Risk factors for and outcomes of ring expulsions with a 1-year contraceptive vaginal system.

BACKGROUND: The US Food and Drug Administration-approved segesterone acetate and ethinyl estradiol ring-shaped contraceptive vaginal system, known as Annovera (Sever Pharma Solutions/QPharma, Malmö, Sweden), was inserted and removed under a woman's control for a 21 day in and 7 day out regimen for up to 13 cycles of use. OBJECTIVE: We aimed to describe the patterns of ring expulsion over time, to identify potential predictors of expulsion, and to evaluate the impact of expulsions on method discontinuation and pregnancy risk. STUDY DESIGN: Using data from 2064 participants who were enrolled in 2 multinational phase 3 clinical trials on the use of this contraceptive vaginal system, we examined data from participants' daily diaries for documentation of complete ring expulsion. We modeled the odds of reported expulsions over time with adjustment for background and demographic characteristics using mixed-effects logistic regression models with random intercepts. We compared the probability of continuation between those who did and those who did not report expulsions in the first cycle of use using survival analysis and hazards modeling. To determine if expulsions during the first cycle of use affected the risk for pregnancy, we calculated Pearl Indices. RESULTS: Most participants (75%) never experienced any expulsions during any cycle of use, and 91% to 97% did not experience an expulsion during any 1 cycle. The incidence of expulsion was highest in cycle 1 (9%). The odds of experiencing expulsions decreased by half in cycles 2 to 8 when compared with cycle 1 (0.48; 95% confidence interval, 0.40-0.58), and in cycles 9 to 13, expulsions were about a third of that in cycle 1 (0.32; 95% confidence interval, 0.26-0.41). Of those who did experience expulsions, most (62%-84%) experienced ≤2 expulsions per cycle. Participants from study sites in Latin America vs those in the United States had higher odds of not experiencing an expulsion (odds ratio, 1.95; 95% confidence interval, 1.45-2.63). Women with a higher education level had higher odds of experiencing an expulsion. Notably, parity, age, and body mass index were not associated with expulsion. Participants who experienced any expulsions in cycle 1 were more likely to discontinue use early (hazard ratio, 1.28; 95% confidence interval, 1.14-1.43) than participants who did not have an expulsion. The Pearl Index for participants who had expulsions during cycle 1 was 3.99 (95% confidence interval, 1.29-9.31), which was higher than that among participants who reported no expulsions (Pearl Index, 2.39; 95% confidence interval, 1.61-3.41), but the overlapping confidence intervals indicate that there is not sufficient evidence to demonstrate an association between expulsions and pregnancy risk. CONCLUSION: Expulsions were infrequent overall, decreased with subsequent cycles of use, and were not associated with body mass index or parity. Early discontinuation of product use was higher among participants who experienced an expulsion during cycle 1. Although it is unclear whether pregnancy risk was associated with expulsions, early recognition of expulsions among users may identify those at higher risk for discontinuation and may highlight when enhanced anticipatory counselling and guidance may be advantageous.

Application of variance components to the identification of determinants of modern contraceptive use in the Tanzania demographic and health survey data.

BACKGROUND: Over time, demographic and health survey (DHS) data remain valuable to examine variables relating to nationally representative population outcomes for low- and middle-income countries. In Tanzania, there are very limited DHS-based studies on the uptake of Modern Contraceptive Use (MCU). Present studies have focused on measurements at the level of individuals, yet research has shown that MCU variations exists at other levels within populations. In this study, we use a variance component modelling approach to explore variation in MCU at primary sampling unit (PSU) and regional levels while considering survey sample weights. METHODS: Using DHS data from 2016-2017 in Tanzania, we study different variance structures and the respective variation on MCU in a sample of 5263 Women of Reproductive Age (WRA) defined as between the ages of 15-49 years. First, a single variance component was used, followed by its extension to a random coefficient model and we tracked changes in the models. RESULTS: There was an influence of random variations on MCU on the levels of populations much explained by PSU-level clustering than region. On the fixed part, age of a woman, husband education level, desire to have children, and exposure to media and wealth tertiles were important determinants for MCU. Compared to WRA in 15-19 years, the odds of MCU among middle aged women (20-29 and 30-39 years) were 1.94 (95%CI:1.244-3.024) and 2.28 (95%CI:1.372-3.803). Also, increases in media exposure and middle and rich wealth tertiles women led to higher odds for MCU. We also found the presence of random effects influence of wealth tertiles levels on MCU. CONCLUSION: This study highlighted the utility of accounting for variance structures in addressing determinants of MCU while using DHS national level data. Apart from MCU, the DHS data have been widely applied to examine other variables pertaining to public health issues. This approach could be considered a better modelling technique for the DHS studies compared to traditional survey approaches, and to guide hierarchical population-based interventions to increase MCU.

