Evaluation of e-mail contact to conduct follow-up among adolescent women participating in a longitudinal cohort study of contraceptive use.

BACKGROUND: The purpose of this study was to determine whether e-mail contact is a viable method for gathering information from adolescent women about contraceptive use. STUDY DESIGN: Adolescent women initiating contraception followed in a prospective longitudinal cohort study and who had access to the Internet were randomized to the control or intervention arm and were contacted at 3, 6 and 12 months after enrollment. The control arm completed follow-up surveys in-person or by telephone. The intervention arm received Web-based surveys via e-mail. RESULTS: There were 46 women in each group. Women in both groups were approximately 20 years old, were sexually active minority women, and were in school or employed. While participants in the intervention group initially had lower response rates than those in the control group (59% vs. 91%, respectively), with the addition of traditional follow-up methods, the overall response rates were comparable (94% vs. 91%, respectively). CONCLUSIONS: E-mail follow-up with Web-based surveys was effective amongst adolescent women at risk for unintended pregnancy. This indicates that e-mail contact could be used as a preliminary follow-up strategy to capture a substantial proportion of participants and that standard follow-up can be used as a second-line approach. A two-pronged approach with initial e-mail contact and traditional follow-up for participants who do not respond may be a viable method when evaluating sensitive areas such as contraceptive use.

An over-the-counter simulation study of a single-tablet emergency contraceptive in young females.

OBJECTIVES: To evaluate use of a single-tablet (levonorgestrel 1.5 mg) emergency contraceptive administered to young females under simulated over-the-counter conditions. Secondary objectives were to assess repeat use, pregnancy, and adverse events. METHODS: Females aged 11-17 years requesting emergency contraception at teen reproductive health clinics in five cities were eligible to participate. Participants read the study product label and determined whether and how to use the product without interacting with providers. Study product was dispensed to participants who appropriately selected to use it; participants were contacted 1, 4, and 8 weeks later to assess use, pregnancy, and adverse events. The incidences of outcomes were calculated and regression analysis was used to assess the effect of age and use status (ever used or no previous use) on primary outcomes. RESULTS: Of the 345 females enrolled, 279 were younger than age 17 years. Among the 340 participants included in the selection analysis, 311 (91.5%) (97.5% confidence interval 87.5- 94.5%) participants appropriately selected to use or not use product. Among the 298 participants who used product, 274 (92.9%) (97.5% confidence interval 88.8-95.8%) correctly used it as labeled. Selection and correct use were not associated with age. Fifty-seven participants (18.8%) used additional emergency contraception over the study period and seven (2.3%) participants who used product became pregnant; there were no unusual adverse events. CONCLUSION: Restricting young females' use of a single-tablet emergency contraceptive by prescription only is not warranted, because females younger than 17 years can use it in a manner consistent with over-the-counter access. LEVEL OF EVIDENCE: II.

Contraceptive discontinuation and repeat unintended pregnancy within 1 year after an abortion.

BACKGROUND: We examined 12-month hormonal contraceptive continuation and pregnancy rates by abortion history. STUDY DESIGN: Women who wanted to avoid pregnancy for at least 1 year were recruited at four San Francisco Bay area family planning clinics on regular service days and on abortion care days. Participants completed baseline and follow-up questionnaires. Multivariable Cox models assessed the factors associated with method discontinuation and pregnancy. RESULTS: Women who were enrolled into the study on the day of their abortion were 20% more likely to discontinue their contraceptive method than women who never had an abortion [adjusted hazard ratio (AHR)=1.21, 95% confidence interval (CI)=1.03-1.42]. Women who had a recent abortion or previous abortion were 60% more likely to have a pregnancy during follow-up than women who never had an abortion (AHR=1.63, 95% CI =1.21-2.20, and AHR=1.66, 95% CI=1.18-2.33, respectively). CONCLUSION: The experience of having an unintended pregnancy and abortion does not lead to behavioral changes that protect against another unintended pregnancy.

One-year contraceptive continuation and pregnancy in adolescent girls and women initiating hormonal contraceptives.

OBJECTIVE: To assess contraceptive discontinuation, switching, factors associated with method discontinuation, and pregnancy among women initiating hormonal contraceptives. METHODS: This was a 12-month longitudinal cohort study of adolescent girls and women (n=1,387) aged 15 to 24 years attending public family planning clinics who did not desire pregnancy for at least 1 year and selected to initiate the patch, ring, depot medroxyprogesterone acetate, or pills. Participants completed follow-up assessments at 3, 6, and 12 months after baseline. Life table analysis was used to estimate survival rates for contraceptive continuation. Cox proportional hazards models were used to estimate factors associated with method discontinuation. RESULTS: The continuation rate (per 100 person-years) at 12 months was low for all methods; however, it was lowest for patch and depot medroxyprogesterone acetate initiators, 10.9 and 12.1 per 100 person years, respectively (P≤.003); continuation among ring initiators was comparable to pill initiators, 29.4 and 32.7 per 100 person-years, respectively (P=.06). Discontinuation was independently associated with method initiated and younger age. The only factors associated with lower risk of discontinuation were greater intent to use the method and being in school or working. The pregnancy rate (per 100 person-years) was highest for patch and ring initiators (30.1 and 30.5) and comparable for pill and depot medroxyprogesterone acetate initiators (16.5 and 16.1; P<.001). CONCLUSION: The patch and the ring may not be better options than the pill or depot medroxyprogesterone acetate for women at high risk for unintended pregnancy. This study highlights the need for counseling interventions to improve contraceptive continuation, education about longer-acting methods, and developing new contraceptives that women may be more likely to continue. LEVEL OF EVIDENCE: II.

