Gross Jessica, Tumwesigye Nazarius M, Mutembo Simon, Moyo Nkumbula, Mukose Aggrey, Chilyabanyama Obvious, Matoba Japhet, Parris KaeAnne, Lee Brianna, Churchill Taralyn, Williamson Dhelia, Pals Sherri, Biribawa Claire, Kagaayi Joseph, Ndubani Phillimon, Okello Francis, Zyambo Zude, Taasi Geoffrey, Magongo Eleanor N, Munthali Gloria, Mwiya Mwiya, Nazziwa Esther, Awor Anna C, Itoh Megumi, Boyd Adetinuke Mary, Macleod David, Rivadeneira Emilia, Oliver Daniel, Ferrand Rashida A, Stecker Carl
US Centers for Disease Control and Prevention, Global Health Center, Division of HIV and TB, Atlanta, GA, USA; US Department of State, Bureau of Global Health Security and Diplomacy, President's Emergency Plan for AIDS Relief, Washington, DC, USA; London School of Hygiene & Tropical Medicine, London, UK.
Makerere University School of Public Health, Kampala, Uganda.
Lancet HIV. 2025 May;12(5):e325-e337. doi: 10.1016/S2352-3018(25)00005-0.
During the COVID-19 pandemic, the US President's Emergency Plan for AIDS Relief supported oral caregiver-assisted HIV self-testing (CG-HIVST) to address the gap in HIV diagnosis of children. We aimed to investigate caregiver uptake, results return, acceptability, and potential social harms of CG-HIVST.
This prospective, interventional, study was done at 32 health facilities in Uganda and 15 health facilities in Zambia. Caregivers aged 18 years and older (plus emancipated minors aged 15-17 years in Uganda) living with HIV who were currently accessing HIV care and considered index cases, with no positive responses to an intimate partner violence screen, and with one or more children aged 18 months to 14 years with unknown HIV status were eligible to participate. Eligible caregivers were offered oral HIVST kits to screen their children and primary outcomes were described by caregiver and child characteristics. Following HIVST kit administration, caregivers were surveyed using a standardised questionnaire to document their perceptions, adverse events, and social harm. Primary outcomes were the uptake of HIVST and the number and proportion of returned screening test results, reactive results, reactive screens with confirmatory HIV testing, confirmatory testing with a positive result, and children who were confirmed HIV-positive who were linked to treatment. This study was registered with ClinicalTrials.gov, NCT04774666 and NCT04754386, and is completed.
From Feb 1 to Oct 31, 2021, 12 998 interested caregivers were screened for eligibility, 4023 of whom were eligible. 3903 (97·0%) accepted HIVST kits to screen their child for HIV (1609 [41·2%] in Zambia and 2294 [58·8%] in Uganda). Among caregivers, 3094 (79·3%) of 3903 were female, and 809 (20·7%) were male. 7601 children were enrolled (3779 [49·7%] were female and 3822 [50·3%] were male). 4766 (97·9%) of 4866 test results were returned in Uganda and 2647 (96·8%) of 2735 in Zambia. 119 (1·6%) of 7413 children had reactive HIVST results, requiring confirmatory testing. Of 116 children with confirmatory testing, 43 were confirmed HIV-positive (HIV prevalence 0·7% [n=32] in Uganda and 0·4% [n=11] in Zambia) and 100% were linked to antiretroviral therapy. Adverse events were rare (11 [0·4%] of 2720) and minor, and there were no reports of social harm or violence. Caregivers surveyed reported the HIVST kit was easy to use (2637 [97·0%] of 2718), they would use it again (2650 [99·1%] of 2674), and they would recommend it to other parents (2615 [97·8%] of 2674).
Our findings suggest that oral CG-HIVST is acceptable, feasible, and safe, with no reports of social harm, and has the potential to expand access to HIV testing for children while reducing the service delivery burden on health facilities.
US President's Emergency Plan for AIDS Relief and Wellcome Trust.
在新冠疫情期间，美国总统艾滋病紧急救援计划支持由照料者协助的口服式艾滋病毒自我检测（CG-HIVST），以填补儿童艾滋病毒诊断方面的空白。我们旨在调查照料者对CG-HIVST的接受情况、检测结果反馈情况、可接受性以及潜在的社会危害。
这项前瞻性干预研究在乌干达的32个医疗机构和赞比亚的15个医疗机构开展。年龄在18岁及以上（在乌干达还包括15至17岁的独立未成年人）且感染艾滋病毒、正在接受艾滋病毒护理并被视为索引病例、对亲密伴侣暴力筛查无阳性反应、有一名或多名年龄在18个月至14岁且艾滋病毒感染状况未知的儿童的照料者有资格参与。为符合条件的照料者提供口服艾滋病毒自我检测试剂盒以筛查其子女，并根据照料者和儿童特征描述主要结果。在发放艾滋病毒自我检测试剂盒后，使用标准化问卷对照料者进行调查，以记录他们的看法、不良事件和社会危害。主要结果包括艾滋病毒自我检测的接受情况、返回的筛查检测结果数量及比例、反应性结果、进行确证艾滋病毒检测的反应性筛查、确证检测呈阳性结果以及被确证艾滋病毒呈阳性并与治疗建立联系的儿童。本研究已在ClinicalTrials.gov注册，注册号为NCT04774666和NCT04754386，现已完成。
2021年2月1日至10月31日，对12998名感兴趣的照料者进行了资格筛查，其中4023人符合条件。3903人（97.0%）接受了艾滋病毒自我检测试剂盒以筛查其子女（赞比亚1609人[41.2%]，乌干达2294人[58.8%]）。在照料者中，3903人中有3094人（79.3%）为女性，809人（20.7%）为男性。共纳入7601名儿童（3779名[49.7%]为女性，3822名[50.3%]为男性）。乌干达4866份检测结果中的4766份（97.9%）和赞比亚2735份检测结果中的2647份（96.8%）得到了反馈。7413名儿童中有119名（1.6%）艾滋病毒自我检测结果呈反应性，需要进行确证检测。在116名接受确证检测的儿童中，43名被确证艾滋病毒呈阳性（乌干达艾滋病毒感染率为0.7%[n = 3
