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.

Brief educational strategies for improving contraception use in young people.

BACKGROUND: Global high rates of unplanned pregnancy and abortion among young women demonstrate the need for increased access to modern contraceptive services. In sub-Saharan Africa, the birth rate for those aged 15 to 19 years is 121 per 1000. In the USA, 6% of teens aged 15 to 19 years became pregnant in 2010. Most pregnancies among young women to age 25 are unintended. OBJECTIVES: The aim was to identify brief educational interventions for improving contraceptive use among young people that are feasible for implementing in a clinic or similar setting with limited resources. SEARCH METHODS: To 7 March 2016, we searched for studies in CENTRAL, PubMed, POPLINE, Web of Science, ClinicalTrials.gov and ICTRP. SELECTION CRITERIA: We considered randomized controlled trials (RCTs) that assigned individuals or clusters as well as non-randomized studies (NRS). We included young people to age 25.The intervention had to be sufficiently brief for a clinic, i.e. one to three sessions of 15 to 60 minutes plus potential follow-up. The strategy had to emphasize one or more effective methods of contraception. Primary outcomes were pregnancy and contraceptive 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 dichotomous outcomes, we calculated the Mantel-Haenszel odds ratio (OR) with 95% confidence interval (CI). For continuous variables, we computed the mean difference (MD) with 95% CI. We used adjusted measures for cluster RCTs, typically ORs, that the investigators reported. For NRS, which need to control for confounding, we also used reported adjusted measures. We did not conduct meta-analysis due to varied interventions and outcome measures. MAIN RESULTS: We found 11 studies, published from 1983 to 2015, that included a total of 8338 participants. Ten were from the USA and one was from China. We focused here on intervention effects for our primary outcomes. Five studies showed some effect on contraceptive use. Of three RCTs that examined innovative counseling, one showed an intervention effect. At one year, adolescents with developmental counseling were more likely to use contraception effectively than those with standard counseling (OR 48.38, 95% CI 5.96 to 392.63).Three studies used an audiovisual tool plus counseling; two reported some effect on contraceptive use. An NRS with young men, aged 15 to 18, examined a slide-tape presentation plus reproductive health consultation. At one year, the intervention group was more likely than the standard-care group to report using an effective contraceptive and having a partner who used oral contraceptives (OCs), both at last intercourse (reported adjusted OR 1.51 and 1.66, respectively). Another study utilized a computer program for contraceptive decision-making plus standard counseling for women to age 20. At one year, fewer women in the intervention group at one site had not used OCs compared with the counseling-only group (3.4% versus 8.8%; reported P = 0.05).Three RCTs provided phone follow-up after counseling, one of which showed an effect on contraceptive use among women age 16 to 24. Women who received counseling plus phone calls to encourage contraceptive use were more likely than the counseling-only group to report consistent OC use at three months (OR 1.41, 95% CI 1.06 to 1.87) and six months (OR 1.39, 95% CI 1.03 to 1.87). Also at three months, they were more likely to report condom use at last sex (OR 1.45, 95% CI 1.03 to 2.03).Two cluster randomized trials trained providers on contraceptive methods and counseling. One trial with an intervention effect tested comprehensive contraceptive services for women to age 25, postabortion. At six months, the comprehensive-service group was more likely than the standard-care group to use an effective contraceptive (reported adjusted OR 2.03, 95% CI 1.04 to 3.98) and to use condoms consistently and correctly (reported adjusted OR 5.68, 95% CI 3.39 to 9.53). AUTHORS' CONCLUSIONS: Few studies tested brief strategies for young people. We noted heterogeneity across studies in participants' ages and life situations. Of five studies with some effect, one provided moderate-quality evidence; four were older studies with low-quality evidence. More intensive strategies could be more effective, but would also be challenging for many clinics to implement.

Behavioral interventions for improving contraceptive use among women living with HIV.

