radix, Asa E., Mayer, Kenneth H., Beyrer, Chris, Stevenson, Meg, Aguayo-Romero, Rodrigo A., Schneider, Jason S., Wawrzyniak, Andrew J., Cannon, Christopher M., Brown, Carolyn A., Ragone, Leigh, Vannappagari, Vani, and Wirtz, Andrea L.
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- 2025
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3. Clinical characteristics and COVID-19-related outcomes of immunocompromised patients receiving tixagevimab/cilgavimab pre-exposure prophylaxis in Japan
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Taniguchi, Toshibumi, Homma, Tomoyuki, Tamai, Yoichi, Arita, Yoshifumi, Fujiwara, Masakazu, Kuroishi, Naho, Sugiyama, Keiji, Kanazu, Shinichi, and Maruyama, Atsushi
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- 2025
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4. Associations of HIV pre-exposure prophylaxis (PrEP) indication, HIV risk perception and unwillingness to use PrEP among people who inject drugs in Baltimore, MD
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Verinumbe, Tarfa, Lucas, Gregory M., Zook, Katie, Weir, Brian, Landry, Miles, Page, Kathleen R., Sherman, Susan G., and Falade-Nwulia, Oluwaseun
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- 2024
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5. Understanding the journey towards rabies vaccination for travellers: Results of a cross-sectional survey with patients and providers in the US, Germany, Sweden, and Switzerland
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Cummins, Jennifer, Lienert, Florian, Su, Annabel, Melander, Elaine, West, Rebecca L., and Salgado, Fernanda
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- 2024
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6. An updated overview on long-acting therapeutics for the prevention and treatment of human immunodeficiency virus (HIV) from a perspective of pharmaceutics
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Dinh, Linh, Blackard, Jason T., Robertson, Jaime, Atreya, Abby, Horner, Shaina, Brown, Jennifer L., Gomez, Luis A., Beegle, Stephen, Mahon, Lanesa, Eades, William, Abdolmohammadpourbonab, Shayan, Liu, William, Meeds, Heidi L., Fedders, Kevin, Twitty, T.Dylanne, Welge, Jeffrey A., and Yan, Bingfang
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- 2025
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7. Real-world experience of tixagevimab/cilgavimab prophylaxis in Japanese patients with immunodeficiency
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Inoue, Kento, Tomomasa, Dan, Nakagama, Yu, Takeuchi, Hiroaki, Tanaka, Yukie, Tanimoto, Kousuke, Kamiya, Takahiro, Isoda, Takeshi, Takagi, Masatoshi, Tanaka, Keisuke, Yoshifuji, Kota, Miwa, Yuki, Ohnishi, Hidenori, Okada, Satoshi, Mori, Takehiko, Yasuda, Shinsuke, Kido, Yasutoshi, Morio, Tomohiro, and Kanegane, Hirokazu
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- 2025
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8. Testing the feasibility, acceptability, and preliminary efficacy of integrating accommodation strategies into an HIV prevention intervention for people who inject drugs with cognitive dysfunction
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Mistler, Colleen B., Shrestha, Roman, and Copenhaver, Michael M.
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- 2025
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9. Tuberculous Osteomyelitis of the scapular spine revealing HIV-1 infection
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Idsaid, Khaoula, Idalene, Malika, Danaoui, Khadija, Driss, Wiam Ait, Elfargani, Rania, Soraa, Nabila, and Tassi, Noura
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- 2025
10. Impact of HIV pre-exposure prophylaxis (PREP) on health-related quality of life (QOL) of patients followed up at a reference center in São Paulo, Brazil
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Takada-de-Souza, Michelle Kaoru, Picone, Camila de Melo, Avelino-Silva, Vivian Iida, Freitas, Angela Carvalho, and Segurado, Aluisio Cotrim
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- 2024
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11. Impaired neutralizing antibody efficacy of tixagevimab-cilgavimab 150+150 mg as pre-exposure prophylaxis against Omicron BA.5. A real-world experience in booster vaccinated immunocompromised patients
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Schiaroli, Elisabetta, Gidari, Anna, Brachelente, Giovanni, Bicchieraro, Giulia, Spaccapelo, Roberta, Bastianelli, Sabrina, Pierucci, Sara, Busti, Chiara, Pallotto, Carlo, Malincarne, Lisa, Camilloni, Barbara, Falcinelli, Flavio, De Socio, Giuseppe Vittorio, Villa, Alfredo, Mencacci, Antonella, and Francisci, Daniela
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- 2023
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12. Pre-exposure prophylaxis to prevent hematophagous bat-mediated rabies outbreaks in remote Amazon communities: Lessons from a pilot for public health policy
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Rocha, Felipe, Vargas, Alexander, Nogueira de Abreu, Elke Maria, Augusto Pompei, Julio Cesar, Natal Vigilato, Marco Antonio, Lima, Daniel Magalhaes, Vianna, Raphael Schneider, Cosivi, Ottorino, Recuenco, Sergio E, Costa, Wagner Augusto, Hardt, Luciana, Correa Scheffer Ferreira, Karin, Santos Cunha Neto, Rene dos, Chaves, Luciana Botelho, da Silva, Andrea de Cassia Rodrigues, Begot, Alberto Lopes, Azevedo Andrade, Jorge Alberto, Marcos, Weber, Rocha, Silene Manrique, Lima Junior, Francisco Edilson Ferreira, and Wada, Marcelo Yoshito
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- 2024
13. Awareness, intention to use pre-exposure prophylaxis, and factors associated with awareness among men who have sex with men in the Republic of Korea
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Jang, Sarang and Sohn, Aeree
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- 2024
14. Health System Factors Influencing the Integration of Pre-Exposure Prophylaxis into Antenatal and Postnatal Clinic Services in Cape Town, South Africa.
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Court, Lara, Nelson, Aurelie, Taliep, Reghana, Dean, Sarah, Mvududu, Rufaro, Knight, Lucia, Dovel, Kathryn, Coates, Thomas, Myer, Landon, and Davey, Dvora
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Humans ,South Africa ,Pre-Exposure Prophylaxis ,Female ,HIV Infections ,Pregnancy ,Prenatal Care ,Infectious Disease Transmission ,Vertical ,Qualitative Research ,Anti-HIV Agents ,Postnatal Care ,Adult ,Focus Groups ,Health Personnel ,Breast Feeding - Abstract
INTRODUCTION: Oral pre-exposure prophylaxis (PrEP) is an effective and safe option to prevent HIV acquisition and vertical HIV transmission in pregnant and breastfeeding women. Understanding health system factors influencing the integration of PrEP into care for pregnant and breastfeeding women is key to increasing access. We explored managers and health care workers (HCWs) experiences with integrating PrEP into antenatal care and postnatal care services in primary health care clinics in Cape Town, South Africa. METHODS: This exploratory qualitative study used codebook thematic analysis, where HCWs were purposively, heterogeneously sampled from an implementation science study. Semistructured individual interviews were conducted with 9 managerial-level staff, and 3 focus group discussions were conducted with HCWs (nurses, midwives, and HIV counselors) providing PrEP (6-7 HCWs per group) between November 2022 and January 2023 (N=28). Interview guides covered health system facilitators, barriers, and recommendations. The Health Systems Dynamics framework guided data analysis and presentation of results. RESULTS: PrEP integration into antenatal care services was described as acceptable and feasible; however, changes to HIV testing policy and indicators in breastfeeding women are needed to integrate PrEP into postnatal clinics, together with identification of mother and baby as a dyad in visits. Results showed that supportive policies facilitated wider, simplified PrEP provision. The availability and accessibility of prescribing nurses and lay HIV counselors, PrEP (both within facilities and in communities), and information about PrEP for implementers and pregnant and breastfeeding women will be pivotal to facilitating integration. CONCLUSION: Facilitators for PrEP integration include task-shifting PrEP education and identification of women for PrEP initiation to HIV counselors, changes to national guidelines defining who can prescribe PrEP, revision and integration of PrEP training for HCWs, community-level interventions for PrEP demand creation and stigma reduction, and provision of differentiated PrEP delivery options.
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- 2024
15. Illness Narratives Without the Illness: Biomedical HIV Prevention Narratives from East Africa
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Johnson-Peretz, Jason, Atwine, Fredrick, Kamya, Moses R, Ayieko, James, Petersen, Maya L, Havlir, Diane V, and Camlin, Carol S
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Language ,Communication and Culture ,Literary Studies ,Infectious Diseases ,Sexually Transmitted Infections ,HIV/AIDS ,Prevention ,Good Health and Well Being ,Humans ,HIV Infections ,Narration ,Kenya ,Uganda ,Pre-Exposure Prophylaxis ,Male ,Female ,Illness narratives ,East Africa ,Luo ,Swahili ,HIV ,Philosophy ,General Arts ,Humanities & Social Sciences ,Cultural studies ,Applied ethics - Abstract
Illness narratives invite practitioners to understand how biomedical and traditional health information is incorporated, integrated, or otherwise internalized into a patient's own sense of self and social identity. Such narratives also reveal cultural values, underlying patterns in society, and the overall life context of the narrator. Most illness narratives have been examined from the perspective of European-derived genres and literary theory, even though theorists from other parts of the globe have developed locally relevant literary theories. Further, illness narratives typically examine only the experience of illness through acute or chronic suffering (and potential recovery). The advent of biomedical disease prevention methods like post- and pre-exposure prophylaxis (PEP and PrEP) for HIV, which require daily pill consumption or regular injections, complicates the notion of an illness narrative by including illness prevention in narrative accounts. This paper has two aims. First, we aim to rectify the Eurocentrism of existing illness narrative theory by incorporating insights from African literary theorists; second, we complicate the category by examining prevention narratives as a subset of illness narratives. We do this by investigating several narratives of HIV prevention from informants enrolled in an HIV prevention trial in Kenya and Uganda in 2022.
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- 2024
16. “I Heard of PrEP—I Didn’t Think I Needed it.” Understanding the Formation of HIV Risk Perception Among People Who Inject Drugs
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Mars, Sarah, Ondocsin, Jeff, Koester, Kimberly A, Mars, Valerie, Mars, Gerald, and Ciccarone, Daniel
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Public Health ,Health Sciences ,Opioid Misuse and Addiction ,Drug Abuse (NIDA only) ,Prevention ,Clinical Research ,Behavioral and Social Science ,Sexually Transmitted Infections ,Substance Misuse ,Infectious Diseases ,HIV/AIDS ,Opioids ,Social Determinants of Health ,Infection ,Good Health and Well Being ,Humans ,HIV Infections ,Pre-Exposure Prophylaxis ,Substance Abuse ,Intravenous ,Male ,Adult ,Female ,Pilot Projects ,West Virginia ,Health Knowledge ,Attitudes ,Practice ,Middle Aged ,Qualitative Research ,Injecting drug use ,HIV ,Risk perception ,Pre-exposure prophylaxis ,Cultural theory ,Modes of social organization ,Psychiatry - Abstract
Uptake of pre-exposure prophylaxis medication (PrEP) to prevent HIV among people who inject drugs (PWID) remains extremely low in the United States. West Virginia's rising HIV incidence and highest drug overdose rate in the nation makes it an important locus for opioid use and HIV risk interaction. In this pilot study we pioneered the use of Cultural Theory among PWID to understand HIV-related risk perception arising from four contrasting modes of social organization. Carried out during an HIV outbreak, we explored PrEP uptake qualitatively as a window onto risk perception. Of the 26 interviewees, 18 were HIV- and despite the medication's free availability from the health center where recruitment took place, none had taken PrEP, half considering they were not at risk. Intimate couples who showed characteristics of 'enclaves' considered the boundary around themselves protective against HIV, creating a safe space or 'invisible risk group'. Higher HIV risk was perceived among those who were housed compared to those living homeless. Beliefs about the causation of the local HIV outbreak and the validity of scientific research corresponded with characteristics of the contrasting modes of social organization and the approach is promising for informing public health interventions among PWID.
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- 2024
17. A Review of Implementation Strategies to Enhance PrEP Delivery for People Experiencing Housing Insecurity: Advancing a Multifaceted High-Touch, Low-Barrier Approach.