Hormonal contraceptive method choice among young, low-income women: how important is the provider?

OBJECTIVES: Several new methods are available, but we know little about successful integration of contraceptive technologies into services. We investigated provider factors associated with the initiation of new hormonal methods among women at high risk of unintended pregnancy. METHODS: This cohort study enrolled 1387 women aged 15-24 starting hormonal contraception (vaginal ring, transdermal patch, oral contraceptive, or injectable) at four family planning clinics in low-income communities. We measured provider factors associated with method choice, using multinomial logistic regression. RESULTS: Ring and patch initiators were more likely than women starting oral contraceptives to report that they chose their method due to provider counseling (p<0.001). Contraceptive knowledge in general was low, but initiation of a new method, the ring, was associated with higher knowledge about all methods after seeing the provider (p<0.001). Method initiated varied with provider site (p<0.001). These associations remained significant, controlling for demographics and factors describing the provider-patient relationship, including trust in provider and continuity of care. CONCLUSION: Women's reports of provider counseling and of their own contraceptive knowledge after the visit was significantly associated with hormonal method initiated. PRACTICE IMPLICATIONS: More extensive counseling and patient education should be expected for successful integration of new hormonal methods into clinical practice.

Contraceptive decision-making in sexual relationships: young men's experiences, attitudes and values.

Much attention has been focused on efforts to reduce unintended pregnancy by improving contraceptive use among high-risk women; however, there is limited information to guide interventions to engage young men in contraceptive decision-making. We conducted focus groups of young men, aged 19-26, from diverse racial backgrounds from low-income communities in the San Francisco Bay Area to examine social norms about sexual relationships and how they impact on contraceptive use. The data were analysed using content analysis. A range of relationships were described, however casual relationships predominated. While young men expressed strong desires to avoid pregnancy in casual relationships, the unpredictable nature of relationships, together with low communication and regard for the women involved, made stressing consistent contraceptive use among partners unlikely. The themes expressed by these young men about sex and behaviour in different relationships illustrate a spectrum of decision-making dilemmas and illustrate the inherent difficulty in fully engaging young men in contraceptive decision-making. A strategy is needed to address relationship values, dynamics and condom use beyond STI-prevention frameworks and young women's ability to make appropriate contraceptive choices in light of the inherent difficulties and uncertainty associated with casual relationships.

Attitudes toward the vaginal ring and transdermal patch among adolescents and young women.

PURPOSE: The vaginal ring and the transdermal patch offer important contraceptive options for women at high risk for unintended pregnancy. Little is known about what adolescents and young women think about these methods and why use of the ring has been relatively low compared with the patch. We sought to examine young women's attitudes and perceptions about the ring and the patch to better understand the relationship between perceptions of these methods and decisions to use them. METHODS: Sixteen focus groups of young women aged 15-26 years (n=113) from family planning clinics in the San Francisco Bay Area were convened. Data from the focus groups were analyzed using standard content analysis. RESULTS: Although young women expressed apprehension and doubt about both methods, for the most part women expressed more positive attitudes about the patch. Two related themes for the ring and the patch were identified: "lack of trust in effectiveness," and "method use concerns". Two themes unique to the ring ("concerns regarding vaginal insertion" and "sexual partner perceptions") and three themes unique to the patch ("ease of remembering," "visibility issues," and "perceived health risk") were identified. CONCLUSIONS: Increased provider education about apprehensions related to the ring and the patch may lead to increased use of the ring and may counter recent declines in use of the patch. It would be unfortunate if these safe and effective options for young women were to be underused because negative attitudes and perceptions about these methods acted as barriers to adoption.

Adolescent and young women's experience with the vaginal ring and oral contraceptive pills.