Effect of peer counselling on acceptance of modern contraceptives among female refugee adolescents in northern Uganda: A randomised controlled trial.

BACKGROUND: The unmet need for contraceptives among refugee adolescents is high globally, leaving girls vulnerable to unintended pregnancies. Lack of knowledge and fear of side effects are the most reported reasons for non-use of contraceptives amongst refugee adolescents. Peer counselling, the use of trained adolescents to offer contraceptive counselling to fellow peers, has showed effectiveness in increasing use of contraceptives in non-refugee adolescent resarch. OBJECTIVE: To determine the effect of peer counselling on acceptance of modern contraceptives among female refugee adolescents in northern Uganda. METHODS: A randomised controlled trial carried out in Palabek refugee settlement in northern Uganda, May to July 2019. Adolescents were included if they were sexually active or in any form of union, wanted to delay child bearing, and were not using any contraceptives. A total of 588 consenting adolescents were randomised to either peer counselling or routine counselling, the standard of care. RESULTS: Adolescents who received peer counselling were more likely to accept a contraceptive method compared to those who received routine counselling (PR: 1·24, 95% CI: 1·03 to 1·50, p = 0·023). Adolescents whose partners had attained up to tertiary education were more likely to accept a method than those whose partners had secondary or less education (PR: 1·45, 95% CI: 1·02 to 2·06, p = 0·037). In both groups, the most frequently accepted methods were the injectable and implant, with the commonest reasons for non-acceptance of contraception being fear of side effects and partner prohibition. CONCLUSION: Our data indicates that peer counselling has a positive effect on same day acceptance of modern contraceptives and should therefore be considered in future efforts to prevent adolescent pregnancies in refugee settings. Future peer counselling interventions should focus on how to effectively address adolescents' fear of side effects and partner prohibition, as these factors continue to impede decision making for contraceptive uptake.

Patterns and determinants of modern contraceptive discontinuation among women of reproductive age: Analysis of Kenya Demographic Health Surveys, 2003-2014.

OBJECTIVES: This study aimed to examine patterns and determinants of modern contraceptive discontinuation among women in Kenya. METHODS: Secondary analysis was conducted using national representative Kenya Demographic and Health Surveys of 2003, 2008/9, and 2014. These household cross-sectional surveys targeted women of reproductive age from 15 to 49 years who had experienced an episode of modern contraceptive use within five years preceding the surveys from 2003 (n = 2686), 2008/9 (n = 2992), and 2014 (5919). The contraceptive discontinuation rate was defined as the number of episodes discontinued divided by the total number of episodes. Weighted descriptive statistics, multivariable logistic regression analysis, and Cox proportional hazards analysis were used to examine the determinants of contraceptive discontinuation. RESULTS: The 12-month contraceptive discontinuation rate for all methods declined from 37.5% in 2003 and 36.7% in 2008/9 to 30.5% in 2014. Consistently across the three surveys, intrauterine devices had the lowest 12-month discontinuation rate (6.4% in 2014) followed by implants (8.0%, in 2014). In 2014, higher rates were seen for pills (44.9%) and male condoms (42.9%). The determinants of contraceptive discontinuation among women of reproductive age in the 2003 survey included users of short-term contraception methods, specifically for those who used male condoms (hazard ratio [HR] = 3.30, 95% confidence interval [CI] = 2.13-5.11) and pills (HR = 2.68; 95CI = 1.79-4.00); and younger women aged 15-19 year (HR = 2.07; 95% CI = 1.49-2.87) and 20-24 years (HR = 1.94; 95% CI = 1.61-2.35). The trends in the most common reasons for discontinuation from 2003 to 2014 revealed an increase among those reporting side effects (p = 0.0002) and those wanting a more effective method (p<0.0001). A decrease was noted among those indicating method failure (p<0.0001) and husband disapproval (p<0.0001). CONCLUSIONS: Family planning programs should focus on improving service quality to strengthen the continuation of contraceptive use among those in need. Women should be informed about potential side effects and reassured on health concerns, including being provided options for method switching. The health system should avail a wider range of contraceptive methods and ensure a constant supply of commodities for women to choose from. Short-term contraceptive method users and younger women may need greater support for continued use.