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Velloza, Jennifer, Mehtani, Nicky, Hickey, Matthew, Imbert, Elizabeth, Appa, Ayesha, and Riley, Elise
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Care engagement ,HIV ,Homelessness and unstable housing ,Implementation strategies ,Pre-exposure prophylaxis ,Prevention ,Humans ,HIV Infections ,Ill-Housed Persons ,Pre-Exposure Prophylaxis ,Housing ,Anti-HIV Agents ,United States - Abstract
PURPOSE OF REVIEW: This review summarizes key implementation strategies to advance oral and long-acting PrEP delivery for unstably housed people in the United States. RECENT FINDINGS: People experiencing homelessness and housing instability face barriers to PrEP uptake and adherence including lack of safe medication storage, competing basic needs, insurances issues, and/or mental health or substance use disorders. Recent advancements in HIV treatment and prevention provide evidence on high-touch, low-barrier implementation approaches to address these challenges. We compiled these approaches into a multi-component implementation strategy, SHELTER, which includes: low-barrier primary care, case management, incentives, outreach, care coordination, multidisciplinary provider collaboration, data tracking, and robust provider-patient relationships. The US has fallen short of our Ending the Epidemic targets, in part due to challenges in PrEP delivery for people experiencing housing instability. SHELTER provides a comprehensive approach for considering critical components of HIV prevention for this population that can be used in future oral and long-acting PrEP programs.
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- 2024
18. Type 1 Human Immunodeficiency Virus (HIV-1) Incidence, Adherence, and Drug Resistance in Individuals Taking Daily Emtricitabine/Tenofovir Disoproxil Fumarate for HIV-1 Pre-exposure Prophylaxis: Pooled Analysis From 72 Global Studies
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Landovitz, Raphael J, Tao, Li, Yang, Juan, de Boer, Melanie, Carter, Christoph, Das, Moupali, Baeten, Jared M, Liu, Albert, Hoover, Karen W, Celum, Connie, Grinsztejn, Beatriz, Morris, Sheldon, Wheeler, Darrell P, Mayer, Kenneth H, Golub, Sarit A, Bekker, Linda-Gail, Diabaté, Souleymane, Hoornenborg, Elske, Myers, Janet, Leech, Ashley A, McCormack, Sheena, Chan, Philip A, Sweat, Michael, Matthews, Lynn T, Grant, Robert, Beyrer, Chris, Brown, Joelle, Clark, Jesse, Colson, Paul, Eakle, Robyn, Farley, Jason, Flash, Charlene A, Gallardo, Jorge, Gottlieb, Geoffrey, Grangeiro, Alexandre, Heffron, Renee, Hosek, Sybil, Hull, Mark, Idoko, John, Inwani, Irene, Koenig, Helen, Kurth, Ann, Lee, Shui-shan, Mayer, Kenneth, Mboup, Souleymane, Meyer, Jaimie, Mills, Anthony, Mujugira, Andrew, Pala, Pietro, Phoenix, John, Piatt, Janice, Russell, Darren, Sanders, Eduard, Scott, Rachel, Sevelius, Jae, Shang, Hong, Siegel, Marc, Swaminathan, Shobha, Tamayo, Vivian, Tan, Darrell, Taylor, Allan, and Vuylsteke, Bea
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Medical Microbiology ,Biomedical and Clinical Sciences ,Clinical Sciences ,Infectious Diseases ,Health Disparities ,Clinical Trials and Supportive Activities ,Sexually Transmitted Infections ,Clinical Research ,HIV/AIDS ,Prevention ,Women's Health ,Infection ,Good Health and Well Being ,Humans ,HIV Infections ,HIV-1 ,Male ,Female ,Incidence ,Anti-HIV Agents ,Pre-Exposure Prophylaxis ,Adult ,Drug Resistance ,Viral ,Medication Adherence ,Prospective Studies ,Middle Aged ,Tenofovir ,Emtricitabine ,Emtricitabine ,Tenofovir Disoproxil Fumarate Drug Combination ,Young Adult ,pre-exposure prophylaxis ,emtricitabine ,tenofovir disoproxil fumarate ,Global F/TDF PrEP Study Team ,Biological Sciences ,Medical and Health Sciences ,Microbiology ,Clinical sciences - Abstract
BackgroundOral pre-exposure prophylaxis (PrEP) with emtricitabine/tenofovir disoproxil fumarate (F/TDF) has high efficacy against HIV-1 acquisition. Seventy-two prospective studies of daily oral F/TDF PrEP were conducted to evaluate HIV-1 incidence, drug resistance, adherence, and bone and renal safety in diverse settings.MethodsHIV-1 incidence was calculated from incident HIV-1 diagnoses after PrEP initiation and within 60 days of discontinuation. Tenofovir concentrations in dried blood spots (DBS), drug resistance, and bone/renal safety indicators were evaluated in a subset of studies.ResultsAmong 17 274 participants, there were 101 cases with new HIV-1 diagnosis (.77 per 100 person-years; 95% confidence interval [CI]: .63-.94). In 78 cases with resistance data, 18 (23%) had M184I or V, 1 (1.3%) had K65R, and 3 (3.8%) had both mutations. In 54 cases with tenofovir concentration data from DBS, 45 (83.3%), 2 (3.7%), 6 (11.1%), and 1 (1.9%) had average adherence of
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- 2024
19. Facilitators and barriers of HIV pre-exposure prophylaxis use among four key populations in Iran.
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Moameri, Hossein, Shahrbabaki, Parvin, Tavakoli, Fatemeh, Saberi, Parya, Mirzazadeh, Ali, Goudarzi, Reza, and Sharifi, Hamid
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Barriers ,Facilitators ,HIV ,Iran ,Key populations ,Pre-exposure prophylaxis ,Humans ,Iran ,Pre-Exposure Prophylaxis ,HIV Infections ,Male ,Female ,Adult ,Qualitative Research ,Homosexuality ,Male ,Interviews as Topic ,Sex Workers ,Sexual Partners ,Substance Abuse ,Intravenous ,Health Knowledge ,Attitudes ,Practice ,Middle Aged ,Anti-HIV Agents - Abstract
BACKGROUND: Pre-exposure prophylaxis (PrEP) significantly reduces HIV transmission, but it is not commonly prescribed in Iran. Therefore, this study aimed to identify facilitators and barriers to PrEP use among four key populations (KPs) in Iran. METHODS: We conducted in-depth qualitative interviews with female sex workers (FSW), men who have sex with men (MSM), people who inject drugs (PWID), and sexual partners of people living with HIV (PLHIV) to obtain deep insights into the participants experiences, beliefs, and viewpoints. We included HIV experts, including staff from the HIV control department, healthcare providers with HIV experience, health policymakers, infectious disease specialists, and university professors. We performed a content analysis to identify facilitators and barriers to PrEP implementation among KPs. RESULTS: We interviewed seven FSW, seven MSM, four PWID, four sexual partners of PLHIV, and 18 HIV experts. The facilitators theme emerged in four main categories, including eight different factors: 1) Individual and interpersonal factors (motivations, fear of testing positive for HIV, and safety nets and financial support), 2) Age and sex differences, 3) Organizational factors (appropriate PrEP distribution, information sharing, and receipt of high-quality services, 4) Efficacy of PrEP. The barriers theme emerged in three main categories, including four factors: 1) Individual factors (insufficient knowledge and awareness, and fragile trust), 2) Cultural barriers, and 3) Organizational factors (inadequate infrastructure and organizational barriers). CONCLUSIONS: We identified key facilitators and barriers to successful PrEP implementation among KPs in Iran. By addressing these barriers, Iran has an opportunity to include PrEP programs in its HIV prevention efforts for KPs.
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- 2024
20. HIV pre-exposure prophylaxis programmatic preferences among people who inject drugs: findings from a discrete choice experiment
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Eger, William H, Bazzi, Angela R, Valasek, Chad J, Vera, Carlos F, Harvey-Vera, Alicia, Strathdee, Steffanie A, and Pines, Heather A
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Pre-exposure prophylaxis ,Substance abuse ,Intravenous ,Community health services ,Prescriptions ,Telemedicine ,Discrete choice experiment - Abstract
Background Pre-exposure prophylaxis (PrEP) holds promise for decreasing new HIV infections among people who inject drugs (PWID), yet daily oral PrEP use is low, and PrEP modality and delivery strategy preferences in this population remain understudied.Methods From May 2022-June 2023, we conducted a discrete choice experiment (DCE) with PWID in San Diego, California. Participants viewed 18 PrEP program scenarios in sets of three and chose their preferred scenario within each set. Scenarios consisted of various combinations of five characteristics: PrEP modality (injectable, implantable, oral), frequency of use (annual, bi-monthly, daily), service location (community-based organization, clinic, telemedicine), prescription access location (on-site, street outreach, mail), and adherence supports (social support, outreach worker, phone/text reminder). Multinomial logit regression estimated probabilities of choosing PrEP program scenarios as a function of the five characteristics to estimate part-worth utility scores (PWUS; reflecting relative preferences for specific characteristic values) and relative importance scores (RIS; reflecting the relative influence of each characteristic on program choice). We also explored differences by hypothesized modifiers of preferences (i.e., sex assigned at birth, housing status, injection frequency, prior PrEP awareness).Results Among 262 participants, mean age was 43.1 years, and most reported male sex assigned at birth (69.5%), identified as non-Hispanic (60.3%), and were previously unaware of PrEP (75.2%). Frequency of use (RIS: 51.5) and PrEP modality (RIS: 35.3) had the greatest influence on PrEP program choice. Within these characteristics, participants had relative preferences for annual use (PWUS: 0.83) and oral PrEP (PWUS: 0.57), and relative aversions to daily use (PWUS: -0.76) and implantable PrEP (PWUS: -0.53). Generally, participants did not indicate preferences for specific service or prescription access locations, or adherence supports; however, among those with prior PrEP awareness, prescription access location and adherence supports had a slightly greater influence on PrEP program choices.Conclusion Our study considered diverse PrEP scenarios and highlighted potential preferences for long-acting oral modalities. Although not currently available, renewed investment in long-acting oral PrEP formulations may facilitate PrEP care engagement among PWID. Additional delivery and implementation strategy research is needed to support PrEP uptake and persistence in this population.
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- 2024
21. Factors Associated with Usage of Oral-PrEP among Female Sex Workers in Nairobi, Kenya, Assessed by Self-Report and a Point-of-Care Urine Tenofovir Immunoassay.
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Shah, Pooja, Spinelli, Matthew, Irungu, Erastus, Kabuti, Rhoda, Ngurukiri, Pauline, Babu, Hellen, Kungu, Mary, Champions, The, Nyabuto, Chrispo, Mahero, Anne, Devries, Karen, Kyegombe, Nambusi, Medley, Graham, Gafos, Mitzy, Seeley, Janet, Weiss, Helen, Kaul, Rupert, Gandhi, Monica, Beattie, Tara, and Kimani, Joshua
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Adolescent girls and young women ,Female sex workers ,HIV prevention ,Hierarchical modelling ,Kenya ,PrEP ,Humans ,Female ,Sex Workers ,Kenya ,Pre-Exposure Prophylaxis ,Adult ,HIV Infections ,Tenofovir ,Self Report ,Anti-HIV Agents ,Medication Adherence ,Young Adult ,Adolescent ,Point-of-Care Systems ,Administration ,Oral ,Point-of-Care Testing ,Cross-Sectional Studies ,Social Stigma - Abstract
Pre-exposure prophylaxis (PrEP) is highly effective at reducing HIV acquisition. We aimed to estimate usage of oral-PrEP, and factors associated with adherence among female sex workers (FSWs) in Nairobi, Kenya, using a novel point-of-care urine tenofovir lateral flow assay (LFA). The Maisha Fiti study randomly selected FSWs from Sex Worker Outreach Program clinics in Nairobi. Data were collected from 1003 FSWs from June-October 2019, including surveys on self-reported oral-PrEP adherence. Adherence was also measured using the LFA for HIV-negative FSWs currently taking oral-PrEP. Informed by a social-ecological theoretical framework, we used hierarchical multivariable logistic regression models to estimate associations between individual, interpersonal/community, and structural/institutional-level factors and either self-reported or LFA-assessed adherence. Overall, 746 HIV-negative FSWs aged 18-40 participated in the study, of whom 180 (24.1%) self-reported currently taking oral-PrEP. Of these, 56 (31.1%) were adherent to oral-PrEP as measured by LFA. In the multivariable analyses, associations with currently taking oral-PrEP included having completed secondary education, high alcohol/substance use, feeling empowered to use PrEP, current intimate partner, no recent intimate partner violence, having support from sex worker organisations, experiencing sex work-related stigma, and seeking healthcare services despite stigma. Associations with oral-PrEP LFA-measured adherence measured included having only primary education, experience of childhood emotional violence, belonging to a higher wealth tertile, and being nulliparous. Oral-PrEP adherence, measured by self-report or objectively, is low among FSWs in Nairobi. Programs to improve oral-PrEP usage among FSWs should work to mitigate social and structural barriers and involve collaboration between FSWs, healthcare providers and policymakers.