BACKGROUND: Contraception services can help meet the family planning goals of women living with HIV as well as prevent mother-to-child transmission. Due to antiretroviral therapy, survival has improved for people living with HIV, and more HIV-positive women may desire to have a child or another child. Behavioral interventions, involving counseling or education, can help women choose and use an appropriate contraceptive method. OBJECTIVES: We systematically reviewed studies of behavioral interventions for HIV-positive women intended to inform contraceptive choice, encourage contraceptive use, or promote adherence to a contraceptive regimen. SEARCH METHODS: Until 2 August 2016, we searched MEDLINE, CENTRAL, Web of Science, POPLINE, ClinicalTrials.gov and ICTRP. For the initial review, we examined reference lists and unpublished project reports, and we contacted investigators in the field. SELECTION CRITERIA: Studies evaluated a behavioral intervention for improving contraceptive use for family planning (FP). The comparison could have been another behavioral intervention, usual care, or no intervention. We also considered studies that compared HIV-positive versus HIV-negative women. We included non-randomized studies as well as randomized controlled trials (RCTs).Primary outcomes were pregnancy and contraception use, e.g. uptake of a new method or improved use or continuation of current method. Secondary outcomes were knowledge of contraceptive effectiveness and attitude about contraception or a specific contraceptive method. DATA COLLECTION AND ANALYSIS: Two authors independently extracted the data. One entered the data into RevMan and a second verified accuracy. We evaluated RCTs according to recommended principles. For non-randomized studies, we examined the quality of evidence using the Newcastle-Ottawa Quality Assessment Scale. Given the need to control for confounding factors in non-randomized studies, we used adjusted estimates from the models when available. Where we did not have adjusted analyses, we calculated the odds ratio (OR) with 95% confidence interval (CI). Due to varied study designs and interventions, we did not conduct meta-analysis. MAIN RESULTS: With three new reports, 10 studies from seven African countries met our eligibility criteria. Eight non-randomized studies included 8980 participants. Two cluster RCTs had 7136 participants across 36 sites. Three studies compared a special FP intervention versus usual care, three examined FP services integrated with HIV services, and four compared outcomes for HIV-positive and HIV-negative women.In four studies with high or moderate quality evidence, the special intervention was associated with contraceptive use or pregnancy. A study from Nigeria compared enhanced versus basic FP services. All sites had integrated FP and HIV services. Women with enhanced services were more likely to use a modern contraceptive method versus women with basic services (OR 2.48, 95% CI 1.31 to 4.72). A cluster RCT conducted in Kenya compared integrated FP and HIV services versus standard referral to a separate FP clinic. Women with integrated services were more likely to use more effective contraception (adjusted OR 1.81, 95% CI 1.24 to 2.63). Another cluster RCT compared an HIV prevention and FP intervention versus usual care in Kenya, Namibia, and Tanzania. Women at the special intervention sites in Tanzania were more likely to use highly effective contraception (adjusted OR 2.25, 95% CI 1.24 to 4.10). They were less likely to report unprotected sex (no condom use) at last intercourse (adjusted OR 0.23, 95% CI 0.14 to 0.40). Across the three countries, women at the special intervention sites were less likely to report any unprotected sex in the past two weeks (adjusted OR 0.56, 95% CI 0.32 to 0.99). A study in Côte d'Ivoire integrated HIV and FP services. HIV-positive women had a lower incidence of undesired pregnancy, but not overall pregnancy, compared with HIV-negative women (1.07 versus 2.38; reported P = 0.023). AUTHORS' CONCLUSIONS: The studies since 2009 focused on using modern or more effective methods of contraception. In those later reports, training on FP methods and counseling was more common, which may strengthen the intervention and improve the ability to meet clients' needs. The quality of evidence was moderate from the more recent studies and low for those from the 1990s.Comparative research involving contraceptive counseling for HIV-positive women is limited. The FP field needs better ways to help women choose an appropriate contraceptive and continue using that method. Improved counseling methods are especially needed for limited resource settings, such as clinics focusing on people living with HIV.

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.

Hormonal contraceptives for contraception in overweight or obese women.

