Strategies to improve adherence and continuation of shorter-term hormonal methods of contraception.

BACKGROUND: Worldwide, hormonal contraceptives are among the most popular reversible contraceptives. Despite high perfect-use effectiveness rates, typical-use effectiveness rates for shorter-term methods such as oral and injectable contraceptives are much lower. In large part, this disparity reflects difficulties in ongoing adherence to the contraceptive regimen and low continuation rates. Correct use of contraceptives to ensure effectiveness is vital to reducing unintended pregnancy. OBJECTIVES: To determine the effectiveness of strategies aiming to improve adherence to, and continuation of, shorter-term hormonal methods of contraception compared with usual family planning care. SEARCH METHODS: We searched to July 2018 in the following databases (without language restrictions): The Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 7), PubMed via MEDLINE, POPLINE, Web of Science, ClinicalTrials.gov, and the International Clinical Trials Registry Platform (ICTRP). SELECTION CRITERIA: We included randomized controlled trials (RCTs) comparing strategies aimed to facilitate adherence and continuation of shorter-term hormonal methods of contraception (such as oral contraceptives (OCs), injectable depot medroxyprogesterone acetate (DMPA or Depo-Provera), intravaginal ring, or transdermal patch) with usual family planning care in reproductive age women seeking to avoid pregnancy. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures recommended by Cochrane. Primary outcomes were continuation or discontinuation of contraceptive method, rates of discontinuation due to adverse events (menstrual disturbances and all other adverse events), and adherence to method use as indicated by missed pills and on-time/late injections. Pregnancy was a secondary outcome. MAIN RESULTS: We included 10 RCTs involving 6242 women. Six trials provided direct in-person counseling using either multiple counseling contacts or multiple components during one visit. Four trials provided intensive reminders of appointments or next dosing, of which two provided additional educational health information as well as reminders. All trials stated 'usual care' as the comparison.The certainty of the evidence ranged from very low to moderate. Main limitations were risk of bias (associated with poor reporting of methodological detail, lack of blinding, and incomplete outcome data), inconsistency, indirectness, and imprecision.Continuation of hormonal contraceptive methodsIt is uncertain whether intensive counseling improves continuation of hormonal contraceptive methods compared with usual care (OR 1.28, 95% CI 1.07 to 1.54; 2624 participants; 6 studies; I2 = 79%; very low certainty evidence). The evidence suggested: if the chance of continuation with usual care is 39%, the chance of continuation with intensive counseling would be between 41% and 50%. The overall pooled OR suggested continuation of improvement, however, when stratified by contraceptive method type, the positive results were restricted to DMPA.It is uncertain whether reminders (+/- educational information) improve continuation of hormonal contraceptive methods compared with usual care (OR 1.33, 95% CI 1.03 to 1.73; 933 participants; 2 studies; I2 = 69%; very low certainty evidence).The evidence suggested: if the chance of continuation with usual care is 52%, the chance of continuation with reminders would be between 52% and 65%.Discontinuation due to adverse eventsThe evidence suggested that counseling may be associated with a decreased rate of discontinuation due to adverse events compared with usual care, with a lower rate of discontinuation due to menstrual disturbances (OR 0.20, 95% CI 0.11 to 0.37; 350 participants; 1 study; low certainty evidence), but may make little or no difference to all other adverse events (OR 0.73, 95% CI 0.36 to 1.47; 350 participants; 1 study; low certainty evidence). The evidence suggested: if the chance of discontinuation with usual care due to menstrual disturbances is 32%, the chance of discontinuation with intensive counseling would be between 5% and 15%; and that if the chance of discontinuation with usual care due to other adverse events is 55%, the chance of discontinuation with intensive counseling would be between 30% and 64%.Discontinuation was not reported among trials that investigated the use of reminders (+/- educational information).Adherence Adherence was not reported among trials that investigated the use of intensive counseling.Among trials that investigated reminders (+/- educational information), there was no conclusive evidence of a difference in adherence as indicated by missed pills (MD 0.80, 95% CI -1.22 to 2.82; 73 participants; 1 study; moderate certainty evidence) or by on-time injections (OR 0.84, 95% CI 0.54 to 1.29; 350 participants; 2 studies; I2 = 0%; low certainty evidence). The evidence suggested: if the chance of adherence to method use as indicated by on-time injections with usual care is 50%, the chance of adherence with method use as indicated by on-time injections with reminders would be between 35% and 56%.PregnancyThere was no conclusive evidence of a difference in rates of pregnancy between intensive counseling and usual care (OR 1.24, 95% CI 0.98 to 1.57; 1985 participants; 3 studies; I2 = 0%, very low certainty evidence). The evidence suggested: if the chance of pregnancy with usual care is 18%, the chance of pregnancy with counseling would be between 18% and 25%.Pregnancy was not reported among trials that investigated the use of reminders (+/- educational information). AUTHORS' CONCLUSIONS: Despite the importance of this topic, studies have not been published since the last review in 2013 (nine studies) with only one study added in 2019 that neither changed the results nor improved the certainty of evidence.Overall, the certainty of evidence for strategies to improve adherence and continuation of contraceptives is low. Intensive counseling and reminders (with or without educational information) may be associated with improved continuation of shorter-term hormonal contraceptive methods when compared with usual family planning care. However, this should be interpreted with caution due to the low certainty of the evidence. Included trials used a variety of shorter-term hormonal contraceptive methods which may account for the high heterogeneity. It is possible that the effectiveness of strategies for improving adherence and continuation are contingent on the contraceptive method targeted. There was limited reporting of objectively measurable outcomes (e.g. electronic monitoring device) among included studies. Future trials would benefit from standardized definitions and measurements of adherence, and consistent terminology for describing interventions and comparisons. Further research requires larger studies, follow-up of at least one year, and improved reporting of trial methodology.