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- 2024
22. Applying CFIR to assess multi-level barriers to PrEP delivery in rural South Africa: Processes, gaps and opportunities for service delivery of current and future PrEP modalities
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Baron, Deborah, Leslie, Hannah H, Mabetha, Denny, Becker, Nozipho, Kahn, Kathleen, and Lippman, Sheri A
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Health Services and Systems ,Public Health ,Health Sciences ,Human Society ,Women's Health ,Prevention ,Behavioral and Social Science ,Sexually Transmitted Infections ,Mental Health ,Infectious Diseases ,Social Determinants of Health ,Pediatric ,Clinical Research ,Health Services ,HIV/AIDS ,Dissemination and Implementation Research ,Generic health relevance ,Good Health and Well Being ,Humans ,South Africa ,Pre-Exposure Prophylaxis ,Female ,HIV Infections ,Adolescent ,Rural Population ,Young Adult ,Qualitative Research ,Health Services Accessibility ,Anti-HIV Agents ,Delivery of Health Care ,Adult ,Interviews as Topic ,PrEP ,CFIR ,AGYW ,HIV ,Medical and Health Sciences ,Economics ,Studies in Human Society ,Health sciences ,Human society - Abstract
Despite established efficacy for oral pre-exposure prophylaxis (PrEP) in reducing HIV incidence, multi-level barriers within the health system, clinics, and the processes that shape practice have hindered service delivery and subsequent population-level effects. We applied the Consolidated Framework for Implementation Research (CFIR) to assess the context of PrEP delivery for adolescent girls and young women (AGYW) in rural South Africa and identify the factors supporting and impeding PrEP implementation to develop strategies to improve PrEP delivery. Between 2021 and 2022, we conducted in-depth interviews with five young women with PrEP use experience and 11 healthcare providers as well as four key informant stakeholder interviews. Tailored interviews organized around the CFIR domains provided multiple perspectives on the inter-connected processes, gaps, and opportunities between health systems, clinics, communities, and PrEP services. Shifts in PrEP policies, funding pressures, and inconsistent communications from the National Department of Health spurred fragmented planning, engagement, execution, and monitoring of PrEP delivery processes within clinics already struggling to address multiple population health needs. Resulting challenges included: conflicting priorities within clinics and across NGO partners, unclear goals and targets, staffing and space constraints, and insufficient community engagement. Individual clinics' implementation climate and readiness to deliver PrEP varied in terms of operational plans and delivery models. Interviewees reported complexity of initiation procedures and support for PrEP maintenance, with opportunities to improve systems communications and processes to facilitate integrated services and more user-friendly experiences. Applying CFIR identified opportunities to strengthen PrEP delivery across levels within this complex service delivery setting.
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- 2024
23. Feasibility of Emergency Department-Initiated HIV Pre-Exposure Prophylaxis
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Bisom-Rapp, Ezra, Patel, Kishan, Jaradeh, Katrin, Hayirli, Tuna C., and Peabody, Christopher R.
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Pre-Exposure Prophylaxis ,HIV PrEP ,Emergency Department Pre-exposure Prophylaxis ,Same-Day PrEP - Abstract
Introduction: Pre-exposure prophylaxis (PrEP) for HIV—using antiretroviral medication in non-infected individuals to prevent HIV—has immense potential to slow the spread of the virus. However, uptake has been insufficient, and stark racial disparities exist in both HIV acquisition and PrEP usage, making PrEP access a health equity issue. A promising venue to engage high-risk populations in PrEP care is the emergency department (ED); however, existing ED PrEP initiatives have been costly or have had limited success. We hypothesize that two strategies could overcome these barriers: prescribing PrEP during an ED visit and providing patients with an initial supply of PrEP medication in the ED. Here, we describe the results of a qualitative study exploring multidisciplinary emergency clinicians and HIV clinicians’ needs and views about the feasibility of such an initiative.Methods: We conducted 22 semi-structured interviews with multidisciplinary clinicians from an urban, safety-net medical center in the ED and the on-site HIV clinic that provides PrEP services.We performed thematic analysis to summarize challenges and potential solutions described by participants.Results: Participants’ responses fell into three thematic categories: operational challenges; patient-level considerations; and potential impacts. Operational challenges highlighted the difficulty of PrEP initiation in a busy ED and clinician support needs. Patient-level considerations included the complex psychosocial needs of ED patients who could benefit from PrEP. Finally, participants anticipated that an ED-based PrEP initiation program could positively impact both individual patients and public health.Conclusion: Interviews with emergency department and HIV clinic staff revealed important considerations and potential solutions for ED-initiated PrEP workflows. Clinicians in both specialties were enthusiastic about such an initiative, which could facilitate its success. This study lays the groundwork for the future design of an efficient and innovative workflow to leverage the ED as an essential entry point into HIV prevention services.
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- 2024
24. A Mixed Methods Evaluation of Pharmacists' Readiness to Provide Long-Acting Injectable HIV Pre-exposure Prophylaxis in California
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Beltran, Raiza M, Hunter, Lauren A, Packel, Laura J, De Martini, Loriann, Holloway, Ian W, Dong, Betty J, Lam, Jerika, McCoy, Sandra I, and Ochoa, Ayako Miyashita
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Biomedical and Clinical Sciences ,Public Health ,Health Sciences ,Clinical Research ,HIV/AIDS ,Health Disparities ,Infectious Diseases ,Sexually Transmitted Infections ,Good Health and Well Being ,Humans ,California ,Pharmacists ,Pre-Exposure Prophylaxis ,Male ,Female ,HIV Infections ,Cross-Sectional Studies ,Adult ,Anti-HIV Agents ,Middle Aged ,Surveys and Questionnaires ,Attitude of Health Personnel ,Injections ,Young Adult ,HIV prevention ,pre-exposure prophylaxis ,long-acting injectable PrEP ,pharmacies ,Clinical Sciences ,Public Health and Health Services ,Virology ,Clinical sciences ,Epidemiology ,Public health - Abstract
BackgroundPre-exposure prophylaxis (PrEP) uptake remains low among people who could benefit, some of whom may prefer alternatives to oral PrEP, such as long-acting injectable pre-exposure prophylaxis (LAI-PrEP). We evaluated the potential for LAI-PrEP provision in pharmacies through a mixed methods study of pharmacists in California, where Senate Bill 159 enables pharmacists to independently provide oral PrEP.MethodsIn 2022-2023, we conducted an online cross-sectional survey of California pharmacists and pharmacy students (n = 919) and in-depth interviews with pharmacists (n = 30), both of which included modules assessing attitudes about PrEP provision. Using log-binomial regression, we estimated prevalence ratios (PRs) comparing survey participants' willingness to provide LAI-PrEP by pharmacy- and individual-level characteristics. Qualitative interview data were analyzed using Rapid Qualitative Analysis to identify factors that may affect pharmacists' provision of LAI-PrEP.ResultsHalf of the survey participants (53%) indicated that they would be willing to administer LAI-PrEP using gluteal injection in their pharmacy. Willingness was higher among participants who worked in pharmacies that provided vaccinations or other injections (56% vs. 46%; PR: 1.2; 95% confidence interval: 1.0-1.4) and/or oral PrEP under Senate Bill 159 (65% vs. 51%; PR: 1.3; 95% confidence interval: 1.1-1.5) than among participants whose pharmacies did not. Interviewed participants reported barriers to LAI-PrEP provision, including the need for increased training and staffing, a private room for gluteal injections, better medication access, and payment for services.ConclusionPharmacies offer a promising setting for increased LAI-PrEP access. However, pharmacists may require additional training, resources, and policy changes to make implementation feasible.
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- 2024
25. Barriers and Facilitators to Accessing PrEP and Other Sexual Health Services Among Immigrant Latino Men Who Have Sex with Men in Los Angeles County
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Brooks, Ronald A, Nieto, Omar, Rosenberg-Carlson, Elena, Morales, Katherine, Üsküp, Dilara K, Santillan, Martin, and Inzunza, Zurisadai
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Gender Studies ,Human Society ,Clinical Research ,Social Determinants of Health ,HIV/AIDS ,Minority Health ,Behavioral and Social Science ,Sexual and Gender Minorities (SGM/LGBT*) ,Infectious Diseases ,Sexually Transmitted Infections ,Prevention ,Health Services ,Health Disparities ,Infection ,Good Health and Well Being ,Adult ,Humans ,Male ,Middle Aged ,Young Adult ,Emigrants and Immigrants ,Health Services Accessibility ,Hispanic or Latino ,HIV Infections ,Homosexuality ,Male ,Los Angeles ,Patient Acceptance of Health Care ,Pre-Exposure Prophylaxis ,Qualitative Research ,Sexual and Gender Minorities ,Sexual Health ,Social Stigma ,HIV pre-exposure prophylaxis ,Immigrant ,Latino ,Men who have sex with men ,Sexual health services ,Sexual orientation ,Public Health and Health Services ,Other Studies in Human Society ,Psychology ,Clinical Psychology ,Gender studies ,Clinical and health psychology ,Social and personality psychology - Abstract
In the United States, immigrant Latino men who have sex with men (ILMSM) are, compared to white MSM, disproportionately burdened by HIV and lack access to highly effective HIV prevention strategies, such as pre-exposure prophylaxis (PrEP). Qualitative research centered on exploring barriers that ILMSM experience in accessing PrEP and other sexual services is extremely limited, despite a high prevalence of HIV in this population. In this study, a purposive sample of ILMSM (n = 25) was recruited to participate in a semi-structured in-depth interview to identify the distinct barriers and facilitators ILMSM experience in accessing sexual health services given their complex intersectional identities of being an immigrant, Latino, and a sexual minority man. Using a thematic analysis approach, nine themes were generated from the data representing barriers and facilitators. Barriers included: (1) cost and a lack of health insurance, (2) complexity of PrEP assistance programs; (3) challenges related to the immigrant experience; (4) impact of gay stigma; and (5) communication challenges. Facilitators included: (1) improving affordability and accessibility of PrEP services; (2) receiving services from LGBT- or Latine LGBT-centered clinics; (3) receiving services from medical providers who are gay and/or Latino; and (4) providing targeted community outreach, education, and promotion of PrEP to ILMSM. While many of the barriers illuminated in the study were structural (e.g., cost and lack of health insurance), and not easy to overcome, the findings highlight a range of facilitators that can support access to PrEP and other sexual health services for ILMSM. Considering these findings, we suggest strategies that may enhance access to needed sexual health services among ILMSM.
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- 2024
26. First Case of HIV Seroconversion With Integrase Resistance Mutations on Long-Acting Cabotegravir for Prevention in Routine Care
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Koss, Catherine A, Gandhi, Monica, Halvas, Elias K, Okochi, Hideaki, Chu, Carolyn, Glidden, David V, Gomez, Lisa Georgetti, Heaps, Amy L, Conroy, Amy A, Tran, Michael, Shetler, Cory, Hoeth, Dianna, Kuncze, Karen, Louie, Alexander, Garza, Hana Rivera, Mugoma, Erick Wafula, Penrose, Kerri J, Chohan, Bhavna H, Ayieko, James O, Mills, Anthony, Patel, Rupa R, Mellors, John W, and Parikh, Urvi M
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Medical Microbiology ,Biomedical and Clinical Sciences ,Clinical Sciences ,Genetics ,Sexually Transmitted Infections ,Women's Health ,Infectious Diseases ,HIV/AIDS ,Prevention ,Infection ,Good Health and Well Being ,breakthrough infection ,HIV prevention ,pharmacokinetics ,pre-exposure prophylaxis ,resistance ,Clinical sciences ,Medical microbiology - Abstract
BackgroundLong-acting cabotegravir (CAB-LA) is highly effective for HIV prevention, but delayed HIV diagnoses and integrase strand transfer inhibitor (INSTI) resistance were observed in trials. We report the first case in routine clinical care of HIV infection on CAB-LA with INSTI resistance.MethodsThe SeroPrEP study enrolls individuals in the United States who acquire HIV on pre-exposure prophylaxis modalities to assess diagnostics, antiretroviral (ARV) drug levels, resistance, and treatment outcomes. Resistance mutations in full-length HIV-1 integrase were identified by single-genome sequencing (SGS). Cabotegravir concentrations in plasma and hair segments were measured by liquid chromatography-tandem mass spectrometry.ResultsA 23-year-old gender-nonbinary person, male at birth, restarted CAB-LA 6 months after discontinuation due to losing insurance. Prior to restart, HIV-1 RNA was not detected, but 20 days elapsed before CAB-LA injection. After the second CAB-LA injection, HIV antigen/antibody returned reactive (HIV-1 RNA 451 copies/mL). SGS of plasma HIV-1 RNA identified INSTI mutation Q148R in 2/24 sequences 2 days postdiagnosis; commercial genotype failed amplification. Cabotegravir hair concentration was 0.190 ng/mg 2 weeks prediagnosis; plasma cabotegravir was high (3.37 μg/mL; ∼20× PA-IC90) 14 days postdiagnosis. Viral suppression was maintained for 6 months on darunavir/cobicistat/emtricitabine/tenofovir alafenamide, then switched to doravirine + emtricitabine/tenofovir alafenamide due to nausea.ConclusionsIn this first case of HIV infection on CAB-LA with INSTI resistance in routine care, cabotegravir resistance was detected only with a sensitive research assay. Accelerated pathways to minimize time between HIV testing and CAB-LA initiation are needed to optimize acute HIV detection and mitigate resistance risk. Sustained product access regardless of insurance is imperative to reduce HIV infections on CAB-LA.
