{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,8]],"date-time":"2026-10-08T02:18:27Z","timestamp":1791425907529,"version":"4.3.3"},"reference-count":44,"publisher":"JMIR Publications Inc.","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JMIR Form Res"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec sec-type=\"background\">\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Cisgender women account for 23% of new HIV diagnoses in the United States, but there are significant socio-structural barriers to engagement and retention in the preexposure prophylaxis (PrEP) cascade, particularly for women of color.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec sec-type=\"objective\">\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>In response to the lack of evidence-based interventions to improve PrEP initiation, adherence, and persistence among women in the United States, we developed and piloted a clinic-based, socio-structural intervention to measure (1) the feasibility of delivering the adapted intervention and (2) clinic team and patient perspectives on the intervention, in preparation for a future trial on engagement and retention in the PrEP cascade among women.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec sec-type=\"methods\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      We previously applied the ADAPT-ITT (Assessment, Decision, Adaptation, Production, Topical experts, Integration, Training, Testing) model to develop a culturally appropriate, evidence-based intervention, responsive to Black women\u2019s HIV prevention needs. In the present study, we set out to complete the\n                      <jats:italic>Training<\/jats:italic>\n                      and\n                      <jats:italic>Testing<\/jats:italic>\n                      phases: namely, to hire and train a PrEP navigator and to train clinic staff to deliver the adapted intervention. We completed a 4-month pilot to assess the feasibility of delivering the intervention and collecting outcomes of interest and initial outcome trends (compared to baseline). We further assessed the clinic team and patient perspectives on the intervention to understand the potential for future scale and delivery.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec sec-type=\"results\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The clinic team participants found the adapted Women\u2019s PrEP project (W-PrEP) intervention both highly feasible and relevant to patients, with minimal impact on clinic flow. Patient participants reported that the W-PrEP intervention was highly relevant and appreciated the education and counseling from the PrEP navigator\u2014many learning about PrEP for the first time from the navigator and health care provider. The outcome measures were both feasible to collect and appropriate to capture the primary outcomes of interest. Finally, the W-PrEP intervention increased the proportion of patients counseled about PrEP from 65% to 76% of patients seen (\n                      <jats:italic>P<\/jats:italic>\n                      &lt;.001).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec sec-type=\"conclusions\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The intervention and outcome data collection was feasible, and open-ended clinic team and patient perspectives showed positive feedback about the intervention and relevance. The associated increase in PrEP counseling is promising but necessitates further evaluation of the effects of the W-PrEP intervention on the PrEP cascade (eg, initiation, persistence, adherence) in a larger randomized trial.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.2196\/80653","type":"journal-article","created":{"date-parts":[[2025,10,20]],"date-time":"2025-10-20T14:00:08Z","timestamp":1760968808000},"page":"e80653-e80653","source":"Crossref","is-referenced-by-count":1,"title":["\u201cThe Women\u2019s PrEP Project,\u201d a Clinic-Based, Socio-Structural Intervention to Improve the Provision of Preexposure Prophylaxis for Cisgender Women: Interrupted Time Series Pilot"],"prefix":"10.2196","volume":"9","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1519-9222","authenticated-orcid":false,"given":"Rachel K","family":"Scott","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3503-3289","authenticated-orcid":false,"given":"Shawnika