Location and removal of non-palpable subdermal single-rod contraceptive implant.

OBJECTIVE: The objective of the study was to present the experience of the family planning service Hospital General de México, in locating and removing no palpable subdermal single-rod contraceptive implants. MATERIALS AND METHODS: A descriptive, prospective, and cross-sectional study was performed from January 2011 to April 2018. RESULTS: Hundred and sixty-four patients in whom the implant was not palpable were reviewed, the time between insertion and removal averaged 3.3 years (maximum 10 years and minimum 3 months). Three implants were inserted in the right arm, the rest on the left one. Forty-seven implants were found in fatty tissue (29%), 18 in fascia (11%), 94 in muscle (57%), 2 in the armpit (1.2%), and 3 were not found (1.8%). CONCLUSIONS: The no palpable implant is caused by an incorrect insertion technique. Migration should not be assumed as a cause of difficult location. Amount of non-palpable implants is not possible to determine due to a lack of records, but approximately 3% are considered non-palpable. Ultrasound has proven to be the study of choice to locate an incorrect inserted implant. In this case, the total number of implants was located, except in two patients.

OBJETIVO: Presentar la experiencia del servicio de planificación familiar del Hospital General de México Dr. Eduardo Liceaga en la localización y la extracción de implantes anticonceptivos subdérmicos no palpables. MATERIALS Y MÉTODOS: Estudio clínico descriptivo, prospectivo y transversal, realizado desde enero de 2011 hasta abril de 2018 en el servicio de planificación familiar del Hospital General de México Dr. Eduardo Liceaga. RESULTADOS: Se incluyeron 164 pacientes con implantes no palpables, de los cuales 161 se localizaron por ultrasonido. El promedio entre la inserción y el retiro fue de 3.3 años. Tres implantes fueron insertados en el brazo derecho y el resto en el izquierdo; tres no se encontraron. CONCLUSIÓN: Por su fácil acceso y simplicidad, el ultrasonido es el método de elección para localizar implantes profundos no palpables.

Relationship Type and Use of the Vaginal Ring for HIV-1 Prevention in the MTN 020/ASPIRE Trial.

Gender roles and imbalances in sexual power contribute to the heightened HIV-1 risk faced by women in Sub-Saharan Africa. This has led prevention research to focus on the development of female controlled methods. Despite the design of products such as vaginal rings to be used autonomously by women, male partners and women's perceptions of relationships influence HIV prevention choices. To understand the influences that male partners and dyadic dynamics had on the use of the Dapivirine Vaginal Ring in the ASPIRE trial, this analysis of qualitative data explored the types of intimate partner relationships that women engaged in. This paper describes how partners facilitated or challenged women's ring use and how women dealt with these challenges within six different types of relationships characterized by power dynamics and commitment levels. We offer insights into how future use of female-initiated HIV prevention products can be promoted through recognition of different relationship types.

Association between the use of free-of-charge intrauterine devices and a history of induced abortion: a retrospective study.

BACKGROUND: To determine whether use of intrauterine device (IUD) is influenced by a history of induced abortion and the type of contraceptives used until costs are covered. METHODS: We analyzed data from 301 female residents in Mecklenburg-West Pomerania, an economically challenged community. The women, aged between 20 and 35 years, were entitled to receive unemployment benefits, and had access to free-of-charge oral contraceptives, ring or IUD. Cross-sectional data were analyzed using logistic regression. RESULTS: There were 112 (37.2%) women with a history of induced abortion, and 46 (15.3%) reported exclusively using less effective contraceptives (e.g. condoms). In a univariate logistic regression, use of an IUD was associated with a history of having had an induced abortion. Furthermore, uptake of an IUD was associated with women who had, until costs were covered, exclusively choice to use less effective contraceptives (OR = 3.281, 95% CI: 1.717; 6.273). Both associations remained significant in a multivariate model. CONCLUSIONS: Free contraceptives provided to women receiving unemployment benefits may increase the use of IUDs, especially among those with a history of an induced abortion and those using less effective contraceptives.

Evaluating the potential impact and cost-effectiveness of dapivirine vaginal ring pre-exposure prophylaxis for HIV prevention.

