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.

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.

Suspect online sellers and contraceptive access.

BACKGROUND: Issues surrounding contraception access have been a national focus. During this debate, adolescent and adult women may seek these products online. Due to safety concerns, including potential counterfeit forms, we wished to assess whether online "no prescription" contraceptives were available. STUDY DESIGN: We assessed online availability of reversible, prescription contraceptive methods resulting in <10 undesired pregnancies/year, i.e., Depo-Provera shot; oral contraceptives; NuvaRing; Ortho Evra patch; Paragard and Mirena IUDs; and Implanon/Nexplanon implants. Using Google search "buy ITEM no prescription," we reviewed the first five result pages for "no prescription" vendors. Searches were conducted 1/3/2012-2/20/2012. RESULTS: All contraceptives were available as "no prescription" products. Furthermore, IUDs were advertised as "over-the-counter" and YouTube videos provided "how to" videos, including a cartoon version. We also found that illicit online pharmacy marketing is shifting from direct search engine access to social media (Facebook, Twitter, Slidehare, flickr). CONCLUSION: Online contraceptive sales represent patient safety risks and a parallel system of high-risk product access absent professional guidance. Providers should educate patients, while policy makers employ legal strategies to address these systemic risks.

Fertility regulation among women of reproductive age in Ibadan, south-west Nigeria: contraception, abortion or both.

OBJECTIVES: To assess the role of contraception and abortion in fertility regulation amongst Southwestern Nigerian women. SUBJECTS AND METHODS: A survey was conducted through a self- administered questionnaire to women of reproductive age group attending gynecology clinic. Multinominal logistic regression was done to analyze the independent effects of social and demographic variables on the odds that women would adopt any fertility regulation methods instead of doing nothing. RESULTS: Only 13% of surveyed women were using modern contraception. About 42.2% of women had had induced abortion, 15% of them neither use contraception nor abortion. Fifteen per cent of women surveyed used both contraception and abortion for fertility control. Muslims women had lower odds than Christians to use any of three fertility regulation methods instead of doing nothing. Unmarried and high levels of educational attainment were associated with significant odds of adopting each of three fertility regulation methods (Odd ratios; 1.38 - 35.5). CONCLUSIONS: There is a need for better fertility regulation. High dependency on abortion especially among the young, unmarried and high level educational status should be discouraged. Government and non-governmental agencies should assist in making modern contraceptives widely available with adequate rural coverage.

How commonly do US abortion clinics offer contraceptive services?

BACKGROUND: About half of US women having abortions have already had at least one prior abortion. Facilitating access to contraception may help these women avoid subsequent unintended pregnancies. Information is needed to document the availability of contraceptive services in abortion care settings in the United States. STUDY DESIGN: Data for this cross-sectional mixed-methods study were collected between December 2008 and September 2009 and come from two sources: 15 semistructured telephone interviews and 173 structured questionnaires administered to a nationally representative sample of eligible facilities. Respondents were administrators at large (400+ abortions per year), nonhospital facilities that provide abortion services in the United States. RESULTS: Virtually all (96%) abortion clinics incorporate contraceptive education into abortion care, and the three most common methods reported to be distributed are the birth control pill (99%), the vaginal ring (61%) and Depo-Provera (58%). Almost one-third reported being able to offer post-abortion intrauterine device insertion. Most facilities (82%) accept some form of insurance for either contraceptive or abortion services, and those with a broader family planning focus are significantly more likely to do so. Administrators at the majority of facilities (56%) report that patients most commonly do not pay additional fees for contraceptive services because they are included in the cost of abortion services. CONCLUSION: Although almost all large, non-hospital abortion providers in the United States are able to provide some level of contraceptive care to their abortion patients, the degree to which they are able to do so is influenced by a wide range of factors.

A comparison of contraceptive procurement pre- and post-benefit change.

BACKGROUND: In 2002, the Kaiser Foundation Health Plan in California changed its coverage policy to include 100% universal coverage for the most effective forms of contraception and for emergency contraceptive pills (ECPs). This study sought to evaluate whether removing the cost of contraception as a potential barrier to utilization would lead to a change in the mix of contraceptive methods prescribed and purchased by a large health plan and whether those changes could theoretically result in averting a greater number of unintended pregnancies. STUDY DESIGN: A retrospective observational study was conducted to describe the mix of reversible contraceptives procured before and after the benefit change at Kaiser Permanente Northern California. We then estimated couple-years of protection (CYP) to examine whether the contraceptive mix changed to more effective reversible methods. RESULTS: After the contraceptive benefit change, CYP increased by 28% (from 2001-2002 to 2003-2004), while the number of females aged 15-44 enrolled in this health plan fell by 1%. CYP for intrauterine contraceptives (IUCs) and injectables rose by 137% and 32%, respectively, while CYP for the pill, patch and ring rose only by 16%. The estimated average annual contraceptive failure rate among women using hormonal contraceptives and IUCs declined from 7.0% to 6.4%. Purchasing of the ECP rose by 88%. CONCLUSION: Removal of the cost of contraception may result in increased utilization of more effective methods and ECPs.