BACKGROUND: Obesity has reached epidemic proportions around the world. Effectiveness of hormonal contraceptives may be related to metabolic changes in obesity or to greater body mass or body fat. Hormonal contraceptives include oral contraceptives (OCs), injectables, implants, hormonal intrauterine contraception (IUC), the transdermal patch, and the vaginal ring. Given the prevalence of overweight and obesity, the public health impact of any effect on contraceptive efficacy could be substantial. OBJECTIVES: To examine the effectiveness of hormonal contraceptives in preventing pregnancy among women who are overweight or obese versus women with a lower body mass index (BMI) or weight. SEARCH METHODS: Until 4 August 2016, we searched for studies in PubMed (MEDLINE), CENTRAL, POPLINE, Web of Science, ClinicalTrials.gov, and ICTRP. We examined reference lists of pertinent articles to identify other studies. For the initial review, we wrote to investigators to find additional published or unpublished studies. SELECTION CRITERIA: All study designs were eligible. The study could have examined any type of hormonal contraceptive. Reports had to contain information on the specific contraceptive methods used. The primary outcome was pregnancy. Overweight or obese women must have been identified by an analysis cutoff for weight or BMI (kg/m(2)). DATA COLLECTION AND ANALYSIS: Two authors independently extracted the data. One entered the data into RevMan and a second verified accuracy. The main comparisons were between overweight or obese women and women of lower weight or BMI. We examined the quality of evidence using the Newcastle-Ottawa Quality Assessment Scale. Where available, we included life-table rates. We also used unadjusted pregnancy rates, relative risk (RR), or rate ratio when those were the only results provided. For dichotomous variables, we computed an odds ratio with 95% confidence interval (CI). MAIN RESULTS: With 8 studies added in this update, 17 met our inclusion criteria and had a total of 63,813 women. We focus here on 12 studies that provided high, moderate, or low quality evidence. Most did not show a higher pregnancy risk among overweight or obese women. Of five COC studies, two found BMI to be associated with pregnancy but in different directions. With an OC containing norethindrone acetate and ethinyl estradiol (EE), pregnancy risk was higher for overweight women, i.e. with BMI ≥ 25 versus those with BMI < 25 (reported relative risk 2.49, 95% CI 1.01 to 6.13). In contrast, a trial using an OC with levonorgestrel and EE reported a Pearl Index of 0 for obese women (BMI ≥ 30) versus 5.59 for nonobese women (BMI < 30). The same trial tested a transdermal patch containing levonorgestrel and EE. Within the patch group, obese women in the "treatment-compliant" subgroup had a higher reported Pearl Index than nonobese women (4.63 versus 2.15). Of five implant studies, two that examined the six-capsule levonorgestrel implant showed differences in pregnancy by weight. One study showed higher weight was associated with higher pregnancy rate in years 6 and 7 combined (reported P < 0.05). In the other, pregnancy rates differed in year 5 among the lower weight groups only (reported P < 0.01) and did not involve women weighing 70 kg or more.Analysis of data from other contraceptive methods indicated no association of pregnancy with overweight or obesity. These included depot medroxyprogesterone acetate (subcutaneous), levonorgestrel IUC, the two-rod levonorgestrel implant, and the etonogestrel implant. AUTHORS' CONCLUSIONS: The evidence generally did not indicate an association between higher BMI or weight and effectiveness of hormonal contraceptives. However, we found few studies for most contraceptive methods. Studies using BMI, rather than weight alone, can provide information about whether body composition is related to contraceptive effectiveness. The contraceptive methods examined here are among the most effective when used according to the recommended regimen.We considered the overall quality of evidence to be low for the objectives of this review. More recent reports provided evidence of varying quality, while the quality was generally low for older studies. For many trials the quality would be higher for their original purpose rather than the non-randomized comparisons here. Investigators should consider adjusting for potential confounding related to BMI or contraceptive effectiveness. Newer studies included a greater proportion of overweight or obese women, which helps in examining effectiveness and side effects of hormonal contraceptives within those groups.

Education for contraceptive use by women after childbirth.

