McCarthy Ona L, Aliaga Carolina, Torrico Palacios Maria Eugenia, López Gallardo Jhonny, Huaynoca Silvia, Leurent Baptiste, Edwards Phil, Palmer Melissa, Ahamed Irrfan, Free Caroline
The London School of Hygiene and Tropical Medicine, London, United Kingdom.
CIES Salud Sexual Salud Reproductiva, La Paz, Bolivia.
J Med Internet Res. 2020 Jun 22;22(6):e14073. doi: 10.2196/14073.
Although the most effective methods of contraception are available in Bolivia, unmet need for contraception among women aged 15 to 19 years is estimated to be 38% (2008), and the adolescent fertility rate is 71 per 1000 women (2016). Mobile phones are a popular mode to deliver health behavior support. We developed a contraceptive behavioral intervention for young Bolivian women delivered by mobile phone and guided by behavioral science. The intervention consists of short instant messages sent through an app over 4 months.
This trial aimed to evaluate the effect of the intervention on young Bolivian women's use of and attitudes toward the effective contraceptive methods available in Bolivia.
This was a parallel group, individually randomized superiority trial with a 1:1 allocation ratio. Women were eligible if they were aged 16 to 24 years, owned a personal Android mobile phone, lived in La Paz or El Alto, reported an unmet need for contraception, and could read Spanish. The target sample size was 1310 participants. Participants allocated to the intervention had access to an app with standard family planning information and intervention messages. Participants allocated to the control group had access to the same app and control messages. Coprimary outcomes were use of effective contraception and acceptability of at least one method of effective contraception at 4 months. Secondary outcomes were use of effective contraception during the study, acceptability of the individual methods, service uptake, unintended pregnancy, and abortion. Process outcomes included knowledge, perceived norms, personal agency, and intention. Outcomes were analyzed using logistic and linear regression. We also asked participants about physical violence.
A total of 640 participants were enrolled, and 67.0% (429) of them contributed follow-up data for the coprimary outcome, the use of effective contraception. There was no evidence that use differed between the groups (33% control vs 37% intervention; adjusted odds ratio [OR] 1.19, 95% CI 0.80 to 1.77; P=.40). There was a borderline significant effect regarding acceptability (63% control vs 72% intervention; adjusted OR 1.49, 95% CI 0.98 to 2.28; P=.06). There were no statistically significant differences in any of the secondary or process outcomes. The intervention dose received was low. In the control group, 2.8% (6/207) reported experiencing physical violence compared with 1.9% (4/202) in the intervention group (Fisher exact test P=.75).
This trial was unable to provide definitive conclusions regarding the effect of the intervention on use and acceptability of effective contraception because of under recruitment. Although we cannot strongly recommend implementation, the results suggest that it would be safe and may increase the acceptability of effective contraception if the intervention messages were offered alongside the download of the app.
ClinicalTrials.gov NCT02905526; https://clinicaltrials.gov/ct2/show/NCT02905526.
尽管玻利维亚有最有效的避孕方法，但据估计，15至19岁女性的避孕需求未得到满足的比例为38%（2008年），青少年生育率为每1000名女性71例（2016年）。手机是提供健康行为支持的一种流行方式。我们开发了一种通过手机为玻利维亚年轻女性提供的避孕行为干预措施，并以行为科学为指导。该干预措施包括通过应用程序在4个月内发送的简短即时消息。
本试验旨在评估该干预措施对玻利维亚年轻女性使用和接受玻利维亚现有有效避孕方法的影响。
这是一项平行组、个体随机优效性试验，分配比例为1:1。符合条件的女性年龄在16至24岁之间，拥有个人安卓手机，居住在拉巴斯或埃尔阿尔托，报告有未满足的避孕需求，且能阅读西班牙语。目标样本量为1310名参与者。分配到干预组的参与者可以访问一个包含标准计划生育信息和干预消息的应用程序。分配到对照组的参与者可以访问相同的应用程序和对照消息。共同主要结局是在4个月时使用有效避孕方法以及至少接受一种有效避孕方法的可接受性。次要结局是研究期间使用有效避孕方法、各种避孕方法的可接受性、服务利用情况、意外怀孕和堕胎。过程结局包括知识、感知规范、个人能动性和意愿。使用逻辑回归和线性回归分析结局。我们还询问了参与者有关身体暴力的情况。
共招募了640名参与者，其中67.0%（429名）为共同主要结局（使用有效避孕方法）提供了随访数据。没有证据表明两组之间的使用情况存在差异（对照组为33%，干预组为37%；调整后的优势比[OR]为1.19，95%置信区间为0.80至1.77；P = 0.40）。在可接受性方面有边缘显著效应（对照组为63%，干预组为72%；调整后的OR为1.49，95%置信区间为0.98至2.28；P = 0.06）。在任何次要或过程结局方面均无统计学显著差异。接受的干预剂量较低。在对照组中，2.8%（6/207）报告经历过身体暴力，而干预组为1.9%（4/202）（Fisher精确检验P = 0.75）。
由于招募不足，本试验无法就该干预措施对有效避孕方法的使用和可接受性的影响得出明确结论。尽管我们不能强烈推荐实施，但结果表明，如果在应用程序下载时提供干预消息，该措施可能是安全的，并且可能会提高有效避孕方法的可接受性。
ClinicalTrials.gov NCT02905526；https://clinicaltrials.gov/ct2/show/NCT02905526