BACKGROUND: Expanded HIV prevention options are needed to increase uptake of HIV prevention among women, especially in generalized epidemics. As the dapivirine vaginal ring moves forward through regulatory review and open-label extension studies, the potential public health impact and cost-effectiveness of this new prevention method are not fully known. We used mathematical modeling to explore the impact and cost-effectiveness of the ring in different implementation scenarios alongside scale-up of other HIV prevention interventions. Given the knowledge gaps about key factors influencing the ring's implementation, including potential uptake and delivery costs, we engaged in a stakeholder consultation process to elicit plausible parameter ranges and explored scenarios to identify the possible range of impact, cost, and cost-effectiveness. METHODS AND FINDINGS: We used the Goals model to simulate scenarios of oral and ring pre-exposure prophylaxis (PrEP) implementation among female sex workers and among other women ≤21 years or >21 years with multiple male partners, in Kenya, South Africa, Uganda, and Zimbabwe. In these scenarios, we varied antiretroviral therapy (ART) coverage, dapivirine ring coverage and ring effectiveness (encompassing efficacy and adherence) by risk group. Following discussions with stakeholders, the maximum level of PrEP coverage (oral and/or ring) considered in each country was equal to modern contraception use minus condom use in the two age groups. We assessed results for 18 years, from 2018 to 2035. In South Africa, for example, the HIV infections averted by PrEP (ring plus oral PrEP) ranged from 310,000 under the highest-impact scenario (including ART held constant at 2017 levels, high ring coverage, and 85% ring effectiveness) to 55,000 under the lowest-impact scenario (including ART reaching the UNAIDS 90-90-90 targets by 2020, low ring coverage, and 30% ring effectiveness). This represented a range of 6.4% to 2.2% of new HIV infections averted. Given our assumptions, the addition of the ring results in 11% to 132% more impact than oral PrEP alone. The cost per HIV infection averted for the ring ranged from US$13,000 to US$121,000. CONCLUSIONS: This analysis offers a wide range of scenarios given the considerable uncertainty over ring uptake, consistency of use, and effectiveness, as well as HIV testing, prevention, and treatment use over the next two decades. This could help inform donors and implementers as they decide where to allocate resources in order to maximize the impact of the dapivirine ring in light of funding and implementation constraints. Better understanding of the cost and potential uptake of the intervention would improve our ability to estimate its cost-effectiveness and assess where it can have the most impact.

Dapivirine vaginal ring for HIV prevention: modelling health outcomes, drug resistance and cost-effectiveness.

INTRODUCTION: A vaginal ring containing dapivirine is effective for HIV prevention as pre-exposure prophylaxis (PrEP). We evaluated the potential epidemiological impact and cost-effectiveness of dapivirine vaginal ring PrEP among 22- to 45-year-old women in KwaZulu-Natal, South Africa. METHODS: Using mathematical modelling, we studied dapivirine vaginal ring PrEP implementation, either unprioritized, or prioritized based on HIV incidence (≥3% per year), age (22 to 29 years) or female sex worker status, alongside the implementation of voluntary medical male circumcision and antiretroviral therapy scaled-up to UNAIDS Fast-Track targets. Outcomes over the intervention (2019 to 2030) and lifetime horizons included cumulative HIV infections, life-years lived, costs and cost-effectiveness. We assessed the incremental cost-effectiveness ratios against the revealed willingness to pay ($500) and the standard (2017 per capita gross domestic product; $6161) cost-effectiveness thresholds for South Africa. RESULTS: Compared to a reference scenario without PrEP, implementation of dapivirine vaginal ring PrEP, assuming 56% effectiveness and covering 50% of 22 to 29-year-old or high-incidence women, prevented 10% or 11% of infections by 2030 respectively. Equivalent, unprioritized coverage (30%) prevented fewer infections (7%), whereas 50% coverage of female sex workers had the least impact (4%). Drug resistance attributable to PrEP was modest (2% to 4% of people living with drug-resistant HIV). Over the lifetime horizon, dapivirine PrEP implementation among female sex workers was cost-saving, whereas incidence-based PrEP cost $1898 per life-year gained, relative to PrEP among female sex workers and $989 versus the reference scenario. In a scenario of 37% PrEP effectiveness, PrEP had less impact, but prioritization to female sex workers remained cost-saving. In uncertainty analysis, female sex worker PrEP was consistently cost-saving; and over the lifetime horizon, PrEP cost less than $6161 per life-year gained in over 99% of simulations, whereas incidence- and age-based PrEP cost below $500 per life-year gained in 61% and 49% of simulations respectively. PrEP adherence and efficacy, and the effectiveness of antiretroviral therapy for HIV prevention, were the principal drivers of uncertainty in the cost-effectiveness of PrEP. CONCLUSIONS: Dapivirine vaginal ring PrEP would be cost-saving in KwaZulu-Natal if prioritized to female sex workers. PrEP's impact on HIV prevention would be increased, with potential affordability, if prioritized to women by age or incidence.