BACKGROUND: Contraceptive education is generally a standard component of postpartum care, although the effectiveness is seldom examined. The assumptions that form the basis of such programs include postpartum women being motivated to use contraception and that they will not return to a health provider for family planning advice. Women may wish to discuss contraception both prenatally and after hospital discharge. Nonetheless, two-thirds of postpartum women have unmet needs for contraception. In the USA, many adolescents have repeat pregnancies within a year of giving birth. OBJECTIVES: Assess the effectiveness of educational interventions for postpartum women on contraceptive use SEARCH METHODS: We searched for trials through June 2015 in PubMed, CENTRAL, CINAHL, POPLINE, and Web of Science. For current trials, we searched ClinicalTrials.gov and ICTRP. Previous searches also included EMBASE and PsycInfo. We also examined reference lists of relevant articles. For earlier versions, we contacted investigators to locate additional reports. SELECTION CRITERIA: We considered randomized controlled trials (RCTs) that examined postpartum education about contraceptive use, whether delivered to individuals or to groups of women. Studies that randomized clusters rather than individuals were eligible if the investigators accounted for the clustering in the analysis. The intervention must have started within one month after delivery. DATA COLLECTION AND ANALYSIS: We assessed titles and abstracts identified during the literature searches. The data were abstracted and entered into Review Manager. Studies were examined for methodological quality. For dichotomous outcomes, the Mantel-Haenszel odds ratio (OR) with 95% confidence interval (CI) was calculated. Where data were sFor continuous variables, we computed the mean difference (MD) with 95% CI. Due to varied interventions and outcome measures, we did not conduct meta-analysis. MAIN RESULTS: Twelve trials met our eligibility criteria, included the three added in this update. The studies included a total of 4145 women. Eight trials were conducted in the USA; the others were from Australia, Nepal, Pakistan, and Syria. Four studies provided one session before hospital discharge; three had structured counseling of varying intensity and one involved informal counseling. Of eight interventions with than one contact, five focused on adolescents. Three of the five involved home visiting, one provided multiple clinic services, and one had in-person contact and phone follow-up. Of the remaining three for women of varying ages, two involved home visits and one provided phone follow-up.Our sensitivity analysis included six trials with evidence of moderate or high quality. In a study with adolescents, the group with home-based mentoring had fewer second births within two years compared to the control group (OR 0.41, 95% CI 0.17 to 1.00). The other five interventions had no effect. Of trials with lower quality evidence, two showed some effectiveness. In Nepal, women with an educational session immediately postpartum were more likely to use contraception at six months than those with a later or no session (OR 1.62, 95% CI 1.06 to 2.50). In an Australian study, teenagers in a structured home-visiting program were more likely to have effective contraception use at six months than those with standard home visits (OR 3.24; 95% CI 1.35 to 7.79). AUTHORS' CONCLUSIONS: We focused our results summary on trials with moderate or high quality evidence. Overall, the overall quality of evidence in this review was moderate to low and the evidence of effectiveness was mostly low quality. The interventions could be improved by strengthening the program design and implementation. Some studies did not report program training for providers, adherence to the intervention protocol, or measurement of participants' knowledge and skills. Many trials did not have an objective outcome measure, i.e., pregnancy test or structured questionnaire for contraceptive use. Valid and reliable outcome measures are needed to obtain meaningful results. Still, given the associated costs and logistics, some programs would not be feasible in many settings.

Combined hormonal versus nonhormonal versus progestin-only contraception in lactation.

