Lopez Laureen M, Stockton Laurie L, Chen Mario, Steiner Markus J, Gallo Maria F
Clinical Sciences, FHI 360, 359 Blackwell St, Suite 200, Durham, North Carolina, USA, 27701.
Cochrane Database Syst Rev. 2014 Mar 30;2014(3):CD010915. doi: 10.1002/14651858.CD010915.pub2.
Dual-method contraception refers to using condoms as well as another modern method of contraception. The latter (usually non-barrier) method is commonly hormonal (e.g., oral contraceptives) or a non-hormonal intrauterine device. Use of two methods can better prevent pregnancy and the transmission of HIV and other sexually transmitted infections (STIs) compared to single-method use. Unprotected sex increases risk for disease, disability, and mortality in many areas due to the prevalence and incidence of HIV/STI. Millions of women, especially in lower-resource areas, also have an unmet need for protection against unintended pregnancy.
We examined comparative studies of behavioral interventions for improving use of dual methods of contraception. Dual-method use refers to using condoms as well as another modern contraceptive method. Our intent was to identify effective interventions for preventing pregnancy as well as HIV/STI transmission.
Through January 2014, we searched MEDLINE, CENTRAL, POPLINE, EMBASE, COPAC, and Open Grey. In addition, we searched ClinicalTrials.gov and ICTRP for current trials and trials with relevant data or reports. We examined reference lists of pertinent papers, including review articles, for additional reports.
Studies could be either randomized or non-randomized. They examined a behavioral intervention with an educational or counseling component to encourage or improve the use of dual methods, i.e., condoms and another modern contraceptive. The intervention had to address preventing pregnancy as well as the transmission of HIV/STI. The program or service could be targeted to individuals, couples, or communities. The comparison condition could be another behavioral intervention to improve contraceptive use, usual care, other health education, or no intervention.Studies had to report use of dual methods, i.e., condoms plus another modern contraceptive method. We focused on the investigator's assessment of consistent dual-method use or use at last sex. Outcomes had to be measured at least three months after the behavioral intervention began.
Two authors evaluated abstracts for eligibility and extracted data from included studies. For the dichotomous outcomes, the Mantel-Haenszel odds ratio (OR) with 95% CI was calculated using a fixed-effect model. Where studies used adjusted analysis, we presented the results as reported by the investigators. No meta-analysis was conducted due to differences in interventions and outcome measures.
We identified four studies that met the inclusion criteria: three randomized controlled trials and a pilot study for one of the included trials. The interventions differed markedly: computer-delivered, individually tailored sessions; phone counseling added to clinic counseling; and case management plus a peer-leadership program. The latter study, which addressed multiple risks, showed an effect on contraceptive use. Compared to the control group, the intervention group was more likely to report consistent dual-method use, i.e., oral contraceptives and condoms. The reported relative risk was 1.58 at 12 months (95% CI 1.03 to 2.43) and 1.36 at 24 months (95% CI 1.01 to 1.85). The related pilot study showed more reporting of consistent dual-method use for the intervention group compared to the control group (reported P value = 0.06); the investigators used a higher alpha (P < 0.10) for this pilot study. The other two trials did not show any significant difference between the study groups in reported dual-method use or in test results for pregnancy or STIs at 12 or 24 months.
AUTHORS' CONCLUSIONS: We found few behavioral interventions for improving dual-method contraceptive use and little evidence of effectiveness. A multifaceted program showed some effect but only had self-reported outcomes. Two trials were more applicable to clinical settings and had objective outcomes measures, but neither showed any effect. The included studies had adequate information on intervention fidelity and sufficient follow-up periods for change to occur. However, the overall quality of evidence was considered low. Two trials had design limitations and two had high losses to follow up, as often occurs in contraceptive trials. Good quality studies are still needed of carefully designed and implemented programs or services.
双重避孕法是指同时使用避孕套以及另一种现代避孕方法。后一种(通常非屏障式)方法通常是激素类(如口服避孕药)或非激素类宫内节育器。与单一方法相比,使用两种方法能更好地预防怀孕以及艾滋病毒和其他性传播感染(STIs)的传播。由于艾滋病毒/性传播感染的流行率和发病率,无保护性行为在许多地区会增加疾病、残疾和死亡风险。数百万妇女,尤其是资源匮乏地区的妇女,对预防意外怀孕的保护措施也有未满足的需求。
我们研究了旨在提高双重避孕法使用的行为干预的比较研究。双重避孕法的使用是指同时使用避孕套以及另一种现代避孕方法。我们的目的是确定预防怀孕以及艾滋病毒/性传播感染传播的有效干预措施。
截至2014年1月,我们检索了MEDLINE、CENTRAL、POPLINE、EMBASE、COPAC和Open Grey。此外,我们在ClinicalTrials.gov和ICTRP中检索了当前试验以及有相关数据或报告的试验。我们查阅了相关论文(包括综述文章)的参考文献列表以获取更多报告。
研究可以是随机的或非随机的。它们研究了一种具有教育或咨询成分的行为干预,以鼓励或改善双重方法(即避孕套和另一种现代避孕方法)的使用。该干预必须涉及预防怀孕以及艾滋病毒/性传播感染的传播。该项目或服务可以针对个人、夫妻或社区。对照条件可以是另一种改善避孕方法使用的行为干预、常规护理、其他健康教育或无干预。研究必须报告双重方法的使用情况,即避孕套加另一种现代避孕方法。我们关注研究者对持续使用双重方法或最后一次性行为时使用情况的评估。结局必须在行为干预开始后至少三个月进行测量。
两位作者评估摘要的合格性,并从纳入研究中提取数据。对于二分结局,使用固定效应模型计算Mantel-Haenszel比值比(OR)及95%置信区间(CI)。若研究使用了调整分析,我们按研究者报告的结果呈现。由于干预措施和结局测量的差异,未进行荟萃分析。
我们确定了四项符合纳入标准的研究:三项随机对照试验和其中一项纳入试验的一项试点研究。干预措施差异显著:计算机提供的个性化课程;在诊所咨询基础上增加电话咨询;病例管理加同伴领导项目。后一项研究涉及多种风险,显示对避孕方法使用有影响。与对照组相比,干预组更有可能报告持续使用双重方法,即口服避孕药和避孕套。12个月时报告的相对风险为1.58(95%CI 1.03至2.43),24个月时为1.36(95%CI 1.01至1.85)。相关试点研究显示,与对照组相比,干预组报告持续使用双重方法的情况更多(报告的P值 = 0.06);该试点研究的研究者使用了更高的α水平(P < 0.10)。另外两项试验在12个月或24个月时,在报告的双重方法使用情况或怀孕或性传播感染检测结果方面,研究组之间未显示出任何显著差异。
我们发现很少有行为干预措施可改善双重避孕法的使用,且几乎没有有效性证据。一个多方面的项目显示出一些效果,但仅有自我报告的结局。两项试验更适用于临床环境且有客观的结局测量,但均未显示出任何效果。纳入研究有关于干预保真度的充分信息以及足够的随访期以实现变化。然而,证据总体质量被认为较低。两项试验存在设计局限性,两项试验有高失访率,这在避孕试验中经常出现。仍需要精心设计和实施的项目或服务的高质量研究。