Evaluating a Longitudinal Cohort of Clinics Engaging in the Family Planning Elevated Contraceptive Access Program: Study Protocol for a Comparative Interrupted Time Series Analysis.
ABSTRACT: BACKGROUND:Access to high-quality, comprehensive contraceptive care is an inherent component of reproductive human rights. However, hindrances to specific aspects of contraceptive provision, including availability, accessibility, acceptability, and quality, continue to perpetuate unmet needs. The state of Utah has recently passed a series of contraceptive policies intended to improve contraceptive access. Despite these positive changes to theoretical access, fiscal appropriations to support the implementation of these policies have been minimal, and many individuals still struggle to access contraception. OBJECTIVE:The Family Planning Elevated Contraceptive Access Program (FPE CAP), part of a larger statewide contraceptive initiative, specifically aims to improve contraceptive access within health clinics. This paper describes the study protocol for evaluating the success of FPE CAP. METHODS:Health clinics apply for membership in the FPE CAP. On acceptance in the program, they receive a cash grant for clinical supplies, equipment, and personnel expenses; reimbursement for contraceptive services and methods for eligible clients; technical support, training, and proctoring on counseling and providing all methods of contraception; method stocking of intrauterine devices and implants; and demand generation activities, including local media campaigns, to inform community members about the FPE CAP and possible eligibility. FPE collects monthly service delivery reports from participating clinics for evaluation purposes. The primary outcomes of FPE CAP are level and trend changes in contraceptive service delivery among individuals earning ?138% federal poverty level (FPL) following membership in FPE CAP and among FPE CAP clients earning between 139% and 250% FPL (including those ineligible for Medicaid) compared with historical data and control clinics. To assess this, we will conduct comparative interrupted time series analyses assessing the level and trend changes in intervention and control clinics 12 months before the intervention, for the 2-year duration of the intervention, and for the subsequent 12 months following the intervention. RESULTS:We found that the study is adequately powered (>80% power) with our planned number of clinics and the number of months of data available in the study. To date, we have successfully completed the recruitment and enrollment of 8 of the expected 9 health organizations and 4 of the control clinics. Completed health organization enrollment for both intervention and control organizations is expected to be completed in December 2020. CONCLUSIONS:The study aims to provide insight into a new approach to contraceptive initiatives by addressing comprehensive aspects of contraceptive care at the health system level. Ongoing state policy changes and implementation components may affect the evaluation outcomes. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/18308.
Project description:INTRODUCTION:Many individuals in the USA do not have access to the contraceptive methods they desire. Contraceptive initiatives have emerged at the state and national levels to remove barriers to access, and many initiatives have reported success. Other initiatives may want to build on or replicate that success, but data are scarce on the details of how and why certain interventions work. This paper describes the protocol for the planned process evaluation of Family Planning Elevated (FPE), a statewide contraceptive initiative in Utah. METHODS:FPE will conduct a process evaluation during the planning and implementation phases of the programme. The process evaluation will document (1) the community, state and national contexts in which the programme is implemented, (2) how FPE is implemented and (3) the mechanism by which FPE creates impact. We will collect qualitative data via interviews with FPE staff, providers and staff participating in the programme, and key stakeholders and policy-makers throughout the state. The team process evaluator will record FPE decision making and implementation activities by taking field notes during weekly FPE meetings. Quantitatively, we will collect monthly data reports from FPE-participating clinics, analytics reports from the media campaign and survey results from patients in FPE-participating clinics. The findings of the process evaluation will allow other contraceptive initiatives to learn from FPE's efforts and replicate successful components of the programme. ETHICS AND DISSEMINATION:The study received approval from the University of Utah's Institutional Review Board. Findings from the process evaluation and outcome evaluation will be published, shared with other contraceptive initiatives and presented at conferences. TRIAL REGISTRATION NUMBER:NCT03877757.