Theory-based interventions for contraception.

BACKGROUND: The explicit use of theory in research helps expand the knowledge base. Theories and models have been used extensively in HIV-prevention research and in interventions for preventing sexually transmitted infections (STIs). The health behavior field uses many theories or models of change. However, many educational interventions addressing contraception have no explicit theoretical base. OBJECTIVES: To review randomized controlled trials (RCTs) that tested a theoretical approach to inform contraceptive choice and encourage or improve contraceptive use. SEARCH METHODS: To 1 November 2016, we searched for trials that tested a theory-based intervention for improving contraceptive use in PubMed, CENTRAL, POPLINE, Web of Science, ClinicalTrials.gov, and ICTRP. For the initial review, we wrote to investigators to find other trials. SELECTION CRITERIA: Included trials tested a theory-based intervention for improving contraceptive use. Interventions addressed the use of one or more methods for contraception. The reports provided evidence that the intervention was based on a specific theory or model. The primary outcomes were pregnancy and contraceptive choice or use. DATA COLLECTION AND ANALYSIS: We assessed titles and abstracts identified during the searches. One author extracted and entered the data into Review Manager; a second author verified accuracy. We examined studies for methodological quality.For unadjusted dichotomous outcomes, we calculated the Mantel-Haenszel odds ratio (OR) with 95% confidence interval (CI). Cluster randomized trials used various methods of accounting for the clustering, such as multilevel modeling. Most reports did not provide information to calculate the effective sample size. Therefore, we presented the results as reported by the investigators. We did not conduct meta-analysis due to varied interventions and outcome measures. MAIN RESULTS: We included 10 new trials for a total of 25. Five were conducted outside the USA. Fifteen randomly assigned individuals and 10 randomized clusters. This section focuses on nine trials with high or moderate quality evidence and an intervention effect. Five based on social cognitive theory addressed preventing adolescent pregnancy and were one to two years long. The comparison was usual care or education. Adolescent mothers with a home-based curriculum had fewer second births in two years (OR 0.41, 95% CI 0.17 to 1.00). Twelve months after a school-based curriculum, the intervention group was more likely to report using an effective contraceptive method (adjusted OR 1.76 ± standard error (SE) 0.29) and using condoms during last intercourse (adjusted OR 1.68 ± SE 0.25). In alternative schools, after five months the intervention group reported more condom use during last intercourse (reported adjusted OR 2.12, 95% CI 1.24 to 3.56). After a school-based risk-reduction program, at three months the intervention group was less likely to report no condom use at last intercourse (adjusted OR 0.67, 95% CI 0.47 to 0.96). The risk avoidance group (abstinence-focused) was less likely to do so at 15 months (OR 0.61, 95% CI 0.45 to 0.85). At 24 months after a case management and peer-leadership program, the intervention group reported more consistent use of hormonal contraceptives (adjusted relative risk (RR) 1.30, 95% CI 1.06 to 1.58), condoms (RR 1.57, 95% CI 1.28 to 1.94), and dual methods (RR 1.36, 95% CI 1.01 to 1.85).Four of the nine trials used motivational interviewing (MI). In three studies, the comparison group received handouts. The MI group more often reported effective contraception use at nine months (OR 2.04, 95% CI 1.47 to 2.83). In two studies, the MI group was less likely to report using ineffective contraception at three months (OR 0.31, 95% CI 0.12 to 0.77) and four months (OR 0.56, 95% CI 0.31 to 0.98), respectively. In the fourth trial, the MI group was more likely than a group with non-standard counseling to initiate long-acting reversible contraception (LARC) by one month (OR 3.99, 95% CI 1.36 to 11.68) and to report using LARC at three months (OR 3.38, 95% CI 1.06 to 10.71). AUTHORS' CONCLUSIONS: The overall quality of evidence was moderate. Trials based on social cognitive theory focused on adolescents and provided multiple sessions. Those using motivational interviewing had a wider age range but specific populations. Sites with low resources need effective interventions adapted for their settings and their typical clients. Reports could be clearer about how the theory was used to design and implement the intervention.

