Observational studyClinical infectious diseases : an official publication of the Infectious Diseases Society of America2021
Results from a Pre-exposure Prophylaxis Demonstration Project for At-risk Cisgender Women in the United States.
Observational study in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
17 citing papers in PubMed, 29 citations in OpenAlex.
- The impact of intimate partner violence on PrEP adherence among U.S. Cisgender women at risk for HIV.BMC public health · 2024Trial
- Phase 1 randomized pharmacokinetic and safety study of a 90-day tenofovir vaginal ring in the United States.Journal of the International AIDS Society · 2024Trial
- PrEP as a "Hidden Message": The Impact of Partner Dynamics on Oral PrEP Adherence Among Cisgender Women in Serodiscordant Relationships.AIDS and behavior · 2026Article
- Prioritizing Barriers and Facilitators to PrEP Uptake Among Black Cisgender Women: Key Factors Identified Through Nominal Group Technique.International journal of environmental research and public health · 2026Article
- HIV/STI Prevention Strategies During COVID-19 Among PrEP-Eligible Cisgender Women in New York State: A Qualitative Analysis.International journal of environmental research and public health · 2026Article
- Toward an End to the HIV Epidemic for Black Women in the US South: Redefining the Success of Preexposure Prophylaxis Uptake for Black Women.Sexually transmitted diseases · 2025Article
- Prevalence and correlates of PrEP use and missed PrEP doses due to alcohol among sexually active adults and sexual minority men in San Francisco.Drug and alcohol dependence · 2025Article
- Article
- A qualitative exploration of how to support PrEP adherence among young men who have sex with men.AIDS care · 2024Article
- Assessing the Preliminary Efficacy of a Nonrandomized, Clinic-Based HIV Risk Reduction Pilot Intervention for PrEP-Initiated, Alcohol- and Other Drug-Using Women of Color in Miami, FL.Journal of racial and ethnic health disparities · 2023Article
- Predictors of PrEP retention in at risk patients seen at a HIV primary care clinic in San Diego.International journal of STD & AIDS · 2023Article
- Implementation of an Educational Intervention to Improve HIV Pre-Exposure Prophylaxis Services for Women in an Urban Sexual Health Clinic.AIDS patient care and STDs · 2023Article
- Achieving the "Ending the HIV Epidemic in the U.S." incidence reduction goals among at-risk populations in the South.BMC public health · 2023Article
- Understanding Retention in the HIV Pre-Exposure Prophylaxis Cascade Among Cisgender Women.AIDS patient care and STDs · 2023Article
- High PrEP uptake and objective longitudinal adherence among HIV-exposed women with personal or partner plans for pregnancy in rural Uganda: A cohort study.PLoS medicine · 2023Article
- Intention to Initiate HIV Pre-exposure Prophylaxis Among Cisgender Women in a High HIV Prevalence U.S. City.Women's health issues : official publication of the Jacobs Institute of Women's HealthArticle
- US Black cisgender women and pre-exposure prophylaxis for human immunodeficiency virus prevention: A scoping review.Women's health (London, England)Article
Corrections and comments
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Authors and funding
16 authors at 8 institutions in 1 country.
Funding
Abstract
backgroundDaily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) is effective for reducing human immunodeficiency virus (HIV) acquisition among cisgender women. We report results from the first US observational open-label demonstration project of pre-exposure prophylaxis (PrEP) among at-risk cisgender women.
methodsAdherence Enhancement Guided by Individualized Texting and Drug Levels was a 48-week, single-arm, open-label demonstration study of daily oral TDF/FTC in cisgender women ≥18 years old at risk for HIV. Adherence was supported using 2-way text messaging and titrated adherence counseling based on rapid-turnaround tenofovir diphosphate concentrations from dried blood spots. Study visits occurred at baseline, weeks 4 and 12, and quarterly through week 48. Outcomes included TDF/FTC adherence, retention, and persistence.
resultsFrom June 2016 to October 2018, 136 cisgender women enrolled (mean age, 40 years (standard deviation, 11); 38% non-Hispanic Black and 19% Latina). At 48 weeks, 84 (62%) participants were retained and 62 (46%) remained on PrEP. More than one-third (12/31) of those on study but off PrEP throughout the study discontinued TDF/FTC because of side effects, and 1 adverse event led to study discontinuation. Of 120 participants with drug concentrations measured, 67 (56%) had at least 1 concentration consistent with 6 doses/week; 22 (18%) had consistent ≥6 doses/week across all study visits attended. There were no incident HIV infections and 4 incident bacterial sexually transmitted infections.
conclusionAdequate PrEP adherence for protective drug concentrations was not achieved for most study participants. More work needs to be done to fully explicate the reasons for nonadherence and low retention in cisgender women.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.