Project description:Avoiding unintended pregnancies is important for the health of adolescents living with HIV and has the additional benefit of preventing potential vertical HIV transmission. Health facility providers represent an untapped resource in understanding the barriers and facilitators adolescents living with HIV face when accessing contraception. By understanding these barriers and facilitators to contraceptive use among adolescent females living with HIV, this study aimed to understand how best to promote contraception within this marginalized population.We conducted structured in-depth interviews with 40 providers at 21 Family AIDS Care & Education Services - supported clinics in Homabay, Kisumu and Migori counties in western Kenya from July to August 2014. Our interview guide explored the providers' perspectives on contraceptive service provision to adolescent females living with HIV with the following specific domains: contraception screening and counselling, service provision, commodity security and clinic structure. Transcripts from the interviews were analyzed using inductive content analysis.According to providers, interpersonal factors dominated the barriers adolescent females living with HIV face in accessing contraception. Providers felt that adolescent females fear disclosing their sexual activity to parents, peers and providers, because of repercussions of perceived promiscuity. Furthermore, providers mentioned that adolescents find seeking contraceptive services without a male partner challenging, because some providers and community members view adolescents unaccompanied by their partners as not being serious about their relationships or having multiple concurrent relationships. On the other hand, providers noted that institutional factors best facilitated contraception for these adolescents. Integration of contraception and HIV care allows easier access to contraceptives by removing the stigma of coming to a clinic solely for contraceptive services. Youth-friendly services, including serving youth on days separate from adults, also create a more comfortable setting for adolescents seeking contraceptive services.Providers at these facilities identified attitudes of equating seeking contraceptive services with promiscuity by parents, peers and providers as barriers preventing adolescent females living with HIV from accessing contraceptive services. Health facilities should provide services for adolescent females in a youth-friendly manner and integrate HIV and contraceptive services.
Project description:Objective:This study investigated the attitude of Korean physicians toward women's access to emergency contraceptive pills (ECPs) and the reclassification of ECP to a behind-the-counter (BTC) drug. Methods:This study involved 946 physicians who had prescribed ECP in South Korea. The written questionnaires were completed by obstetricians and gynecologists, family physicians, internal medicine doctors, and pediatricians. Results:Regarding the barriers limiting women's access to ECP, 24.8% of physicians responded that women lacked information about ECP and 22.5% felt that women were likely to be emotionally burdened by visits to clinics or hospitals to obtain ECP prescriptions. Ninety-two percent of physicians responded that ECP should remain a prescription drug while 6.1% stated preferences for a switch to a BTC drug. Physicians who opposed the switch were concerned about the potential abuse of ECP. In order to prevent ECP abuse, the most important factor to be considered was education on contraception. Conclusion:A majority of Korean physicians opposed the reclassification of ECP to a BTC drug owing to their belief in increasing the role of educational initiatives about contraception and contraceptive practices before improving the access to ECP. This study is also of the opinion that contraceptive education for youth and adults in Korea should be more realistic and active, with an emphasis on regular contraception use before reclassification. Furthermore, we believe that efforts are needed to ensure accuracy of information on contraception to facilitate women's access to ECP.
Project description:INTRODUCTION:Oral emergency contraception (EC) can prevent unintended pregnancy but it is important to start a regular method of contraception. Women in the UK usually access EC from a pharmacy but then need a subsequent appointment with a general practitioner or a sexual and reproductive health (SRH) service to access regular contraception. Unintended pregnancies can occur during this time. METHODS AND ANALYSIS:Bridge-It is a pragmatic cluster randomised cohort cross-over trial designed to determine whether pharmacist provision of a bridging supply of a progestogen-only pill (POP) plus rapid access to a local SRH clinic, results in increased uptake of effective contraception and prevents more unintended pregnancies than provision of EC alone. Bridge-It involves 31 pharmacies in three UK regions (London, Lothian and Tayside) aiming to recruit 626-737 women. Pharmacies will give EC (levonorgestrel) according to normal practice and recruit women to both intervention and the control phases of the study. In the intervention phase, pharmacists will provide the POP (desogestrel) and offer rapid access to an SRH clinic. In the control phase, pharmacists will advise women to attend a contraceptive provider for contraception (standard care).Women will be asked 4?months later about contraceptive use. Data linkage to abortion registries will provide abortion rates over 12 months. The sample size is calculated on the primary outcome of effective contraception use at 4?months (yes/no) with 90% power and a 5% level of significance. Abortion rates will be an exploratory secondary analysis. Process evaluation includes interviews with pharmacists, SRH clinicians and women. Cost-effectiveness analysis will use a healthcare system perspective and be expressed as incremental cost-effectiveness ratio. ETHICS AND DISSEMINATION:Ethical approval was received from South East Scotland REC June 2017. Results will be published in peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER:ISRCTN70616901.
