A risk-differentiated, community-led intervention to strengthen uptake and engagement with HIV prevention and care cascades among female sex workers in Zimbabwe (AMETHIST): a cluster randomised trial.

IF 19.9 1区 医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Lancet Global Health Pub Date : 2024-09-01 DOI:10.1016/S2214-109X(24)00235-3
Frances M Cowan, Fortunate Machingura, M Sanni Ali, Sungai T Chabata, Albert Takaruza, Jeffrey Dirawo, Memory Makamba, Tsitsi Hove, Loveleen Bansi-Matharu, Primrose Matambanadzo, Maryam Shahmanesh, Joanna Busza, Richard Steen, Raymond Yekeye, Amon Mpofu, Owen Mugurungi, Andrew N Phillips, James R Hargreaves
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The aim of this study was to determine the effect of risk-differentiated, peer-led support for female sex workers in Zimbabwe on the risk of HIV acquisition and HIV transmission from sex among female sex workers.</p><p><strong>Methods: </strong>In this cluster randomised, open-label, controlled study, 22 clinics dedicated to female sex workers co-located in government health facilities throughout Zimbabwe were allocated (1:1, through restricted randomisation) to usual care or AMETHIST intervention. Usual care comprised HIV testing, pre-exposure prophylaxis (PrEP), referral to government antiretroviral therapy (ART) services, contraception, condoms, syndromic management of sexually transmitted infections, health education, legal advice, and peer support. AMETHIST added peer-led microplanning tailored to individuals' risk and participatory self-help groups. All cisgender women (aged >18 years) who had sold sex within the past 30 days and lived or worked within trial cluster areas were eligible. Intervention status was not masked to programme implementers but was masked to survey teams and laboratory staff. After 28 months, a respondent-driven sampling (RDS) survey was done in the female sex worker population around each clinic, which measured the primary outcome, the combined proportion of female sex workers in the surveyed population at risk of transmitting HIV (ie, were HIV positive, not virally suppressed, and not consistently using condoms) or at risk of acquiring HIV (ie, were HIV negative and not consistently using condoms or PrEP). We report prespecified analyses of the disaggregated proportions of female sex workers in the surveyed population at risk of either transmission or acquisition of HIV. Analyses were prespecified, RDS-weighted, and age-adjusted. This trial is registered with the Pan African Clinical Trials Registry, PACTR202007818077777.</p><p><strong>Findings: </strong>The AMETHIST intervention was started on May 15, 2019, and data were collected from June 1, 2019, until Dec 13, 2021. The RDS survey was done from Oct 18 to Dec 13, 2021, with 2137 women included in the usual care group (11 clusters) and 2131 in the AMETHIST intervention group (11 clusters) after excluding survey seeds (n=132) and women with missing key data (n=44). 1973 (46·2%) of the 4268 female sex workers surveyed were living with HIV; of these, 863 (93·5%; RDS-adjusted) of 931 women in the intervention group and 927 (88·8%) of 1042 in the usual care group were virologically suppressed. 287 (22·4%) of 1200 HIV-negative women in the intervention group and 194 (15·7%) of 1096 in the usual care group reported currently taking PrEP, of whom only two (0·4%) of 569 had protective tenofovir diphosphate concentrations in dried blood spots (>700 fmol/dried blood punch). 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Sustaining treatment and reinvigorating prevention remain crucial.</p><p><strong>Funding: </strong>The Wellcome Trust and the Bill & Melinda Gates Foundation.</p><p><strong>Translations: </strong>For the Shona and Ndebele translations of the abstract see Supplementary Materials section.</p>","PeriodicalId":48783,"journal":{"name":"Lancet Global Health","volume":"12 9","pages":"e1424-e1435"},"PeriodicalIF":19.9000,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11345450/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Lancet Global Health","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/S2214-109X(24)00235-3","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH","Score":null,"Total":0}
引用次数: 0

Abstract

Background: Female sex workers remain disproportionately affected by HIV. The aim of this study was to determine the effect of risk-differentiated, peer-led support for female sex workers in Zimbabwe on the risk of HIV acquisition and HIV transmission from sex among female sex workers.