Balancing workload, motivation and job satisfaction in Rwanda: assessing the effect of adding family planning service provision to community health worker duties.

BACKGROUND: Task shifting from higher cadre providers to CHWs has been widely adopted to address healthcare provider shortages, but the addition of any service can potentially add to an already considerable workload for CHWs. Objective measures of workload alone, such as work-related time and travel may not reflect howCHWs actually perceive and react to their circumstances. This study combined perception and objectivemeasures of workload to examine their effect on quality of services, worker performance, and job and clientsatisfaction. METHODS: Three hundred eighty-three CHWs from control and intervention districts, where the intervention group was trained to provide contraceptive resupply, completed diaries of work-related activities for one month. Interviews were also conducted with a subset of CHWs and their clients. RESULTS: CHW diaries did not reveal significant differences between intervention and control groups in time spent on service provision or travel. Over 90% of CHWs reported workload manageability, job satisfaction, and motivation to perform their jobs. Clients were highly satisfied with CHW services and most stated preference for future services from CHWs. CONCLUSION: The study demonstrated that adding resupply of hormonal contraceptives to CHWs' tasks would not place undue burden on them. Accordingly, the initiative was scaled up in all 30 districts in the country.

Behavioral interventions for improving dual-method contraceptive use.

BACKGROUND: 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. OBJECTIVES: 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. SEARCH METHODS: 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. SELECTION CRITERIA: 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. DATA COLLECTION AND ANALYSIS: 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. MAIN RESULTS: 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.

Skin patch and vaginal ring versus combined oral contraceptives for contraception.

