An interactive website to aid young women’s choice of contraception: feasibility and efficacy RCT

Background Effective use of contraception can reduce numbers of unintended pregnancies, but misunderstandings and concerns about contraception abound. Increasingly, women seek health-care information online. Objectives To develop an interactive website to aid informed choice of contraceptive method, including long-acting reversible contraception (Phase I), and test its effectiveness in a parallel, single-blind randomised trial (Phase II). Approval came from London – Camden & King’s Cross Research Ethics Committee (reference 17/LO/0112). Setting and participants For both phases, women aged 15–30 years were recruited from general practice, sexual health services, maternity services, community pharmacies and an abortion service. Design In Phase I, we conducted three systematic literature reviews, a review of YouTube (YouTube, LLC, San Bruno, CA, USA) videos about contraception, and focus groups and interviews with young women to explore barriers to and concerns and misperceptions about contraception. We then iteratively co-designed an interactive website, Contraception Choices [URL: www.contraceptionchoices.org (accessed June 2020)], with young women and a software company. In Phase II, we evaluated the website through a randomised trial that began as a feasibility trial. Early demand for Contraception Choices stimulated a design change from a feasibility to an efficacy trial, with follow-up for clinical outcomes at 3 and 6 months. A randomisation list was incorporated into the trial software program to allocate participants to the intervention (website) or control group (standard care). Intervention Contraception Choices is a co-designed, evidence-based, interactive website to aid informed choice of contraception. It provides information about different methods, addresses common concerns and offers tailored contraceptive options in response to individual preferences. Main outcome measures Qualitative – participant views and experience of the intervention, assessed through qualitative interviews. Quantitative primary outcomes – follow-up rate at 6 months in the initial feasibility trial, using a long-acting reversible contraception method, and satisfaction with contraceptive method at 6 months in the efficacy trial. Results A total of 927 women were randomised online to the website (n = 464) or control group (n = 463), of whom 739 (80%) provided follow-up data at 6 months [786 women (85%) provided data at 3 and/or 6 months that were included in the analysis of primary outcomes]. There was little difference between groups in the proportion using long-acting reversible contraception at 6 months [30.4% intervention vs. 31.0% control, adjusted odds ratio after imputation 0.87 (95% confidence interval 0.60 to 1.27)] or in satisfaction with contraceptive method [proportion being ‘satisfied’ or ‘very satisfied’, 82.6% intervention vs. 82.1% control, adjusted odds ratio 0.93 (95% confidence interval 0.69 to 1.25)]. Qualitative evaluation indicated highly positive views about the website and increased knowledge of contraceptive methods that could dispel misperceptions. Women appreciated having information tailored to their specific needs and felt better prepared before consultations. Limitations We did not include intermediate measures, such as knowledge of contraceptive methods, intention to change method or confidence in discussing contraception with a health-care professional, which may have indicated other benefits of using the website. In future, the website should be studied in different settings (e.g. schools and in routine practice) to see whether or not it improves the quality or efficiency of contraceptive consultations. Conclusions Our systematic review indicated wide-ranging influences on women’s use of contraception globally. The website, Contraception Choices, was very popular with young women and contraception service providers. It was not associated with statistically significant differences in use of long-acting reversible contraception or satisfaction with contraceptive method at 6 months. Trial registration Current Controlled Trials ISRCTN13247829. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 56. See the NIHR Journals Library website for further project information.

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Internet-delivered Cognitive-Behavioral Therapy (iCBT) for Adults with Prolonged Grief Disorder (PGD): A Study Protocol for a Randomized Feasibility Trial

BMJ Open ◽

10.1136/bmjopen-2020-046477 ◽

2021 ◽

Vol 11 (7) ◽

pp. e046477

Author(s):

Cintia Tur ◽

Daniel Campos ◽

Rocio Herrero ◽

Sonia Mor ◽

Alba López-Montoyo ◽

...