BACKGROUND: Postpartum contraception improves the health of mothers and children by lengthening birth intervals. For lactating women, contraception choices are limited by concerns about hormonal effects on milk quality and quantity and passage of hormones to the infant. Ideally, the contraceptive chosen should not interfere with lactation or infant growth. Timing of contraception initiation is also important. Immediately postpartum, most women have contact with a health professional, but many do not return for follow-up contraceptive counseling. However, immediate initiation of hormonal methods may disrupt the onset of milk production. OBJECTIVES: To determine the effects of hormonal contraceptives on lactation and infant growth SEARCH METHODS: We searched for eligible trials until 2 March 2015. Sources included the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, POPLINE, Web of Science, LILACS, ClinicalTrials.gov, and ICTRP. We also examined review articles and contacted investigators. SELECTION CRITERIA: We sought randomized controlled trials in any language that compared hormonal contraception versus another form of hormonal contraception, nonhormonal contraception, or placebo during lactation. Hormonal contraception includes combined or progestin-only oral contraceptives, injectable contraceptives, implants, and intrauterine devices.Trials had to have one of our primary outcomes: breast milk quantity or biochemical composition; lactation initiation, maintenance, or duration; infant growth; or timing of contraception initiation and effect on lactation. Secondary outcomes included contraceptive efficacy while breastfeeding and birth interval. DATA COLLECTION AND ANALYSIS: For continuous variables, we calculated the mean difference (MD) with 95% confidence interval (CI). For dichotomous outcomes, we computed the Mantel-Haenszel odds ratio (OR) with 95% CI. Due to differing interventions and outcome measures, we did not aggregate the data in a meta-analysis. MAIN RESULTS: In 2014, we added seven trials for a new total of 11. Five reports were published before 1985 and six from 2005 to 2014. They included 1482 women. Four trials examined combined oral contraceptives (COCs), and three studied a levonorgestrel-releasing intrauterine system (LNG-IUS). We found two trials of progestin-only pills (POPs) and two of the etonogestrel-releasing implant. Older studies often lacked quantified results. Most trials did not report significant differences between the study arms in breastfeeding duration, breast milk composition, or infant growth. Exceptions were seen mainly in older studies with limited information.For breastfeeding duration, two of eight trials indicated a negative effect on lactation. A COC study reported a negative effect on lactation duration compared to placebo but did not quantify results. Another trial showed a lower percentage of the LNG-IUS group breastfeeding at 75 days versus the nonhormonal IUD group (reported P < 0.05) but no significant difference at one year.For breast milk volume, two older studies indicated lower volume for the COC group versus the placebo group. One trial did not quantify results. The other showed lower means (mL) for the COC group, e.g. at 16 weeks (MD -24.00, 95% CI -34.53 to -13.47) and at 24 weeks (MD -24.90, 95% CI -36.01 to -13.79). Another four trials did not report any significant difference between the study groups in milk volume or composition with two POPs, a COC, or the etonogestrel implant.Seven trials studied infant growth; one showed greater weight gain (grams) for the etonogestrel implant versus no method for six weeks (MD 426.00, 95% CI 58.94 to 793.06) but less compared with depot medroxyprogesterone acetate (DMPA) from 6 to 12 weeks (MD -271.00, 95% CI -355.10 to -186.90). The others studied POPs, COCs versus POPs, or an LNG-IUS. AUTHORS' CONCLUSIONS: Results were not consistent across the 11 trials. The evidence was limited for any particular hormonal method. The quality of evidence was moderate overall and low for three of four placebo-controlled trials of COCs or POPs. The sensitivity analysis included six trials with moderate quality evidence and sufficient outcome data. Five trials indicated no significant difference between groups in breastfeeding duration (etonogestrel implant insertion times, COC versus POP, and LNG-IUS). For breast milk volume or composition, a COC study showed a negative effect, while an implant trial showed no significant difference. Of four trials that assessed infant growth, three indicated no significant difference between groups. One showed greater weight gain in the etonogestrel implant group versus no method but less versus DMPA.

Strategies for improving postpartum contraceptive use: evidence from non-randomized studies.