BACKGROUND: The delivery of combination contraceptive steroids from a transdermal contraceptive patch or a contraceptive vaginal ring offers potential advantages over the traditional oral route. The transdermal patch and vaginal ring could require a lower dose due to increased bioavailability and improved user compliance. OBJECTIVES: To compare the contraceptive effectiveness, cycle control, compliance (adherence), and safety of the contraceptive patch or the vaginal ring versus combination oral contraceptives (COCs). SEARCH METHODS: Through February 2013, we searched MEDLINE, POPLINE, CENTRAL, LILACS, ClinicalTrials.gov, and ICTRP for trials of the contraceptive patch or the vaginal ring. Earlier searches also included EMBASE. For the initial review, we contacted known researchers and manufacturers to identify other trials. SELECTION CRITERIA: We considered randomized controlled trials comparing a transdermal contraceptive patch or a contraceptive vaginal ring with a COC. DATA COLLECTION AND ANALYSIS: Data were abstracted by two authors and entered into RevMan. For dichotomous variables, the Peto odds ratio (OR) with 95% confidence intervals (CI) was calculated. For continuous variables, the mean difference was computed. We also assessed the quality of evidence for this review. MAIN RESULTS: We found 18 trials that met our inclusion criteria. Of six patch studies, five examined the marketed patch containing norelgestromin plus ethinyl estradiol (EE); one studied a patch in development that contains levonorgestrel (LNG) plus EE. Of 12 vaginal ring trials, 11 examined the same marketing ring containing etonogestrel plus EE; one studied a ring being developed that contains nesterone plus EE.Contraceptive effectiveness was not significantly different for the patch or ring versus the comparison COC. Compliance data were limited. Patch users showed better compliance than COC users in three trials. For the norelgestromin plus EE patch, ORs were 2.05 (95% CI 1.83 to 2.29) and 2.76 (95% CI 2.35 to 3.24). In the levonorgestrel plus EE patch report, patch users were less likely to have missed days of therapy (OR 0.36; 95% CI 0.25 to 0.51). Of four vaginal ring trials, one found ring users had more noncompliance (OR 3.99; 95% CI 1.87 to 8.52), while another showed more compliance with the regimen (OR 1.67; 95% CI 1.04 to 2.68).More patch users discontinued early than COC users. ORs from two meta-analyses were 1.59 (95% CI 1.26 to 2.00) and 1.56 (95% CI 1.18 to 2.06) and another trial showed OR 2.57 (95% CI 0.99 to 6.64). Patch users also had more discontinuation due to adverse events than COC users. Users of the norelgestromin-containing patch reported more breast discomfort, dysmenorrhea, nausea, and vomiting. In the levonorgestrel-containing patch trial, patch users reported less vomiting, headaches, and fatigue.Of 11 ring trials with discontinuation data, two showed the ring group discontinued less than the COC group: OR 0.32 (95% CI 0.16 to 0.66) and OR 0.52 (95% CI 0.31 to 0.88). Ring users were less likely to discontinue due to adverse events in one study (OR 0.32; 95% CI 0.15 to 0.70). Compared to the COC users, ring users had more vaginitis and leukorrhea but less vaginal dryness. Ring users also reported less nausea, acne, irritability, depression, and emotional lability than COC users.For cycle control, only one trial study showed a significant difference. Women in the patch group were less likely to have breakthrough bleeding and spotting. Seven ring studies had bleeding data; four trials showed the ring group generally had better cycle control than the COC group. AUTHORS' CONCLUSIONS: Effectiveness was not significantly different for the methods compared. Pregnancy data were available from half of the patch trials but two-thirds of ring trials. The patch could lead to more discontinuation than the COC. The patch group had better compliance than the COC group. Compliance data came from half of the patch studies and one-third of the ring trials. Patch users had more side effects than the COC group. Ring users generally had fewer adverse events than COC users but more vaginal irritation and discharge.The quality of the evidence for this review was considered low for the patch and moderate for the ring. The main reasons for downgrading were lack of information on the randomization sequence generation or allocation concealment, the outcome assessment methods, high losses to follow up, and exclusions after randomization.

Theory-based interventions for contraception.