Project description:As access to antiretroviral therapy increases, more HIV-infected patients in sub-Saharan Africa may desire fertility. We conducted a cross-sectional study of reproductive health knowledge, attitudes and practices to identify factors associated with desired fertility among women and men receiving care at two large public HIV clinics in Lilongwe, Malawi. Research assistants administered questionnaires to participants. We performed descriptive, bivariable and multivariable analysis of factors related to desired fertility and of factors related to contraceptive non-use among participants who did not desire fertility. One-third of participants desired future children. Having a partner who desired fertility and having lower parity were associated with desiring children among both genders. For women, believing that pregnancy was unhealthy was associated with decreased fertility desire. Fifty-five percent of women and 69% of men who did not want children in the future reported using contraception at last intercourse. Increasing age, lower parity, and making the decision to use contraception herself were associated with contraceptive non-use among women who did not desire fertility. Having discussed family planning with his partner was associated with contraceptive use among men who did not desire fertility. Knowledge of these factors can guide reproductive health counseling and service provision.
Project description:Unintended pregnancy is associated with poorer health outcomes for women and their families. In Tajikistan, around 26% of married 15-24 year old women have an unmet need for contraception. There is some evidence that interventions delivered by mobile phone can affect contraceptive-related behaviour and knowledge. We developed an intervention delivered by mobile phone app instant messaging to improve acceptability of effective contraceptive methods among young people in Tajikistan.This was a randomized controlled trial among Tajik people aged 16-24. Participants allocated to the intervention arm had access to an app plus intervention messages. Participants allocated to the control arm had access to the app plus control messages. The primary outcome was acceptability of at least one method of effective contraception at 4 months. Secondary outcomes were use of effective contraception at 4 months and during the study, acceptability of individual methods, service uptake, unintended pregnancy and induced abortion. Process outcomes were knowledge, perceived norms, personal agency and intention. Outcomes were analysed using logistic and linear regression. We conducted a pre-specified subgroup analysis and a post-hoc analysis of change in acceptability from baseline to follow-up.Five hundred and seventy-three participants were enrolled. Intervention content was included on the app, causing contamination. Four hundred and seventy-two (82%) completed follow-up for the primary outcome. There was no evidence of a difference in acceptability of effective contraception between the groups (66% in the intervention arm vs 64% in the control arm, adjusted OR 1.21, 95% CI .80-1.83, p =?0.36). There were no differences in the secondary or process outcomes between groups. There was some evidence that the effect of the intervention was greater among women compared to men (interaction test p =?0.03). There was an increase in acceptability of effective contraception from baseline to follow-up (2% to 65%, p <?0.001).The whole intervention delivered by instant messaging provided no additional benefit over a portion of the intervention delivered by app pages. The important increase in contraceptive acceptability from baseline to follow-up suggests that the intervention content included on the app may influence attitudes. Further research is needed to establish the effect of the intervention on attitudes towards and use of effective contraception among married/sexually active young people.Clinicaltrial.gov NCT02905513 . Date of registration: 14 September 2016.
Project description:BACKGROUND:We describe the rationale and protocol for a randomized noninferiority controlled trial (RCT) to determine if the Flexi-T380(+) copper intrauterine contraceptive device (IUD) is comparable in terms of effectiveness and expulsion rates to the most common Canadian IUD currently in use, NovaT-200, when placed immediately after a first-trimester abortion. METHODS/DESIGN:Consenting women choosing to use an IUD after an abortion for a pregnancy of less than 12 weeks of gestation will be randomized to device-type groups to receive immediate post-abortion placement of either a Flexi-T380(+) IUD, a device for which no current evidence on expulsion or effectiveness rates is available, or the Nova-T200 IUD, the only other brand of copper IUD available in Canada at the time of study initiation. The primary outcome measure is IUD expulsion rate at 1 year. Secondary outcomes include: pregnancy rate, method continuation rate, complication rates (infection, perforation), and satisfaction with contraceptive method. A non-intervention group of consenting women choosing a range of other post-abortion contraception methods, including no contraception, will be included for comparison of secondary outcomes. Web-based contraception satisfaction questionnaires, clinical records, and government-linked health administrative databases will be used to assess primary and secondary outcomes. DISCUSSION:The RCT design, combined with access to clinical records at all provincial abortion clinics, and to information in provincial single-payer linked administrative health databases, birth registry, and hospital records, offers a unique opportunity to determine if a novel IUD has a comparable expulsion rate to that of the current standard IUD in Canada, in addition to the first opportunity to determine pregnancy rate and method satisfaction at 1 year post-abortion for women choosing a range of post-abortion contraceptive options. We highlight considerations of design, implementation, and evaluation of the first trial to provide rigorous evidence for the effectiveness of current Canadian IUDs when inserted after first-trimester abortion. TRIAL REGISTRATION:ClinicalTrials.gov Identifier NCT01174225.
