Gati Mirembe Brenda, Donnell Deborah, Krows Meighan, Zwane Zinhle, Bukusi Elizabeth, Panchia Ravindre, Louw Cheryl, Mwelase Noluthando, Selepe Pearl, Senne Melissa, Naidoo Logashvari, Chihana Rachel, Kasaro Margaret, Nuwagaba-Biribonwoha Harriet, Kotze Philip, Gill Katherine, MacDonald Pippa, vanHeerden Alastair, Bosman Shannon, Jaggernath Manjeetha, du Preez Phillip, Ward Amy, Peters Remco P H, Delany-Moretlwe Sinead, Peacock Sue, Johnson Rachel, Caucutt Jason, Morrison Susan, Wang Guohong, Gandhi Monica, Velloza Jennifer, Heffron Renee, Celum Connie
Makerere University-Johns Hopkins University, Kampala, Uganda.
Fred Hutchinson Cancer Center, Seattle, Washington, USA.
J Int AIDS Soc. 2024 Dec;27(12):e26389. doi: 10.1002/jia2.26389.
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.
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.
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).
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.
clinicaltrials.gov NCT05746065.
在非洲，青少年女孩和年轻女性（AGYW）占新增艾滋病毒感染病例的三分之二。非洲的AGYW对口服艾滋病毒暴露前预防（PrEP）的接受程度较高，但依从性较低，通过即时护理依从性监测和量身定制的咨询可能会提高依从性。
2022年8月至2023年7月，我们在南非、斯威士兰、肯尼亚、马拉维、乌干达和赞比亚的20个地点，针对16至30岁有性行为的AGYW开展了一项PrEP示范项目。参与者在入组时接受基于替诺福韦的口服PrEP，并在第1、3和6个月进行随访。通过即时护理定性侧流尿液替诺福韦（TFV）检测评估PrEP依从性，该检测可显示前4天内是否使用了PrEP，检测时还会结合尿液TFV结果进行实时依从性咨询（第1个月检测的占70.8%，第3个月检测的占35.3%，第6个月检测的占83.9%）。我们对总体依从性进行了估计，并对缺失的检测结果进行了校正，同时使用修正泊松回归分析了在第1个月或第3个月获得尿液TFV检测结果与随后尿液TFV检测呈阳性之间的关联。
在3087名入组的AGYW中，中位年龄为24岁（四分位间距21 - 27岁），75.7%来自南非，2878名（93.2%）在入组时开始使用PrEP，107名（3.5%）在入组后开始使用。第1、3和6个月的访视留存率为92.
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