Methods: In this cluster randomised, open-label, controlled study, 22 clinics dedicated to female sex workers co-located in government health facilities throughout Zimbabwe were allocated (1:1, through restricted randomisation) to usual care or AMETHIST intervention. Usual care comprised HIV testing, pre-exposure prophylaxis (PrEP), referral to government antiretroviral therapy (ART) services, contraception, condoms, syndromic management of sexually transmitted infections, health education, legal advice, and peer support. AMETHIST added peer-led microplanning tailored to individuals' risk and participatory self-help groups. All cisgender women (aged >18 years) who had sold sex within the past 30 days and lived or worked within trial cluster areas were eligible. Intervention status was not masked to programme implementers but was masked to survey teams and laboratory staff. After 28 months, a respondent-driven sampling (RDS) survey was done in the female sex worker population around each clinic, which measured the primary outcome, the combined proportion of female sex workers in the surveyed population at risk of transmitting HIV (ie, were HIV positive, not virally suppressed, and not consistently using condoms) or at risk of acquiring HIV (ie, were HIV negative and not consistently using condoms or PrEP). We report prespecified analyses of the disaggregated proportions of female sex workers in the surveyed population at risk of either transmission or acquisition of HIV. Analyses were prespecified, RDS-weighted, and age-adjusted. This trial is registered with the Pan African Clinical Trials Registry, PACTR202007818077777.

Findings: The AMETHIST intervention was started on May 15, 2019, and data were collected from June 1, 2019, until Dec 13, 2021. The RDS survey was done from Oct 18 to Dec 13, 2021, with 2137 women included in the usual care group (11 clusters) and 2131 in the AMETHIST intervention group (11 clusters) after excluding survey seeds (n=132) and women with missing key data (n=44). 1973 (46·2%) of the 4268 female sex workers surveyed were living with HIV; of these, 863 (93·5%; RDS-adjusted) of 931 women in the intervention group and 927 (88·8%) of 1042 in the usual care group were virologically suppressed. 287 (22·4%) of 1200 HIV-negative women in the intervention group and 194 (15·7%) of 1096 in the usual care group reported currently taking PrEP, of whom only two (0·4%) of 569 had protective tenofovir diphosphate concentrations in dried blood spots (>700 fmol/dried blood punch). There was no effect of the intervention on the primary endpoint of risk of both HIV transmission and acquisition (intervention group n=1156/2131, RDS-adjusted proportion 55·3%; usual care group n=1104/2137, RDS-adjusted proportion 52·7%; age-adjusted risk difference -0·9%, 95% CI -5·7% to 3·9%, p=0·70). For the secondary outcomes, the proportion of women living with HIV at risk of transmission was low and significantly reduced in the intervention group (n=63/931, RDS-adjusted proportion 5·8%) compared with the usual care group (103/1041, 10·4%), with an age-adjusted risk difference of -5·5% (95% CI -8·2% to -2·9%, p=0·0003). Risk of acquisition among HIV-negative women was similar in the intervention (n=1093/1200, RDS-adjusted proportion 92·1%) and the usual care group (1001/1096, 92·2%), with an age-adjusted risk difference of -0·6% (95% CI -4·6 to 3·4, p=0·74).

Interpretation: There was no overall benefit of the intervention on combined risk of transmission or acquisition. Viral load suppression in women living with HIV was high and appeared to be further improved by AMETHIST, suggesting potential for impressive uptake and adherence to ART in vulnerable and mobile populations. Sustaining treatment and reinvigorating prevention remain crucial.

Funding: The Wellcome Trust and the Bill & Melinda Gates Foundation.

Translations: For the Shona and Ndebele translations of the abstract see Supplementary Materials section.

