Qin Chuanyu, Li Yifan, Qiu Shengyue, He Yu, Yim Vivian Wan-Cheong, Tang Shenglan, Du Heng, Gong Wenfeng, Tucker Joseph D, Tang Weiming, Lin Leesa, Smith Jennifer, Wu Dan, Li Jing
Sichuan University No 4 West China Teaching Hospital: Sichuan University West China School of Public Health.
Community Health Center.
Res Sq. 2023 May 25:rs.3.rs-2903998. doi: 10.21203/rs.3.rs-2903998/v1.
China has low human papillomavirus(HPV) vaccination rate due to lack of public funding and mistrust in domestic vaccines. This pilot study evaluated the feasibility and preliminary effectiveness of an innovative pay-it-forward strategy, which has a participant receive a subsidized vaccine and offers her an opportunity to donate to support other girls, in improving HPV vaccine uptake among 15-18-year-old adolescent girls.
A two-arm randomized controlled pilot trial was performed in one vaccination clinic in Western China. Adolescent girls (via caregivers) were invited to participate the study via online dissemination of the pilot study. Eligible ones were then randomly allocated using a sealed envelope method into standard-of-care or pay-it-forward arm in a 1:1 ratio. Pay-it-forward participants received hand-written postcard messages, a subsidized vaccine, and an opportunity to donate and (or) write postcards for future recipient girls. Standard-of-care participants self-paid for vaccines. The primary outcome was the first-dose HPV vaccine uptake, which was calculated using multivariable logistic regression, presented as crude/adjusted odds ratios (cORs/aORs) and 95% con dence intervals (CIs). Standard scales were used to assess the feasibility of the program.
A total of 100 participants (50 in each arm) were recruited from Jan 4, 2022 to Feb 18, 2022. The HPV vaccine uptake rate was 98% (49/50) in the pay-it-forward arm and 82% (41/50) in the standard-of-care arm (OR = 10.76, 95% : 1.31-88.47, = 0.027; a = 12.12, 95% : 1.37-107.29, = 0.025). The completion rate of full schedule of HPV vaccination in the two arms was 100% (49/49) and 95.1% (39/41), respectively. Of all 49 vaccinated girls in the pay-it-forward arm, 38 (77.6%) donated to support future participants, and the total donation accounted for 33.3% of prepaid subsidization. Among caregivers in the pay-it-forward arm, 97.6% (41/42) believed that this strategy was feasible.
The pilot showed feasibility and preliminary effectiveness of a pay-it-forward strategy to increase HPV vaccination rate. The high uptake rate in the standard-of-care arm is likely caused by the selection bias associated with the online dissemination approach and secured vaccine supply through the program. Further adaption of the intervention package and a population-based recruitment pathway are needed to better reflect local contexts and enhance the generalizability of the subsequent formal trial.
Chinese Clinical Trial Registry (ChiCTR), ChiCTR2200055542. Retrospectively registered on 11 January 2022, https://www.chictr.org.cn/showproj.html?proj=139738.
由于缺乏公共资金以及对国产疫苗的不信任,中国的人乳头瘤病毒(HPV)疫苗接种率较低。这项试点研究评估了一种创新的“传递爱心”策略在提高15至18岁青春期女孩HPV疫苗接种率方面的可行性和初步效果,该策略让参与者获得补贴疫苗,并为其提供一个捐赠机会以支持其他女孩。
在中国西部的一家疫苗接种诊所进行了一项双臂随机对照试验。通过在线发布试点研究邀请青春期女孩(通过监护人)参与。符合条件的女孩随后使用密封信封法以1:1的比例随机分配到标准治疗组或“传递爱心”组。“传递爱心”组的参与者收到手写明信片信息、补贴疫苗,以及一个捐赠和(或)为未来的受助女孩写明信片的机会。标准治疗组的参与者自行支付疫苗费用。主要结局是首剂HPV疫苗接种率,使用多变量逻辑回归进行计算,以粗/调整比值比(cORs/aORs)和95%置信区间(CIs)表示。使用标准量表评估该项目的可行性。
2022年1月4日至2022年2月18日共招募了100名参与者(每组50名)。“传递爱心”组的HPV疫苗接种率为98%(49/50),标准治疗组为82%(41/50)(OR = 10.76,95%:1.31 - 88.47,P = 0.027;aOR = 12.12,95%:1.37 - 107.29,P = 0.025)。两组HPV疫苗全程接种完成率分别为100%(49/49)和95.1%(39/41)。在“传递爱心”组的49名接种疫苗的女孩中,38名(77.6%)进行了捐赠以支持未来的参与者,总捐赠额占预先支付补贴的33.3%。在“传递爱心”组的监护人中,97.6%(41/42)认为该策略可行。
该试点显示了“传递爱心”策略在提高HPV疫苗接种率方面的可行性和初步效果。标准治疗组的高接种率可能是由与在线传播方法相关的选择偏倚以及通过该项目确保的疫苗供应导致的。需要进一步调整干预方案并采用基于人群的招募途径,以更好地反映当地情况并提高后续正式试验的可推广性。
中国临床试验注册中心(ChiCTR),ChiCTR2200055542。于2022年1月11日追溯注册,https://www.chictr.org.cn/showproj.html?proj=139738。