Biomedical, female-initiated HIV prevention methods can help reduce disproportionately high HIV rates among women in sub-Saharan Africa, but male partner resistance and intimate partner violence (IPV) may impact ability to ensure effective use. To support consistent use of the dapivirine vaginal ring (VR), we pilot-tested the impact of the CHARISMA relationship counseling intervention ("CHARISMA") with women enrolled in the multi-site open-label Microbicide Trials Network (MTN) 025/HOPE trial at the Wits Reproductive Health and HIV Research Institute (Wits RHI) site in Johannesburg, South Africa. Lay counselors used a 42-item tool with five subscales to assess relationships and IPV and provide tailored counseling at enrolment, followed by a booster counselling session at Month 1 and follow-up checks at Months 3 and 6. We evaluated potential impact by examining self-reported ring disclosure to partners, partner clinic attendance, self-reported incident social harms (SH) and IPV, and biomarkers of ring adherence at Wits RHI. We subsequently compared these outcomes at three comparator HOPE study sites using multivariable regression models. Comparator study sites were purposively selected as those most similar to Wits RHI for baseline characteristics identified a priori. At Wits RHI, 95 of 96 (99%) HOPE participants enrolled into the CHARISMA pilot study. Mean age was 30, 36.8% lived with a partner, and 85.3% received their partner's financial support. During the six months of pilot study follow-up, participants reported: ring use disclosure to partners at 72.7% visits; 4.3% partners attending the research clinic; one partner-related SH; and 9.5% experienced incident IPV. The mean level of dapivirine released from returned used rings was 3.4 mg (SD 1.56), suggesting moderate adherence. Participants in the CHARISMA pilot had high background prevalence and incidence of IPV but were nevertheless able to adhere to ring use, and some male partners came to the research clinic. In adjusted regression models, compared to Wits RHI, partner clinic attendance was lower at all comparator sites; and significantly so at Site A (aRR 0.12, 95% CI 0.00-0.98). Sites B and C had lower levels of dapivirine released (suggesting lower adherence), but this difference was not significant. Site B women were more likely to report ring disclosure to partners at FU visits (aRR 1.12, 95% CI 1.00-1.25). IPV reported during follow-up was significantly lower at Site B (aRR 0.20, 95% CI 0.04-0.98, p = 0.047). CHARISMA taught women skills to decide on levels of ring-use disclosure to partners or others; therefore it is difficult to interpret differences in ring disclosure to partners with other sites. Similarly, CHARISMA heightened participants' awareness of abuse, possibly increasing IPV reports. Testing CHARISMA under fully-powered controlled conditions will improve understanding of its impact on women's relationships and ability to use female-initiated HIV prevention methods.

中文翻译：

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将以关系为中心的咨询干预与向约翰内斯堡妇女提供用于预防艾滋病毒的 Dapivirine 环相结合：CHARISMA 试点研究的结果。

由女性发起的生物医学 HIV 预防方法可以帮助降低撒哈拉以南非洲妇女中过高的 HIV 感染率，但男性伴侣的抵抗和亲密伴侣暴力 (IPV) 可能会影响确保有效使用的能力。为了支持持续使用 dapivirine 阴道环 (VR)，我们对参加多站点开放标签杀菌剂试验网络 (MTN) 025/HOPE 的女性进行了 CHARISMA 关系咨询干预（“CHARISMA”）的影响试点测试在南非约翰内斯堡的 Wits 生殖健康和艾滋病毒研究所 (Wits RHI) 进行试验。外行辅导员使用包含 42 个项目和五个分量表的工具来评估人际关系和 IPV，并在注册时提供量身定制的咨询，随后在第 1 个月进行强化咨询，并在第 3 个月和第 6 个月进行后续检查。我们通过检查自我报告的戒指披露给合作伙伴、合作伙伴诊所出勤率、自我报告的事件社会危害 (SH) 和 IPV 以及 Wits RHI 戒指依从性的生物标志物来评估潜在影响。我们随后使用多变量回归模型在三个比较 HOPE 研究地点比较了这些结果。比较研究地点被有目的地选择为与 Wits RHI 最相似的地点，用于先验确定的基线特征。在 Wits RHI，96 名 HOPE 参与者中有 95 名 (99%) 参加了 CHARISMA 试点研究。平均年龄为 30 岁，36.8% 的人与伴侣同住，85.3% 的人得到伴侣的经济支持。在为期六个月的试点研究随访期间，参与者报告： 72.7% 的来访者向合作伙伴披露戒指使用情况；4.3% 的合作伙伴参加研究诊所；一名与合作伙伴相关的 SH；和9。5% 经历过事件 IPV。从回收的用过的戒指中释放的 dapivirine 的平均水平为 3.4 mg (SD 1.56)，表明中等依从性。CHARISMA 试点的参与者具有较高的 IPV 背景流行率和发病率，但仍然能够坚持使用戒指，并且一些男性伴侣来到研究诊所。在调整后的回归模型中，与 Wits RHI 相比，所有比较地点的合作伙伴诊所出勤率都较低；站点 A 尤其如此（aRR 0.12，95% CI 0.00-0.98）。站点 B 和 C 释放的 dapivirine 水平较低（表明依从性较低），但这种差异并不显着。Site B 女性更有可能在 FU 访问时向合作伙伴报告戒指泄露 (aRR 1.12, 95% CI 1.00-1.25)。随访期间报告的 IPV 在 B 点显着较低（aRR 0.20，95% CI 0.04-0.98，p = 0.047）。CHARISMA 教会了女性技能来决定向合作伙伴或其他人披露戒指使用的程度；因此，很难解释向其他网站的合作伙伴披露戒指的差异。同样，CHARISMA 提高了参与者对虐待的认识，可能增加了 IPV 报告。在全功率受控条件下测试 CHARISMA 将提高对其对女性关系的影响的理解以及使用女性发起的 HIV 预防方法的能力。