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- 2024
27. Impact of a point-of-care urine tenofovir assay on adherence to HIV pre-exposure prophylaxis among women in Kenya: a randomised pilot trial.
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Gandhi, Monica, Glidden, David, Chakravarty, Deepalika, Wang, Guohong, Biwott, Charlene, Mogere, Peter, Maina, Gakuo, Njeru, Irene, Kiptinness, Catherine, Okello, Phelix, Spinelli, Matthew, Chatterjee, Purba, Velloza, Jennifer, Ogello, Vallery, Medina-Marino, Andrew, Okochi, Hideaki, Mugo, Nelly, and Ngure, Kenneth
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Humans ,Female ,Tenofovir ,Pre-Exposure Prophylaxis ,HIV Infections ,Kenya ,Pilot Projects ,Adult ,Anti-HIV Agents ,Medication Adherence ,Point-of-Care Systems ,Counseling ,Hair ,Young Adult ,Point-of-Care Testing - Abstract
BACKGROUND: Adherence challenges with oral tenofovir-based pre-exposure prophylaxis (PrEP) are common. We developed a point-of-care assay to objectively assess tenofovir in urine and conducted a pilot trial examining the impact of counselling informed by use of this urine assay on long-term PrEP adherence. METHODS: This randomised trial enrolled women not in serodiscordant partnerships 3 months after PrEP initiation at the Kenya Medical Research Institute to compare standard-of-care adherence counselling versus counselling informed by the urine assay (urine-test counselling group) every 3 months for 12 months. In the standard of care group, urine samples were stored and tested at study end without participant feedback. Here we report the adherence primary outcome of hair concentrations of tenofovir at 12 months as a long-term metric (undetectable levels defined long-term non-adherence), as well as urine concentrations of tenofovir at each visit as a short-term adherence metric and acceptability of the assay assessed by quantitative surveys. Data were analysed by randomisation group. This completed trial was registered with ClinicalTrials.gov (NCT03935464). FINDINGS: From March 17, 2021 to Jan 18, 2022 we enrolled 49 women in the urine-test counselling group and 51 in the standard of care group; retention was 86 (86%) of 100. Nine (21%) of 42 in the urine-test counselling group had hair samples at 12 months with tenofovir concentrations below the limit of quantification compared with 15 (37%) of 41 in the standard of care group. The relative odds of long-term non-adherence in the standard of care group compared with urine-test counselling were 3·53 (95% CI 1·03-12·03; p=0·044). Pre-intervention, urine tenofovir was detectable in 65% in the urine-test counselling group and 71% in the standard of care group (p=0·68). At 12 months, 31 (72%) of 43 in the intervention group had detectable urine tenofovir compared with 19 (45%) of 42 in the standard of care group (p=0·0015). 40 (93%) of 43 participants liked the test very much and only one disliked the test. One participant in the standard of care group was withdrawn at the 6-month visit due to HIV seroconversion. INTERPRETATION: A low-cost urine tenofovir assay to inform PrEP counselling resulted in improvement in both short-term and long-term metrics of adherence. This urine tenofovir assay could help to improve long-term PrEP adherence. FUNDING: National Institute of Allergy and Infectious Diseases and National Institutes of Health.
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- 2024
28. Suppressed HIV antibody responses following exposure to antiretrovirals – evidence from PrEP randomized trials and early antiretroviral treatment initiation studies
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Avelino-Silva, Vivian I, Stone, Mars, Bakkour, Sonia, Di Germanio, Clara, Schmidt, Michael, Conway, Ashtyn L, Wright, David, Grebe, Eduard, Custer, Brian, Kleinman, Steven H, Deng, Xutao, Lingappa, Jairam R, Defechereux, Patricia, Mehrotra, Megha, Grant, Robert M, Vasan, Sandhya, Facente, Shelley, Phanuphak, Nittaya, Sacdalan, Carlo, Akapirat, Siriwat, de Souza, Mark, Busch, Michael P, Norris, Philip J, and Study-IV-Pediatric, NHLBI Recipient Epidemiology and Donor Evaluation
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Medical Microbiology ,Biomedical and Clinical Sciences ,Clinical Sciences ,Immunology ,Clinical Trials and Supportive Activities ,Prevention ,Biotechnology ,Sexually Transmitted Infections ,HIV/AIDS ,Infectious Diseases ,Clinical Research ,4.1 Discovery and preclinical testing of markers and technologies ,Infection ,Good Health and Well Being ,HIV testing ,antiretroviral therapy ,delayed diagnosis ,diagnostics ,pre-exposure prophylaxis ,serologic tests ,Microbiology ,Public Health and Health Services ,Clinical sciences ,Epidemiology ,Public health - Abstract
BACKGROUND: Exposure to antiretrovirals at or early after HIV acquisition can suppress viral replication and blunt antibody (Ab) responses; a reduced HIV detectability could impact diagnosis and blood donation screening. METHODS: We used three antigen (Ag)/Ab assays and one nucleic acid test (NAT) to analyze samples collected in pre-exposure prophylaxis (PrEP) trials (iPrEx; Partners PrEP) before infection detection by Ab-only rapid diagnostic tests (RDTs), and in early antiretroviral treatment (ART) initiation studies (RV254; SIPP). RESULTS: Reactivity using NAT and Ag/Ab assays in samples collected up to 8 weeks prior to the first reactive RDT from 251 PrEP trials participants varied between 49-61% for active PrEP users and between 27-37% for placebo users. Among RV254 participants, reactivity in Ag/Ab assays was
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- 2024
29. Social, economic, and physical side effects impact PrEP uptake and persistence among transgender women in Peru.
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Naz-McLean, Sarah, Clark, Jesse, Huerta, Leyla, Mayer, Kenneth, Lama, Javier, Reisner, Sari, and Perez-Brumer, Amaya
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HIV ,Peru ,PrEP ,Transgender women ,Humans ,Peru ,Female ,Transgender Persons ,Adult ,HIV Infections ,Pre-Exposure Prophylaxis ,Qualitative Research ,Male ,Medication Adherence ,Pilot Projects ,Young Adult ,Anti-HIV Agents ,Interviews as Topic ,Socioeconomic Factors ,Middle Aged - Abstract
INTRODUCTION: Oral pre-exposure prophylaxis (PrEP) for HIV-1 infection is over 99% effective in protecting against HIV acquisition when used consistently and appropriately. However, PrEP uptake and persistent use remains suboptimal, with a substantial gap in utilization among key populations who could most benefit from PrEP. In Latin America specifically, there is poor understanding of barriers to PrEP uptake and persistence among transgender (trans) women. METHODS: In April-May 2018, we conducted qualitative interviews lasting 25-45 min as part of an end-of-project evaluation of TransPrEP, a pilot RCT that examined the impact of a social network-based peer support intervention on PrEP adherence among trans women in Lima, Peru. Participants in the qualitative evaluation, all adult trans women, included individuals who either (1) screened eligible to participate in the TransPrEP pilot, but opted not to enroll (n = 8), (2) enrolled, but later withdrew (n = 6), (3) were still actively enrolled at the time of interview and/or successfully completed the study (n = 16), or (4) were study staff (n = 4). Interviews were audio recorded and transcribed verbatim. Codebook development followed an immersion/crystallization approach, and coding was completed using Dedoose. RESULTS: Evaluation participants had a mean age of 28.2 years (range 19-47). When describing experiences taking PrEP, participant narratives highlighted side effects that spanned three domains: physical side effects, such as prolonged symptoms of gastrointestinal distress or somnolence; economic challenges, including lost income due to inability to work; and social concerns, including interpersonal conflicts due to HIV-related stigma. Participants described PrEP use within a broader context of social and economic marginalization, with a focus on daily survival, and how PrEP side effects negatively contributed to these stressors. Persistence was, in some cases, supported through the interventions educational workshops. CONCLUSION: This research highlights the ways that physical, economic, and social side effects of PrEP can impact acceptability and persistence among trans women in Peru, amplifying and layering onto existing stressors including economic precarity. Understanding the unique experiences of trans women taking PrEP is crucial to informing tailored interventions to improve uptake and persistence.
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- 2024
30. We chose PrEP because I wanted to be sure that this child my wife was going to conceive was indeed mine. Factors influencing the choice of safer conception methods and experiences with its use: a qualitative study among HIV sero-discordant couples in Zimbabwe.
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Brown, Joelle, Musara, Petina, Gitome, Serah, Chitukuta, Miria, Mataveke, Bismark, Chirenda, Thandiwe, Mgodi, Nyaradzo, Mutero, Prisca, Matubu, Allen, Chareka, Gift, Chasakara, Charles, Murombedzi, Caroline, Makurumure, Tinei, Hughes, Carolyn, Bukusi, Elizabeth, Cohen, Craig, Shiboski, Stephen, Darbes, Lynae, Rutherford, George, Chirenje, Z, and Mhlanga, Felix
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ART ,HIV prevention ,HIV-discordant couples ,LMIC ,PrEP ,Safer conception ,Semen washing ,Vaginal insemination ,Zimbabwe ,sub-Saharan Africa ,Humans ,Zimbabwe ,Male ,Female ,Adult ,HIV Infections ,Qualitative Research ,Pre-Exposure Prophylaxis ,Fertilization ,Choice Behavior ,Interviews as Topic ,Middle Aged ,Pilot Projects ,Young Adult ,HIV Seropositivity ,Pregnancy - Abstract
BACKGROUND: Safer conception services are needed to minimize HIV transmission among HIV sero-discordant couples desiring pregnancy. Few studies have evaluated the choices couples make when they are offered multiple safer conception methods or real-world method acceptability. This paper addresses an important knowledge gap regarding factors that influence the choice of safer conception methods, couples actual experiences using safer conception methods, and why some couples switch safer conception methods. METHODS: Between February and June 2019, we conducted semi-structured in-depth interviews among 14 men and 17 women, representing 17 couples who exited the SAFER study-a pilot safer conception study for HIV sero-discordant couples in Zimbabwe that offered couples a choice of ART with monthly viral load monitoring (ART/VL), oral PrEP, vaginal insemination, and semen washing. All couples in SAFER had used at least two safer conception methods. RESULTS: We found that safer conception method choice often centered around a desire for intimacy, condomless sex, and certainty in the conception process, particularly for men. Method-related attributes such as familiarity, perceived ease of use, side effects, and perceived level of effectiveness in preventing HIV and achieving pregnancy influenced method choice, switching, and satisfaction. Concerns were expressed about each safer conception method and couples were willing to try different methods until they found method(s) that worked for them. The majority of participants reported having positive experiences using safer conception, especially those using ART/VL + PrEP, citing that they were able to attempt pregnancy for the first time with peace of mind and experienced joy and satisfaction from being able to achieve pregnancy safely. CONCLUSIONS: The differences in method preferences and experiences voiced by participants in this study and in other studies from the region point to the importance of having a variety of safer conception options in the service delivery package and addressing concerns about paternity, intimacy, and method-related attributes to enable HIV sero-discordant couples to safely achieve their reproductive goals.