J","family":"Hull","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7401-9159","authenticated-orcid":false,"given":"Deanna","family":"Kerrigan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7008-0147","authenticated-orcid":false,"given":"Yan","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9303-7659","authenticated-orcid":false,"given":"Mandi","family":"Pratt-Chapman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9821-2383","authenticated-orcid":false,"given":"Tara","family":"Mathias-Prabhu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-3898-2378","authenticated-orcid":false,"given":"Naquia","family":"Unwala","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3972-0959","authenticated-orcid":false,"given":"Marisa","family":"Sadauskas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4368-0136","authenticated-orcid":false,"given":"Bat-zion","family":"Hose","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0638-8101","authenticated-orcid":false,"given":"Marjanna","family":"Smith","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-8868-1366","authenticated-orcid":false,"given":"Patricia","family":"Moriarty","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-9285-3010","authenticated-orcid":false,"given":"Tranessa","family":"Hanson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-1361-4062","authenticated-orcid":false,"given":"Ariam","family":"Tedla","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-0711-0486","authenticated-orcid":false,"given":"Pamela","family":"Lotke","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4665-9866","authenticated-orcid":false,"given":"Peggy","family":"Ye","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5734-0810","authenticated-orcid":false,"given":"Hannah","family":"Arem","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1010","published-online":{"date-parts":[[2025,12,3]]},"reference":[{"key":"R1","unstructured":"Fast facts: HIV and women. Centers for Disease Control and Prevention. 2024. URL: https:\/\/www.cdc.gov\/hiv\/data-research\/facts-stats\/women.html [Accessed 01-08-2024]"},{"key":"R2","unstructured":"AtlasPlus - charts. Centers for Disease Control and Prevention. URL: https:\/\/gis.cdc.gov\/grasp\/nchhstpatlas\/charts.html [Accessed 27-12-2024]"},{"issue":"4","key":"R3","doi-asserted-by":"publisher","first-page":"238","DOI":"10.1016\/j.annepidem.2017.02.003","article-title":"Lifetime risk of a diagnosis of HIV infection in the United States","volume":"27","author":"Hess","journal-title":"Ann Epidemiol"},{"key":"R4","unstructured":"HIV diagnoses, deaths, and prevalence. Centers for Disease Control and Prevention. 2024. URL: https:\/\/www.cdc.gov\/hiv-data\/nhss\/hiv-diagnoses-deaths-prevalence.html [Accessed 27-12-2024]"},{"key":"R5","doi-asserted-by":"publisher","DOI":"10.1086\/651483","article-title":"Preventing HIV infection in women: a global health imperative","volume":"50 Suppl 3","author":"Abdool Karim","journal-title":"CLIN INFECT DIS"},{"key":"R6","doi-asserted-by":"publisher","DOI":"10.1016\/j.bpobgyn.2019.12.001","article-title":"Male and female condoms: their key role in pregnancy and STI\/HIV prevention","volume":"66","author":"Beksinska","journal-title":"Best Pract Res Clin Obstet Gynaecol"},{"issue":"5","key":"R7","doi-asserted-by":"publisher","first-page":"399","DOI":"10.1056\/NEJMoa1108524","article-title":"Antiretroviral prophylaxis for HIV prevention in heterosexual men and women","volume":"367","author":"Baeten","journal-title":"N Engl J Med"},{"issue":"5","key":"R8","doi-asserted-by":"publisher","first-page":"423","DOI":"10.1056\/NEJMoa1110711","article-title":"Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana","volume":"367","author":"Thigpen","journal-title":"N Engl J Med"},{"issue":"13","key":"R9","doi-asserted-by":"publisher","first-page":"2155","DOI":"10.1097\/QAD.0b013e3283629037","article-title":"Efficacy of preexposure prophylaxis for HIV-1 prevention among high-risk heterosexuals: subgroup analyses from a randomized trial","volume":"27","author":"Murnane","journal-title":"AIDS"},{"issue":"11","key":"R10","doi-asserted-by":"publisher","first-page":"930","DOI":"10.1001\/jama.2024.0464","article-title":"HIV preexposure prophylaxis with emtricitabine and tenofovir disoproxil fumarate among cisgender women","volume":"331","author":"Marrazzo","journal-title":"JAMA"},{"issue":"10337","key":"R11","doi-asserted-by":"publisher","first-page":"1779","DOI":"10.1016\/S0140-6736(22)00538-4","article-title":"Cabotegravir for the prevention of HIV-1 in women: results from HPTN 084, a phase 3, randomised clinical trial","volume":"399","author":"Delany-Moretlwe","journal-title":"Lancet"},{"issue":"13","key":"R12","doi-asserted-by":"publisher","first-page":"1179","DOI":"10.1056\/NEJMoa2407001","article-title":"Twice-yearly lenacapavir or daily F\/TAF for HIV prevention in cisgender women","volume":"391","author":"Bekker","journal-title":"N Engl J Med"},{"issue":"2","key":"R13","doi-asserted-by":"publisher","first-page":"114","DOI":"10.1080\/13625180802011302","article-title":"Barriers