BACKGROUND: The explicit use of theory in research helps expand the knowledge base. Theories and models have been used extensively in HIV-prevention research and in interventions for preventing sexually transmitted infections (STIs). The health behavior field uses many theories or models of change. However, educational interventions addressing contraception often have no stated theoretical base. OBJECTIVES: Review randomized controlled trials (RCTs) that tested a theoretical approach to inform contraceptive choice; encourage contraceptive use; or promote adherence to, or continuation of, a contraceptive regimen. SEARCH METHODS: Through June 2013, we searched computerized databases for trials that tested a theory-based intervention for improving contraceptive use (MEDLINE, POPLINE, CENTRAL, PsycINFO, ClinicalTrials.gov, and ICTRP). Previous searches also included EMBASE. For the initial review, we wrote to investigators to find other trials. SELECTION CRITERIA: Trials tested a theory-based intervention for improving contraceptive use. We excluded trials focused on high-risk groups and preventing sexually transmitted infections or HIV. Interventions addressed the use of one or more contraceptive methods for contraception. The reports provided evidence that the intervention was based on a specific theory or model. The primary outcomes were pregnancy, contraceptive choice or use, and contraceptive adherence or continuation. DATA COLLECTION AND ANALYSIS: The primary author evaluated abstracts for eligibility. Two authors 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. Cluster randomized trials used various methods of accounting for the clustering, such as multilevel modeling. Most reports did not provide information to calculate the effective sample size. Therefore, we presented the results as reported by the investigators. No meta-analysis was conducted due to differences in interventions and outcome measures. MAIN RESULTS: We included three new trials for a total of 17. Ten randomly assigned individuals and seven were cluster-randomized. Eight trials showed some intervention effect.Two of 12 trials with pregnancy or birth data showed some effect. A theory-based group was less likely than the comparison group to have a second birth (OR 0.41; 95% CI 0.17 to 1.00) or to report a pregnancy (OR 0.24 (95% CI 0.10 to 0.56); OR 0.27 (95% CI 0.11 to 0.66)). The theoretical bases were social cognitive theory (SCT) and another social cognition model.Of 12 trials with data on contraceptive use (non-condom), six showed some effect. A theory-based group was more likely to consistently use oral contraceptives (OR 1.41; 95% CI 1.06 to 1.87), hormonal contraceptives (reported relative risk (RR) 1.30; 95% CI 1.06 to 1.58) or dual methods (reported RR 1.36; 95% CI 1.01 to 1.85); to use an effective contraceptive method (reported effect size 1.76; OR 2.04 (95% CI 1.47 to 2.83)) or use more habitual contraception (reported P < 0.05); and were less likely to use ineffective contraception (OR 0.56; 95% CI 0.31 to 0.98). Theories and models included the Health Belief Model (HBM), SCT, SCT plus another theory, other social cognition, and motivational interviewing (MI).For condom use, a theory-based group had favorable results in 5 of 11 trials. The main differences were reporting more consistent condom use (reported RR 1.57; 95% CI 1.28 to 1.94) and more condom use during last sex (reported results: risk ratio 1.47 (95% CI 1.12 to 1.93); effect size 1.68; OR 2.12 (95% CI 1.24 to 3.56); OR 1.45 (95% CI 1.03 to 2.03)). The theories were SCT, SCT plus another theory, and HBM.Nearly all trials provided multiple sessions or contacts. SCT provided the basis for seven trials focused on adolescents, of which five reported some effectiveness. Two others based on other social cognition models had favorable results with adolescents. Of six trials including adult women, five provided individual sessions. Some effect was seen in two using MI and one using the HBM. Two based on the Transtheoretical Model did not show any effect. AUTHORS' CONCLUSIONS: Eight trials provided evidence of high or moderate quality. Family planning researchers and practitioners could adapt the effective interventions, although most provided group sessions for adolescents. Three were conducted outside the USA. Clinics and low-resource settings need high-quality evidence on changing behavior. Thorough use of single theories would help in identifying what works, as would better reporting on research design and intervention implementation.

Strategies to improve adherence and acceptability of hormonal methods of contraception.

