Alignment of PrEP adherence with periods of HIV risk among adolescent girls and young women in South Africa and Zimbabwe: a secondary analysis of the HPTN 082 randomised controlled trial.
Alignment of PrEP adherence with periods of HIV risk among adolescent girls and young women in South Africa and Zimbabwe: a secondary analysis of the HPTN 082 randomised controlled trial.
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DOI：
10.1016/s2352-3018(22)00195-3
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发表时间：
2022-10
期刊：
影响因子：
16.1
通讯作者：
Celum, Connie
中科院分区：
文献类型：
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作者：
Velloza, Jennifer;Donnell, Deborah;Hosek, Sybil;Anderson, Peter L.;Chirenje, Z. Mike;Mgodi, Nyaradzo;Bekker, Linda-Gail;Marzinke, Mark A.;Delany-Moretlwe, Sinead;Celum, Connie
非洲少女和年轻妇女（AGYW）坚持每日口服艾滋病毒暴露前预防（PrEP）的挑战。然而，使用PrEP最重要的方面是在风险期间的高依从性（“预防有效依从性”）。非洲AGYW需要了解艾滋病毒风险和PrEP使用的时间模式。HPTN 082是2016-2018年在南非和津巴布韦的AGYW（16-24岁）中进行的开放标签PrEP研究。在第13、26和52周，我们测量了干血斑中替诺福韦（TFV）-二磷酸盐（DP）浓度的累积PrEP依从性和前一周使用血浆中TFV的PrEP使用情况。行为和性传播感染数据每季度收集一次。我们根据无安全套性行为、≥1名伴侣、伴侣的HIV状态和抗逆转录病毒药物使用、性交易、性活动前后的药物或酒精使用以及实验室诊断的STI将访视分类为二元“任何HIV风险”变量。在这项方案定义的次要分析中，我们使用广义估计方程评估HIV风险（反映前三个月的行为）与累积和近期PrEP依从性（二分为TFV-DP </≥700 fmol/punch，TFV </≥40 ng/mL）以及第13、26和52周之间的任何PrEP使用（可定量药物浓度）之间的相关性。在427例AGYW中，分别有364例（85%）、226例（60%）、243例（65%）和224例（61%）在入组时以及第13、26和52周时报告了≥1个风险因素。访视时的任何HIV风险均与TFV-DP ≥700 fmol/punch（校正的相对风险[RR]：1.57; 95%置信区间[CI]：1.09-2.25）和血浆TFV ≥40 ng/mL（aRR：1.36; 95% CI：1.11-1.65）的可能性更大相关。任何风险也与可定量的TFV-DP（aRR：1.15; 95% CI：1.03-1.29）和血浆TFV（aRR：1.27; 95% CI：1.09-1.49）相关。我们观察到显着的剂量反应关系的危险因素和药物浓度之间的数量。艾滋病毒风险与PrEP依从性之间的关联表明，非洲AGYW能够在风险期间使用PrEP，这是预防有效PrEP依从性的指标。我们的研究结果支持PrEP范式的转变，以承认“预防有效的坚持”的做法，这可能会改善PrEP交付和坚持支持AGYW在艾滋病毒流行的设置。美国国立卫生研究院
African adolescent girls and young women (AGYW) have adherence challenges with daily oral HIV pre-exposure prophylaxis (PrEP). However, the most important aspect of PrEP use is high adherence during periods of risk (“prevention-effective adherence”). An understanding of temporal patterns of HIV risk and PrEP use is needed among African AGYW. HPTN 082 was an open-label PrEP study among AGYW (ages 16-24) in South Africa and Zimbabwe from 2016-2018. At Weeks 13, 26, and 52, we measured cumulative PrEP adherence with tenofovir (TFV)-diphosphate (DP) concentrations in dried blood spots and PrEP use in the prior week using TFV in plasma. Behavioral and STI data were collected quarterly. We categorized visits into a binary “any HIV risk” variable based on condomless sex, ≥1 partner, partner’s HIV status and antiretroviral use, transactional sex, drug or alcohol use around sexual activity, and laboratory-diagnosed STIs. In this protocol-defined secondary analysis, we used generalized estimating equations to evaluate associations between HIV risk (reflecting behavior during three prior months) and cumulative and recent PrEP adherence (dichotomized as TFV-DP </≥700 fmol/punch, TFV </≥40 ng/mL) and any PrEP use (quantifiable drug concentrations) in intervals between Weeks 13, 26, and 52. Among 427 AGYW, 364 (85%), 226 (60%), 243 (65%), and 224 (61%) reported ≥1 risk factor at enrollment and weeks 13, 26, and 52, respectively. Any HIV risk at the visit was associated with greater likelihood of TFV-DP ≥700 fmol/punch (adjusted relative risk [RR]:1.57; 95% confidence interval [CI]: 1.09-2.25) and plasma TFV ≥40 ng/mL (aRR:1.36; 95% CI: 1.11-1.65). Any risk was also associated with quantifiable TFV-DP (aRR:1.15; 95% CI: 1.03-1.29) and plasma TFV (aRR:1.27; 95% CI: 1.09-1.49). We observed significant dose-response relationships between number of risk factors and drug concentrations. The association between HIV risk and PrEP adherence indicates that African AGYW were able to use PrEP during periods of risk, an indicator of prevention-effective PrEP adherence. Our findings support a shift in the PrEP paradigm to acknowledge “prevention-effective adherence” practices, which may improve PrEP delivery and adherence support for AGYW in HIV endemic settings. US NIH