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.
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.
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.
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).
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.
National Institutes of Health.
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。
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。
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）。
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。
美国国立卫生研究院。
