Improving Reproductive Health Communication Between Providers and Women Affected by Homelessness and Substance Use in San Francisco: Results from a Community-Informed Workshop.

OBJECTIVES: Many cisgender women affected by homelessness and substance use desire pregnancy and parenthood. Provider discomfort with patient-centered counseling about reproductive choices and supporting reproductive decisions of these women poses barriers to reproductive healthcare access. METHODS: We used participatory research methods to develop a half-day workshop for San Francisco-based medical and social service providers to improve reproductive counseling of women experiencing homelessness and/or who use substances. Guided by a stakeholder group comprising cisgender women with lived experience and providers, goals of the workshop included increasing provider empathy, advancing patient-centered reproductive health communication, and eliminating extraneous questions in care settings that perpetuate stigma. We used pre/post surveys to evaluate acceptability and effects of the workshop on participants' attitudes and confidence in providing reproductive health counseling. We repeated surveys one month post-event to investigate lasting effects. RESULTS: Forty-two San Francisco-based medical and social service providers participated in the workshop. Compared to pre-test, post-test scores indicated reduced biases about: childbearing among unhoused women (p < 0.01), parenting intentions of pregnant women using substances (p = 0.03), and women not using contraception while using substances (p < 0.01). Participants also expressed increased confidence in how and when to discuss reproductive aspirations (p < 0.01) with clients. At one month, 90% of respondents reported the workshop was somewhat or very beneficial to their work, and 65% reported increased awareness of personal biases when working with this patient population. CONCLUSIONS FOR PRACTICE: A half-day workshop increased provider empathy and improved provider confidence in reproductive health counseling of women affected by homelessness and substance use.

Measuring Men's Gender Norm Beliefs Related to Contraception: Development of the Masculine Norms and Family Planning Acceptance Scale.

Male partner resistance is identified as a key factor that influences women's contraceptive use. Examination of the masculine norms that shape men's resistance to contraception-and how to intervene on these norms-is needed. To assess a gender-transformative intervention in Kenya, we developed and evaluated a masculinity-informed instrument to measure men's contraceptive acceptance-the Masculine Norms and Family Planning Acceptance (MNFPA) scale. We developed draft scale items based on qualitative research and administered them to partnered Kenyan men (n = 150). Item response theory-based methods were used to reduce and psychometrically evaluate final scale items. The MNFPA scale had a Cronbach's α of 0.68 and loaded onto a single factor. MNFPA scores were associated with self-efficacy and intention to accept a female partner's use of contraception; scores were not associated with current contraceptive use. The MNFPA scale is the first rigorously developed and psychometrically evaluated tool to assess men's contraceptive acceptance as a function of male gender norms. Future work is needed to test the MNFPA measure in larger samples and across different contexts. The scale can be used to evaluate interventions that seek to shift gender norms to increase men's positive engagement in pregnancy spacing and prevention.

Barriers to postpartum contraception: differences among women based on parity and future fertility desires.

Timely use of contraception in the postpartum year is critical for pregnancy spacing, which protects a mother's health and improves her ability to care for children. This qualitative study explored contraceptive decision-making among postpartum women in Nairobi, Kenya, with a focus on accounts of how women overcame barriers to postpartum contraceptive use. Focus groups (n = 61) and in-depth interviews (n = 30) explored experiences, barriers and actual use of postpartum contraception. Data were analysed using framework analysis, a method that organises qualitative data into themes and then interprets the data by mapping participant characteristics to these themes. Contraceptive use among women who desired future fertility was hindered by fear of side-effects and concern for partner disapproval. However, women who were satisfied with their family size more easily overcame these barriers. Tailoring postpartum contraceptive counselling to both assuage the concerns of women who desire future fertility and address the long-term contraceptive needs of mothers who desire to stop child-bearing could play a role in reducing the unmet need for contraception. .

The impact of an IUD and implant intervention on dual method use among young women: Results from a cluster randomized trial.

Long-acting reversible contraceptives (LARCs) are highly effective at preventing pregnancy but do not protect against sexually transmitted infection (STI). Recent efforts to improve access to intrauterine devices (IUDs) and implants have raised concerns about STI prevention and reduced condom use, particularly among teenagers and young women. We evaluated whether a provider-targeted intervention to increase LARC access negatively impacted dual method use and STI incidence among an at-risk patient population. We conducted a cluster randomized trial in 40 reproductive health centers across the United States from May 2011 to May 2013. After training providers at 20 intervention sites, we recruited 1500 sexually-active women aged 18-25years who did not desire pregnancy and followed them for one year. We assessed intervention effects on dual method use, condom use and STI incidence, modeling dual method use with generalized estimating equations and STI incidence with Cox proportional hazard regression models, accounting for clustering. We found no differences between intervention and control groups in dual method use (14.3% vs. 14.4%, aOR 1.03, 95% CI 0.74-1.44) or condom use (30% vs. 31%, aOR 1.03, 95% CI 0.79-1.35) at last sex at one year. STI incidence was 16.5 per 100 person-years and did not differ between intervention and control groups (aHR 1.20, 95% CI 0.88-1.64). A provider training intervention to increase LARC access neither compromised condom use nor increased STI incidence among young women. Dual method use was very low overall, highlighting the need to bolster STI prevention efforts among adolescents and young women.

Does Integrating Family Planning into HIV Services Improve Gender Equitable Attitudes? Results from a Cluster Randomized Trial in Nyanza, Kenya.