Use of self home-made diaphragm for protection against pregnancy and sexually-transmitted infections: case report.

This is a case report of a 44-year-old woman who used a home-made diaphragm for 16 years to protect herself from pregnancy and sexually-transmitted infections. The woman stitched a piece of cloth with folded polythene inside. This case report provides a vivid illustration of the limitations of available methods of protection for women. It consists of an introduction to the topic, a description of her experiences using her home-made diaphragm and a discussion of the significance of the case. This report supports the need for additional research on female-controlled methods of protection against sexually-transmitted infections, methods that can be used without male knowledge and co-operation, such as vaginal microbicides and cervical barriers against infection, including the diaphragm.

Documented short-term continuation rates for combined hormonal contraceptives in an indigent population with ready access to contraceptive supplies.

OBJECTIVE: One problem women have successfully using combined hormonal contraception is the limited supplies they are dispensed. Patients at the Women's Health Care Clinic at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center have virtually no barriers to method switching, so it is possible to estimate the impacts that more generous prescribing policies have on short-term continuation rates. STUDY DESIGN: Anonymous chart review of all women who initiated hormonal contraception between Jan. 1 and June 30, 2005. RESULTS: Only 40.4% of women had documented use for at least 3 months. Women dispensed supplies for 3 or more cycles at the initial visit were more likely to continue use for 3 months (47.8%) than were women dispensed fewer cycles (31.9%) (P < .0001). CONCLUSION: More liberal dispensing policies may increase the wastage of combined hormonal contraceptive product, but they significantly increase at least intermediate term use of those methods.

Comparison of diaphragm and combined oral contraceptive pill users in the Australian family planning setting.

OBJECTIVES: To determine the number of women fitted with a diaphragm or cervical cap at family planning clinics across the Australian State of New South Wales (NSW) from 2000 to 2005. To compare the demographic characteristics of women fitted with this form of contraceptive with women prescribed the combined oral contraceptive pill (COCP). METHOD: An audit of women presenting for contraceptive services between 2000 and 2005 was undertaken. The demographic characteristics of women fitted with a barrier method or prescribed the COCP between 1st April, 2002, and 31st October, 2004, were obtained from the Family Planning NSW Activity Data Set (FADS). RESULTS: The proportion of women fitted with a diaphragm or cap remained constant between 2001 and 2005 at approximately 5%. During the 31 months that the study period lasted, 793 women were fitted with a diaphragm or cervical cap compared with 8047 women prescribed the COCP during the same time frame (including 76 women who received both a diaphragm and COCP prescription during this period). Women fitted with the barrier contraceptive were significantly more likely to be older, to have received a tertiary level education and to have private health insurance than their counterparts prescribed the COCP. They were less likely to come from a non-English speaking background. DISCUSSION: The diaphragm and cervical cap are viable contraceptive methods for a specific group of older, well-educated women. The possible benefits of female-controlled barrier devices in the prevention of sexually transmissible infections may result in a wider demographic use in the future.

Does a competitive voucher program for adolescents improve the quality of reproductive health care? A simulated patient study in Nicaragua.

BACKGROUND: Little is known about how sexual and reproductive (SRH) health can be made accessible and appropriate to adolescents. This study evaluates the impact and sustainability of a competitive voucher program on the quality of SRH care for poor and underserved female adolescents and the usefulness of the simulated patient (SP) method for such evaluation. METHODS: 28,711 vouchers were distributed to adolescents in disadvantaged areas of Managua that gave free-of-charge access to SRH care in 4 public, 10 non-governmental and 5 private clinics. Providers received training and guidelines, treatment protocols, and financial incentives for each adolescent attended. All clinics were visited by female adolescent SPs requesting contraception. SPs were sent one week before, during (with voucher) and one month after the intervention. After each consultation they were interviewed with a standardized questionnaire. Twenty-one criteria were scored and grouped into four categories. Clinics' scores were compared using non-parametric statistical methods (paired design: before-during and before-after). Also the influence of doctors' characteristics was tested using non-parametric statistical methods. RESULTS: Some aspects of service quality improved during the voucher program. Before the program started 8 of the 16 SPs returned 'empty handed', although all were eligible contraceptive users. During the program 16/17 left with a contraceptive method (p = 0.01). Furthermore, more SPs were involved in the contraceptive method choice (13/17 vs.5/16, p = 0.02). Shared decision-making on contraceptive method as well as condom promotion had significantly increased after the program ended. Female doctors had best scores before- during and after the intervention. The improvements were more pronounced among male doctors and doctors older than 40, though these improvements did not sustain after the program ended. CONCLUSION: This study illustrates provider-related obstacles adolescents often face when requesting contraception. The care provided during the voucher program improved for some important outcomes. The improvements were more pronounced among providers with the weakest initial performance. Shared decision-making and condom promotion were improvements that sustained after the program ended. The SP method is suitable and relatively easy to apply in monitoring clinics' performance, yielding important and relevant information. Objective assessment of change through the SP method is much more complex and expensive.