Keyword(s):

Randomised Trial ◽

Study Participant ◽

Feasibility Trial ◽

Control Group ◽

Depression Symptoms ◽

Prolonged Grief Disorder ◽

Prolonged Grief ◽

Loved One ◽

Face To Face

IntroductionGrief is an emotional reaction to the loss of a loved one with a natural recovery. Approximately 10% of people who lose a loved one develop prolonged grief disorder (PGD). Internet-based and computer-based interventions (ie, internet-delivered cognitive–behavioural therapy, iCBT) are a cost-effective alternative that makes it possible to reach more people with PGD. The main aim of this study is to assess the feasibility of a new iCBT—called GROw—for PGD. As a secondary objective, the potential effectiveness of GROw will be explored.Methods and analysisThis study is a two-arm feasibility randomised trial. A total of 48 adults with PGD who meet the eligibility criteria will be randomised to the experimental group (iCBT: GROw) or the active control group (face-to-face CBT treatment). The treatment is organised sequentially in eight modules in the iCBT format and 8–10 sessions in the face-to-face format, and both formats have the same therapeutic components. There will be five assessment points with qualitative and quantitative evaluations: screening, baseline, after the intervention, 3-month follow-up and 12-month follow-up. Consistent with the objectives, the measures are related to the feasibility outcomes for the main aim of the study (participant adherence, expectations and satisfaction with the treatment, preferences, alliance and utility) and psychological and mental health outcomes for secondary analyses (symptoms of grief, symptoms of depression, symptoms of anxiety, affectivity, quality of life, work and social adaptation, post-traumatic growth, purpose in life, mindfulness and compassion).Ethics and disseminationThe Ethics Committee of the Universitat Jaume I (Castellón, Spain) granted approval for the study (CD/002/2019). Dissemination will include publications and presentations at national and international conferences.Trial registration numberNCT04462146.

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Predictors of contraceptive method discontinuation among adolescent and young women in three West African countries (Burkina Faso, Mali, and Niger)

BMC Women s Health ◽

10.1186/s12905-021-01326-0 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Adja Mariam Ouédraogo ◽

Adama Baguiya ◽

Rachidatou Compaoré ◽

Kadari Cissé ◽

Désiré Lucien Dahourou ◽

...

Keyword(s):

Marital Status ◽

Burkina Faso ◽

Young Women ◽

Contraceptive Method ◽

Occupation Number ◽

Education Level ◽

Demographic And Health Surveys ◽

Contraceptive Methods ◽

Unintended Pregnancies ◽

Contraceptive Discontinuation

Abstract Background The effective use of contraception among adolescents and young women can reduce the risk of unintended pregnancies. However, the prevalence of contraceptive use remains low in this age group. The objective of this study was to estimate the rate of contraceptive method discontinuation among adolescents and young women and to identify its associated factors in Burkina Faso, Mali, and Niger. Method This was a secondary analysis of data from Demographic and Health Surveys of Burkina Faso (2010), Mali (2012–2013), and Niger (2012). The dependent variable was the time to discontinuation of contraceptive methods. Independent variables were represented by sociodemographic, socioeconomic, and cultural characteristics. Mixed-effects survival analysis with proportional hazards was used to identify the predictors. Results A total of 2,264 adolescents and young women aged 15 to 24 years were included in this analysis, comprising 1,100 in Burkina Faso, 491 in Mali, and 673 in Niger. Over the last five years, the overall contraceptive discontinuation rate was 68.7% (50.1% in Burkina Faso, 59.6% in Mali, and 96.8% in Niger). At the individual level, in Burkina Faso, occupation (aHR = 0.33), number of living children (aHR = 2.17), marital status (aHR = 2.93), and region (aHR = 0.54) were associated with contraceptive discontinuation. Except for education and marital status, we found the same factors in Mali. In Niger, a women's education level (aHR = 1.47) and her partner (aHR = 0.52) were associated with discontinuation. At the community level, the region of origin was associated with discontinuation of contraceptive methods. Conclusion Most adolescents and young women experienced at least one episode of discontinuation. Discontinuation of contraceptive methods is associated with the level of education, occupation, number of children, marital status, and desire for children with the spouse. Promotion of contraceptive interventions should target adolescents, young women, and their partners, as well as those with a low education level or in a union.

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A novel brief treatment for methamphetamine use disorders in South Africa: a randomised feasibility trial

Addiction Science & Clinical Practice ◽

10.1186/s13722-020-00209-3 ◽

2021 ◽

Vol 16 (1) ◽

Author(s):

K. Sorsdahl ◽

D. J. Stein ◽

S. Pasche ◽

Y. Jacobs ◽

R. Kader ◽

...