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以社区为主导的风险区分干预措施,旨在加强津巴布韦女性性工作者对艾滋病预防和护理级联的吸收和参与(AMETHIST):分组随机试验。
背景:女性性工作者受 HIV 感染的比例仍然过高。本研究旨在确定在津巴布韦为女性性工作者提供有风险区分的同伴支持对女性性工作者感染 HIV 和通过性行为传播 HIV 风险的影响:在这项分组随机、开放标签、对照研究中,津巴布韦各地政府医疗机构中的 22 家女性性工作者专用诊所被分配(1:1,通过限制性随机分配)接受常规护理或 AMETHIST 干预。常规护理包括 HIV 检测、暴露前预防 (PrEP)、政府抗逆转录病毒疗法 (ART) 服务转介、避孕、安全套、性传播感染综合症管理、健康教育、法律咨询和同伴支持。AMETHIST 增加了针对个人风险的同伴引导式微型规划和参与式自助小组。所有在过去 30 天内卖过性,并在试验群组地区内居住或工作的顺性别女性(年龄大于 18 岁)都符合条件。计划实施者不会被告知干预情况,但调查小组和实验室工作人员会被告知干预情况。28 个月后,我们对每个诊所周围的女性性工作者人群进行了受访者驱动的抽样调查(RDS),该调查测量了主要结果,即调查人群中存在传播 HIV 风险(即 HIV 阳性、病毒未被抑制且未坚持使用安全套)或存在感染 HIV 风险(即 HIV 阴性且未坚持使用安全套或 PrEP)的女性性工作者的综合比例。我们报告了对调查人群中存在传播或感染 HIV 风险的女性性工作者比例进行的预设分析。分析经过预设、RDS 加权和年龄调整。该试验已在泛非临床试验注册中心(PACTR202007818077777)注册:AMETHIST干预于2019年5月15日开始,数据收集时间为2019年6月1日至2021年12月13日。RDS调查于2021年10月18日至12月13日进行,在排除调查种子选手(n=132)和关键数据缺失的妇女(n=44)后,2137名妇女被纳入常规护理组(11个群组),2131名妇女被纳入AMETHIST干预组(11个群组)。在接受调查的 4268 名女性性工作者中,1973 人(46-2%)感染了艾滋病毒;其中,干预组 931 名女性中的 863 人(93-5%;RDS 调整后)和常规护理组 1042 名女性中的 927 人(88-8%)病毒得到抑制。在干预组的 1200 名 HIV 阴性女性中,有 287 人(22-4%)、在常规护理组的 1096 人中,有 194 人(15-7%)表示目前正在服用 PrEP,其中 569 人中只有 2 人(0-4%)的干血斑中存在保护性的二磷酸替诺福韦浓度(>700 fmol/干血冲)。干预措施对艾滋病毒传播和感染风险的主要终点没有影响(干预组 n=1156/2131,RDS 调整后比例为 55-3%;常规护理组 n=1104/2137,RDS 调整后比例为 52-7%;年龄调整后风险差异为 -0-9%,95% CI -5-7%至 3-9%,p=0-70)。在次要结果方面,与常规护理组(103/1041,10-4%)相比,干预组(n=63/931,RDS 调整后比例为 5-8%)中有传播风险的女性 HIV 感染者比例较低且显著减少,年龄调整后的风险差异为 -5-5%(95% CI -8-2% 至 -2-9%,p=0-0003)。干预组(n=1093/1200,RDS调整后比例为92-1%)和常规护理组(1001/1096,92-2%)中HIV阴性女性的感染风险相似,年龄调整后的风险差异为-0-6%(95% CI -4-6至3-4,p=0-74):解释:干预措施对传播或感染的综合风险没有总体益处。感染艾滋病病毒的妇女的病毒载量抑制率很高,AMETHIST似乎进一步改善了这一情况,这表明在易感人群和流动人群中,抗逆转录病毒疗法的接受率和坚持率有可能大幅提高。持续治疗和重振预防仍然至关重要:资金来源:惠康信托基金会和比尔及梅琳达-盖茨基金会:摘要的绍纳语和恩代贝勒语译文见补充材料部分。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Lancet Global Health
Lancet Global Health PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH-
CiteScore
44.10
自引率
1.20%
发文量
763
审稿时长
10 weeks
期刊介绍: The Lancet Global Health is an online publication that releases monthly open access (subscription-free) issues.Each issue includes original research, commentary, and correspondence.In addition to this, the publication also provides regular blog posts. The main focus of The Lancet Global Health is on disadvantaged populations, which can include both entire economic regions and marginalized groups within prosperous nations.The publication prefers to cover topics related to reproductive, maternal, neonatal, child, and adolescent health; infectious diseases (including neglected tropical diseases); non-communicable diseases; mental health; the global health workforce; health systems; surgery; and health policy.
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