Dzinamarira Tafadzwa, Muvunyi Claude Mambo, Mashamba-Thompson Tivani Phosa
Department of Public Health Medicine, School of Nursing and Public Health, University of KwaZulu-Natal, Durban, 4001, South Africa.
College of Medicine and Health Sciences, University of Rwanda, Kigali, Rwanda.
Pilot Feasibility Stud. 2021 Nov 12;7(1):202. doi: 10.1186/s40814-021-00940-x.
Health education interventions tailored to suit men have the potential to improve health outcomes for this underserved population. HIV self-testing (HIVST) is a promising approach to overcoming challenges associated with low HIV testing rates among men. The primary objective of this study is to assess the feasibility of conducting a definitive trial to determine the effectiveness of a locally adapted and optimized health education program (HEP) on the uptake of HIVST among men in Kigali, Rwanda.
This study employs a pilot pragmatic randomized controlled trial to evaluate an HIVST HEP for men. Participants were randomized to the intervention (HEP) arm or to the control arm. In the intervention group, the adapted HEP was administered in addition to routine health education. In the non-intervention group, only routine health education was offered. Participant data was collected first upon recruitment and then after 3 months' follow-up using interviewer-administered questionnaires.
There was a 100% response rate at enrollment and no loss to follow-up at exit. There was significant association between the study arm and knowledge of HIVST. Participants in the control arm had a mean knowledge score of 67% compared to 92% among participants in the intervention arm. There was an association between the study arm and HIVST uptake: 67% of the study participants in the intervention arm self-reported HIVST uptake compared to 23% of the participants in the control arm.
This pilot study demonstrates the feasibility of a larger trial to assess the effectiveness of an HEP intervention on uptake of HIVST among men. We found preliminary evidence of increased uptake of HIVST in the intervention group.
Pan African Clinical Trial Registry PACTR201908758321490 . Registered on 8 August 2019.
针对男性量身定制的健康教育干预措施,有可能改善这一服务不足人群的健康状况。艾滋病毒自我检测(HIVST)是克服男性艾滋病毒检测率低相关挑战的一种有前景的方法。本研究的主要目的是评估开展一项确定性试验的可行性,以确定在卢旺达基加利对男性采用本地化调整和优化的健康教育项目(HEP)对艾滋病毒自我检测接受情况的有效性。
本研究采用试点实用随机对照试验来评估针对男性的艾滋病毒自我检测健康教育项目。参与者被随机分配到干预组(HEP)或对照组。在干预组中,除常规健康教育外还实施调整后的HEP。在非干预组中,仅提供常规健康教育。参与者数据在招募时首次收集,然后在3个月随访后通过访谈员管理的问卷收集。
入组时的应答率为100%,随访结束时无失访情况。研究分组与艾滋病毒自我检测知识之间存在显著关联。对照组参与者的平均知识得分是67%,而干预组参与者为92%。研究分组与艾滋病毒自我检测接受情况之间存在关联:干预组67%的研究参与者自我报告接受了艾滋病毒自我检测,而对照组为23%。
这项试点研究证明了开展一项更大规模试验以评估健康教育项目干预对男性艾滋病毒自我检测接受情况有效性的可行性。我们发现了干预组艾滋病毒自我检测接受情况增加的初步证据。
泛非临床试验注册中心PACTR201908758321490。于2019年8月8日注册。