STUDY OBJECTIVE: To compare acceptability of the vaginal contraceptive ring to that of oral contraceptive pills. DESIGN: Randomized, cross-over, 6-month study. SETTING: Urban family planning clinic for young low-income patients. PARTICIPANTS: Sexually active females aged 15-21 years (n = 130). INTERVENTIONS: Participants were randomly assigned to use the vaginal ring or oral contraceptive pills for an initial study interval of three 28-day cycles, followed by three cycles of the alternate method. MAIN OUTCOME MEASURES: Participants completed surveys about method use, acceptability, and side effects at baseline, after three cycles, and after six cycles. We analyzed study data using ANOVA models for cross-over designs. RESULTS: We did not detect higher compliance with the ring as compared to oral contraceptive pills (P = 0.176), although overall approval of the ring was significantly higher on several items measured, including liked using method (P = 0.015), would recommend it to friends (P = 0.012), and not as hard to remember to use method correctly (P < or = 0.000). Participants were less worried about health risks while using the ring (P = 0.006), but reported that the ring was more likely to interfere with sex than the pill (P < or = 0.001) and that sex partners liked the pill (P = 0.034). Most women did not report bothersome side effects with either method. CONCLUSIONS: Adolescent and young women showed favorable acceptability of the vaginal contraceptive ring compared to oral contraceptive pills.

Impact of sexual networks on risk for gonorrhea and chlamydia among low-income urban African American adolescents.

OBJECTIVE: To determine whether African American adolescents, whose recent sex partners reported having another sex partner, are at increased risk for exposure to genital chlamydial infection or gonorrhea. STUDY DESIGN: A household sample of low-income urban African American adolescents 14 to 19 years of age, up to two of their close friends, and their sex partners were interviewed and tested for gonorrhea and chlamydial infection. RESULTS: Thirty-four of 145 adolescents had at least one recent sex partner infected with Neisseria gonorrhoeae and/or Chlamydia trachomatis. The adjusted model showed that adolescents, whose recent sex partners reported having another sex partner, were more likely to have a recent sex partner with gonorrhea and/or chlamydial infection. CONCLUSION: In addition to individual factors, network factors may explain why African American adolescents are at increased risk for exposure to sexually transmitted infections (STIs). Multi-level community-based interventions may need to address network factors along with personal behaviors in order to prevent STIs among low-income urban African American adolescents.

Optimized dose delivery of the peptide cyclosporine using hydrofluoroalkane-based metered dose inhalers.

The goal of this study was to illustrate the potential to deliver relatively high doses of a therapeutic peptide using hydrofluoroalkane (HFA) metered dose inhaler (MDI) drug delivery systems. For the purposes of this study, cyclosporine was used as the model compound. Cyclosporine formulations, varying in peptide concentration, ethanol cosolvent concentration, and propellant type, were evaluated and optimized for product performance. As ethanol concentration was decreased from 10 to 3% by weight, fine particle fraction (the mass of cyclosporine which passes through a 4.7-micron cut point divided by the total mass of cyclosporine delivered ex-valve) increased from 34 to 68% for 227 and 33 to 52% for 134a formulations. Because of the excellent solubility properties of cyclosporine in HFA-based systems, minimal or no ethanol was needed as a cosolvent to achieve cyclosporine concentrations of 1.5% w/w. With these formulations, it was possible to obtain a fine particle mass (mass of particles <4.7 microns) greater than 500 microg per actuation. In addition, one formulation was chosen for stability analysis: 0.09% w/w cyclosporine, 10% w/w ethanol, 134a. Three different types of container closure systems (stainless steel, aluminum, and epoxy-coated canisters) and two storage configurations (upright and inverted) were evaluated. Cyclosporine was determined to be stable in HFA 134a-based MDI systems, regardless of container closure system and configuration, over a 2-year period. Cyclosporine represents a compelling example of how significant peptide doses are attainable through the use of solution-based MDIs. It has been shown that through formulation optimization, 2-3 mg of the peptide, cyclosporine, may be delivered in five actuations to the lung for local or systemic therapy.

Access and attitudinal factors related to breast and cervical cancer rescreening: why are Latinas still underscreened?

To identify access, attitudes, and health practices of Latina women undergoing regular mammography and Pap smear screening, 977 Latinas aged 40 to 74, residing in four California cities, answered a telephone interview. Forty-one percent of women had regular mammography, and 73% had regular Pap smear screening. Cancer screening maintenance was associated with having health insurance, a regular place of care, and fewer fatalistic attitudes about cancer. Regular mammography and Pap smear screening were also associated with ever being married, attending church, and having taken hormone replacement therapy. Being older than 50, residing in the United States a long time, and having had a hysterectomy predicted mammography maintenance. Pap smear screening maintenance was negatively associated with poverty, old age, and negative attitudes toward physicians. There are structural and attitudinal barriers to regular cancer screening among Latinas. Interventions that increase access to care and address women's attitudes about cancer are needed.

What's to know about study recruitment? We asked recruiters.

To address the historic lack of research on women's health and women's exclusion from many significant clinical trials, governmental mandates have been implemented to increase their participation. To accomplish recruitment goals, it is imperative that a better understanding is reached about women's attitudes about research. In an effort to contribute information about recruitment, focus groups with study recruiters from San Francisco Bay Area research facilities were convened. Study recruiters provide a unique perspective on women's decision-making processes. The focus group discussions provided information on successful recruitment techniques employed by research recruiters that may be replicated across research studies.