Division of Infectious Diseases, Department of Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland, United States of America.
Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.
PLoS Med. 2021 Jan 6;18(1):e1003475. doi: 10.1371/journal.pmed.1003475. eCollection 2021 Jan.
Effective implementation strategies are needed to increase engagement in HIV services in hyperendemic settings. We conducted a pragmatic cluster-randomized trial in a high-risk, highly mobile fishing community (HIV prevalence: approximately 38%) in Rakai, Uganda, to assess the impact of a community health worker-delivered, theory-based (situated Information, Motivation, and Behavior Skills), motivational interviewing-informed, and mobile phone application-supported counseling strategy called "Health Scouts" to promote engagement in HIV treatment and prevention services.
The study community was divided into 40 contiguous, randomly allocated clusters (20 intervention clusters, n = 1,054 participants at baseline; 20 control clusters, n = 1,094 participants at baseline). From September 2015 to December 2018, the Health Scouts were deployed in intervention clusters. Community-wide, cross-sectional surveys of consenting 15 to 49-year-old residents were conducted at approximately 15 months (mid-study) and at approximately 39 months (end-study) assessing the primary programmatic outcomes of self-reported linkage to HIV care, antiretroviral therapy (ART) use, and male circumcision, and the primary biologic outcome of HIV viral suppression (<400 copies/mL). Secondary outcomes included HIV testing coverage, HIV incidence, and consistent condom use. The primary intent-to-treat analysis used log-linear binomial regression with generalized estimating equation to estimate prevalence risk ratios (PRR) in the intervention versus control arm. A total of 2,533 (45% female, mean age: 31 years) and 1,903 (46% female; mean age 32 years) residents completed the mid-study and end-study surveys, respectively. At mid-study, there were no differences in outcomes between arms. At end-study, self-reported receipt of the Health Scouts intervention was 38% in the intervention arm and 23% in the control arm, suggesting moderate intervention uptake in the intervention arm and substantial contamination in the control arm. At end-study, intention-to-treat analysis found higher HIV care coverage (PRR: 1.06, 95% CI: 1.01 to 1.10, p = 0.011) and ART coverage (PRR: 1.05, 95% CI: 1.01 to 1.10, p = 0.028) among HIV-positive participants in the intervention compared with the control arm. Male circumcision coverage among all men (PRR: 1.05, 95% CI: 0.96 to 1.14, p = 0.31) and HIV viral suppression among HIV-positive participants (PRR: 1.04, 95% CI: 0.98 to 1.12, p = 0.20) were higher in the intervention arm, but differences were not statistically significant. No differences were seen in secondary outcomes. Study limitations include reliance on self-report for programmatic outcomes and substantial contamination which may have diluted estimates of effect.
A novel community health worker intervention improved HIV care and ART coverage in an HIV hyperendemic setting but did not clearly improve male circumcision coverage or HIV viral suppression. This community-based, implementation strategy may be a useful component in some settings for HIV epidemic control.
ClinicalTrials.gov NCT02556957.
需要有效的实施策略来提高在高度流行地区的艾滋病毒服务参与度。我们在乌干达拉凯的一个高危、高流动性的渔业社区(HIV 流行率:约 38%)进行了一项实用的集群随机试验,以评估由社区卫生工作者提供的、基于理论(情境信息、动机和行为技能)、基于动机访谈的、并通过移动电话应用程序支持的咨询策略“健康侦察员”对促进艾滋病毒治疗和预防服务参与的影响。
研究社区分为 40 个连续的随机分配的集群(20 个干预集群,n = 1054 名基线参与者;20 个对照集群,n = 1094 名基线参与者)。从 2015 年 9 月至 2018 年 12 月,健康侦察员在干预集群中部署。大约在 15 个月(中期研究)和 39 个月(期末研究)时,对同意的 15 至 49 岁的居民进行了社区范围的横断面调查,评估了主要的方案结果,包括自我报告的与艾滋病毒护理的联系、抗逆转录病毒治疗(ART)的使用和男性割礼,以及主要的生物学结果是艾滋病毒病毒抑制(<400 拷贝/ml)。次要结果包括艾滋病毒检测覆盖率、艾滋病毒发病率和持续使用避孕套。主要的意向治疗分析使用对数线性二项式回归和广义估计方程来估计干预组与对照组之间的患病率风险比(PRR)。共有 2533 名(45%为女性,平均年龄:31 岁)和 1903 名(46%为女性;平均年龄 32 岁)居民分别完成了中期研究和期末研究调查。在中期研究中,两组之间的结果没有差异。在期末研究中,自我报告接受健康侦察员干预的比例在干预组为 38%,在对照组为 23%,这表明干预组的干预接受度中等,对照组的干预接受度较高。在期末研究中,意向治疗分析发现,与对照组相比,艾滋病毒阳性参与者在干预组中接受艾滋病毒护理(PRR:1.06,95%CI:1.01 至 1.10,p = 0.011)和接受抗逆转录病毒治疗(PRR:1.05,95%CI:1.01 至 1.10,p = 0.028)的比例更高。所有男性中男性割礼的覆盖率(PRR:1.05,95%CI:0.96 至 1.14,p = 0.31)和艾滋病毒阳性参与者中艾滋病毒病毒抑制率(PRR:1.04,95%CI:0.98 至 1.12,p = 0.20)在干预组中较高,但差异无统计学意义。次要结果无差异。研究的局限性包括依赖于方案结果的自我报告和大量的干扰,这可能会稀释效果的估计。
一项新的社区卫生工作者干预措施提高了艾滋病毒高度流行地区的艾滋病毒护理和抗逆转录病毒治疗的覆盖率,但并未明显提高男性割礼的覆盖率或艾滋病毒病毒的抑制率。这种基于社区的实施策略可能是某些地区艾滋病毒流行控制的有用组成部分。
ClinicalTrials.gov NCT02556957。