BACKGROUND: Nearly two-thirds of women in their first postpartum year have an unmet need for family planning. Adolescents often have repeat pregnancies within a year of giving birth. Women may receive counseling on family planning both antepartum and postpartum. Decisions about contraceptive use made right after counseling may differ considerably from actual postpartum use. In earlier work, we found limited evidence of effectiveness from randomized trials on postpartum contraceptive counseling. For educational interventions, non-randomized studies may be conducted more often than randomized trials. OBJECTIVES: We reviewed non-randomized studies of educational strategies to improve postpartum contraceptive use. Our intent was to examine associations between specific interventions and postpartum contraceptive use or subsequent pregnancy. SEARCH METHODS: We searched for eligible non-randomized studies until 3 November 2014. Sources included CENTRAL, PubMed, POPLINE, and Web of Science. We also sought current trials via ClinicalTrials.gov and ICTRP. For additional citations, we examined reference lists of relevant reports and reviews. SELECTION CRITERIA: The studies had to be comparative, i.e., have intervention and comparison groups. The educational component could be counseling or another behavioral strategy to improve contraceptive use among postpartum women. The intervention had to include contact within six weeks postpartum. The comparison condition could be another behavioral strategy to improve contraceptive use, usual care, other health education, or no intervention. Our primary outcomes were postpartum contraceptive use and subsequent pregnancy. DATA COLLECTION AND ANALYSIS: Two authors evaluated abstracts for eligibility and extracted data from included studies. We computed the Mantel-Haenszel odds ratio (OR) for dichotomous outcomes and the mean difference (MD) for continuous measures, both with 95% Confidence Intervals (CI). Where studies used adjusted analyses for continuous outcomes, we presented the results as reported by the investigators. Due to differences in interventions and outcome measures, we did not conduct meta-analysis. To assess the evidence quality, we used the Newcastle-Ottawa Quality Assessment Scale. MAIN RESULTS: Six studies met our inclusion criteria and included a total of 5143 women. Of three studies with self-reported pregnancy data, two showed pregnancy to be less likely in the experimental group than in the comparison group (OR 0.48, 95% CI 0.27 to 0.87) (OR 0.60, 95% CI 0.41 to 0.87). The interventions included a clinic-based counseling program and a community-based communication project.All studies showed some association of the intervention with contraceptive use. Two showed that treatment-group women were more likely to use a modern method than the control group: ORs were 1.77 (95% CI 1.08 to 2.89) and 3.08 (95% CI 2.36 to 4.02). In another study, treatment-group women were more likely than control-group women to use pills (OR 1.78, 95% CI 1.26 to 2.50) or an intrauterine device (IUD) (OR 3.72, 95% CI 1.27 to 10.86) but less likely to use and injectable method (OR 0.23, 95% CI 0.05 to 1.00). One study used a score for method effectiveness. The methods of the special-intervention group scored higher than those of the comparison group at three months (MD 13.26, 95% CI 3.16 to 23.36). A study emphasizing IUDs showed women in the intervention group were more likely to use an IUD (OR 1.79, 95% CI 1.20 to 2.69) and less likely to use no method (OR 0.48, 95% CI 0.31 to 0.75). In another study, contraceptive use was more likely among women in a health service intervention compared to women in a community awareness program at four months (OR 1.79, 95% CI 1.40 to 2.30) or women receiving standard care at 10 to 12 months (OR 2.08, 95% CI 1.58 to 2.74). That study was the only one with a specific component on the lactational amenorrhea method (LAM) that had sufficient data on LAM use. Women in the health service group were more likely than those in the community awareness group to use LAM (OR 41.36, 95% CI 10.11 to 169.20). AUTHORS' CONCLUSIONS: We considered the quality of evidence to be very low. The studies had limitations in design, analysis, or reporting. Three did not adjust for potential confounding and only two had sufficient information on intervention fidelity. Outcomes were self reported and definitions varied for contraceptive use. All studies had adequate follow-up periods but most had high losses, as often occurs in contraception studies.

Service delivery characteristics associated with contraceptive use among youth clients in integrated voluntary counseling and HIV testing clinics in Kenya.

Youth attending voluntary counseling and HIV testing (VCT) services often have unmet need for contraception. Integrated family planning (FP) and HIV services can address dual HIV and unintended pregnancy prevention needs. However, little is known about which VCT service characteristics, such as quality of care, strength of FP-HIV service integration, and youth-friendliness, affect contraceptive behavior. This study explores the facility- and provider-level characteristics that may be associated with same day uptake or intention to use contraception after a VCT visit, and contraceptive use three months later among youth clients, controlling for client characteristics. This was a descriptive study conducted in 20 integrated VCT clinics across Kenya. Data collection included 20 structured clinic observations, 349 baseline interviews with male and female clients aged 15-24 after their VCT visit plus 277 follow-up interviews with clients three months later, and interviews with 46 providers who served the clients at the study clinics. Client, provider, and structured observation data were linked and multi-level logistic path models were used for analyses. Results revealed little evidence of specific service characteristics being associated with contraceptive behavior. However, VCT providers were not routinely screening for risk of unintended pregnancy or counseling on contraception. Results are likely a reflection of suboptimal integrated services. The clinics were serving youth with unmet contraceptive need and therefore integrated services should be strengthened overall to ensure no missed opportunities.

