Brenda Gati Mirembe, Deborah Donnell, Meighan Krows, Zinhle Zwane, Elizabeth Bukusi, Ravindre Panchia, Cheryl Louw, Noluthando Mwelase, Pearl Selepe, Melissa Senne, Logashvari Naidoo, Rachel Chihana, Margaret Kasaro, Harriet Nuwagaba-Biribonwoha, Philip Kotze, Katherine Gill, Pippa MacDonald, Alastair vanHeerden, Shannon Bosman, Manjeetha Jaggernath, Phillip du Preez, Amy Ward, Remco P. H. Peters, Sinead Delany-Moretlwe, Sue Peacock, Rachel Johnson, Jason Caucutt, Susan Morrison, Guohong Wang, Monica Gandhi, Jennifer Velloza, Renee Heffron, Connie Celum, the INSIGHT Study Team
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African AGYW have had high uptake of oral HIV pre-exposure prophylaxis (PrEP) but low adherence, which might be improved by point-of-care adherence monitoring with tailored counselling.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>From August 2022 to July 2023, we conducted a PrEP demonstration project with sexually active AGYW ages 16−30 years from 20 sites in South Africa, Eswatini, Kenya, Malawi, Uganda and Zambia. Participants were offered oral tenofovir-based PrEP at enrolment and followed up at 1, 3 and 6 months. PrEP adherence was assessed by a point-of-care qualitative lateral flow urine tenofovir (TFV) assay indicating PrEP use in the prior 4 days, which accompanied real-time adherence counselling that incorporated urine TFV results when testing was available (70.8% of month 1, 35.3% of month 3 and 83.9% of month 6 visits). We estimated overall adherence, correcting for missing test results, and analysed the association of having received urine TFV results at month 1 or 3 with subsequent urine TFV test positivity, using modified Poisson regression.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>Of the 3087 AGYW enrolled, the median age was 24 years (interquartile range 21−27), 75.7% were from South Africa, 2878 (93.2%) initiated PrEP at enrolment and 107 (3.5%) after enrolment. Visit retention was 92.0−96.2% for months 1, 3 and 6, and 2518 (90.1%) exited the study with a PrEP refill. Adherence, based on the point-of-care urine tenofovir test positivity rate, was estimated as 72%, 71% and 65% at months 1, 3 and 6, respectively. Women who received one prior urine TFV test had a 42% higher likelihood of a subsequent positive urine TFV test (adjusted odds ratio, OR = 1.42, 95% confidence interval, CI 1.27−1.60), and those having received two prior tests had a 67% higher likelihood (adjusted OR = 1.67; 95% CI 1.41−1.98). Observed HIV incidence was 1.38/100 person-years (95% CI 0.97−2.08).</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>Oral PrEP uptake, recent adherence and persistence were high in a multisite cohort of young African women over 6 months of follow-up. The use of a novel point-of-care tenofovir assay with tailored real-time adherence counselling was associated with increased adherence to PrEP at subsequent visits, warranting further study.</p>\n </section>\n \n <section>\n \n <h3> Clinical trials registration</h3>\n \n <p>clinicaltrials.gov NCT05746065</p>\n </section>\n </div>","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"27 12","pages":""},"PeriodicalIF":4.6000,"publicationDate":"2024-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11628190/pdf/","citationCount":"0","resultStr":"{\"title\":\"High recent PrEP adherence with point-of-care urine tenofovir testing and adherence counselling among young African women: results from the INSIGHT cohort\",\"authors\":\"Brenda Gati Mirembe, Deborah Donnell, Meighan Krows, Zinhle Zwane, Elizabeth Bukusi, Ravindre Panchia, Cheryl Louw, Noluthando Mwelase, Pearl Selepe, Melissa Senne, Logashvari Naidoo, Rachel Chihana, Margaret Kasaro, Harriet Nuwagaba-Biribonwoha, Philip Kotze, Katherine Gill, Pippa MacDonald, Alastair vanHeerden, Shannon Bosman, Manjeetha Jaggernath, Phillip du Preez, Amy Ward, Remco P. 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引用次数: 0
