School of Public Health, University of Zambia, Lusaka, Zambia.
School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Lancet Glob Health. 2021 Dec;9(12):e1719-e1729. doi: 10.1016/S2214-109X(21)00393-4. Epub 2021 Nov 1.
BACKGROUND: Testing men for HIV during their partner's pregnancy can guide couples-based HIV prevention and treatment, but testing rates remain low. We investigated a combination approach, using evidence-based strategies, to increase HIV testing in male partners of HIV-positive and HIV-negative pregnant women. METHODS: We did two parallel, unmasked randomised trials, enrolling pregnant women who had an HIV-positive test result documented in their antenatal record (trial 1) and women who had an HIV-negative test result documented in their antenatal record (trial 2) from an antenatal setting in Lusaka, Zambia. Women in both trials were randomly assigned (1:1) to the intervention or control groups using permuted block randomisation. The control groups received partner notification services only, including an adapted version for women who were HIV-negative; the intervention groups additionally received targeted education on the use of oral HIV self-test kits for their partners, along with up to five oral HIV self-test kits. At the 30 day follow-up we collected information from pregnant women about their primary male partner's HIV testing in the previous 30 days at health-care facilities, at home, or at any other facility. Our primary outcome was reported male partner testing at a health facility within 30 days following randomisation using a complete-case approach. Women also reported male partner HIV testing of any kind (including self-testing at home) that occurred within 30 days. Randomisation groups were compared via probability difference with a corresponding Wald-based 95% CI. The trial is registered at ClinicalTrials.gov (NCT04124536) and all enrolment and follow-up has been completed. FINDINGS: From Oct 28, 2019, to May 26, 2020, 116 women who were HIV-positive (trial 1) and 210 women who were HIV-negative (trial 2) were enrolled and randomly assigned to study groups. Retention at 30 days was 100 (86%) in trial 1 and 200 (95%) in trial 2. Women in the intervention group were less likely to report facility-based male partner HIV testing in trial 1 (3 [6%] of 47 vs 15 [28%] of 53, estimated probability difference -21·9% [95% CI -35·9 to -7·9%]) and trial 2 (3 [3%] of 102 vs 33 [34%] of 98, estimated probability difference -30·7% [95% CI -40·6 to -20·8]). However, reported male partner HIV testing of any kind was higher in the intervention group than in the control group in trial 1 (36 [77%] of 47 vs 19 [36%] of 53, estimated probability difference 40·7% [95% CI 23·0 to 58·4%]) and trial 2 (80 [78%] of 102 vs 54 [55%] of 98, estimated probability difference 23·3% [95% CI 10·7 to 36·0%]) due to increased use of HIV self-testing. Overall, 14 male partners tested HIV-positive. Across the two trials, three cases of intimate partner violence were reported (two in the control groups and one in the intervention groups). INTERPRETATION: Our combination approach increased overall HIV testing in male partners of pregnant women but reduced the proportion of men who sought follow-up facility-based testing. This combination approach might reduce linkages to health care, including for HIV prevention, and should be considered in the design of comprehensive HIV programmes. FUNDING: National Institutes of Health.
背景:在伴侣怀孕期间对男性进行 HIV 检测可以指导基于伴侣的 HIV 预防和治疗,但检测率仍然很低。我们研究了一种组合方法,使用基于证据的策略,增加 HIV 阳性和 HIV 阴性孕妇的男性伴侣的 HIV 检测率。
方法:我们进行了两项平行、不设盲的随机试验,招募了在产前记录中记录 HIV 阳性检测结果的孕妇(试验 1)和在产前记录中记录 HIV 阴性检测结果的孕妇(试验 2),来自赞比亚卢萨卡的产前环境。这两项试验中的女性被随机分配(1:1)到干预组或对照组,使用置换块随机化。对照组仅接受伴侣通知服务,包括针对 HIV 阴性女性的改编版本;干预组还接受了关于使用口腔 HIV 自我检测试剂盒的针对性教育,最多提供五个口腔 HIV 自我检测试剂盒。在 30 天随访时,我们从孕妇那里收集了她们的主要男性伴侣在过去 30 天内在医疗机构、家中或任何其他场所进行 HIV 检测的信息。我们的主要结果是使用完整病例方法报告随机分组后 30 天内在医疗机构进行的男性伴侣检测。女性还报告了在 30 天内进行的任何类型的男性伴侣 HIV 检测(包括在家中进行的自我检测)。通过概率差与基于 Wald 的 95%置信区间(CI)比较随机分组。该试验在 ClinicalTrials.gov(NCT04124536)注册,所有入组和随访均已完成。
发现:从 2019 年 10 月 28 日至 2020 年 5 月 26 日,116 名 HIV 阳性(试验 1)和 210 名 HIV 阴性(试验 2)的女性被招募并随机分配到研究组。试验 1 的 30 天保留率为 100%(86%),试验 2 的保留率为 200%(95%)。干预组的女性更不可能报告医疗机构的男性伴侣 HIV 检测,在试验 1 中(3[6%]例 47 名 vs. 15[28%]例 53 名,估计概率差-21.9%[95%CI-35.9 至-7.9%])和试验 2(3[3%]例 102 名 vs. 33[34%]例 98 名,估计概率差-30.7%[95%CI-40.6 至-20.8%])。然而,干预组报告的任何类型的男性伴侣 HIV 检测都高于对照组,在试验 1 中(36[77%]例 47 名 vs. 19[36%]例 53 名,估计概率差 40.7%[95%CI 23.0 至 58.4%])和试验 2(80[78%]例 102 名 vs. 54[55%]例 98 名,估计概率差 23.3%[95%CI 10.7 至 36.0%]),这是由于更多地使用了 HIV 自我检测。总体而言,有 14 名男性伴侣检测出 HIV 阳性。在这两项试验中,报告了三起亲密伴侣暴力案件(对照组两起,干预组一起)。
解释:我们的组合方法增加了孕妇男性伴侣的整体 HIV 检测率,但减少了寻求后续医疗机构检测的男性比例。这种组合方法可能会减少与保健的联系,包括预防 HIV 的联系,在设计综合 HIV 方案时应予以考虑。
资助:美国国立卫生研究院。
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