Meeting the needs of adolescent post-abortion care patients in the Dominican Republic.

Counselling on contraception and contraceptive method provision are key components of post-abortion care (PAC). Some studies have suggested that adolescent PAC patients receive worse care than older women seeking these services. This study aimed to evaluate an intervention whose goal was to improve the counselling and contraceptive uptake of PAC patients, with special attention given to the needs of adolescent patients, in the four public hospitals in the Dominican Republic where PAC services were not being routinely offered. The counselling intervention effort included provider training and the development of adolescent-friendly information, education and communication (IEC) materials. Eighty-eight providers were interviewed at baseline and 6 months after the intervention was implemented. Six months after providers were trained, 140 adolescent PAC patients (< or = 19 years of age) and 134 older PAC patients (20-35 years) were interviewed about the contraceptive counselling messages and contraceptive methods they received before they were discharged from hospital. The adolescent and older PAC patients were matched on study hospital and time of arrival. Significant improvements were noted in provider knowledge and attitudes. No changes were noted in provider-reported PAC counselling behaviours, with close to 70% of providers reporting they routinely assess patients' fertility intentions, discuss contraception, assess STI/HIV risk and discuss post-abortion complications. Adolescent and older PAC patients reported receiving PAC counselling messages at similar rates. Forty per cent of adolescent PAC patients and 45% of older PAC patients who wanted to delay pregnancy were discharged with a contraceptive method. Adolescents were more likely to receive an injectable contraceptive method whereas older women were discharged with a variety of methods. The PAC counselling intervention increased provider knowledge and improved their attitudes and benefited both adolescent and older patients.

Nursing Home Design and COVID-19: Balancing Infection Control, Quality of Life, and Resilience.

Many nursing home design models can have a negative impact on older people and these flaws have been compounded by Coronavirus Disease 2019 and related infection control failures. This article proposes that there is now an urgent need to examine these architectural design models and provide alternative and holistic models that balance infection control and quality of life at multiple spatial scales in existing and proposed settings. Moreover, this article argues that there is a convergence on many fronts between these issues and that certain design models and approaches that improve quality of life, will also benefit infection control, support greater resilience, and in turn improve overall pandemic preparedness.

Public and Stakeholder Engagement and the Built Environment: a Review.

PURPOSE OF REVIEW: We review 50 articles from 2015 and 2016 that focus upon public and stakeholder engagement as it pertains to the built environment. Our purpose is to understand the current state of the literature and approaches being used to better enable public and stakeholder engagement. As part of this review, we consider whether recent digital and mobile technologies have enabled advances for stakeholder and public participation. RECENT FINDINGS: The literature suggests some positive and some challenging developments. Researchers clearly suggest that most policy-makers and planners understand, and to some extent, aspire toward enabling more inclusive participatory planning processes. That said, there is far less consensus as to how to make meaningful inclusive participatory processes possible even with digital, as well as more traditional, tools. This lack of consensus is true across all academic disciplines reviewed. We discuss these issues as well as current solutions offered by many scholars. We find that no single solution can be applied to different situations, as contextual factors create different problems in different situations, and that the participation process itself can create biases that can-intentionally or unintentionally-benefit some participants over others. We conclude with a series of questions for practitioners and researchers to consider when evaluating inclusive engagement.

Evidence-Based Strategies for Shortening Informed Consent Forms in Clinical Research.