to condom use","volume":"13","author":"Sarkar","journal-title":"Eur J Contracept Reprod Health Care"},{"key":"R14","unstructured":"The HIV prevention pipeline. AVAC. 2024. URL: https:\/\/avac.org\/resource\/infographic\/the-hiv-prevention-pipeline\/ [Accessed 01-08-2024]"},{"key":"R15","unstructured":"MATRIX: a USAID project to advance the research and development of innovative HIV prevention products for women. MATRIX; 2024. URL: https:\/\/www.matrix4prevention.org [Accessed 01-08-2024]"},{"issue":"12","key":"R16","doi-asserted-by":"publisher","first-page":"850","DOI":"10.1016\/j.annepidem.2018.05.003","article-title":"Estimates of adults with indications for HIV pre-exposure prophylaxis by jurisdiction, transmission risk group, and race\/ethnicity, United States, 2015","volume":"28","author":"Smith","journal-title":"Ann Epidemiol"},{"issue":"41","key":"R17","doi-asserted-by":"publisher","first-page":"1147","DOI":"10.15585\/mmwr.mm6741a3","article-title":"HIV preexposure prophylaxis, by race and ethnicity-United States, 2014-2016","volume":"67","author":"Huang","journal-title":"MMWR Morb Mortal Wkly Rep"},{"key":"R18","unstructured":"Bush S Ng L Magnuson D Piontkowsky D Giler RM . Significant uptake of truvada for preexposure prophylaxis (prep) utilization in the US in late 2014-1Q2015. 2015. URL: https:\/\/www.iapac.org\/AdherenceConference\/presentations\/ADH10_OA74.pdf [Accessed 14-11-2025]"},{"key":"R19","unstructured":"Bush S Magnuson D Rawlings M Hawkins T McCallister S Giler RM . ASM\/ICAAC: racial characteristics of FTC\/TDF for pre-exposure prophylaxis (prep) users in the US. 2016. URL: http:\/\/www.natap.org\/2016\/HIV\/062216_02.htm [Accessed 14-11-2025]"},{"key":"R20","doi-asserted-by":"publisher","DOI":"10.1016\/j.lana.2024.100738","article-title":"Equity of PrEP uptake by race, ethnicity, sex and region in the United States in the first decade of PrEP: a population-based analysis","volume":"33","author":"Sullivan","journal-title":"Lancet Reg Health Am"},{"key":"R21","unstructured":"Compendium | intervention research | research | HIV |. Centers for Disease Control and Prevention. URL: https:\/\/www.cdc.gov\/hivpartners\/php\/compendium\/index.html [Accessed 01-08-2024]"},{"issue":"9","key":"R22","doi-asserted-by":"publisher","first-page":"447","DOI":"10.1089\/apc.2023.0107","article-title":"Implementation of an educational intervention to improve HIV pre-exposure prophylaxis services for women in an urban sexual health clinic","volume":"37","author":"Scott","journal-title":"AIDS Patient Care STDS"},{"issue":"Suppl 1","key":"R23","doi-asserted-by":"publisher","first-page":"S60","DOI":"10.1097\/QAI.0000000000001203","article-title":"Project Shikamana: baseline findings from a community empowerment-based combination HIV prevention trial among female sex workers in Iringa, Tanzania","volume":"74 Suppl 1","author":"Kerrigan","journal-title":"J Acquir Immune Defic Syndr"},{"issue":"2","key":"R24","doi-asserted-by":"publisher","first-page":"141","DOI":"10.1097\/QAI.0000000000002123","article-title":"Project Shikamana: community empowerment-based combination HIV prevention significantly impacts HIV incidence and care continuum outcomes among female sex workers in Iringa, Tanzania","volume":"82","author":"Kerrigan","journal-title":"J Acquir Immune Defic Syndr"},{"issue":"1","key":"R25","doi-asserted-by":"publisher","DOI":"10.2196\/75922","article-title":"Development of a clinic-based, sociostructural intervention to improve the provision of pre-exposure prophylaxis for cisgender women: formative study using the assessment, decision, adaptation, production, topical experts, integration, training, and testing (ADAPT-ITT) framework","volume":"9","author":"Scott","journal-title":"JMIR Form Res"},{"key":"R26","doi-asserted-by":"publisher","DOI":"10.1097\/QAI.0b013e3181605df1","article-title":"The ADAPT-ITT model: a novel method of adapting evidence-based HIV Interventions","volume":"47 Suppl 1","author":"Wingood","journal-title":"J Acquir Immune Defic Syndr"},{"key":"R27","unstructured":"Bronfenbrenner U . Ecological models of human development. In: International Encyclopedia of Education. Vol 3. 2nd ed. Elsevier; 1994. URL: https:\/\/www.ncj.nl\/wp-content\/uploads\/media-import\/docs\/6a45c1a4-82ad-4f69-957e-1c76966678e2.pdf [Accessed 14-11-2025]"},{"issue":"4","key":"R28","doi-asserted-by":"publisher","first-page":"228","DOI":"10.1016\/s1553-7250(08)34030-6","article-title":"A practical, robust implementation and sustainability model (PRISM) for integrating research findings into practice","volume":"34","author":"Feldstein","journal-title":"Jt Comm J Qual Patient Saf"},{"key":"R29","unstructured":"PrEP navigation manual. Please PrEP Me. URL: https:\/\/pleaseprepme.org\/prepnavigatormanual\/ [Accessed 22-01-2025]"},{"key":"R30","unstructured":"Implicit bias: a practical guide for healthcare settings. The George Washington University School of Medicine and Health Sciences. 