Keyword(s):

South Africa ◽

Controlled Trial ◽

Adverse Outcomes ◽

Feasibility Trial ◽

Control Group ◽

Brief Treatment ◽

Middle Income ◽

Methamphetamine Use ◽

Intention To Treat

Abstract Background Effective brief treatments for methamphetamine use disorders (MAUD) are urgently needed to complement longer more intensive treatments in low and middle income countries, including South Africa. To address this gap, the purpose of this randomised feasibility trial was to determine the feasibility of delivering a six-session blended imaginal desensitisation, plus motivational interviewing (IDMI) intervention for adults with a MAUD. Methods We enrolled 60 adults with a MAUD and randomly assigned them 1:1 to the IDMI intervention delivered by clinical psychologists and a control group who we referred to usual care. Feasibility measures, such as rates of recruitment, consent to participate in the trial and retention, were calculated. Follow-up interviews were conducted at 6 weeks and 3 months post-enrollment. Results Over 9 months, 278 potential particiants initiated contact. Following initial screening 78 (28%) met inclusion criteria, and 60 (77%) were randomised. Thirteen of the 30 participants assigned to the treatment group completed the intervention. Both psychologists were highly adherent to the intervention, obtaining a fidelity rating of 91%. In total, 39 (65%) participants completed the 6-week follow-up and 40 (67%) completed the 3-month follow-up. The intervention shows potential effectiveness in the intention-to-treat analysis where frequency of methamphetamine use was significantly lower in the treatment than in the control group at both the 6 week and 3-month endpoints. No adverse outcomes were reported. Conclusions This feasibility trial suggests that the locally adapted IDMI intervention is an acceptable and safe intervention as a brief treatment for MAUD in South Africa. Modifications to the study design should be considered in a fully powered, definitive controlled trial to assess this potentially effective intervention. Trial registration The trial is registered with the Pan African Clinical Trials Registry (Trial ID: PACTR201310000589295)

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Bone Metabolism Markers and their Correlation with Body Mass Index in Aerobic Physical Activity

SCRIPTA MEDICA ◽

10.7251/scmed1802092b ◽

2018 ◽

Vol 49 (2) ◽

Author(s):

Zorislava Bajić ◽

Nela Rašeta ◽

Nenad Ponorac

Keyword(s):

Physical Activity ◽

Body Mass Index ◽

Bone Formation ◽

Body Mass ◽

Young Women ◽

Intervention Group ◽

Positive Influence ◽

Control Group ◽

Bone Resorption Marker

Introduction: Bone formation marker osteocalcin (OC) and bone resorption marker C-terminal telopeptide of type 1 collagen (CTX) can be used to detect or to monitor the early responses of the skeleton to physical activity. Literature suggests that it is likely that higher body mass index (BMI) has positive effect on bones and can postpone onset of osteoporosis.Aim of the Study: The aim of this study is to:1.Determine the effect of aerobic physical acitivity on OC and CTX in young women2.Investigate correlation of OC, CTX and BMI in young women engaged into structured aerobic excerciseMaterial and methods: Study included 64 healthy young women, aged 19 to 25 years, devided into two groups: intervention group (n=32) and control group (n=32). The study duration was six weeks with follow-up period of four weeks. The intervention group underwent structured aerobic physical activity program for six weeks, but the control group did not receive such program. Level of OC, CTX and BMI were measured at baseline, after 6-week aerobic program, and after 4-week follow up (only intervention group).Results: There was significant increase of OC level after 6-week aerobic program, while level of CTX did not changed. OC level was at its maximum immediately after finishing the program in the participants with normal BMI (p<0.001). There was no statistically significant interaction of BMI and CTX level.Conclusion: Aerobic physical activity increases level of osteocalcin, suggesting that it has positive influence on bone formation in young women, primarily in women with normal BMI.

