76 Clinical Trials for Various Conditions
This is a prospective study involving two phases: 1) adaptation and 2) intervention, in adolescents aged 14-21 experiencing homelessness. The overarching goal is to develop and evaluate the effectiveness and feasibility of a counselling intervention to improve access to contraception among AYA experiencing homelessness. During the first phase, referred to as the adaption phase, we will rely on collective input from formative groups of AYA experiencing homelessness to adapt the CHOICE counselling intervention for this underserved and under-resourced population. In the second phase, referred to as the intervention phase, we will evaluate the effectiveness and feasibility of the adapted intervention (CHOICE-AYA).
Nearly 9 of every 10 pregnant opioid-dependent women report that the current pregnancy was unintended and the majority of non-pregnant opioid-maintained women do not use contraception or use less effective methods like condoms. This proposal aims to further test a novel contraceptive management program to increase use of more effective contraceptives among opioid-maintained women at risk of unintended pregnancy.
Nearly 9 of every 10 pregnant opioid-dependent women report that the current pregnancy was unintended and the majority of non-pregnant opioid-maintained women do not use contraception or use less effective methods like condoms. This proposal aims to develop and test a novel contraceptive management program to increase use of more effective contraceptives among opioid-maintained women and to examine the impact of more effective contraceptive use on condom use. The proposed research may reduce unintended pregnancy among opioid-dependent women without increasing their risk of sexually transmitted infections and the knowledge gained will also have implications for addressing high rates of unintended pregnancy in the general population.
This study is an examination of "high risk" young women, 15-24 years of age, who initiate first time use of vaginal ring, oral contraceptives, contraceptive path, or Depo-provera.
Consistent and correct use of an effective contraceptive method is a primary determinant in preventing pregnancy. Unfortunately, only a minority of healthcare providers adequately address women's contraceptive needs. We have developed a standardized behavioral-based contraceptive counseling model that can be used by providers and other clinic staff to address this limitation. The model, ESP, is an adaptation of motivational interviewing and involves: Exploring discrepancies between pregnancy intention and contraceptive use and between risk of STDs and condom use; Sharing information; and Promoting behaviors to reduce risk. Study question: Does ESP counseling lead to an increase in consistency and effectiveness of contraceptive use among women at risk of unintended pregnancy? Methods: Randomized controlled trial of 747 women, ages 16-44, at self-identified risk of unintended pregnancy enrolled from March 2003 to September 2004 at healthcare settings in North Carolina. Intervention participants received individualized ESP counseling from a health educator to address barriers to effective and consistent contraceptive use. Risk reduction steps were negotiated. Pregnancy, Chlamydia infection and contraceptive use were assessed at baseline and follow-up. "Highly effective" contraceptive use was defined as a combination of effectiveness and consistency. Women in the control arm received general preventive health counseling (e.g., smoking and exercise). Differences between the study arms at 12-months may illustrate the longer term influence of the intervention.
The purpose of the study is to learn more about menstrual changes in progestin contraception users. The investigators are hoping to find out what changes in the endometrium lead to different bleeding patterns during the first year of progestin contraception use. Participants will choose to receive the contraceptive implant (Etonogestrel implant also called Nexplanon) or the contraceptive injectable (Depo-medroxyprogesterone acetate (DMPA) also called Depo-Provera) for up to 12 months. They will be asked to have 4 endometrial biopsies over the course of the study, as well as blood draws, physical exams, and pregnancy tests. Participants will also use a daily text message or email diary to report bleeding patterns. This study's plan is to comprehensively phenotype bleeding patterns and profile the entire endometrium using single-cell RNA seq data (sCRNAseq).
The main goal of this non-interventional study (NIS) is to evaluate user satisfaction with Kyleena in a real-life setting and to identify factors which influence user satisfaction, taking into account previously used contraceptive methods and reasons for use of Kyleena.
Since the introduction of the combined hormonal contraceptive pill, dosages of ethinyl estradiol (EE) have steadily decreased from more than 150mcg to 20mcg in an attempt to improve the risk profile associated with the COC. In 2010, the Food and Drug Administration approved a oral contraceptive pill containing EE 10mcg/NET acetate 1mg (Tradename Lo loestrin). However, no studies have compared this formulation to pills containing either higher doses of estrogen or progestin alone. It is not known whether EE 10mcg is sufficient to prevent follicular development or to support the endometrium as well as higher doses of EE. This trial addresses the question of whether an oral contraceptive pill with EE 10mcg/Norethindrone acetate 1mg will better suppress ovulation or have a better side effect profile than a progestin only pill with a nearly equal dose of norethindrone.