BACKGROUND: Worldwide, hormonal contraceptives are among the most popular reversible contraceptives. Despite their high theoretical effectiveness, typical use results in much lower effectiveness. In large part, this disparity reflects difficulties in adherence to the contraceptive regimen and low rates for long-term continuation. OBJECTIVES: The intent was to determine the effectiveness of ancillary counseling techniques to improve adherence to, and continuation of, hormonal methods of contraception. SEARCH METHODS: Through August 2013, we searched computerized databases for randomized controlled trials (RCTs) comparing client-provider interventions with standard family planning counseling. Sources included CENTRAL, MEDLINE, EMBASE, POPLINE, ClinicalTrials.gov and ICTRP. Earlier searches also included LILACS, PsycINFO, Dissertation Abstracts, African Index Medicus, and IMEMR. SELECTION CRITERIA: We included RCTs of an intensive counseling technique or other client-provider intervention compared to routine family planning counseling. Interventions included group motivation; structured, peer, or multi-component counseling; and intensive reminders of appointments or next dosing. Outcome measures were discontinuation, reasons for discontinuation, number of missed pills or on-time injections, and pregnancy. DATA COLLECTION AND ANALYSIS: One author evaluated the titles and abstracts from the searches to determine eligibility. Two authors extracted data from the included studies. We calculated the Mantel-Haenszel odds ratio (OR) for dichotomous outcomes. For continuous variables, the mean difference (MD) was computed; RevMan uses the inverse variance approach. For all analyses, 95% confidence intervals (CI) were also computed. Since the studies identified differed in both interventions and outcome measures, we did not conduct a meta-analysis. MAIN RESULTS: Nine RCTs met our inclusion criteria. Five involved direct counseling; of those, two also provided multiple contacts by telephone. Four other trials provided intensive reminders, two of which also provided health education information. Three trials showed some benefit of the experimental intervention. In a counseling intervention, women who received repeated structured information about the injectable depot medroxyprogesterone acetate (DMPA) were less likely to discontinue the method by 12 months (OR 0.27; 95% CI 0.16 to 0.44) than women who had routine counseling. The intervention group was also less likely to discontinue due to menstrual disturbances (OR 0.20; 95% CI 0.11 to 0.37). Another trial showed a group with special counseling plus phone calls was more likely than the special-counseling group to report consistent use of oral contraceptives (OC) at 3 months (OR 1.41; 95% CI 1.06 to 1.87), though not at 12 months. The group with only special counseling did not differ significantly from those with standard care for any outcome. The third trial compared daily text-message reminders about OCs plus health information versus standard care. Women in the text-message group were more likely than the standard-care group to continue OC use by six months (OR 1.54; 95% CI 1.14 to 2.10). The text-message group was also more likely to avoid an interruption in OC use longer than seven days (OR 1.53; 95% CI 1.13 to 2.07). AUTHORS' CONCLUSIONS: Only three trials showed some benefit of strategies to improve adherence and continuation. However, several had small sample sizes and six had high losses to follow up. The overall quality of evidence was considered moderate. The intervention type and intensity varied greatly across the studies. A combination of intensive counseling and multiple contacts and reminders may be needed to improve adherence and acceptability of contraceptive use. High-quality RCTs with adequate power and well-designed interventions could help identify ways to improve adherence to, and continuation of, hormonal contraceptive methods.

Influence of smoking on the healing of conservatively treated displaced midshaft clavicle fractures.

Aims: Tobacco, in addition to being one of the greatest public health threats facing our world, is believed to have deleterious effects on bone metabolism and especially on bone healing. It has been described in the literature that patients who smoke are approximately twice as likely to develop a nonunion following a non-specific bone fracture. For clavicle fractures, this risk is unclear, as is the impact that such a complication might have on the initial management of these fractures. Methods: A systematic review and meta-analysis were performed for conservatively treated displaced midshaft clavicle fractures. Embase, PubMed, and Cochrane Central Register of Controlled Trials (via Cochrane Library) were searched from inception to 12 May 2022, with supplementary searches in Open Grey, ClinicalTrials.gov, ProQuest Dissertations & Theses, and Google Scholar. The searches were performed without limits for publication date or languages. Results: The meta-analysis included eight studies, 2,285 observations, and 304 events (nonunion). The random effects model predicted a pooled risk ratio (RR) of 3.68 (95% confidence interval 1.87 to 7.23), which can be considered significant (p = 0.003). It indicates that smoking more than triples the risk of nonunion when a fracture is treated conservatively. Conclusion: Smoking confers a RR of 3.68 for developing a nonunion in patients with a displaced middle third clavicle fracture treated conservatively. We know that most patients with pseudarthrosis will have pain and a poor functional outcome. Therefore, patients should be informed of the significantly higher risks of nonunion and offered smoking cessation efforts and counselling. Moreover, surgery should be considered for any patient who smokes with this type of fracture.

Evaluation of a Serious Video Game to Facilitate Conversations About Human Papillomavirus Vaccination for Preteens: Pilot Randomized Controlled Trial.