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Informed choice in modern contraceptive method use: pattern and predictors among young women in India

Journal of Biosocial Science ◽

10.1017/s0021932019000828 ◽

2019 ◽

Vol 52 (6) ◽

pp. 846-859 ◽

Cited By ~ 1

Author(s):

Manas Ranjan Pradhan ◽

Surendra Kumar Patel ◽

Antim Alok Saraf

Keyword(s):

Oral Contraceptive ◽

Side Effects ◽

Young Women ◽

Contraceptive Method ◽

Reproductive Rights ◽

Oral Contraceptive Pill ◽

Informed Choice ◽

Married Women ◽

Modern Contraceptive ◽

Modern Contraceptive Method

AbstractResearch on informed choice in modern contraceptive method acceptance by young married women is pertinent in the broader context of individual freedom and reproductive rights, especially in countries where women continue to have limited control over their reproductive and contraceptive choices. This study in India asked: (1) is young married women’s acceptance of specific modern contraceptive methods an informed choice? and (2) what are the enablers and barriers to informed choice? The study used data for currently married women aged 15–24 (N = 20,752) from the fourth round of the National Family Health Survey (NFHS-4) conducted in 2015–16. A Method Information Index (MII) was calculated as a measure of informed choice from the percentage of users who responded ‘yes’ to all three questions on: whether they were informed about methods other than the one they received, told about the method-specific side-effects, and advised what to do if they experienced side-effects. Binary logistic regression analysis was carried out to examine the adjusted effect of factors associated with the MII separately for female sterilization, the intrauterine device and the oral contraceptive pill, and a combined MII including all three methods plus injectables. One-fifth of the study women used any modern contraceptive method at the time of survey, of which only 36% had fully informed choice. The likelihood of being informed about the methods was significantly higher among those using the oral contraceptive pill (OR: 1.75, CI 1.58–1.94), IUD (OR: 2.23, CI 1.97–2.52) and injectables (OR: 1.37, CI 0.97–1.94) compared with those who were sterilized. Informed choice varied by region and the socioeconomic profile of the users. Inadequately informed choice violates the reproductive rights of young women and might result in higher post-use health problems, discontinuation of and unmet need for contraceptives, unintended pregnancies, induced abortions and regret, adversely affecting women’s health. Training of health/family planning workers in India about the importance of reproductive rights is urgently required to enhance informed contraceptive choice and improve the health of young married women.

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Endoscopic sutured gastroplasty in addition to lifestyle modification: short-term efficacy in a controlled randomised trial

Gut ◽

10.1136/gutjnl-2020-322026 ◽

2020 ◽

pp. gutjnl-2020-322026

Author(s):

Vincent Huberty ◽

Ivo Boskoski ◽

Vincenzo Bove ◽

Pauline Van Ouytsel ◽

Guido Costamagna ◽

...

Keyword(s):

Weight Loss ◽

Lifestyle Modification ◽

Controlled Trial ◽

Randomised Trial ◽

Body Weight Loss ◽

Total Body Weight ◽

Control Group ◽

Short Term ◽

Randomised Controlled

ObjectiveEndoscopic suture gastroplasty (ESG) has been developed as an alternative treatment for moderately obese patients. We present our results of a short-term randomised controlled trial on a new suturing technique, the Endomina system (E-ESG, Endo Tools therapeutics, Belgium).DesignEligible patients (body mass index 30–40 kg/m2) were randomised in a 2:1 ratio to receive lifestyle modification plus E-ESG or lifestyle modification alone (control group); dietetic counselling and follow-up were identical. Endpoints included a mean excess weight loss (EWL) of more than 25% 12 months after E-ESG and a 15% EWL difference at 6 months between groups. At 6 months, a cross-over to E-ESG was offered to the control group. All patients were followed for a total of 12 months after E-ESG.ResultsOf the 71 patients included (five male, mean age 40 years), mean EWL at 6 months was significantly higher in the treatment (38.6%, n=45) than in the control group (13.4%, n=21; p<0.001). At 6 months, satiety tests demonstrated a higher decrease in mean volume (41% vs 2.5%, p<0.001), and mean quality of life (QoL) was also higher in the treatment group (52.8 vs 45.1 p<0.05). No procedure-related or device-related severe adverse events were observed. Twelve months follow-up after E-ESG showed a mean EWL of 45.1%, which translated into a total body weight loss of 11.8%.ConclusionsThis study demonstrates that E-ESG is safe and effective, providing a 25% better EWL at 6 months than lifestyle modification alone. This weight loss was maintained and resulted in a significant improvement in QoL up to 18 months after treatment.Trial registration numberNCT03255005.