摘要
导言：在非洲，少女和年轻妇女（AGYW）占新感染艾滋病毒的三分之二。非洲农村妇女对口服艾滋病毒暴露前预防（PrEP）的接受程度很高，但依从性较低，这可以通过护理点依从性监测和量身定制的咨询来改善。方法：于2022年8月至2023年7月，在南非、斯威士兰、肯尼亚、马拉维、乌干达和赞比亚的20个地点开展了16-30岁性活跃的AGYW PrEP示范项目。参与者在入组时给予口服替诺福韦为基础的PrEP，并在1、3和6个月随访。通过定点定性侧流尿液替诺福韦（TFV）检测来评估PrEP依从性，该检测表明在前4天使用了PrEP，并伴有实时依从性咨询，其中包括尿液TFV检测结果（第1个月为70.8%，第3个月为35.3%，第6个月为83.9%）。我们估计了总体依从性，校正了缺失的检测结果，并使用修正泊松回归分析了在第1个月或第3个月接受尿液TFV检测结果与随后尿液TFV检测阳性的关系。结果：入组的3087例AGYW中位年龄为24岁（四分位数范围21-27岁），75.7%来自南非，2878例（93.2%）入组时开始PrEP， 107例（3.5%）入组后开始PrEP。第1、3和6个月的访问保留率为92.0-96.2%，2518人（90.1%）在补充PrEP后退出了研究。根据即时尿替诺福韦试验阳性率，依从性在第1个月、第3个月和第6个月分别为72%、71%和65%。先前接受过一次尿液TFV检查的女性随后尿液TFV检查阳性的可能性高出42%（校正优势比，OR = 1.42, 95%可信区间，CI 1.27-1.60），而先前接受过两次尿液TFV检查的女性后续尿液TFV检查阳性的可能性高出67%(校正OR = 1.67；95% ci 1.41-1.98)。观察到的HIV感染率为1.38/100人年（95% CI 0.97-2.08）。结论：在为期6个月的多地点非洲年轻女性随访中，口服PrEP的摄取、近期依从性和持久性都很高。使用一种新型的点护理替诺福韦检测和量身定制的实时依从性咨询与后续就诊时对PrEP的依从性增加有关，值得进一步研究。临床试验注册：clinicaltrials.gov NCT05746065。
High recent PrEP adherence with point-of-care urine tenofovir testing and adherence counselling among young African women: results from the INSIGHT cohort
Introduction
Adolescent girls and young women (AGYW) account for two-thirds of new HIV infections in Africa. African AGYW have had high uptake of oral HIV pre-exposure prophylaxis (PrEP) but low adherence, which might be improved by point-of-care adherence monitoring with tailored counselling.
Methods
From August 2022 to July 2023, we conducted a PrEP demonstration project with sexually active AGYW ages 16−30 years from 20 sites in South Africa, Eswatini, Kenya, Malawi, Uganda and Zambia. Participants were offered oral tenofovir-based PrEP at enrolment and followed up at 1, 3 and 6 months. PrEP adherence was assessed by a point-of-care qualitative lateral flow urine tenofovir (TFV) assay indicating PrEP use in the prior 4 days, which accompanied real-time adherence counselling that incorporated urine TFV results when testing was available (70.8% of month 1, 35.3% of month 3 and 83.9% of month 6 visits). We estimated overall adherence, correcting for missing test results, and analysed the association of having received urine TFV results at month 1 or 3 with subsequent urine TFV test positivity, using modified Poisson regression.
Results
Of the 3087 AGYW enrolled, the median age was 24 years (interquartile range 21−27), 75.7% were from South Africa, 2878 (93.2%) initiated PrEP at enrolment and 107 (3.5%) after enrolment. Visit retention was 92.0−96.2% for months 1, 3 and 6, and 2518 (90.1%) exited the study with a PrEP refill. Adherence, based on the point-of-care urine tenofovir test positivity rate, was estimated as 72%, 71% and 65% at months 1, 3 and 6, respectively. Women who received one prior urine TFV test had a 42% higher likelihood of a subsequent positive urine TFV test (adjusted odds ratio, OR = 1.42, 95% confidence interval, CI 1.27−1.60), and those having received two prior tests had a 67% higher likelihood (adjusted OR = 1.67; 95% CI 1.41−1.98). Observed HIV incidence was 1.38/100 person-years (95% CI 0.97−2.08).
Conclusions
Oral PrEP uptake, recent adherence and persistence were high in a multisite cohort of young African women over 6 months of follow-up. The use of a novel point-of-care tenofovir assay with tailored real-time adherence counselling was associated with increased adherence to PrEP at subsequent visits, warranting further study.
期刊介绍：
The Journal of the International AIDS Society (JIAS) is a peer-reviewed and Open Access journal for the generation and dissemination of evidence from a wide range of disciplines: basic and biomedical sciences; behavioural sciences; epidemiology; clinical sciences; health economics and health policy; operations research and implementation sciences; and social sciences and humanities. Submission of HIV research carried out in low- and middle-income countries is strongly encouraged.
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