Young Women's Stated Preferences for Biomedical HIV Prevention: Results of a Discrete Choice Experiment in Kenya and South Africa.

BACKGROUND: Integrating end-user perspectives into the design of new biomedical HIV prevention products is recognized as vital to informing the product development pipeline. SETTING: Kisumu, Kenya; and Soshanguve, South Africa. METHODS: We conducted a discrete choice experiment survey with 536 women aged 18-30 years to assess preferences for hypothetical HIV prevention products characterized by the attributes of efficacy, pregnancy prevention, delivery form, dosing frequency, and side effects. Participants included product-experienced women from Tablet, Ring, Injection as Options TRIO, a cross-over clinical study evaluating 3 placebo delivery forms (oral tablets, vaginal rings, and injections), and a product-naive sample recruited from the same communities. Analyses used random parameters logit and latent class models. RESULTS: HIV prevention efficacy was a strong determinant of stated choice overall; however, in South Africa, delivery form was just as important, with an injection every 2-3 months most preferred and a daily oral tablet least preferred. In Kenya, product-experienced women preferred monthly injections and least preferred a monthly ring. Respondents indicated a preference for multipurpose prevention technologies that combine HIV and pregnancy protection. Latent class analyses confirmed these findings and delineated heterogeneity in preferences across subgroups defined by age, past experience with the delivery forms, and education. CONCLUSIONS: Despite an overall preference for products with high efficacy, we identified attributes salient to future uptake and use of HIV prevention products. Preferences for injectable products underscored interest in this pre-exposure prophylaxis delivery form. Likewise, the multipurpose prevention technology feature was valued in both Kenya and South Africa and most influenced interest in vaginal rings.

The relationship between vaginal ring use and intimate partner violence and social harms: formative research outcomes from the CHARISMA study in Johannesburg, South Africa.

Despite being designed for autonomous use, research suggests partner approval is often in women's microbicide use. Microbicide study participants have described many ways product use affects relationships, from improving sexual pleasure to increasing harm, including exacerbating intimate partner violence (IPV). As the dapivirine ring proceeds closer to licensure, supporting women's agency to use microbicides safely is a priority. We conducted 42 in-depth interviews with former participants of the Microbicide Trials Network (MTN)-020 trial of the dapivirine vaginal ring and their male partners in Johannesburg, South Africa, to explore how ring use and partnership dynamics interacted. We sampled women who reported harms or partner non-support and women with supportive partners. Male and female narratives revealed high background levels of IPV. Women described how study participation/ring use exacerbated violence, and for a few couples served as a rationale for additional abuse. In response, women described feeling powerless and fearful of conflict, resulting in product nonuse. For one participant violence was reduced, and for several others, empowerment was sparked. These findings suggest future providers have the opportunity to shift more women from a place of fear/violence to one of safety/empowerment through the integration of IPV screening and relationship counselling.

Non-use of Contraception by Canadian Youth Aged 15 to 24: Findings From the 2009-2010 Canadian Community Health Survey.

OBJECTIVES: Non-use of contraception is an important contributor to unintended pregnancy. This study assessed non-use of contraception and its determinants among Canadian youth aged 15 to 24. METHODS: Data from the 2009-2010 Canadian Community Health Survey respondents aged 15 to 24 were used to identify non-users of contraception among heterosexual youth who had had intercourse within the previous 12 months, were not pregnant or sterilized, and felt it was important to avoid pregnancy. Sociodemographic, behavioural, and geographic factors were compared for non-users and users of contraception. RESULTS: Among youth at risk for unintended pregnancy, 15.5% were non-users of contraception. There were no differences between sexes. Across regions of Canada, Quebéc had the highest proportion of at-risk youth, but at-risk Quebéc youth were the least likely to be non-users (7.4%; CI 5.7%-9.0%) compared with at-risk youth in the Territories (28.3%; CI 21.6%-35.0%). In the multivariable analysis, aside from residence outside of Quebéc, younger age, lower income, Aboriginal identification (adjusted OR [aOR] 1.67; CI 1.18-2.37), and smoking (aOR 1.55; CI 1.24-1.92) were associated with non-use. Canadian-born youth (aOR 0.61; CI 0.39-0.96) and those enrolled in school (aOR 0.63; CI 0.50-0.81) were less likely to be non-users. CONCLUSION: The 15.5% of Canadian youth at risk for unintended pregnancy who were non-users of contraception represent an estimated 300 000 Canadian youth. Policies and programs to promote and support access to sexual health services and effective contraception with specific attention to supporting the needs of younger teens, Aboriginal youth, newcomers, low-income youth, and youth who are not in school are needed.