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Knowlege and attitudes of long-acting reversible contraceptive methods among young women in Baltimore City

Contraception ◽

10.1016/j.contraception.2011.05.091 ◽

2011 ◽

Vol 84 (3) ◽

pp. 326

Author(s):

R. McDonald-Mosley ◽

K. Severson ◽

A.E. Burke ◽

J. Perritt ◽

R. Jamshidi ◽

...

Keyword(s):

Young Women ◽

Contraceptive Methods ◽

Baltimore City ◽

Long Acting ◽

Long Acting Reversible Contraceptive

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Discontinuation and switching of postpartum contraceptive methods over twelve months in Burkina Faso and the DRC: a secondary analysis of the Yam-Daabo trial

10.21203/rs.3.rs-63481/v2 ◽

2020 ◽

Author(s):

Abou Coulibaly ◽

Tieba Millogo ◽

Adama Baguiya ◽

Nguyen Toan Tran ◽

Rachel Yodi ◽

...

Keyword(s):

Contraceptive Method ◽

Intervention Group ◽

Secondary Analysis ◽

Modern Method ◽

Control Group ◽

Modern Contraceptive ◽

Contraceptive Methods ◽

Modern Methods ◽

Contraceptive Discontinuation ◽

Equal Effectiveness

Abstract Introduction : Women who use contraceptive methods sometimes stop early, use methods intermittently or switched contraceptive methods. All these events (discontinuations and switching) contribute to the occurrence of unwanted and close pregnancies. This study aimed to explore contraceptive discontinuation and switching during the Yam-Daabo project to measure the effect of interventions on the continuation of contraceptive methods use.Methods: We conducted a secondary analysis of the Yam-Daabo trial data. We choose the discontinuation and switching of a modern contraceptive method as outcome measures. We performed a survival analysis by using the Stata software package to estimate the effect of the interventions on contraceptive discontinuation. We also studied the main reasons for discontinuation and switching.Results: In total, 637 out of the 1,120 women used at least one contraceptive method (of any type), with 267 women in the control and 370 in the intervention group. Modern methods were used by 179 women of control group compared to 279 women of intervention group with 24 and 32 who discontinued, respectively. We observed no statistically significant association between interventions and modern methods discontinuation and switching. However, the discontinuation of modern methods was higher in pills and injectables users than implants and IUDs users. The pooled data comparison showed that, in reference to the women who had not switched while using a modern method, the likelihood of switching to a less or equal effectiveness method among the women of the control group was 3.8(95% CI: 1.8-8.0) times the likelihood of switching to a less or equal effectiveness method among the women of the intervention group. And this excess was statistically significant (p<0.001). The main reason for discontinuation and switching was method-related (141 over 199), followed by partner opposition with 20 women.Conclusion: The results of this study show no statistically significant association between interventions and modern methods discontinuation. Discontinuation is more related to the methods themselves than to any other factor. It is also important to set up specific actions targeting women's partners and influential people in the community to counter inhibiting beliefs.Trial registration: Pan African Clinical Trials Registry (PACTR201609001784334, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1784).

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C-Reactive Protein Level Predicts Cardiovascular Risk in Chinese Young Female Population

Oxidative Medicine and Cellular Longevity ◽

10.1155/2021/6538079 ◽

2021 ◽

Vol 2021 ◽

pp. 1-5

Author(s):

Ruifang Liu ◽

Fangxing Xu ◽

Qian Ma ◽

Yujie Zhou ◽

Tongku Liu

Keyword(s):

