Mkandawire James, Ssewamala Fred M, Hahn Judith A, Mulauzi Nancy, Neilands Torsten B, Tebbetts Scott, Darbes Lynae A, Brown Derek S, Conroy Amy A
Invest in Knowledge, Zomba, Malawi.
Brown School, Washington University in St. Louis, St. Louis, Missouri, USA.
BMJ Open. 2025 Feb 10;15(2):e097247. doi: 10.1136/bmjopen-2024-097247.
Heavy alcohol use has the potential to derail progress towards UNAIDS 95-95-95 targets for countries in sub-Saharan Africa (SSA). Within couples, alcohol use is closely linked with factors such as intimate partner violence and economic insecurity and can result in poor adherence to antiretroviral therapy (ART) and HIV clinical outcomes. We hypothesise that a combined economic and relationship intervention for couples that builds on the prior success of standalone economic and relationship-strengthening interventions will be efficacious for improving HIV clinical outcomes and reducing alcohol use. The synergy of these interventions has not been assessed in SSA-specifically among people living with HIV who drink alcohol. To test this hypothesis, we will test an economic and relationship-strengthening intervention, found to be feasible and acceptable in a pilot study in Malawi. We will conduct a full-scale, randomised controlled trial (RCT) to evaluate the efficacy and cost-effectiveness of .
We will enrol 250 adult married couples having at least one partner living with HIV and reporting heavy alcohol use. There will be two arms: or an enhanced usual care control arm. Couples in the Mlambe arm will receive incentivised matched savings accounts and monthly sessions on financial literacy, relationship skills, and alcohol reduction education and counselling. Participants will be assessed at baseline, 11 months, 15 months and 20 months to examine effects on heavy alcohol use, HIV viral suppression, ART adherence and couple relationship dynamics. Study hypotheses will be tested using multilevel regression models, considering time points and treatment arms. Programmatic costs will be ascertained throughout the study and incremental cost-effectiveness ratios will be computed for each arm.
The RCT has been approved by the University of California, San Francisco (UCSF) (Human Research Protection Program; Protocol Number 23-40642), and the study has been approved by the National Health Sciences Research Committee (NHSRC; Protocol Number 24/05/4431) in Malawi. Adverse events and remedial actions will be reported to authorities both in Malawi and at UCSF. Results will be disseminated to study participants, local health officials and HIV policy makers and through presentations at conferences and publications in peer-reviewed journals.
ClinicalTrials.gov Protocol Registration; NCT06367348 registered on 19 April 2024; https://register.
gov/. Protocol Version 1.0: 22 October 2024.
大量饮酒可能会阻碍撒哈拉以南非洲（SSA）国家实现联合国艾滋病规划署的95-95-95目标。在夫妻中，饮酒与亲密伴侣暴力和经济不安全等因素密切相关，并可能导致对抗逆转录病毒疗法（ART）的依从性差以及艾滋病毒临床结果不佳。我们假设，在先前独立的经济和关系强化干预措施取得成功的基础上，针对夫妻的经济和关系联合干预措施将有助于改善艾滋病毒临床结果并减少饮酒。这些干预措施的协同作用尚未在撒哈拉以南非洲进行评估，特别是在饮酒的艾滋病毒感染者中。为了验证这一假设，我们将测试一种在马拉维的一项试点研究中被发现可行且可接受的经济和关系强化干预措施。我们将进行一项全面的随机对照试验（RCT），以评估其疗效和成本效益。
我们将招募250对成年已婚夫妇，其中至少有一方感染艾滋病毒且报告有大量饮酒行为。将有两个组：Mlambe组或强化常规护理对照组。Mlambe组的夫妻将获得激励性配对储蓄账户，并参加关于金融知识、关系技能以及减少饮酒教育和咨询的月度课程。将在基线、11个月、15个月和20个月对参与者进行评估，以检查对大量饮酒、艾滋病毒病毒抑制、ART依从性和夫妻关系动态的影响。将使用多级回归模型检验研究假设，同时考虑时间点和治疗组。在整个研究过程中确定项目成本，并计算每组的增量成本效益比。
该RCT已获得加利福尼亚大学旧金山分校（UCSF）（人类研究保护项目；协议编号23-40642）的批准，该研究也已获得马拉维国家卫生科学研究委员会（NHSRC；协议编号24/05/4431）的批准。不良事件和补救措施将向马拉维和UCSF的当局报告。研究结果将传播给研究参与者、当地卫生官员和艾滋病毒政策制定者，并通过在会议上的报告和在同行评审期刊上发表。
ClinicalTrials.gov协议注册；于2024年4月19日注册，编号为NCT06367348；https://register.
gov/。协议版本1.0：2024年10月22日。