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- 2024
31. Client experiences with “Dynamic Choice Prevention,” a model for flexible patient‐centred HIV prevention delivery in rural Eastern Africa
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Camlin, Carol S, Arunga, Titus, Johnson‐Peretz, Jason, Akatukwasa, Cecilia, Atwine, Fredrick, Onyango, Angeline, Owino, Lawrence, Kamya, Moses R, Petersen, Maya L, Chamie, Gabriel, Kakande, Elijah, Kabami, Jane, Balzer, Laura B, Havlir, Diane V, and Ayieko, James
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Biomedical and Clinical Sciences ,Health Services and Systems ,Public Health ,Clinical Sciences ,Health Sciences ,HIV/AIDS ,Prevention ,Sexually Transmitted Infections ,Infectious Diseases ,Behavioral and Social Science ,Women's Health ,Mental Health ,Health Disparities ,Clinical Research ,7.1 Individual care needs ,8.1 Organisation and delivery of services ,Infection ,Generic health relevance ,Good Health and Well Being ,Humans ,HIV Infections ,Female ,Male ,Adult ,Rural Population ,Pre-Exposure Prophylaxis ,Qualitative Research ,Interviews as Topic ,Africa ,Eastern ,Young Adult ,Patient-Centered Care ,Middle Aged ,Anti-HIV Agents ,pre-exposure prophylaxis ,post-exposure prophylaxis ,HIV self-testing ,differentiated care ,HIV stigma ,sub-Saharan Africa ,HIV self‐testing ,post‐exposure prophylaxis ,pre‐exposure prophylaxis ,sub‐Saharan Africa ,Public Health and Health Services ,Other Medical and Health Sciences ,Clinical sciences ,Epidemiology ,Public health - Abstract
IntroductionIdentifying the optimal approaches to offering HIV prevention to meet the needs of those at risk is a high priority, particularly given the expanding toolkit of biomedical HIV prevention options. An ongoing study in rural East African communities evaluated the uptake of choices in product, testing mode and location of care delivery through a structured patient-centred HIV prevention delivery model. In this qualitative study, we sought to understand clients' experiences of this "dynamic choice prevention model" (DCP) and highlight pathways of action to inform HIV prevention delivery models.MethodsIn-depth semi-structured interviews were conducted from November 2021 through March 2022 with a purposively selected sample of n = 56 participants in DCP trials (across outpatient departments, antenatal clinics and community settings), and n = 21 healthcare providers (total n = 77). A seven-person multi-regional team translated and inductively coded transcript data. We used a framework analysis approach to identify emergent themes.ResultsIndividuals taking up HIV pre-exposure prophylaxis (PrEP) reported feelings of relief, liberation from fears of acquiring HIV and satisfaction with being able to take action despite partners' behaviours. Couples used a range of approaches afforded by the study to persuade partners to get tested and opt for PrEP. Post-exposure prophylaxis (PEP) use was less common, although women welcomed it in the event of sexual coercion or assault. Participants discussed switching from PEP to PrEP after familiarizing themselves with usage and ascertaining ongoing risk. Participants felt respected by providers, trusted them and appreciated being able to contact them directly for telephone support. Prevention uptake was hindered by stigma, limited experience with and knowledge of prevention methods, gendered and generational power dynamics within intimate partnerships and families, and negative perceptions of methods due to the products themselves. Participants anticipated long-acting injectable PrEP could solve their challenges regarding pill size, daily pill burden and the likelihood of unwanted disclosure.ConclusionsDiverse preferences and barriers to uptake of prevention require a choice of HIV prevention options, locations and delivery modalities-but in addition, flexible, competent and friendly care provision is crucial to promote uptake. Helping clients feel valued, and addressing their unique needs and challenges, enables their agency to prioritize their health.
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- 2024
32. Reducing intersectional stigma among transgender women in Brazil to promote uptake of HIV testing and PrEP: study protocol for a randomised controlled trial of Manas por Manas
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Sevelius, Jae, Veras, Maria Amelia Sousa Mascena, Gomez, Jose Luis, Saggese, Gustavo, Mocello, Adrienne Rain, Bassichetto, Katia Cristina, Neilands, Torsten B, and Lippman, Sheri A
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Biomedical and Clinical Sciences ,Public Health ,Health Sciences ,Clinical Sciences ,Behavioral and Social Science ,Women's Health ,HIV/AIDS ,Clinical Trials and Supportive Activities ,Social Determinants of Health ,Sexually Transmitted Infections ,Sexual and Gender Minorities (SGM/LGBT*) ,Clinical Research ,Health Disparities ,Prevention ,Mental Health ,Infectious Diseases ,3.1 Primary prevention interventions to modify behaviours or promote wellbeing ,Infection ,Good Health and Well Being ,Humans ,Transgender Persons ,Brazil ,Female ,HIV Infections ,Pre-Exposure Prophylaxis ,Social Stigma ,Male ,Adult ,HIV Testing ,Randomized Controlled Trials as Topic ,Young Adult ,Adolescent ,Patient Acceptance of Health Care ,transgender persons ,HIV & AIDS ,primary prevention ,clinical trial ,health equity ,Public Health and Health Services ,Other Medical and Health Sciences ,Biomedical and clinical sciences ,Health sciences ,Psychology - Abstract
IntroductionGlobally, transgender ('trans') women experience extreme social and economic marginalisation due to intersectional stigma, defined as the confluence of stigma that results from the intersection of social identities and positions among those who are oppressed multiple times. Among trans women, gender-based stigma intersects with social positions such as engagement in sex work and substance use, as well as race-based stigma to generate a social context of vulnerability and increased risk of HIV acquisition. In Brazil, trans women are the 'most at-risk' group for HIV, with 55 times higher estimated odds of HIV infection than the general population; further, uptake of HIV testing and pre-exposure prophylaxis (PrEP) among trans women is significantly lower than other at-risk groups. Through extensive formative work, we developed Manas por Manas, a multilevel intervention using HIV prevention strategies with demonstrated feasibility and acceptability by trans women in Brazil, to address intersectional stigma and increase engagement in the HIV prevention continuum.Methods and analysisWe are conducting a two-arm randomised wait-list controlled trial of the intervention's efficacy in São Paulo, Brazil, to improve uptake of HIV testing and PrEP among transgender women (N=400). The primary outcomes are changes in HIV testing (self-testing and clinic based), changes in PrEP uptake and changes in PrEP persistence at baseline and follow-up assessment for 12 months at 3-month intervals.Ethics and disseminationThis study was approved by University of California, San Francisco Institutional Review Board (15-17910) and Comissão Nacional de Ética em Pesquisa (Research Ethics National Commission, CAAE: 25215219.8.0000.5479) in Brazil. Participants provided informed consent before enrolment. We are committed to collaboration with National Institutes of Health officials, other researchers, and health and social services communities for rapid dissemination of data and sharing of materials. The results will be published in peer-reviewed academic journals and scientific presentations.Trial registration numberNCT03081559.
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- 2024
33. A Systematic Review of HIV Pre-exposure Prophylaxis (PrEP) Implementation in U.S. Emergency Departments: Patient Screening, Prescribing, and Linkage to Care.
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Chitle, Pooja, McCoy, Sandra, White, Douglas, and Jackson, Kristopher
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Differentiated service delivery ,Emergency department ,Emergency medicine ,HIV ,PrEP ,Pre-exposure prophylaxis ,Humans ,HIV Infections ,Pre-Exposure Prophylaxis ,Aftercare ,Anti-HIV Agents ,Patient Discharge ,Emergency Service ,Hospital - Abstract
In the pursuit of ending the HIV epidemic, U.S. emergency departments (EDs) have emerged as a valuable setting to increase HIV testing and linkage to care. There is limited data available, however, describing the incorporation of HIV prevention initiatives in U.S. EDs. Over the last decade, HIV pre-exposure prophylaxis (PrEP) has significantly changed the HIV prevention landscape globally and very little is known about the provision of PrEP in U.S. EDs. To address this gap in the literature, we conducted a systematic review of peer-reviewed quantitative studies and conference abstracts spanning July 2012 - October 2022. Of 433 citations, 11 articles and 13 abstracts meet our inclusion criteria, representing 18 unique studies addressing PrEP screening, prescribing, and/or linkage to PrEP care.Most studies describe screening processes to identify PrEP-eligible patients (n = 17); most studies leveraged a patients STI history as initial PrEP eligibility screening criteria. Fewer studies describe PrEP prescribing (n = 2) and/or linkage to PrEP care (n = 8).Findings from this systematic review highlight the potential for U.S. EDs to increase PrEP uptake among individuals at risk for HIV infection. Despite a growing number of studies exploring processes for incorporating PrEP into the ED setting, such studies are small-scale and time limited. Models providing prescribing PrEP in the ED show higher initiation rates than post-discharge engagement models. Electronic health record (EHR)-based HIV screening is valuable, but post-ED linkage rates are low. Our findings emphasize the need to establish best practices for initiating and supporting prevention effective PrEP use in the ED setting.
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- 2024
34. The importance of developmental assets in HIV prevention behaviors among young black men who have sex with men (MSM)
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Boyd, Donte T, Harris, Orlando O, Abu-Ba’are, Gamji Rabiu, Nelson, LaRon, and Wilton, Leo
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Biomedical and Clinical Sciences ,Public Health ,Health Sciences ,Human Society ,Clinical Sciences ,Social Work ,Sexually Transmitted Infections ,Clinical Research ,Infectious Diseases ,Health Disparities ,Behavioral and Social Science ,HIV/AIDS ,Prevention ,Sexual and Gender Minorities (SGM/LGBT*) ,Pediatric ,Good Health and Well Being ,Humans ,Male ,HIV Infections ,Young Adult ,Adolescent ,Cross-Sectional Studies ,Homosexuality ,Male ,Black or African American ,Adult ,Pre-Exposure Prophylaxis ,HIV Testing ,Social Support - Abstract
Developmental assets are critical to the health and wellbeing of youth. The current study examines the influence of developmental assets on PrEP use and HIV testing among YBMSM ages 18-24. Using a cross-sectional survey of YBMSM (N = 225), this study explored the role of external (e.g., family support, other adult support) and internal (e.g., personal responsibility) assets in explaining HIV prevention behaviors. Participants were recruited from Mechanical Turk (M-Turk) internet-based platform, social media sites, and community-based organizations. A path analysis was conducted to investigate the direct/indirect effects of internal and external assets on PrEP use and HIV testing. Family support (β = 0.40, p
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- 2024
35. HPTN 083‐02: factors influencing adherence to injectable PrEP and retention in an injectable PrEP study
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Psaros, Christina, Goodman, Georgia R, Lee, Jasper S, Rice, Whitney, Kelley, Colleen F, Oyedele, Temitope, Coelho, Lara E, Phanuphak, Nittaya, Singh, Yashna, Middelkoop, Keren, Griffith, Sam, McCauley, Marybeth, Rooney, James, Rinehart, Alex R, Clark, Jesse, Go, Vivian, Sugarman, Jeremy, Fields, Sheldon D, Adeyeye, Adeola, Grinsztejn, Beatriz, Landovitz, Raphael J, Safren, Steven A, and Team, the HPTN 083‐02 Study
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Public Health ,Biomedical and Clinical Sciences ,Clinical Sciences ,Health Sciences ,Health Disparities ,Sexual and Gender Minorities (SGM/LGBT*) ,Infectious Diseases ,Clinical Trials and Supportive Activities ,Social Determinants of Health ,Minority Health ,Sexually Transmitted Infections ,HIV/AIDS ,Behavioral and Social Science ,Clinical Research ,Prevention ,Mental Health ,3.1 Primary prevention interventions to modify behaviours or promote wellbeing ,Infection ,Good Health and Well Being ,Quality Education ,Humans ,Male ,Pre-Exposure Prophylaxis ,Medication Adherence ,HIV Infections ,Female ,Anti-HIV Agents ,Adult ,Transgender Persons ,Homosexuality ,Male ,Young Adult ,Pyridones ,Brazil ,Injections ,Pyridines ,Interviews as Topic ,Tenofovir ,Emtricitabine ,Tenofovir Disoproxil Fumarate Drug Combination ,Middle Aged ,Diketopiperazines ,HIV prevention ,injectable PrEP ,men who have sex with men ,pre-exposure prophylaxis ,qualitative ,transgender women ,HPTN 083‐02 Study Team ,pre‐exposure prophylaxis ,Public Health and Health Services ,Other Medical and Health Sciences ,Clinical sciences ,Epidemiology ,Public health - Abstract
IntroductionHPTN 083 demonstrated the superiority of long-acting cabotegravir (CAB-LA) versus daily oral emtricitabine/tenofovir disoproxil fumarate (TDF/FTC) as pre-exposure prophylaxis (PrEP) among cisgender men and transgender women who have sex with men (MSM/TGW). HPTN 083 provided the first opportunity to understand experiences with injectable PrEP in a clinical trial.MethodsParticipants from two US sites (Chicago, IL and Atlanta, GA) and one international site (Rio de Janeiro, Brazil) were purposively sampled for individual qualitative interviews (N = 40), between November 2019 and March 2020, to explore trial experiences, barriers to adherence and other factors that may have impacted study implementation or outcomes. The blinded phase ended early due to efficacy; this analysis includes interviews conducted prior to unblinding with three groups defined by adherence (i.e. injection visit attendance): adherent (n = 27), non-adherent (n = 12) and early discontinuers (n = 1). Data were organized using NVivo software and analysed using content analysis.ResultsParticipants (mean age: 27) were primarily cisgender MSM (90%) and Black/African American (60%). Reasons for trial enrolment and PrEP use included a preference for using HIV prevention medication versus treatment in the event of HIV acquisition; the ability to enhance health via study-related education and services; access to a novel, convenient HIV prevention product at no cost; and contributing to MSM/TGW communities through research. Participants contrasted positive experiences with study staff with their routine clinical care, and emphasized increased scheduling flexibility, thorough communication, non-judgemental counselling and open, affirming environments (e.g. compassion, less stigma) as adherence facilitators. Injection experiences were positive overall; some described early injection-related anxiety, which abated with time and when given some measure of control (e.g. pre-injection countdown), and minimal injection site discomfort. Some concerns and misperceptions about injectable PrEP were reported. Barriers to adherence, across all adherence categories, included structural factors (e.g. financial constraints, travel) and competing demands (e.g. work schedules).ConclusionsRespondents viewed injectable PrEP trial participation as a positive experience and a means of enhancing wellbeing. Study site flexibility and affirming clinic environments, inclusive of non-judgemental counselling, were key facilitators of adherence. To support injection persistence, interventions that address structural barriers and promote flexible means of injection delivery may be most effective.
