Direct provision versus facility collection of HIV self-tests among female sex workers in Uganda: A cluster-randomized controlled health systems trial.
Direct provision versus facility collection of HIV self-tests among female sex workers in Uganda: A cluster-randomized controlled health systems trial.
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DOI：
10.1371/journal.pmed.1002458
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发表时间：
2017-11
期刊：
影响因子：
15.8
通讯作者：
Bärnighausen T
中科院分区：
文献类型：
--
作者：
Ortblad K;Kibuuka Musoke D;Ngabirano T;Nakitende A;Magoola J;Kayiira P;Taasi G;Barresi LG;Haberer JE;McConnell MA;Oldenburg CE;Bärnighausen T
艾滋病毒自检允许在任何地点和时间进行艾滋病毒检测，无需卫生工作者。因此，艾滋病毒自我检测可能对女性性工作者特别有用，她们应该经常进行检测，但在获得医疗保健设施时面临耻辱以及经济和时间障碍。我们在乌干达坎帕拉的FSWs中进行了一项集群随机对照卫生系统试验，以衡量两种艾滋病毒自我检测交付模式对艾滋病毒检测的影响及其与护理结果的联系。FSW同伴教育者组（1名同伴教育者和8名参与者）被随机分为(1)直接提供艾滋病毒自检，(2)在医疗机构提供免费收集艾滋病毒自检的优惠券，或(3)标准护理艾滋病毒检测。2016年10月18日至11月16日，我们将960名参与者随机分为120个同伴教育小组。参与者的中位年龄为28岁（IQR 24-32）。我们预先指定的主要结果是在1个月和4个月时自我报告任何艾滋病毒检测；我们预先设定的次要结局是自我报告HIV自检使用情况、寻求HIV相关医疗护理和开始抗逆转录病毒治疗。此外，我们分析了2个没有预先指定的次要结果：重复HIV检测的自我报告——了解对频繁检测的干预效果——和基于设施的自我报告——量化替代效应。与标准护理组相比，直接提供组的参与者在1个月时（风险比[RR] 1.33, 95% CI 1.17-1.51, p < 0.001）和4个月时（RR 1.14, 95% CI 1.07-1.22, p < 0.001）接受艾滋病毒检测的可能性明显更高。直接供应组的参与者在1个月（RR 1.18, 95% CI 1.07-1.31, p = 0.001）和4个月（RR 1.03, 95% CI 1.01-1.05, p = 0.02）进行HIV检测的可能性也明显高于设施收集组。在1个月时，干预组的参与者因艾滋病毒寻求医疗护理的人数少于标准护理组，但这些差异并不显著，并且在4个月时减小了幅度。各研究组在ART起始治疗方面没有统计学上的显著差异。在4个月时，直接供应组的参与者比标准护理组（RR 1.51, 95% CI 1.29-1.77, p < 0.001）和设施收集组（RR 1.22, 95% CI 1.08-1.37, p = 0.001）的参与者更有可能进行两次艾滋病毒检测。艾滋病毒自我检测组的参与者几乎完全用自我检测取代了基于设施的检测。报告了两种与HIV自检相关的不良事件：人际暴力和精神痛苦。研究的局限性包括自我报告的结果，以及在类似环境下FSWs之外有限的推广。在这项研究中，HIV自我检测似乎是安全的，并且在fsw中增加了最近和重复的HIV检测。我们发现，直接提供艾滋病毒自检比被动提供艾滋病毒自检在医疗机构收集更有效地增加了fsw的艾滋病毒检测。艾滋病毒自我检测可以在支持需要经常进行艾滋病毒检测的艾滋病毒干预措施方面发挥重要作用，例如艾滋病毒治疗作为预防、改变行为以减少传播和接触前预防。在一项群体随机试验中，Katrina Ortblad及其同事研究了乌干达女性性工作者艾滋病毒自我检测的提供情况。艾滋病毒自检可以增加艾滋病毒检测的便利性和隐私性，因为它允许个人在他们选择的任何时间和地点进行艾滋病毒检测，而且没有其他人在场。许多撒哈拉以南非洲国家的政府正在考虑为女服务员进行艾滋病毒自我检测，但几乎没有证据表明这一人群中艾滋病毒自我检测的实施、接受和效果。我们以1:1:1的比例随机将960名FSWs分为120个同伴教育组(1)直接提供艾滋病毒自检，(2)在医疗机构提供免费收集艾滋病毒自检的优惠券，以及(3)基于护理机构的标准艾滋病毒检测服务。参与者在随机分组后不久接受了1次HIV自检（在直接供应组）或1次优惠券（在设施收集组），3个月后再次接受。与设施收集组和标准护理组相比，直接供应组的任何近期艾滋病毒检测（1个月和4个月）和重复艾滋病毒检测（4个月）明显更高。干预部门的社会福利机构几乎完全取代了以设施为基础的艾滋病毒检测。干预组在1个月时寻求艾滋病毒相关医疗服务的妇女比标准护理组少；然而，这种差异在4个月后消失。艾滋病毒自我检测似乎是安全的，在乌干达的性工作者中增加了最近和重复的艾滋病毒检测。主动直接为女工提供爱滋病病毒自检，比被动提供免费爱滋病病毒自检券（可在医疗机构收集爱滋病病毒自检券）更有效。几乎所有能够获得艾滋病毒自我检测的女服务员都使用这种新的检测技术，而不是基于设施的艾滋病毒检测。在家庭和其他私人场所（而不是在医疗机构）进行自我检测可能会在短期内减少与护理的联系。撒哈拉以南非洲各国政府应该考虑为家庭妇女进行艾滋病毒自我检测，但要确保通过加强联系的干预措施提供这种检测。在可能的情况下，政府应采用主动的艾滋病毒自我检测模式（直接向女服务员提供艾滋病毒自我检测），而不是被动的模式（要求女服务员在医疗机构收集自我检测）。
HIV self-testing allows HIV testing at any place and time and without health workers. HIV self-testing may thus be particularly useful for female sex workers (FSWs), who should test frequently but face stigma and financial and time barriers when accessing healthcare facilities. We conducted a cluster-randomized controlled health systems trial among FSWs in Kampala, Uganda, to measure the effect of 2 HIV self-testing delivery models on HIV testing and linkage to care outcomes. FSW peer educator groups (1 peer educator and 8 participants) were randomized to either (1) direct provision of HIV self-tests, (2) provision of coupons for free collection of HIV self-tests in a healthcare facility, or (3) standard of care HIV testing. We randomized 960 participants in 120 peer educator groups from October 18, 2016, to November 16, 2016. Participants’ median age was 28 years (IQR 24–32). Our prespecified primary outcomes were self-report of any HIV testing at 1 month and at 4 months; our prespecified secondary outcomes were self-report of HIV self-test use, seeking HIV-related medical care and ART initiation. In addition, we analyzed 2 secondary outcomes that were not prespecified: self-report of repeat HIV testing—to understand the intervention effects on frequent testing—and self-reported facility-based testing—to quantify substitution effects. Participants in the direct provision arm were significantly more likely to have tested for HIV than those in the standard of care arm, both at 1 month (risk ratio [RR] 1.33, 95% CI 1.17–1.51, p < 0.001) and at 4 months (RR 1.14, 