BACKGROUND: In the United States, the most common sexually transmitted infection, human papillomavirus (HPV), causes genital warts and is associated with an estimated 33,700 newly diagnosed cancer cases annually. HPV vaccination, especially for preteens aged 11 to 12 years, is effective in preventing the acquisition of HPV and HPV-associated cancers. However, as of 2018, completion of the 2- or 3-dose HPV vaccination series increased only from 48.6% to 51.1% in teens aged 13 to 17 years, and this increase was observed only in boys. By comparison, 88.7% of teens had more than one dose of the recommended vaccine against tetanus, diphtheria, and acellular pertussis (Tdap), and 85.1% of teens had more than one dose of meningococcal vaccine. Immunizations for Tdap, meningococcal disease, and HPV can occur at the same clinical visit but often do not. OBJECTIVE: Vaccination against HPV is recommended for routine use in those aged 11 to 12 years in the United States, yet it is underutilized. We aimed to develop an educational video game to engage preteens in the decision to vaccinate. METHODS: Land of Secret Gardens is a metaphor for protecting seedlings (body) with a potion (vaccine). We screened 131 dyads of parents and preteens from 18 primary practices in North Carolina who had not initiated HPV vaccination. We measured vaccination intentions, story immersion, and game play and documented HPV vaccination rates. A total of 55 dyads were enrolled, and we randomly assigned 28 (21 completed) to play the game and 27 (26 completed) to the comparison group. RESULTS: In total, 18 preteens reported playing the game. The vaccination self-efficacy score was higher in the comparison group than the intervention group (1.65 vs 1.45; P=.05). The overall mean decisional balance score trended toward greater support of vaccination, although differences between the groups were not significant.. Vaccine initiation and completion rates were higher in the intervention group (22% vs 15%; P=.31) than in the comparison group (9% vs 2%; P=.10), although the difference was not significant. CONCLUSIONS: Video games help preteens in the decision to pursue HPV vaccination. A serious video game on HPV vaccination is acceptable to parents and preteens and can be played as intended. Gamification is effective in increasing preteen interest in HPV vaccination, as game features support decision making for HPV vaccination. TRIAL REGISTRATION: ClinicalTrials.gov NCT04627298; https://www.clinicaltrials.gov/ct2/show/NCT04627298.

Developing a Serious Videogame for Preteens to Motivate HPV Vaccination Decision Making: Land of Secret Gardens.

INTRODUCTION: Vaccination against human papillomavirus (HPV) is routinely recommended for ages 11-12, yet in 2016 only 49.5% of women and 37.5% of men had completed the three-dose series in the United States. Offering information and cues to action through a serious videogame for preteens may foster HPV vaccination awareness, information seeking, and communication. MATERIALS AND METHODS: An iterative process was used to develop an interactive videogame, Land of Secret Gardens. Three focus groups were conducted with 16 boys and girls, ages 11-12, for input on game design, acceptability, and functioning. Two parallel focus groups explored parents' (n = 9) perspectives on the game concept. Three researchers identified key themes. RESULTS: Preteens wanted a game that is both entertaining and instructional. Some parents were skeptical that games could be motivational. A back-story about a secret garden was developed as a metaphor for a preteen's body and keeping it healthy. The goal is to plant a lush secret garden and protect the seedlings by treating them with a potion when they sprout to keep them healthy as they mature. Points to buy seeds and create the potion are earned by playing mini-games. Throughout play, players are exposed to messaging about HPV and the benefits of the vaccine. Both boys and girls liked the garden concept and getting facts about HPV. Parents were encouraged to discuss the game with their preteens. CONCLUSION: Within a larger communication strategy, serious games could be useful for engaging preteens in health decision making about HPV vaccination.

Randomized controlled trial of the ACTION smoking cessation curriculum in tobacco-growing communities.

We conducted a group randomized trial of an interactive, games-based, tobacco cessation program (ACTION) designed to help adolescents who live in tobacco-growing communities to stop using tobacco. More than 260 high school students participated in this study, in 14 schools across three states. We collected self-reported measures of cigarette and smokeless tobacco use and conducted biochemical validation of self-reported use at three time points (pre-test, immediate post-test, and 90-day follow-up). We used multi-level modeling to account for intraclass clustering at the school and classroom levels, and we analyzed our results using an intent-to-treat approach and a per protocol approach. Using the per protocol analytic approach, ACTION participants were more likely than comparison participants to achieve abstinence at 90-day follow-up. We found no program effects on our secondary outcomes or mediating factors. This study suggests that ACTION has promise as a relatively effective adolescent cessation program, although the overall limited effectiveness of cessation programs for adolescents must be acknowledged.