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- 2024
36. Feasibility of Implementing a Low-Barrier Long-Acting Injectable Antiretroviral Program for HIV Treatment and Prevention for People Experiencing Homelessness
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Mehtani, Nicky J, Strough, Alix, Strieff, Sarah, Zevin, Barry, Eveland, Joanna, Riley, Elise D, and Gandhi, Monica
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Biomedical and Clinical Sciences ,Public Health ,Health Sciences ,Infectious Diseases ,Behavioral and Social Science ,Minority Health ,Mental Health ,Prevention ,Social Determinants of Health ,Health Disparities ,Women's Health ,HIV/AIDS ,Sexually Transmitted Infections ,Infection ,Good Health and Well Being ,Humans ,Adult ,HIV Infections ,Anti-HIV Agents ,Feasibility Studies ,Viremia ,Anti-Retroviral Agents ,Ill-Housed Persons ,Pre-Exposure Prophylaxis ,homelessness ,people who use drugs ,HIV ,long acting antiretrovirals ,cabotegravir ,rilpivirine ,lenacapavir ,antiretroviral treatment ,pre-exposure prophylaxis ,Clinical Sciences ,Public Health and Health Services ,Virology ,Clinical sciences ,Epidemiology ,Public health - Abstract
BackgroundLong-acting (LA) antiretrovirals may provide meaningful benefit to people who use drugs and people experiencing homelessness (PEH) who face disproportionate structural and psychosocial barriers in adhering to daily oral HIV antiretroviral therapy or pre-exposure prophylaxis (PrEP), but their use in these populations has not been studied.SettingThe Maria X. Martinez Health Resource Center is a low-barrier (eg, no appointment) community-based clinic serving San Francisco PEH.MethodsA multidisciplinary care model with robust monitoring and outreach support was developed to provide LA antiretroviral therapy (ART) and LA-PrEP to eligible patients experiencing difficulties adhering to oral antiretrovirals. Feasibility was assessed by evaluating the rates of HIV viremia and on-time injections among patients receiving LA antiretrovirals over the first 24 months of program implementation.ResultsBetween November 2021 and November 2023, 33 patients initiated LA-ART or LA-PrEP (median age, 37 years; 27% transgender/nonbinary; 73% non-White; 27% street homeless; 52% sheltered homeless; 30% with opioid use disorder; 82% with methamphetamine use disorder). Among 18 patients with HIV, 14 initiated LA-ART injections with detectable viremia (median CD4 count, 340 cells/mm 3 ; mean log 10 viral load, 3.53; SD, 1.62), 8 had never previously been virally suppressed, and all but 1 achieved or maintained virologic suppression (mean, 9.67 months; SD, 8.30). Among 15 LA-PrEP patients, all remained HIV negative (mean, 4.73 months; SD, 2.89). Of 224 total injections administered, 8% were delayed >7 days.DiscussionThe implementation of LA antiretrovirals is feasible in low-barrier, highly supportive clinical settings serving vulnerable PEH. Expansion of such programs will be critical in ending the HIV epidemic.
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- 2024
37. Randomized Trial of Dynamic Choice HIV Prevention at Antenatal and Postnatal Care Clinics in Rural Uganda and Kenya
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Kabami, Jane, Koss, Catherine A, Sunday, Helen, Biira, Edith, Nyabuti, Marilyn, Balzer, Laura B, Gupta, Shalika, Chamie, Gabriel, Ayieko, James, Kakande, Elijah, Bacon, Melanie C, Havlir, Diane, Kamya, Moses R, Petersen, Maya, and Team, SEARCH Study
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Biomedical and Clinical Sciences ,Public Health ,Health Sciences ,Clinical Sciences ,HIV/AIDS ,Prevention ,Sexually Transmitted Infections ,Infectious Diseases ,Behavioral and Social Science ,Women's Health ,Pediatric ,Clinical Trials and Supportive Activities ,Clinical Research ,Health Services ,3.1 Primary prevention interventions to modify behaviours or promote wellbeing ,Reproductive health and childbirth ,Good Health and Well Being ,Female ,Humans ,Pregnancy ,HIV Infections ,Kenya ,Postnatal Care ,Postpartum Period ,Pre-Exposure Prophylaxis ,Uganda ,Adolescent ,Young Adult ,HIV ,PrEP ,PEP ,antenatal care ,postnatal care ,person-centered ,SEARCH Study Team ,Public Health and Health Services ,Virology ,Clinical sciences ,Epidemiology ,Public health - Abstract
BackgroundPregnant and postpartum women in Sub-Saharan Africa are at high risk of HIV acquisition. We evaluated a person-centered dynamic choice intervention for HIV prevention (DCP) among women attending antenatal and postnatal care.SettingRural Kenya and Uganda.MethodsWomen (aged 15 years or older) at risk of HIV acquisition seen at antenatal and postnatal care clinics were individually randomized to DCP vs. standard of care (SEARCH; NCT04810650). The DCP intervention included structured client choice of product (daily oral pre-exposure prophylaxis or postexposure prophylaxis), service location (clinic or out of facility), and HIV testing modality (self-test or provider-administered), with option to switch over time and person-centered care (phone access to clinician, structured barrier assessment and counseling, and provider training). The primary outcome was biomedical prevention coverage-proportion of 48-week follow-up with self-reported pre-exposure prophylaxis or postexposure prophylaxis use, compared between arms using targeted maximum likelihood estimation.ResultsBetween April and July 2021, we enrolled 400 women (203 intervention and 197 control); 38% were pregnant, 52% were aged 15-24 years, and 94% reported no pre-exposure prophylaxis or postexposure prophylaxis use for ≥6 months before baseline. Among 384/400 participants (96%) with outcome ascertained, DCP increased biomedical prevention coverage 40% (95% CI: 34% to 47%; P < 0.001); the coverage was 70% in intervention vs. 29% in control. DCP also increased coverage during months at risk of HIV (81% in intervention, 43% in control; 38% absolute increase; 95% CI: 31% to 45%; P < 0.001).ConclusionA person-centered dynamic choice intervention that provided flexibility in product, testing, and service location more than doubled biomedical HIV prevention coverage in a high-risk population already routinely offered access to biomedical prevention options.
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- 2024
38. HIV Prevention Among Men Who Have Sex With Men: Tenofovir Alafenamide Combination Preexposure Prophylaxis Versus Placebo.
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Zivich, Paul, Cole, Stephen, Edwards, Jessie, Glidden, David, Das, Moupali, Shook-Sa, Bonnie, Shao, Yongwu, Mehrotra, Megha, Adimora, Adaora, and Eron, Joseph
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HIV ,PrEP ,bridged comparison ,counterfactual placebo ,indirect comparisons ,tenofovir ,Humans ,Male ,Adenine ,Anti-HIV Agents ,Emtricitabine ,HIV ,HIV Infections ,Homosexuality ,Male ,Pre-Exposure Prophylaxis ,Sexual and Gender Minorities ,Tenofovir - Abstract
BACKGROUND: While noninferiority of tenofovir alafenamide and emtricitabine (TAF/FTC) as preexposure prophylaxis (PrEP) for the prevention of human immunodeficiency virus (HIV) has been shown, interest remains in its efficacy relative to placebo. We estimate the efficacy of TAF/FTC PrEP versus placebo for the prevention of HIV infection. METHODS: We used data from the DISCOVER and iPrEx trials to compare TAF/FTC to placebo. DISCOVER was a noninferiority trial conducted from 2016 to 2017. iPrEx was a placebo-controlled trial conducted from 2007 to 2009. Inverse probability weights were used to standardize the iPrEx participants to the distribution of demographics and risk factors in the DISCOVER trial. To check the comparison, we evaluated whether risk of HIV infection in the shared tenofovir disoproxil fumarate and emtricitabine (TDF/FTC) arms was similar. RESULTS: Notable differences in demographics and risk factors occurred between trials. After standardization, the difference in risk of HIV infection between the TDF/FTC arms was near zero. The risk of HIV with TAF/FTC was 5.8 percentage points lower (95% confidence interval [CI], -2.0% to -9.6%) or 12.5-fold lower (95% CI, .02 to .31) than placebo standardized to the DISCOVER population. CONCLUSIONS: There was a reduction in HIV infection with TAF/FTC versus placebo across 96 weeks of follow-up. CLINICAL TRIALS REGISTRATION: NCT02842086 and NCT00458393.
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- 2024
39. Influence of families and other adult support on HIV prevention outcomes among black men who have sex with men.
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Boyd, Donte, Ramos, S, Maragh-Bass, Allysha, Dyer, Typhanye, Zigah, Edem, and Abu-Baare, Gamji
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BMSM ,Condom use ,Families ,HIV Testing ,PrEP use ,Adult ,Male ,Humans ,Sexual Behavior ,Homosexuality ,Male ,Sexual Partners ,HIV Infections ,Sexual and Gender Minorities ,Pre-Exposure Prophylaxis - Abstract
BACKGROUND: Prior research has consistently shown that the involvement of families plays a vital role in reducing risk behaviors, such as engaging in condomless sex, and promoting HIV prevention behaviors among young Black men who have sex with men (YBMSM). With the aim of expanding the existing knowledge, this study aimed to examine the specific influence of families and other supportive adults in facilitating casual condom use, partner condom use, HIV testing, and preexposure prophylaxis (PrEP) utilization among young Black MSM. METHODS: A sample of YBMSM aged 18-29 years (N = 400) was collected online. We used a path analysis to examine the influence of family factors on PrEP stigma and PrEP use. Respondents were recruited from December 1, 2021, to January 31, 2022. We used a path analysis to examine the direct and indirect effects of family factors on PrEP use through HIV testing and encouraging condom use. RESULTS: Among BMSM, other adult support was positive and directly associated with condom use by both casual partners (β = 0.04, p
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- 2024
40. The potential benefits of long-acting injectable cabotegravir in pregnant and breastfeeding women and their infants.
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Johnson, Leigh, Myer, Landon, Jamieson, Lise, Meyer-Rath, Gesine, Delany-Moretlwe, Sinead, and Joseph Davey, Dvora
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Adult ,Pregnancy ,Infant ,Child ,Humans ,Female ,HIV Infections ,Breast Feeding ,Anti-HIV Agents ,Pre-Exposure Prophylaxis ,South Africa ,Pyridones ,Diketopiperazines - Abstract
BACKGROUND: Pregnant and breastfeeding women (PBW) in sub-Saharan Africa have high HIV incidence rates and associated risk of vertical transmission to their infants. Oral preexposure prophylaxis (PrEP) and injectable PrEP (long-acting cabotegravir, or CAB-LA) can potentially reduce this HIV transmission, but population-level impacts are uncertain. METHODS: We extended a previously developed model of HIV and PrEP in South Africa to allow for variable PrEP duration and preference in PBW. We considered three potential scenarios for PrEP provision to PBW: oral PrEP only, CAB-LA only, and allowing oral/CAB-LA choice, with uptake and retention assumptions informed by South African data, each compared with a base scenario without PrEP for PBW. RESULTS: Without PrEP for PBW, the model estimates 1.31 million new infections will occur between 2025 and 2035 in South African adults and children, including 100 000 in PBW, 16 800 in infants at/before birth, and 35 200 in children through breastmilk. In the oral PrEP-only scenario, these numbers would reduce by 1.2% (95% CI: 0.7-1.7%), 8.6% (4.8-12.9%), 4.0% (2.1-5.8%), and 5.3% (3.0-8.2%) respectively. In the CAB-LA-only scenario, the corresponding reductions would be 6.1% (2.9-9.6%), 41.2% (19.8-65.0%), 12.6% (6.0-19.4%), and 29.5% (13.9-46.8%), respectively, and in the oral/CAB-LA choice scenario, similar reductions would be achieved [5.6% (3.4-8.0%), 39% (23.4-55.9%), 12.4% (7.4-16.8%) and 27.6% (16.5-39.9%) respectively]. CONCLUSION: CAB-LA has the potential to be substantially more effective than oral PrEP in preventing HIV acquisition in PBW and vertical transmission, and can also modestly reduce HIV incidence at a population level.