2024. URL: https:\/\/cme.smhs.gwu.edu\/www.dcrxce.com\/content\/implicit-bias-practical-guide-healthcare-settings#group-tabs-node-course-default1 [Accessed 14-11-2025]"},{"key":"R31","unstructured":"Intro to trauma informed care training modules. Trauma Informed Oregon. 2024. URL: https:\/\/traumainformedoregon.org\/resources\/training\/tic-intro-training-modules\/ [Accessed 02-08-2024]"},{"key":"R32","unstructured":"Young R Bowser M Nesbitt LS . HIV\/AIDS and administration (HAHSTA), \u201cAnnual epidemiology & surveillance report: data through. District of Columbia Department of Health. 2019. URL: https:\/\/dchealth.dc.gov\/node\/1424881 [Accessed 10-11-2025]"},{"issue":"6","key":"R33","doi-asserted-by":"publisher","first-page":"259","DOI":"10.1089\/apc.2020.0004","article-title":"Integrating HIV pre-exposure prophylaxis into family planning care: a RE-AIM framework evaluation","volume":"34","author":"Brant","journal-title":"AIDS Patient Care STDS"},{"key":"R34","unstructured":"US public health service: preexposure prophylaxis for the prevention of HIV infection in the united states\u20142021 update: a clinical practice guideline. Centers for Disease Control and Prevention. 2021. URL: https:\/\/www.cdc.gov\/hiv\/pdf\/risk\/prep\/cdc-hiv-prep-guidelines-2021.pdf [Accessed 10-11-2025]"},{"issue":"4","key":"R35","first-page":"502","volume":"21","author":"Peek","journal-title":"Ethn Dis"},{"issue":"2","key":"R36","doi-asserted-by":"publisher","first-page":"377","DOI":"10.1016\/j.jbi.2008.08.010","article-title":"Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support","volume":"42","author":"Harris","journal-title":"J Biomed Inform"},{"key":"R37","doi-asserted-by":"publisher","DOI":"10.1016\/j.jbi.2019.103208","article-title":"The REDCap consortium: building an international community of software platform partners","volume":"95","author":"Harris","journal-title":"J Biomed Inform"},{"key":"R38","unstructured":"Hamilton AB . Qualitative methods in rapid turn-around health services research. 2013.URL: https:\/\/www.hsrd.research.va.gov\/for_researchers\/cyber_seminars\/archives\/video_archive.cfm?SessionID=780 [Accessed 14-11-2025]"},{"key":"R39","doi-asserted-by":"publisher","DOI":"10.1146\/annurev-publhealth-040218-044215","article-title":"Innovations in mixed methods evaluations","volume":"40","author":"Palinkas","journal-title":"Annu Rev Public Health"},{"issue":"1","key":"R40","doi-asserted-by":"publisher","DOI":"10.1186\/s13012-019-0853-y","article-title":"Comparison of rapid vs in-depth qualitative analytic methods from a process evaluation of academic detailing in the Veterans Health Administration","volume":"14","author":"Gale","journal-title":"Implement Sci"},{"key":"R41","unstructured":"PRS HIV compendium of best practices. Prevention Research Synthesis. URL: https:\/\/wwwn.cdc.gov\/HIVCompendium\/SearchInterventions [Accessed 14-11-2025]"},{"issue":"6","key":"R42","doi-asserted-by":"publisher","first-page":"685","DOI":"10.1097\/JNC.0000000000000182","article-title":"Integrated pharmacy and PrEP navigation services to support PrEP uptake: a quality improvement project","volume":"31","author":"Coleman","journal-title":"J Assoc Nurses AIDS Care"},{"issue":"6","key":"R43","doi-asserted-by":"publisher","DOI":"10.3390\/v15061365","article-title":"Successful integration of HIV PrEP in primary care and women\u2019s health clinical practice: a model for implementation","volume":"15","author":"Casey","journal-title":"Viruses"},{"issue":"5","key":"R44","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0285858","article-title":"POWER Up\u2014Improving pre-exposure prophylaxis (PrEP) uptake among Black cisgender women in the Southern United States: protocol for a stepped-wedge cluster randomized trial (SW-CRT)","volume":"18","author":"Ridgway","journal-title":"PLoS ONE"}],"container-title":["JMIR Formative Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/formative.jmir.org\/2025\/1\/e80653","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T18:14:13Z","timestamp":1782843253000},"score":1,"resource":{"primary":{"URL":"https:\/\/formative.jmir.org\/2025\/1\/e80653"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,12,3]]},"references-count":44,"URL":"https:\/\/doi.org\/10.2196\/80653","relation":{},"ISSN":["2561-326X"],"issn-type":[{"value":"2561-326X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,12,3]]},"article-number":"v9i4e80653"}}