The purpose of this study is to evaluate the effectiveness of a videogame compared to an attention/time control at reducing contraceptive non-use among adolescents.
The study at hand aims to examine whether incorporating use of a contraceptive decision aid (Tuune for Clinics) improves outcomes for patients seeking contraceptive care. To achieve this the investigators will test: the hypothesis that use of the Tuune decision aid in contraceptive care appointments will: (a) improve patient satisfaction, (b) increase patient positivity toward contraceptive use, and (c) improve patient outcomes, including: (ci) greater adherence to their prescribed contraceptive and (cii) fewer negative side-effects, relative to that which is observed for patients receiving a contraceptive recommendation from a traditional contraceptive counseling appointment.
The purpose of this study is to learn more about why some people are at greater risk for oral emergency contraceptive failure while others are not. The investigators want to learn if genetic differences impact the risk of emergency contraception failure.
The purpose of this study is to assess the impact of a contraception decision aid mobile application on: (a) decisional conflict, (b) reproductive health self-efficacy, (c) contraceptive and reproductive health literacy, and (d) contraceptive use intentions.
Approximately 15 million women of reproductive age women in the United States have overweight or obesity and use the combined estrogen and progestin oral contraceptive pill (COC). Although many women report weight gain as a side effect of COCs, a conclusive link between COC use and weight gain has not been established. This investigation will address a major gap in the literature by prospectively evaluating the influence of initiating a COC versus non-hormonal contraceptives (NHCs) on weight, body composition, eating behaviors, and appetite in pre-menopausal women with overweight or obesity. Aim 1 will assess the feasibility of recruiting and retaining a racially/ethnically diverse group of women with overweight and obesity while Aim 2 will explore changes in body weight, body composition, and cardiometabolic risks in these women; Aim 3 will explore changes in dietary and macronutrient energy intake, eating behaviors, and appetite in this subset of women. This research will help the investigators understand the extent to which COCs are associated with weight gain and help guide medical providers in counseling women with overweight and obesity on appropriate contraceptive methods.
Purpose of this study: The purpose of this study is to learn more about how hormonal oral contraceptives affect brain processes and emotional wellbeing. Procedures: If participants agree to participate, the following will happen: 1. Eligibility visit (remote screening session) 2. If participants are eligible to participate in the study, they will be placed in one of two groups. If they are in the first group, they will be asked to take an oral contraception pill ("study drug") every day for 21 days. If they are in the second, they will take a placebo every day for 21 days. A placebo is a pill that looks like medicine but is not real and will have no medical effect on participants. Participants will not get to choose which group they are in, nor will they be told which group they are in. 3. During the three-week period in which participants will take either the study drug or placebo, they will be asked to complete daily check-in surveys on their computer or mobile device. 4. Participants will be asked to attend two additional visits over the course of about three weeks. At these visits, participants will be asked to undergo a urine drug screen, a blood draw, and a magnetic resonance imaging (MRI). They will also be asked to complete behavioral questionnaires.
Pilot study aims to evaluate the effectiveness of "SexHealth Mobile" and improve access to highly effective contraception among women with substance use disorder (SUD) with "SexHealth Mobile" intervention. This intervention will consist of two existing services that will help reach women with or recovering from SUD and provide access to contraception, as well as counseling.
Native CHOICES is a randomized controlled trial of an adapted intervention to reduce the risk of alcohol exposed pregnancies in American Indians and Alaska Natives (AI/ANs). We will enroll 350 AI/AN women living on the Cheyenne River Sioux Indian Reservation or in Rapid City in South Dakota who are 18-44 years old, have risky drinking behaviors, are not currently pregnant but are able to become pregnant, and are sexually active but not using effective contraception.
Women seeking contraception will be randomized to "usual care" or to a "Contraceptive Pathway"
The specific aim of this study is to evaluate whether insertion of a long-acting contraceptive implant in postpartum adolescents prior to hospital discharge increases use of this highly effective contraception during the first twelve months postpartum among adolescents who elect Implanon® as their preferred method of contraception. Additionally, this study aims to compare the acceptability of bleeding in postpartum adolescents who have an etonogestrel contraceptive implant prior to discharge versus those with insertion at the six week postpartum visit. The investigators will evaluate the acceptability of bleeding rather than collect prospective diaries because the investigators feel subjective perceptions of bleeding impact contraceptive continuation more than quantitative differences in bleeding.