Put a Ring in It: Exploring Women's Experiences with the Contraceptive Vaginal Ring in Ontario.

BACKGROUND: Although the contraceptive vaginal ring (CVR) has been available in Canada since 2001, overall use and availability remain low compared with other combined hormonal contraceptive methods. We aimed to explore women's experiences with the CVR in Ontario as well as factors that influenced their decisions to choose the method and continue/discontinue use. METHODS: We conducted a multimethod qualitative study that consisted of an anonymous online survey and in-depth telephone interviews with a subset of survey participants. We used descriptive statistics to analyze the survey data and analyzed our interviews for content and themes using both deductive and inductive techniques. RESULTS: From May to July 2015, we received 103 survey responses and conducted 29 in-depth interviews. Many participants described positive experiences with the CVR and found it to be an especially convenient method. Women who discontinued use of the CVR cited high costs, access barriers, and negative media reports as important factors in their decision. Our participants primarily relied on their physicians for contraceptive information but did not feel fully informed about potential side effects. Several women identified the CVR as an "in between" method in the transition from oral contraceptive pills to the intrauterine device. CONCLUSIONS: Our findings suggest that the CVR represents a convenient and desirable contraceptive option for some women. However, participants expressed a desire for health care providers to provide more comprehensive information about a full range of contraceptive methods. Improving access to a full range of low-cost contraceptives in Ontario seems to be warranted.

Immediate versus delayed postpartum insertion of contraceptive implant for contraception.

BACKGROUND: The spacing of pregnancies has a positive impact on maternal and newborn health. The progestin contraceptive implant, which is a long-acting, reversible method of contraception, has a well-established low failure rate that is compatible with tubal sterilization. The standard provision of contraceptive methods on the first postpartum visit may put some women at risk of unintended pregnancy, either due to loss to follow-up or having sexual intercourse prior to receiving contraception. Therefore, the immediate administration of contraception prior to discharge from the hospital that has high efficacy may improve contraceptive prevalence and prevent unintended pregnancy. OBJECTIVES: To compare the initiation rate, effectiveness, and side effects of immediate versus delayed postpartum insertion of implant for contraception. SEARCH METHODS: We searched for eligible studies up to 28 October 2016 in the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and POPLINE. We examined review articles and contacted investigators. We also checked registers of ongoing clinical trials, citation lists of included studies, key textbooks, grey literature, and previous systematic reviews for potentially relevant studies. SELECTION CRITERIA: We sought randomised controlled trials (RCTs) that compared immediate postpartum versus delayed insertion of contraceptive implant for contraception. DATA COLLECTION AND ANALYSIS: Two review authors (JS, YW) independently screened titles and abstracts of the search results, and assessed the full-text articles of potentially relevant studies for inclusion. They extracted data from the included studies, assessed risk of bias, compared results, and resolved disagreements by consulting a third review author (PL or SK). We contacted investigators for additional data, where possible. We computed the Mantel-Haenszel risk ratio (RR) with 95% confidence interval (CI) for binary outcomes and the mean difference (MD) with 95% CI for continuous variables. MAIN RESULTS: Three studies that included 410 participants met the inclusion criteria of the review. We did not identify any ongoing trials. Two included studies were at low risk of selection, attrition, and reporting biases, but were at high risk of performance and detection biases due to the inability to blind participants to the intervention. One included study was at high risk of attrition bias. The overall quality of the evidence for each comparison ranged from very low to moderate; the main limitations were risk of bias and imprecision.Initiation rate of contraceptive implants at the first postpartum check-up visit was significantly higher in the immediate insertion group than in the delayed insertion group (RR 1.41, 95% CI 1.28 to 1.55; three studies, 410 participants; moderate quality evidence).There appeared to be little or no difference between the groups in the continuation rate of contraceptive implant used at six months after insertion (RR 1.02, 95% CI 0.93 to 1.11; two studies, 125 participants; low quality evidence) or at 12 months after insertion (RR 1.04; 95% CI 0.81 to 1.34; one study, 64 participants;very low quality evidence)Women who received an immediate postpartum contraceptive implant insertion had a higher mean number of days of abnormal vaginal bleeding within six weeks postpartum (MD 5.80 days, 95% CI 3.79 to 7.81; one study, 215 participants; low quality evidence) and a higher rate of other side effects in the first six weeks after birth (RR 2.06, 95% CI 1.38 to 3.06; one study, 215 participants; low quality evidence) than those who received a delayed postpartum insertion. There appeared to be little or no difference between the groups in heavy, irregular vaginal bleeding or associated severe cramping within 12 months (RR 1.01, 95% CI 0.72 to 1.44, one study, 64 participants;very low quality evidence).It was unclear whether there was any difference between the groups in scores for participant satisfaction on a 0-10 scale (MD -0.40, 95% CI -1.26 to 0.46, low quality evidence), or in rates of unintended pregnancy (RR 1.82, 95% CI 0.38 to 8.71, 1 RCT, 64 women, very low quality evidence) at 12 months, or in rate of breastfeeding rate at six months (RR 2.01, 95% CI 0.72 ro 5.63, 1 RCT, 64 women, very low quality evidence) rate did not differ significantly between the groups. AUTHORS' CONCLUSIONS: Evidence from this review indicates that the rate of initiation of contraceptive implant at the first postpartum check-up visit was higher with immediate postpartum insertion than with delayed insertion. There appeared to be little or no difference between the groups in the continuation rate of contraceptive implant use at 6 months. It was unclear whether there was any difference between the groups in continuation of contraceptive use at 12 months or in the unintended pregnancy rate at 12 months.