Project description:Despite improved availability of simple, relatively inexpensive, and highly effective antiretroviral treatment for HIV/AIDS, the disease remains a major public health challenge for women in sub-Saharan Africa (SSA). Given the numerous barriers in access to care for women in this region, every health issue that brings them into contact with the health system should be optimized as an opportunity to integrate HIV/AIDS prevention. Because most non-condom forms of modern contraception require a clinical appointment for use, contraception appointments could provide a confidential opportunity for access to HIV counseling, testing, and referral to care. This study sought to investigate the relationship between contraceptive methods and HIV testing among women in SSA. Data from the Demographic and Health Survey from four African countries-Congo, Mozambique, Nigeria, and Uganda-was used to examine whether modern (e.g., pills, condom) or traditional (e.g., periodic abstinence, withdrawal) forms of contraception were associated with uptake of HIV testing. Data for the current analyses were restricted to 35,748 women with complete information on the variables of interest. Chi-square tests and logistic regression models were used to assess the relationship between uptake of HIV testing and respondents' baseline characteristics and contraceptive methods. In the total sample and in Mozambique, women who used modern forms of contraception were more likely to be tested for HIV compared to those who did not use contraception. This positive association was not demonstrated in Congo, Nigeria, or Uganda. That many women who access modern contraception are not tested for HIV in high HIV burden areas highlights a missed opportunity to deliver an important intervention to promote maternal and child health. Given the increasing popularity of hormonal contraception methods in low-income countries, there is an urgent need to integrate HIV counseling, testing, and treatment into family planning programs. Women on hormonal contraceptives should be encouraged to continue to use condoms for HIV-prevention.
Project description:OBJECTIVE:To assess the effect of a mobile phone-based intervention (mHealth) on post-abortion contraception use by women in Cambodia. METHODS:The Mobile Technology for Improved Family Planning (MOTIF) study involved women who sought safe abortion services at four Marie Stopes International clinics in Cambodia. We randomly allocated 249 women to a mobile phone-based intervention, which comprised six automated, interactive voice messages with counsellor phone support, as required, whereas 251 women were allocated to a control group receiving standard care. The primary outcome was the self-reported use of an effective contraceptive method, 4 and 12 months after an abortion. FINDINGS:Data on effective contraceptive use were available for 431 (86%) participants at 4 months and 328 (66%) at 12 months. Significantly more women in the intervention than the control group reported effective contraception use at 4 months (64% versus 46%, respectively; relative risk, RR: 1.39; 95% confidence interval, CI: 1.17-1.66) but not at 12 months (50% versus 43%, respectively; RR: 1.16; 95% CI: 0.92-1.47). However, significantly more women in the intervention group reported using a long-acting contraceptive method at both follow-up times. There was no significant difference between the groups in repeat pregnancies or abortions at 4 or 12 months. CONCLUSION:Adding a mobile phone-based intervention to abortion care services in Cambodia had a short-term effect on the overall use of any effective contraception, while the use of long-acting contraceptive methods lasted throughout the study period.
Project description:Meeting the reproductive health needs of women in post-conflict settings is a global health priority. In the Democratic Republic of the Congo, social norms perpetuate gender-based violence and contribute to low contraceptive use and high fertility. The Masculinité, Famille, et Foi (MFF) intervention is working with communities in Kinshasa to create normative environments supportive of modern contraception access and use. Our analysis uses survey data collected from 900 men and women in 17 community groups prior to the MFF intervention. We aimed to measure the extent to which social norms influence intentions to use modern contraception. Using multiple items to assess social norms and reference groups related to family planning and gender equity, we identified four distinct social norms constructs through factor analysis. Through structural equation modeling, we found that social norms influence intentions to use modern contraception overall, but that normative influence varies by gender.