Nondaily hormonal contraception: considerations in contraceptive choice and patient counseling.

PURPOSE: To review currently available choices for non-daily hormonal contraception, considering efficacy, safety, patient counseling issues, and appropriate patient selection. DATA SOURCES: Worldwide medical literature and the individual products' prescribing information. CONCLUSIONS: Patients and clinicians have many nondaily hormonal contraceptive options available--from Depo-Provera quarterly injection, which has been available in the United States for over 10 years, to several new entries (Mirena 5-year intrauterine system, Lunelle monthly injection, NuvaRing monthly intravaginal ring, and Ortho Evra weekly transdermal patch). All these options offer high efficacy and enhanced convenience for many patients over daily oral contraceptives (OCs). Barriers to use of these agents may include patients' lack of information as well as fear or misconceptions regarding the hormones and methods. All of these can be addressed with adequate patient counseling and open dialogue. The clinician and patient need to be well-informed regarding these options so that they can work together and identify the best contraceptive fit for the patient---with the ultimate goal being to increase patient satisfaction and adherence and, thus, avoid unintended pregnancy. IMPLICATIONS FOR PRACTICE: Despite the efficacy of OCs, missed pills are quite common and contribute to unintended pregnancy. Many women in all population categories would benefit from the convenience and reliability of nondaily hormonal contraceptives. The highest efficacy rates with typical use are associated with agents that require minimal user participation (i.e., Depo-Provera, Mirena). Compared to daily regimens, all nondaily options offer increased convenience and may contribute to improved patient adherence. However, barriers to use may exist. Patient fears regarding use of hormones can be minimized by discussing the long-term safety of hormonal contraceptives. (The data are predominantly derived from Depo-Provera and OCs because these agents have been available in the United States and in the rest of the world for much longer than the newer nondaily options.) Patient counseling and appropriate expectations regarding changes in menstrual pattern have been demonstrated to further enhance patient adherence to therapy. Finally, patient lifestyle preferences must be considered. The finding that many women are comfortable with or even prefer amenorrhea, which is associated with options such as Depo-Provera, highlights how important it is for clinicians to avoid making assumptions about a patient's contraceptive preferences. Rather, clinicians and patients should exchange information through an open dialogue. For the majority of patients, nondaily hormonal contraceptives should be considered and offered as first-line options.

New contraceptive options.

New contraceptive modalities that are being introduced into the US marketplace reflect many changes in the delivery of existing steroidal products. These products are available now not only as oral medications but also as transdermal, intravaginal, intrauterine, and implantable or injectable devices. Each of these has its own unique profile and enhances the ability of consumers to pick and choose the product that is most acceptable to them. However, development of new barrier contraceptives, particularly those that have the potential to reduce the heterosexual transmission of HIV or to reduce a bacterial infection such as Chlamydia or Neisseria gonorrhea, continues to be moving forward in clinical trials. These products can have a lower efficacy compared with the steroidal products but, because of their other benefits, may be of significant medical use.

Internet availability of contraceptives.

OBJECTIVE: To measure the accessibility of contraceptive supplies over the Internet. METHODS: We performed an Internet search with the use of search engines and key words. We posed as consumers purchasing both prescription and over-the-counter contraceptive supplies. The number of clicks or web pages accessed, costs, shipping time, barriers to access, and prescription requirements were compared for selected birth control supplies. RESULTS: More than 200 web sites were visited to locate at least one site where we could purchase each selected product. Contraceptive supplies, including male and female condoms, spermicides, vaginal sponges, intrauterine devices (IUDs), diaphragms, and cervical caps, were easily obtained without a prescription from foreign web sites. Oral contraceptive pills (OCs) were readily available online in November 1999; some sites had discontinued sales by February 2000, but OCs could still be purchased with no prescription in August 2000. None of the four prescription sites supplied physician or prescriber credentials. The contraceptive costs varied by vendor and product. A type of copper IUD could be purchased for less than $50.00, whereas a single package of emergency contraceptive pills cost $141.00 from one vendor because of prescription and shipping fees. Some emergency contraceptive pills ordered arrived after 72 hours or did not arrive and the purchase was not refunded. A levonorgestrel IUD was shipped without difficulty in December 1999, but a second device, ordered in February 2000, was temporarily impounded by United States Customs. CONCLUSION: This method of contraceptive purchase is accessible, expensive, erratically regulated, and rapidly changing.

Community availability of contraceptives and family limitation.

This study examines the impact of contraceptive service availability on contraceptive use in Korea, Mexico, and Bangladesh. Using World Fertility Survey Data on once-married females and their communities of residence, the multivariate analysis finds that the community level of contraceptive availability directly affects the likelihood of current use, net of the effects of community development, education, parity, and marital duration. The results are supportive of the recent policy emphasis on maximizing the geographic availability of contraceptive services.