Acceptability and use of a dapivirine vaginal ring in a phase III trial.

BACKGROUND: The MTN-020/ASPIRE trial evaluated the safety and effectiveness of the dapivirine vaginal ring for prevention of HIV-1 infection among African women. A nested qualitative component was conducted at six of 15 study sites in Uganda, Malawi, Zimbabwe and South Africa to evaluate acceptability of and adherence to the ring. METHOD: Qualitative study participants (n = 214) were interviewed with one of three modalities: single in-depth interview, up to three serial interviews or an exit Focus Group Discussion. Using semistructured guides administered in local languages, 280 interviews were audio-recorded, transcribed, translated, coded and analyzed. RESULTS: We identified three key findings: first, despite initial fears about the ring's appearance and potential side effects, participants grew to like it and developed a sense of ownership of the ring once they had used it. Second, uptake and sustained adherence challenges were generally overcome with staff and peer support. Participants developed gradual familiarity with ring use through trial progression, and most reported that it was easy to use and integrate into their lives. Using the ring in ASPIRE was akin to joining a team and contributing to a broader, communal good. Third, the actual or perceived dynamics of participants' male partner relationship(s) were the most consistently described influence (which ranged from positive to negative) on participants' acceptability and use of the ring. CONCLUSION: It is critical that demonstration projects address challenges during the early adoption stages of ring diffusion to help achieve its potential public health impact as an effective, long-acting, female-initiated HIV prevention option addressing women's disproportionate HIV burden.

Short Interpregnancy Intervals: Results from the First Baby Study.

BACKGROUND: Short interpregnancy interval (SIPI), defined as 18 months or fewer between delivery and subsequent conception, has become an independent marker of maternal and child health. METHODS: We performed a secondary analysis of 18 months of data from The First Baby Study, a prospective cohort of women followed from pregnancy through 3 years after their first birth. Women with SIPIs by 6, 6 to 12, and 12 to 18 months were compared with those without conceptions at those times. We then analyzed pregnancy intention of the subpopulation of women with a SIPI of 18 months or fewer. Logistic regression analyses determined associations between maternal characteristics, including sociodemographic and reproductive indicators, and SIPI incidence and intention. FINDINGS: Of 3,006 participants, 795 (26.5%) had a repeat pregnancy within 18 months: 58 (1.9%) occurred within 6 months, 242 (8.1%) between 6 and 12 months, and 495 (16.5%) between 12 and 18 months. Incidence of SIPI at each interval differed by maternal characteristics, including income, marital status, and intention. Most women (84%) with a SIPI of 6 months or less classified them as unintended. Less than 2% of women with SIPIs of 18 months or fewer reported any contraceptive use in the postpartum period and no pregnancies occurred with the use of very effective methods, including long-acting reversible contraception. CONCLUSIONS: The population of women at risk for SIPI is not homogenous. Among those with SIPIs, there is a stark contrast in intention between those who conceive early (≤6 months) versus later (≥12 months). Given that almost no pregnancies occurred when women used postpartum contraception, contraceptive counseling and unfettered access should be available for those at greatest risk for an early, repeat, unintended pregnancy.