A randomized study is to learn more about how a supplement called DHEA (dehydroepiandrosterone) affects clotting factors in women taking combined oral contraceptive pills. Current research suggests that the progestin hormone in a specific type of birth control pill may increase a woman's blood clot risk. However, it is unknown exactly how the progestin causes the increased risk. This study aims to learn if taking a daily dose of supplemental androgen (dehydroepiandrosterone, or DHEA) in addition to birth control pills containing DRSP affects proteins related to coagulation.
This study will evaluate a smart phone-based application ("app") designed to inform pregnant women ages 15-25 about their contraception options. The goal of this research will be to evaluate the usability, feasibility and acceptability of this app.
To evaluate the levonorgestrel (LNG) pharmacokinetic (PK) profile following injection of a single 20 mg dose of levonorgestrel butanoate (LB).
The purpose of this web-based study is to determine whether reproductive life planning (RLP), with or without contraceptive action planning (RLP+), will result in reduced risk of unintended pregnancy when compared to an information-only control group.
The Essure procedure, FDA approved since 2002 and CE Mark approved since 2001, is the first permanent birth control method that can be performed in the comfort of a physician's office without hormones, cutting, burning or the risks associated with general anesthesia or tubal ligation. Soft, flexible inserts are placed in a woman's fallopian tubes through the cervix without incisions. Over the next three months, the body forms a natural barrier around the micro-inserts to prevent sperm from reaching the egg. Three months after the Essure procedure, a doctor performs an Essure Confirmation Test. In the United States, this test is called a hysterosalpingogram and evaluates the location of the inserts and whether the fallopian tubes are blocked. Outside of the United States, a standard x-ray is performed to evaluate the location of the inserts. The purpose of this study is to evaluate whether a transvaginal ultrasound is an effective method of confirming micro-insert location.
The purpose of this study is to determine whether NEA TDS is effective in the prevention of pregnancy. The safety of this product will also be evaluated.
The purpose of this study is to help determine if the route by which women receive hormonal contraception causes different changes to occur in the lining of the vagina. The investigators plan to compare an oral route (taking birth control pills) with a vaginal route (using a vaginal ring).
This study is a randomized controlled trial of insertion of the levonorgestrel-releasing intrauterine device (LNG-IUD) immediately following dilation \& evacuation (D\&E) compared to delayed insertion 3-6 weeks post-D\&E. Eighty-eight women undergoing D\&E between 15 0/7 and 23 6/7 weeks gestation will be enrolled at Magee-Womens Hospital, Pittsburgh, PA. The primary outcome is LNG-IUD usage six months following enrollment. We hypothesize that more women receiving immediate insertion will be using the LNG-IUD 6 months after the D\&E procedure than women receiving delayed insertion. Secondary outcomes include the proportion receiving an IUD, continuation rate, complication rates, subject satisfaction, and quality of life. The utility of ultrasonography in predicting expulsion will also be examined. Anticipated problems include poor subject follow-up and coordinating the intra-operative study procedures.
This is a prospective cohort study of individuals purchasing the oral contraceptive pill over the counter (OTC) in pharmacies in 32 US states. The comparison group is people receiving a prescription (Rx) for oral contraception. Both groups will be followed for one year to examine contraceptive continuation rates. This study will also identify who is using the pill OTC and why and evaluate differences in pregnancy intention and measures of contraceptive agency between the two groups.
This study continues an adaptation of the behavioral intervention Care Coordination After Preterm Birth (CCAPB). This is a pragmatic pilot randomized controlled feasibility trial of CCAPB with baseline and post-intervention assessments.
The goal of this study is to pilot test the IN-Control Birth Control Navigator Program in Central Indiana for use by adolescents who would like to access birth control. The investigators hypothesize that facilitating access to contraception through our intervention will ultimately result in increased feelings of autonomy around these decisions and use of hormonal contraception.
This study will entail provision of ulipristal acetate (UPA) for emergency contraception (EC) in the postpartum period for patients who have not chosen to initiate a highly effective form of contraception and study the use of EC overall as well as with regards to participants' perception of reproductive autonomy. The investigators hypothesize that providing an advance supply of EC will increase use and decrease barriers to use. Additionally, the investigators hypothesize that, with thorough EC counseling, participants will develop an increased knowledge base of EC. With increased use and knowledge, the investigators hypothesize that participants will experience greater reproductive autonomy over their contraceptive decisions.