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- 2024
41. Point-of-care testing for sexually transmitted infections and HIV pre-exposure prophylaxis among pregnant women in South Africa, 2021–2022: randomised controlled trial
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de Voux, Alex, Nyemba, Dorothy Chiwoniso, Silliman, Miriam, Mashele, Nyiko, Mvududu, Rufaro, Myer, Landon, and Davey, Dvora Joseph
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Biomedical and Clinical Sciences ,Public Health ,Clinical Sciences ,Health Sciences ,Reproductive Medicine ,Clinical Research ,Clinical Trials and Supportive Activities ,Pediatric AIDS ,Prevention ,Infectious Diseases ,Sexually Transmitted Infections ,Mental Health ,Pediatric ,HIV/AIDS ,Reproductive health and childbirth ,Infection ,Good Health and Well Being ,Female ,Pregnancy ,Humans ,Pre-Exposure Prophylaxis ,Pregnant Women ,South Africa ,HIV Infections ,Sexually Transmitted Diseases ,Point-of-Care Testing ,CHLAMYDIA TRACHOMATIS ,NEISSERIA GONORRHOEAE ,TRICHOMONAS ,Medical Microbiology ,Public Health and Health Services ,Clinical sciences ,Public health - Abstract
ObjectivePregnant and postpartum women (PPW) in Southern Africa are at increased risk of acquiring HIV and curable sexually transmitted infections (STIs). Oral pre-exposure prophylaxis (PrEP) is safe and effective to use during pregnancy to reduce HIV acquisition and vertical transmission. Point-of-care (POC) STI testing can identify PPW at risk of HIV and facilitate risk-differentiated and person-centred counselling to improve PrEP initiation, persistence and adherence. We evaluated the impact of POC STI testing compared with STI syndromic management on PrEP outcomes among PPW in Cape Town, South Africa.MethodsThe STI and PrEP in Pregnancy Study enrolled PPW without HIV and ≤34 weeks pregnant at their regular antenatal care visit with follow-up after 1 month. PPW were randomised to receive POC STI testing or STI syndromic management. PPW randomised to POC STI testing self-collected vaginal swabs for Chlamydia trachomatis, Neisseria gonorhoeae and Trichomonas vaginalis (Cepheid GeneXpert) testing and were offered same-day treatment if diagnosed. We compared PrEP initiation at baseline, PrEP prescription refill at 1 month (persistence) and adherence through tenofovir-diphosphate detection in dried blood spots by randomisation arm. In a secondary analysis, we evaluated the association between an STI diagnosis (positive STI test or reporting STI symptoms) with PrEP outcomes.ResultsWe enrolled and randomised 268 pregnant women. Twenty-eight per cent of women were diagnosed with ≥1 STI. Overall, 65% of women initiated and 79% persisted on PrEP with no significant differences by randomisation arm. Secondary analysis demonstrated that an STI diagnosis (positive STI test or reporting STI symptoms) was associated with higher PrEP initiation (adjusted relative risk=1.28; 95% CI 1.08 to 1.52), controlling for arm, maternal and gestational age.ConclusionsPOC STI testing was not associated with PrEP initiation or persistence relative to syndromic management. However, improving STI diagnosis by supplementing syndromic management with POC STI testing could improve PrEP initiation among PPW.Trial registration numberNCT03902418; Clinical Trials.gov; 1 April 2019.
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- 2024
42. Barriers to Accessing and Engaging in HIV Preventive Care and Pre-Exposure Prophylaxis Experienced by Transgender Women in Florida
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Maragh-Bass, Allysha C, Kiplagat, Sandra, Lavari, Sarah, Sastre, Francisco, Devieux, Jessy G, Jimenez, Daniel, Clarke, Rachel D, Noel, Ines, Schrimshaw, Eric W, Sevelius, Jae, and Cyrus, Elena
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Biomedical and Clinical Sciences ,Public Health ,Health Sciences ,Human Society ,Sexually Transmitted Infections ,Health Disparities ,Infectious Diseases ,Social Determinants of Health ,Clinical Research ,Basic Behavioral and Social Science ,Sexual and Gender Minorities (SGM/LGBT*) ,Prevention ,Mental Health ,Women's Health ,Clinical Trials and Supportive Activities ,HIV/AIDS ,Behavioral and Social Science ,Minority Health ,3.1 Primary prevention interventions to modify behaviours or promote wellbeing ,Good Health and Well Being ,Adult ,Humans ,Female ,Transgender Persons ,Pre-Exposure Prophylaxis ,Florida ,HIV Infections ,Focus Groups ,Anti-HIV Agents ,HIV ,PrEP ,barriers to care ,transgender women ,Toxicology - Abstract
BackgroundPrEP, a biomedical HIV prevention option, continues to be underutilized among transgender women who could benefit from sustained use, especially women of color and those who identify as Latina and/or reside in the southeastern US.ObjectiveWe explored the barriers and facilitators experienced by transgender women who live in Florida regarding accessing, using, and/or staying on PrEP.MethodsIn-depth interviews and focus groups were conducted in either Spanish or English with adult transgender women living in Florida (N = 22). The interviews were audio-recorded, transcribed, and coded in ATLAS.ti using thematic analyses.ResultsThe mean age of the participants was 42.2 years. Among the participants, 73% were Hispanic/Latina, 59% were foreign-born, and approximately one-third were living with HIV (but had past experience with PrEP). Transgender women cited the following barriers to accessing or considering PrEP: (1) costs and benefits of PrEP use; (2) under-representation in clinical trials resulting in unknown or misinformation regarding PrEP side effects; (3) chronic poverty; and (4) trauma and discrimination. Other stressors, such as behavioral healthcare needs, were identified.ConclusionsOur analysis revealed interlocking systems of oppression like transphobia, discrimination, and misgendering, which were common barriers experienced by our participants. These synergistically epidemic (i.e., syndemic) barriers contributed to their feelings of being systematically excluded in social spaces, research, public health planning and policies, laws, and social programs related to PrEP. These structural barriers are impediments to HIV preventive care but also act as a source of stress that contributes to mental health problems, financial vulnerability, substance abuse, and other deleterious health outcomes.
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- 2024
43. Study protocol of a randomized controlled trial to assess the efficacy of the PrEPare for Work intervention to enhance PrEP uptake and optimize adherence for HIV prevention among male sex workers in the U.S.
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Biello, Katie, Chan, Philip, Ndoye, Colleen, Nelson, Lance, Nelson, Elizabeth, Silva, Vanessa, Kwak, Eun, Napoleon, Siena, Cormack Orellana, Carolina, Richards, Olly, Davis, Evan, and Mimiaga, Matthew
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Efficacy trial ,HIV infections ,Male sex work ,Motivational interviewing ,Pre-exposure prophylaxis ,Social cognitive theory ,Male ,Humans ,HIV Infections ,Homosexuality ,Male ,Sex Workers ,Sexual Behavior ,Counseling ,Pre-Exposure Prophylaxis ,Anti-HIV Agents ,Randomized Controlled Trials as Topic - Abstract
BACKGROUND: Male sex workers (MSWs), specifically cisgender men who exchange sex for money, goods, drugs, or other items of value with other cisgender men, are at high risk for HIV infection. Compared to men not engaged in sex work, MSWs are more likely to engage in frequent condomless sex with paying and non-paying sexual partners. While MSWs are often included as a subgroup of gay and bisexual men, data show that a large proportion identify as heterosexual; additionally, most MSWs do not identify as sex workers. This places MSWs in a unique position where they may not engage with traditional HIV prevention programs, and when they do, they may not feel comfortable, leading to poor retention. Thus, HIV prevention interventions that address MSWs unique life circumstances and provide support in exploring their sexual health options are needed. METHODS: In this protocol paper, we describe the design and procedures for a National Institute of Health-funded, randomized controlled trial testing the efficacy of PrEPare for Work,- a theory-based, manualized PrEP uptake and adherence intervention for MSW - using a 2-stage randomization design. Stage 1: MSWs are equally randomized to receive either the PrEPare for Work Stage 1 intervention (strength-based case management and facilitated PrEP linkage) or Standard of Care (SOC) to evaluate successful PrEP uptake (prescription filled) within two months post-randomization. Stage 2: Those who initiate PrEP are then equally re-randomized to receive either the PrEPare for Work Stage 2 intervention (1-on-1 skills training, problem-solving, and motivational interviewing adherence counseling and personalized, daily text message reminders) or SOC to assess adherence (Tenofovir concentrations in hair) over 12 months of follow up. Planned analyses will examine intervention efficacy, specific conceptual mediators, and hypothesized moderators. DISCUSSION: Based on our extensive preliminary research, multi-component, theory-informed interventions targeting this subpopulation of MSWs unique life circumstances are urgently needed. In this study, we are evaluating whether PrEPare for Work can improve PrEP uptake and adherence among MSWs. If this intervention is efficacious, it would be readily disseminated to diverse community organizations that serve MSWs and possibly other community or clinic-based settings. TRIAL REGISTRATION: ClinicalTrials.gov number NCT05736614, registered February 8, 2023.
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- 2024
44. HIV service use among minoritized racial and ethnic transgender and gender non-conforming youth in the U.S South: a qualitative investigation.
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Koenig, Linda J., Gelaude, Deborah, Mizuno, Yuko, Spikes, Pilgrim, Carter, Jarvis Jr., White, Lamont Scales, Randall, Laura A., Betley, Valerie, and Tesfaye, Casey Langer
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TRANSGENDER youth , *HIV prevention , *SOCIAL services , *HEALTH of transgender people , *RACIAL minorities , *PRE-exposure prophylaxis - Abstract
Transgender youth are disproportionately affected by HIV, particularly minoritized youth in the US south. To understand HIV service use among transgender youth, we interviewed 25 young racial and ethnic minority clients of four southern community-based HIV service organizations (CBOs), and CBO staff (
n = 12), about service access and use. Participants were assigned male at birth and identified as female (n = 8), transgender (n = 11) or gender-fluid or nonbinary (n = 6). The majority were Black/African American or mixed race; four were Hispanic or Latino/a. Most were unemployed; nearly half were unstably housed or homeless during the prior year. Four service types were each used by approximately two-thirds of participants: counseling/support, HIV/STD testing/education, pre-exposure prophylaxis education/prescriptions, and transgender-related medical services (primarily hormone provision). Just over a quarter used social services (e.g., housing, employment). Key facilitators to service use included a non-stigmatizing CBO atmosphere, and easy and convenient access. Poor access (e.g., inconvenient hours, location), lack of transportation or parking, social service needs, and lack of money were barriers. Qualitative reports highlighted unmet social service needs, particularly housing, especially for those without HIV. To reduce disparities, HIV prevention for racial and ethnic minoritized transgender youth should simultaneously address hormone provision, HIV risk reduction and social service needs. [ABSTRACT FROM AUTHOR]- Published
- 2025
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45. Social Iatrogenesis and Social Risks Among Queer PrEP Users in Dar Es Salaam.