Efficacy and side-effects profile of the ethinylestradiol and etonogestrel contraceptive vaginal ring: a systematic review and meta-analysis.

OBJECTIVE: To assess the efficacy and tolerability (side-effects profile), and compliance of the combined contraceptive vaginal ring (CCVR) compared with combined oral hormonal contraceptives (COC). DATA SOURCES: The PubMed, Embase, POPLINE, Cochrane Central Register of Controlled Trials (CENTRAL), LILACS, ClinicalTrials.gov, Clinical Trials Registry Platform (ICTRP) and CINAHL databases were searched. METHODS OF STUDY SELECTION: Electronic databases were searched for randomised clinical trials comparing the CCVR with COC with a duration of at least 3 months between 01 December and 15 December 2015. The primary outcome was efficacy. The secondary outcomes were compliance, absence of withdrawal bleeding, breakthrough bleeding, nausea and headache. Heterogeneity was assessed using I2 statistic and Cochran's Q statistic. Results were expressed as odds ratios (OR) with 95% confidence intervals (CIs) using random-effects models or fixed-effects models depending on the heterogeneity. RESULTS: 4368 records were identified, 2844 of which were removed after duplicates and 1524 records were screened. Of these, 1503 were excluded and 21 full text articles were assessed for eligibility. After removing another 7 articles, 14 records were finally included in the qualitative and quantitative analysis. The results show a trend to higher efficacy for the CCVR in preventing pregnancy (Peto OR: 0.52 [95% CI: 0.26-1.04]) and a significantly lower presence of nausea (Peto OR: 0.66 [95% CI: 0.46-0.93]). More cycles were compliant in the CCVR group (Peto OR: 1.22 [95% CI: 1.12-1.32]) and fewer women reported breakthrough bleeding (Peto OR: 0.68 [95% CI: 0.51-0.91]). CONCLUSIONS: Our findings demonstrate that the CCVR is as effective and tolerable as the COC but with a better bleeding profile.

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.

Intrauterine Contraception Continuation in Adolescents and Young Women: A Systematic Review.

STUDY OBJECTIVE: Adolescents are at high risk for unintended pregnancies. Although intrauterine devices (IUDs), long-acting reversible contraceptives (LARCs), are known to be highly effective in preventing pregnancy, little is known about IUD adherence in adolescents. In this systematic review (SR) we examined IUD continuation rates compared with other forms of contraception in young women aged 25 years and younger. DESIGN, SETTING, PARTICIPANTS, INTERVENTIONS, AND MAIN OUTCOME MEASURES: A systematic search of Ovid Medline, Cochrane Library, and Embase was conducted for the years 1946-2015. Included studies examined IUD use in women 25 years of age and younger, compared IUD use with another form of contraception, and measured continuation rates at 12 months. The quality of each study was appraised using the Downs and Black criteria, and 12-month continuation rates among studies were pooled and analyzed according to contraceptive type. RESULTS: Of 3597 articles retrieved, 9 studies met criteria for SR. Synthesized across studies, 12-month continuation was significantly higher for IUD users (86.5%, 12,761/14,747) compared with oral contraceptives (39.6%, 1931/4873), Depo-Provera (Pfizer Inc, New York, NY) hormonal injection (39.8%, 510/1282), vaginal ring (48.9%, 196/401), and transdermal patch (39.8%, 37/93; all P values < .001). There was no statistically significant difference in 12-month continuation between the IUD and another LARC method, the subdermal etonogestrel implant (85.3%, 4671/5474). CONCLUSION: Findings of this SR suggest that continuation rates for IUDs are generally higher compared with other contraceptive methods for women aged 25 years and younger. In a population with high rates of unintended pregnancies, generally low adherence, and imperfect use with other non-LARCs, IUD use should be encouraged.