95% CI 1.07–1.22, p < 0.001). Participants in the direct provision arm were also significantly more likely to have tested for HIV than those in the facility collection arm, both at 1 month (RR 1.18, 95% CI 1.07–1.31, p = 0.001) and at 4 months (RR 1.03, 95% CI 1.01–1.05, p = 0.02). At 1 month, fewer participants in the intervention arms had sought medical care for HIV than in the standard of care arm, but these differences were not significant and were reduced in magnitude at 4 months. There were no statistically significant differences in ART initiation across study arms. At 4 months, participants in the direct provision arm were significantly more likely to have tested twice for HIV than those in the standard of care arm (RR 1.51, 95% CI 1.29–1.77, p < 0.001) and those in the facility collection arm (RR 1.22, 95% CI 1.08–1.37, p = 0.001). Participants in the HIV self-testing arms almost completely replaced facility-based testing with self-testing. Two adverse events related to HIV self-testing were reported: interpersonal violence and mental distress. Study limitations included self-reported outcomes and limited generalizability beyond FSWs in similar settings. In this study, HIV self-testing appeared to be safe and increased recent and repeat HIV testing among FSWs. We found that direct provision of HIV self-tests was significantly more effective in increasing HIV testing among FSWs than passively offering HIV self-tests for collection in healthcare facilities. HIV self-testing could play an important role in supporting HIV interventions that require frequent HIV testing, such as HIV treatment as prevention, behavior change for transmission reduction, and pre-exposure prophylaxis. ClinicalTrials.gov NCT02846402 In a cluster-randomized trial, Katrina Ortblad and colleagues study the provision of HIV self-tests for female sex workers in Uganda. HIV self-testing can increase the convenience and privacy of HIV testing because it allows individuals to test for HIV at any time and place they choose and without the presence of another person. Many sub-Saharan governments are considering HIV self-testing for FSWs, but little evidence exists on the delivery, uptake, and effects of HIV self-testing among members of this population. We randomized 960 FSWs in 120 peer educator groups 1:1:1 to (1) direct provision of HIV self-tests, (2) provision of a coupon for free collection of HIV self-tests in a healthcare facility, and (3) standard of care facility-based HIV testing services. Participants received 1 HIV self-test (in the direct provision arm) or 1 coupon (in the facility collection arm) shortly after randomization and again 3 months later. Any recent HIV testing (at 1 month and at 4 months) and repeat HIV testing (at 4 months) was significantly greater in the direct provision arm compared to the facility collection arm and the standard of care arm. FSWs in the intervention arms almost completely substituted HIV self-testing for facility-based HIV testing. Fewer FSWs in the interventions arms sought HIV-related medical care than those in the standard of care arm at 1 month; however, this difference disappeared by 4 months. HIV self-testing appears to be safe and increases recent and repeat HIV testing among FSW in Uganda. The active approach to directly provide HIV self-tests to FSWs is more effective in increasing HIV testing than the passive approach to offer free access to HIV self-tests via coupons that can be used to collect self-tests in healthcare facilities. Almost all FSWs who had access to HIV self-testing used this new testing technology instead of facility-based HIV testing. It is possible that self-testing in homes and other private locations (rather than in healthcare facilities) may reduce linkage to care in the short term. Sub-Saharan African governments should consider HIV self-testing for FSWs but ensure it is delivered with linkage-enhancing interventions. Where possible, governments should introduce active HIV self-testing models (delivering HIV self-tests directly to FSWs) rather than passive models (requiring FSWs to collect self-tests in healthcare facilities).
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