Cardiovascular Risk ◽

Young Women ◽

Young Female ◽

Control Group ◽

C Reactive Protein ◽

Female Population ◽

Reactive Protein ◽

Coronary Syndrome ◽

Increased Risk

Background. C-reactive protein (CRP) is one of the most common oxidative indexes affected by many diseases. In recent years, there have been many studies on CRP, but the relationship between CRP levels and the cardiovascular risk in the Chinese young female population is still unclear. The purpose of this work is to explore the predictive value of CRP for the cardiovascular risk in the Chinese young female population. Methods. The study is conducted by 1 : 1 case-control to retrospectively analyze 420 young women with acute coronary syndrome (ACS group) who underwent percutaneous coronary intervention (PCI) and 420 young women (control group) who underwent coronary angiography (CAG) to exclude coronary heart disease from January 2007 to December 2016. All patients are divided into three subgroups according to CRP values: subgroup 1: CRP < 1.0 mg / L ( n = 402 ); subgroup 2: 1.0 mg / L ≤ CRP ≤ 3.0 mg / L ( n = 303 ); subgroup 3: CRP > 3.0 mg / L ( n = 135 ). The levels of CRP were observed in the two groups and three subgroups. Results. A total of 840 patients were analyzed. The mean duration of follow-up was 66.37 ± 30.06 months. The results showed that the level of CRP in the ACS group was significantly higher than that in the control group ( 1.30 ± 1.70 vs. 3.33 ± 5.92 , respectively, p < 0.001 ), and patients with higher CRP levels were associated with a significantly increased rate of major adverse cardiovascular events (MACE) (7.0% vs. 8.9% vs. 19.30%, respectively, p < 0.05 ). After adjustment for baseline covariates, CRP level was still an independent predictor for the incidence of MACE, either as a continuous variable or as a categorical variable. There was a significantly higher rate of all-cause mortality and myocardial infarction in patients with higher CRP values during follow-up. Conclusions. The research results show that high CRP is associated with increased risk of ACS in the Chinese young female population. Risk stratification with CRP as an adjunct to predict clinical risk factors might be useful in the Chinese young female population.

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Determinants of long acting contraceptive utilization among hiv positive reproductive age women attending care at art clinics of public health facilities in Arba Minch town, Southern Ethiopia, 2019. A case control study

10.21203/rs.2.20601/v1 ◽

2020 ◽

Author(s):

Betselot Yirsaw ◽

Feleke G Meskel ◽

G-kiros G Michael ◽

Tewoderos Shitemaw

Keyword(s):

Contraceptive Method ◽

Case Control Study ◽

Response Rate ◽

Reproductive Age ◽

Hiv Positive ◽

Contraceptive Methods ◽

Reproductive Age Women ◽

Future Fertility ◽

Long Acting ◽

Control Study

Abstract Background: Long acting and permanent contraceptive methods by far are the most effective, very safe and convenient methods than short acting contraceptive methods. Dual protective which includes use of a reliable hormonal contraceptive method like LAPMs and a barrier method like using the male or female condom is encouraged to prevent further transmission of HIV. But in less developed countries, use of long acting reversible contraceptive or permanent methods (LARCs/PMs) is very low. Therefore the aim of this study was to identify determinants of long acting contraceptive method utilization among HIV positive reproductive age women. Methods: An institutional based case control study was conducted among random sample of 354 HIV positive reproductive age women (total of 97.8% response rate) at Anti-Retroviral Therapy clinics from February 20 to March 20, 2019. Case to control ratio was 1:2. A structured questionnaire and information recorded from ART card review were used to collect the data. Bivariate and Multivariable logistic regression analysis were performed in order to identify the factors significantly associated with long acting contraceptive method utilization at the level of significance of p value <0.25 with 95% CI of COR and <0.05 with 95% CI of AOR respectively.Results: A total of 354 (33.3% cases and 66.7% controls) HIV positive reproductive age women were interviewed with response rate of 97.8%. The study revealed being in age group of 39 and above [AOR=0.17, 95% CI (0.06, 0.48)], being divorced/separated and widowed [AOR=0.05, 95% CI (0.003, 0.61)], having supportive opinion and strongly supportive opinion regarding family planning service availability in ART clinic [AOR= 5.01, 95% CI (1.79, 14.07)], [AOR= 7.81, 95% CI (2.54, 24.01)] and having no future fertility intention [AOR= 7.03, 95% CI (2.73, 18.06)] were statistically significant determinants for long acting contraceptive method utilization.Conclusion: Woman in age group of 39 and above, having no future fertility intention and being divorced/separated and widowed was found to be determinants of long acting contraceptive method utilization among HIV positive reproductive age women. In addition our study support the WHO Strategic Considerations for Strengthening the Linkages between Family Planning and HIV/AIDS Policies, Programs, and Services. Key words: - long acting contraceptive methods, HIV positive reproductive age women, Ethiopia

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