South African Medical Research Council, Gender and Health Research Unit, Cape Town, South Africa.
University of KwaZulu Natal School of Health Science, Durban, South Africa.
Trials. 2021 Dec 11;22(1):897. doi: 10.1186/s13063-021-05792-7.
HIV is one of the greatest public health challenges in South Africa. Potential HIV vaccines and antibodies are thought to be cost-effective biomedical HIV prevention methods and are currently under investigation in phase I, II, and III trials. Consequently, current and future clinical trials need to ensure sufficient recruitment and retention. To achieve this goal, clinical trial staff need to understand the socio-demographic and behavioural characteristics of people volunteering to screen for these trials and their reasons for volunteering.
We conducted a secondary analysis of participant screening data across five vaccine and monoclonal antibody trials at four sites in KwaZulu-Natal, South Africa. Our study reviewed the demographic, behavioural, motivational, and health-related data from the case report forms and screening questionnaires. Descriptive statistics, chi-squared, and one-way ANOVA tests were used to analyse participants' characteristics and motivation to participate in HIV vaccine and monoclonal antibody trials. Analyses were conducted using R version 3.5.2.
Screening data from 1934 participants, including 79.2% of women, were obtained across all five trials (1034 enrolled, 900 screened out/declined). Screened participants predominately self-identified as black, heterosexual, cisgender women or men, many with lower educational backgrounds (43.9% did not complete secondary/high school), and several self-reported HIV-risk behaviours among themselves and their partners. 10.8% of the screened participants were living with HIV. Avoiding HIV risk was the main motivation to participate in clinical trials, followed by altruistic reasons such as a desire to help the community or helping to find a vaccine.
The current recruitment approach of these trials attracts heterosexual participants who seek to reduce HIV risk and support their community. Hence, the data suggest the need for and potential acceptance of continued ongoing HIV prevention efforts. Current trials attract participants with lower educational levels, which may be driven by the site locations, current community mobilisation strategies and research site opening hours. The sites could consider more flexible working hours to accommodate working participants and find ways to connect participants to educational support and opportunities to upgrade education levels for the current clientele.
HVTN 100: A Safety and Immune Response Study of 2 Experimental HIV Vaccines, NCT02404311 . Registered on March 17, 2015. HVTN 111: Safety and Immune Response to a Clade C DNA HIV Vaccine, NCT02997969. Registered on December 16, 2016. HVTN 108: Evaluating the Safety and Immunogenicity of HIV Clade C DNA Vaccine and MF59- or AS01B-Adjuvanted Clade C Env Protein Vaccines in Various Combinations in Healthy, HIV-Uninfected Adults, NCT02915016. Registered on September 22, 2016. HVTN 702: Pivotal Phase 2b/3 ALVAC/Bivalent gp120/MF59 HIV Vaccine Prevention Safety and Efficacy Study in South Africa, NCT02968849. Registered on November 1, 2016. HVTN 703/HPTN 081: Evaluating the Safety and Efficacy of the VRC01 Antibody in Reducing Acquisition of HIV-1 Infection in Women, NCT02568215 . Registered on October 1, 2015.
艾滋病毒是南非面临的最大公共卫生挑战之一。潜在的艾滋病毒疫苗和抗体被认为是具有成本效益的生物医学艾滋病毒预防方法，目前正在 I 期、II 期和 III 期试验中进行研究。因此，目前和未来的临床试验需要确保有足够的招募和保留。为了实现这一目标，临床试验工作人员需要了解自愿参加这些试验的人的社会人口统计学和行为特征，以及他们自愿参加的原因。
我们对南非夸祖鲁-纳塔尔省四个地点的五项疫苗和单克隆抗体试验中的参与者筛选数据进行了二次分析。我们的研究回顾了病例报告表和筛选问卷中的人口统计学、行为、动机和与健康相关的数据。使用描述性统计、卡方检验和单因素方差分析检验了参与者的特征和参与 HIV 疫苗和单克隆抗体试验的动机。使用 R 版本 3.5.2 进行分析。
五项试验共获得了 1934 名参与者的筛选数据，其中包括 79.2%的女性（1034 名入组，900 名筛选出局/拒绝）。筛选参与者主要自我认定为黑种人、异性恋、顺性别女性或男性，许多人教育背景较低（43.9%未完成中学/高中），且许多人自述有自己和伴侣的 HIV 风险行为。10.8%的筛选参与者携带艾滋病毒。避免 HIV 风险是参与临床试验的主要动机，其次是利他主义的原因，如帮助社区或帮助寻找疫苗。
这些试验目前的招募方法吸引了寻求降低 HIV 风险和支持社区的异性恋参与者。因此，数据表明需要并可能接受持续的艾滋病毒预防工作。目前的试验吸引了教育水平较低的参与者，这可能是由地点、当前的社区动员策略和研究地点的开放时间驱动的。这些地点可以考虑更灵活的工作时间，以适应工作参与者，并寻找方法将参与者与教育支持联系起来，并为当前的客户提供升级教育水平的机会。
HVTN 100：两种实验性 HIV 疫苗的安全性和免疫应答研究，NCT02404311。于 2015 年 3 月 17 日注册。HVTN 111：评估 Clade C DNA HIV 疫苗的安全性和免疫应答，NCT02997969。于 2016 年 12 月 16 日注册。HVTN 108：评估 Clade C DNA 疫苗和 MF59 或 AS01B 佐剂 Clade C Env 蛋白疫苗在各种组合中的安全性和免疫原性，在健康、未感染 HIV 的成年人中，NCT02915016。于 2016 年 9 月 22 日注册。HVTN 702：关键 2b/3 期 ALVAC/Bivalent gp120/MF59 HIV 疫苗预防安全性和疗效研究在南非，NCT02968849。于 2016 年 11 月 1 日注册。HVTN 703/HPTN 081：评估 VRC01 抗体在降低女性中 HIV-1 感染获得的安全性和有效性，NCT02568215。于 2015 年 10 月 1 日注册。