Long informed consent forms (ICFs) remain commonplace, yet they can negatively affect potential participants' understanding of clinical research. We aimed to build consensus among six groups of key stakeholders on advancing the use of shorter ICFs in clinical research. Partnering with the HIV Prevention Trials Network (HPTN), we used a modified Delphi process with semistructured interviews and online surveys. Concerns about redundancy of information were common. Respondents supported three strategies for reducing ICF length: (a) 91% agreed or strongly agreed with grouping study procedures by frequency, (b) 91% were comfortable or very comfortable with placing supplemental information into appendices, and (c) 93% agreed or strongly agreed with listing duplicate side effects only once. Implementing these strategies will facilitate adoption of the proposed changes to U.S. regulations on ICF length, should they be enacted.

Introducing female condoms to female sex workers in Central America.

CONTEXT: Female condoms have a potential role in reducing HIV infection among female sex workers in Central America. Research on how to introduce female condoms to this population is warranted. METHODS: Two rounds of focus groups with sex workers (115 in round one and 81 in round two) were conducted in El Salvador and Nicaragua in 2007-2008. In addition, we conducted structured interviews with 95 sex workers and direct observations of six health educators. RESULTS: Women reported that the design of the female condom made insertion and removal difficult to learn. About one-third of participants reported inserting it for the first time alone. Most women reported practicing 2-10 times before feeling skilled enough to use it with partners. Positive perceptions included lubrication, size, comfort and strength. Negative perceptions included the large package, initial physical discomfort and the possibility that the device would scare clients away. The participants preferred to learn to use female condoms from an instructional brochure plus instructor-led training in their workplace. They cited lack of exposure to female condoms among men and women as a barrier to female condom use and recommended education for both men and women; they also recommended distribution of female condoms at places where male condoms are available. CONCLUSIONS: If provisions are made for instructing women on female condom use in places where women will not feel stigmatized, and if supplies are easily and consistently available, uptake of the female condom among female sex workers in Central America seems likely. Health educators' use of promotional tools such as checklists and standardized messages is strongly recommended.

Central American sex workers' introduction of the female condom to different types of sexual partners.

Formative research was conducted in El Salvador and Nicaragua to inform promotion of female condoms to sex workers. Two rounds of focus groups with sex workers were conducted, with female condom training and supplies provided. Structured interviews with sex workers and direct observations of health educators were conducted. One third of sex acts were protected with female condoms in the previous 7 days. Women recommended nonpaying partners as "first try" partners but most frequently reported trying female condoms with clients. With clients, women preferred female condoms over male condoms but expressed no preference with nonpaying partners. Lack of exposure to female condoms among men and women was cited as a key barrier to female condom use. Strategies for persuading all partner types to try the female condom are suggested, and we provided promotional messages, based on results, to assist sex workers in introducing female condoms to different partners.

Randomised controlled trial of alternative male and female condom promotion strategies targeting sex workers in Madagascar.

OBJECTIVES: To assess whether individual clinic-based counselling as a supplement to peer education for male and female condom promotion leads to greater use of protection and lower STI prevalence among sex workers in Madagascar already exposed to intensive male condom promotion. METHODS: In two public dispensaries in Madagascar, a total of 901 sex workers were randomly allocated between two alternative male and female condom promotion INTERVENTIONS: peer education only, or peer education supplemented with individual clinic-based counselling. Participants were followed for 12 months. Every 2 months they made clinic visits, where they were interviewed on condom use. Peer educators counselled all participants on condom use as they accompanied their assigned participants to study visits. Participants assigned to receive the supplemental intervention were counselled by a trained clinician following study interviews. Participants were tested and treated for chlamydia, gonorrhoea and trichomoniasis every 6 months. We used logistic regression to assess whether the more intensive intervention was associated with reduced STI prevalence. Use of protection with clients and non-paying partners was assessed by study arm, site, and visit. RESULTS: There was no statistically significant association between study arm and aggregated STI prevalence. No substantial differences in levels of reported protection were noted between study groups. CONCLUSIONS: This study found little evidence for gains from more thorough clinical counselling on male and female condom use. These findings suggest that less clinically intensive interventions such as peer education could be suitable for male and female condom promotion in populations already exposed to barrier method promotion.