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Haaland, Inga and Ogillo, Karama
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HIV prevention , *PRE-exposure prophylaxis , *SOCIAL stigma , *IATROGENIC diseases , *RISK-taking behavior - Abstract
Pre-exposure prophylaxis, commonly known as PrEP, is an HIV-preventative pill taken to reduce the risk of contracting HIV. During a PrEP study in Dar es Salaam among queer PrEP users, this ethnographic study observed how PrEP users experienced novel types of (social) risks and harms, or social iatrogenesis, imposed by the biomedical HIV prevention pill or the PrEP program. These forms of social iatrogenesis related to lack of autonomy, creating demand for PrEP, then removing services, projectivization of PrEP programs, social risks related to fear of stigma by association, and clinical encounters producing multiple understandings of adherence and usage of PrEP. [ABSTRACT FROM AUTHOR]
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- 2025
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46. Community and familial dynamics influencing risk behavior for HIV acquisition among adolescent girls and young women in Uganda: Qualitative analysis using Protective Motivation Theory.
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Apondi, Rose, Bastiaens, Hilde, Nöstlinger, Christiana, Galbraith, Jennifer, Aholou, Tiffiany M., Medley, Amy, Wanyenze, Rhoda K., Awor, Anna C., Serwadda, David M., Aluzimbi, George, Cheptoris, Juliet, Ogwal, Moses, Nakyanjo, Neema, and Patel, Pragna
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CAREGIVER attitudes , *TEENAGE girls , *AT-risk behavior , *HIV prevention , *PRE-exposure prophylaxis , *YOUNG women - Abstract
Background: In Uganda, adolescent girls', and young women's (AGYW-15-24 years) current HIV prevalence is fourfold compared with their male counterparts due to compounded social, economic, and environmental factors. Using the Protective Motivation Theory (PMT), we explored HIV-acquisition risk sources and perceived protective factors from AGYW and caregivers' perspective. Materials and methods: During 2018, we conducted a qualitative study guided by PMT to explore factors influencing HIV acquisition among AGYW. We purposively sampled two groups of key informants, AGYW at high-risk for HIV acquisition (uninfected) and AGYW living with HIV, varied by age and place of residence (urban/rural). We conducted 34 focus group discussions with AGYW, nine with AGYW parents, and 25 key informant interviews. Data were analyzed using the framework method based on the PMT and developed from participants' narratives. Results: AGYW were knowledgeable about HIV, HIV acquisition risk factors, and HIV prevention interventions. Nonetheless, few AGYW knew about pre-exposure prophylaxis (PrEP). Imbalance in power relations between the genders explained inability of AGYW making safe healthy decisions, with social norms giving men power over women. Parents modelling positively influenced HIV risk behavior. Many AGYW viewed staying in school a protective factor both while at school and further for life. AGYW identified alcohol use, desire for material possessions, discounting HIV disease severity, social norms, and poverty as barriers to engaging in self-protective behaviors. Several AGYW believed that access to AGYW-focused programs would facilitate healthy sex-positive, protective behaviors. Discussion: While PMT focuses on individual factors confirmed by our findings, we found HIV risk behavior to be influenced by complex contextual factors including poverty, gender inequality and cultural norms. Distinct HIV risk factors among AGYW require policy and comprehensive targeted interventions addressing violence, alcohol consumption, increased economic opportunities, educational opportunities, safe-sex practices, and PrEP scale-up which may prevent HIV in AGYW and facilitate HIV epidemic control. [ABSTRACT FROM AUTHOR]
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- 2025
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47. The impact of an educational intervention on undergraduate students’ knowledge, acceptability, and willingness to pay for dapivirine vaginal ring in Nigeria's first indigenous university: a single-arm, non-randomized study.
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Isah, Abdulmuminu, Ezenri, Gabriel, Obi, Ogechi, Okibe, Nnamdi A., Ma’aji, Hadiza Usman, Ugochukwu, Ezinwanne J., Eze, Cynthia C., Amoke, Chisom M., Ezeodimegwu, Augustus, Idabor, Charles C., Abubakar, Mustapha Muhammed, Iloabuchi, Francis, Ugwu, Ikenna John, Asogwa, Chukwuebuka M., Ukwe, Chinwe V., and Ukoha-kalu, Blessing Onyinye
- Abstract
Background: This study aimed to assess the impact of an educational intervention on knowledge, acceptability, and willingness to pay (WTP) for dapivirine vaginal ring (DPV-VR) by undergraduate female students at the University of Nigeria (UNN). Methods: A cross-sectional design was adopted to obtain responses from the respondents using a validated 23-item questionnaire. A sample size of 1500 was estimated from five systematically sampled faculties. Their acceptability was accessed before and after educating them on the dapivirine vaginal ring (DPV-VR). WTP was determined in Naira (N490/$1) using contingent valuation. Descriptive statistics were used to summarize the findings, with inter-faculty comparison done with the Chi-squared test. Results: 1017 students responded to the questionnaire. The modal age was 18–24 years (754 [74.1%]), and most of them (886 [87.1%]) were unmarried. More than half of the respondents had tested for HIV (531 [52.2%])), with 3 (1.5%), 3 (1.7%), 2 (0.6%), 2 (1.8%) and 1 (0.5%) student from Arts, Biological Sciences, Pharmaceutical Sciences, Social Sciences, and Veterinary Medicine, respectively, having positive results. Only 304 (29.9%) of the students had prior knowledge of DPV-VR. There was about a two-fold increase in the acceptability of the dapivirine vaginal ring (DPV-VR) (294 to 596) after the intervention (p ≤ 0.001). Most of the students (466 [45.8%]) indicated that they would be willing to pay < N410.00 for a single dapivirine vaginal ring (DPV-VR). Conclusions: Many of the female students at UNN were willing to use the dapivirine vaginal ring (DPV-VR); even more after they were informed of its importance. Most of the students were willing to pay less than one dollar out-of-pocket for the ring. [ABSTRACT FROM AUTHOR]
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- 2025
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48. Rationale and design of a randomized clinical trial of integrated eHealth for PrEP and medications for opioid use disorders for women in the criminal legal system. The Athena study.
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Meyer, Jaimie P., Brunson, Stacey, Price, Carolina R., Mulrain, Morgan, Nguyen, Julie, Altice, Frederick L., Kyriakides, Tassos C., Cropsey, Karen, and Eaton, Ellen
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OPIOID abuse ,WOMEN criminals ,TREATMENT effectiveness ,HIV prevention ,MEDICAL sciences ,PRE-exposure prophylaxis - Abstract
Background: Women involved in the criminal legal system have elevated rates of opioid use disorder, which is treatable, and HIV, which is preventable with pre-exposure prophylaxis (PrEP). There are significant social and structural barriers to integrated delivery of PrEP and medications for opioid use disorder (MOUD), limiting women's ability to access these life-saving interventions. In a two parallel-arm randomized controlled trial, we are assessing an innovative eHealth delivery model that integrates PrEP with MOUD and is tailored to meet the specific needs of women involved in the criminal legal system. Methods: We will recruit and enroll 250 women involved in the criminal legal system with opioid use disorder across two diverse settings (New Haven, CT and Birmingham, AL). Participants will be randomized to (a) the "Athena strategy," which includes a PrEP decision aid and integrated PrEP/MOUD delivery via eHealth; or (b) enhanced standard of care (SOC) that includes a decision aid-only. During 6-month follow-up, we will assess PrEP initiation as the primary clinical outcome and implementation outcomes that include acceptability, adoption, feasibility, fidelity, implementation cost, and sustainability. Discussion: Results could help determine if reducing the social and structural barriers to PrEP and MOUD for women involved in the criminal legal system will facilitate engagement in treatment and prevention services, thus alleviating health disparities. Trial registration: Clinicaltrials.gov (NCT05547048). Registered September 15, 2022. https://clinicaltrials.gov/study/NCT05547048?term=NCT05547048&rank=1. [ABSTRACT FROM AUTHOR]
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- 2025
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49. Determinants of continuation on HIV pre-exposure propylaxis among female sex workers at a referral hospital in Uganda: a mixed methods study using COM-B model.
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Kawuma, Samuel, Katwesigye, Rodgers, Walusaga, Happy, Akatukunda, Praise, Nangendo, Joan, Kabugo, Charles, Kamya, Moses R., and Semitala, Fred C.
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PROPORTIONAL hazards models , *MEDICAL personnel , *SEMI-structured interviews , *HIV prevention , *PUBLIC health , *PRE-exposure prophylaxis - Abstract
Background: Female sex workers (FSWs) have the highest HIV prevalence in Uganda. Pre-exposure prophylaxis (PrEP) has been recommended as a key component of the HIV combination prevention strategy. Although patient initiation of PrEP has improved, continuation rates remain low. This study evaluated PrEP continuation among FSWs and explored potential determinants of PrEP adherence within a public referral hospital in urban Uganda. Methods: We conducted an explanatory sequential mixed method study at Kiruddu National referral hospital in Uganda. Secondary data on socio demographic characteristics and follow up outcomes of at least one year was collected for all FSWs who were initiated PrEP between May 2020 and April 2021 and data analyzed on July 15,2023. We used Kaplan–Meier survival analysis to evaluate continuation on PrEP from time of initiation and follow-up period. The capability, opportunity, and motivation to change behaviour model was used to explore perspectives and practices of FSWs (n = 24) and health care providers (n = 8) on continuation on PrEP among FSWs, using semi structured interviews. The qualitative data was deductively coded and analyzed thematically, categorizing the themes related to PrEP continuation as facilitators and barriers. Results: Of the 292 FSWs initiated on PrEP, median age was 26 years (interquartile range, 21–29), 101 (34.6) % were active on PrEP, 137 (46.9%) were lost to follow-up, 45 (15.4%) were no longer eligible to continue PrEP, eight (2.7%) were transferred out and one (0.3%) had died. Median survival time on PrEP was 15 months (Interquartile range IQR, 3–21). The continuation rates on PrEP at six (6) and 12 months were 61.1% and 53.1%, respectively. Facilitators of PrEP continuation included awareness of risk associated with sex work, integration of PrEP with other HIV prevention services, presence of PrEP Peer support and use of Drop-in centers. The barriers included low community awareness about PrEP, high mobility of sex workers, substance abuse, and the unfavorable daytime clinic schedules. However, the quantitative findings from the multivariable Cox Proportional Hazards Model did not align with the reported findings for the qualitative evaluation. Conclusion: Continuation on PrEP remains low among FSWs. Interventions for PrEP continuation should address barriers such as low community awareness of PrEP, substance abuse and restrictive health facility policies for scale of the PrEP program among FSWs in Uganda. Integration of PrEP with other services and scale up of community PrEP delivery structures may improve its continuation. [ABSTRACT FROM AUTHOR]
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- 2025
- Full Text
- View/download PDF
50. Achieving the state of Georgia 25% HIV incidence reduction target among men who have sex with men in Atlanta through expanded use of multimodal pre-exposure prophylaxis: A mathematical model.
- Author
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Fraysse, Jeremy, Anderson, Sarah-Jane, Smith, Justin C., Matthews, Derrick D., Sarkar, Supriya, de Aragao, Filipa, and Blissett, Rob
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MEN who have sex with men , *PRE-exposure prophylaxis , *HIV , *MATHEMATICAL models , *PUBLIC health - Abstract
The US faces substantial demographic and geographic disparities in both HIV burden and access to pre-exposure prophylaxis (PrEP), an effective strategy to prevent HIV acquisition. Long-acting cabotegravir (CAB) is a novel, injectable PrEP option which demonstrated superior reduction in risk of HIV acquisition compared to daily-oral PrEP in the HPTN083 trial. We modelled the impact of increased PrEP initiations and the introduction of long-acting CAB on HIV incidence among men who have sex with men (MSM) in Atlanta, Georgia, a population with a high burden of HIV. The Georgia Department of Public Health has set an ambitious 25% HIV incidence reduction target, which could be reached with a daily-oral PrEP coverage of 42.2%. However, the target could be achieved at lower levels of PrEP coverage (34.6%) if a mix of PrEP modalities was used, such as an equal split of long-acting CAB PrEP and daily-oral PrEP. Our results clearly demonstrate that broadening access to new PrEP options has the potential to facilitate the achievement of public health HIV incidence reduction goals at plausible levels of PrEP coverage. [ABSTRACT FROM AUTHOR]
- Published
- 2025
- Full Text
- View/download PDF
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