This study investigated whether integrating family planning (FP) services into HIV care was associated with gender equitable attitudes among HIV-positive adults in western Kenya. Surveys were conducted with 480 women and 480 men obtaining HIV services from 18 clinics 1 year after the sites were randomized to integrated FP/HIV services (N = 12) or standard referral for FP (N = 6). We used multivariable regression, with generalized estimating equations to account for clustering, to assess whether gender attitudes (range 0-12) were associated with integrated care and with contraceptive use. Men at intervention sites had stronger gender equitable attitudes than those at control sites (adjusted mean difference in scores = 0.89, 95 % CI 0.03-1.74). Among women, attitudes did not differ by study arm. Gender equitable attitudes were not associated with contraceptive use among men (AOR = 1.06, 95 % CI 0.93-1.21) or women (AOR = 1.03, 95 % CI 0.94-1.13). Further work is needed to understand how integrating FP into HIV care affects gender relations, and how improved gender equity among men might be leveraged to improve contraceptive use and other reproductive health outcomes.

Integrating family planning into HIV care in western Kenya: HIV care providers' perspectives and experiences one year following integration.

With high rates of unintended pregnancy in sub-Saharan Africa, integration of family planning (FP) into HIV care is being explored as a strategy to reduce unmet need for contraception. Perspectives and experiences of healthcare providers are critical in order to create sustainable models of integrated care. This qualitative study offers insight into how HIV care providers view and experience the benefits and challenges of providing integrated FP/HIV services in Nyanza Province, Kenya. Sixteen individual interviews were conducted among healthcare workers at six public sector HIV care facilities one year after the implementation of integrated FP and HIV services. Data were transcribed and analyzed qualitatively using grounded theory methods and Atlas.ti. Providers reported a number of benefits of integrated services that they believed increased the uptake and continuation of contraceptive methods. They felt that integrated services enabled them to reach a larger number of female and male patients and in a more efficient way for patients compared to non-integrated services. Availability of FP services in the same place as HIV care also eliminated the need for most referrals, which many providers saw as a barrier for patients seeking FP. Providers reported many challenges to providing integrated services, including the lack of space, time, and sufficient staff, inadequate training, and commodity shortages. Despite these challenges, the vast majority of providers was supportive of FP/HIV integration and found integrated services to be beneficial to HIV-infected patients. Providers' concerns relating to staffing, infrastructure, and training need to be addressed in order to create sustainable, cost-effective FP/HIV integrated service models.

Gendered power dynamics and women's negotiation of family planning in a high HIV prevalence setting: a qualitative study of couples in western Kenya.

In sub-Saharan Africa, high burdens of HIV and unmet need for contraception often coexist. Research emphasises the need to engage men and couples in reproductive health, yet couples' negotiations around fertility and family planning in the context of HIV have been sparsely studied. This study examined the gendered power dynamics that frame women's and couples' negotiations of contraceptive use in western Kenya. We conducted 76 in-depth interviews with 38 couples, of whom 22 couples were concordant HIV-positive. Qualitative data were analysed using a grounded theory approach. Direct communication around contraception with men was often challenging due to perceived or expressed male resistance. A substantial minority of women avoided male reproductive decision-making authority through covert contraceptive use, with concern for severe consequences when contraceptive use was discovered. Many men assumed that family planning use signified female promiscuity and that infidelity motivated covert use. Men were more willing to use condoms to avoid HIV re-infection or on the recommendation of HIV care providers, which allowed some women leverage to insist on condom use. Our findings highlight the tension between male dominated reproductive decision making and women's agency and point to the need for gender transformative approaches seeking to challenge masculinities that negatively impact health.

Integrating family planning and HIV services in western Kenya: the impact on HIV-infected patients' knowledge of family planning and male attitudes toward family planning.

Little information exists on the impact of integrating family planning (FP) services into HIV care and treatment on patients' familiarity with and attitudes toward FP. We conducted a cluster-randomized trial in 18 public HIV clinics with 12 randomized to integrated FP and HIV services and 6 to the standard referral-based system where patients are referred to an FP clinic. Serial cross-sectional surveys were done before (n = 488 women, 486 men) and after (n = 479 women, 481 men) the intervention to compare changes in familiarity with FP methods and attitudes toward FP between integrated and nonintegrated (NI) sites. We created an FP familiarity score based on the number of more effective FP methods patients could identify (score range: 0-6). Generalized estimating equations were used to control for clustering within sites. An increase in mean familiarity score between baseline (mean = 5.16) and post-intervention (mean = 5.46) occurred with an overall mean change of 0.26 (95% confidence intervals [CI] = 0.09, 0.45; p = 0.003) across all sites. At end line, there was no difference in increase of mean FP familiarity scores at intervention versus control sites (mean = 5.41 vs. 5.49, p = 0.94). We observed a relative decrease in the proportion of males agreeing that FP was "women's business" at integrated sites (baseline 42% to end line 30%; reduction of 12%) compared to males at NI sites (baseline 35% to end line 42%; increase of 7%; adjusted odds ration [aOR] = 0.43; 95% CI = 0.22, 0.85). Following FP-HIV integration, familiarity with FP methods increased but did not differ by study arm. Integration was associated with a decrease in negative attitudes toward FP among men.

Providers' perspectives on male involvement in family planning in the context of a cluster-randomized controlled trial evaluating integrating family planning into HIV care in Nyanza Province, Kenya.

Integration of family planning (FP) services into HIV care and increasing male partner involvement in FP are being explored as strategies to reduce unmet need for contraception. Providers' views can give valuable insight into current FP care. We evaluated the perspectives of HIV care providers working at HIV clinics in Nyanza Province, Kenya, on male partner involvement in FP. This qualitative study was part of a cluster-randomized controlled trial evaluating the impact of integrating FP into HIV services on contraceptive prevalence among HIV-positive patients in Nyanza Province, Kenya. Thirty individual interviews were conducted among health-care workers at 11 HIV care facilities in Nyanza Province, Kenya. Interviews were conducted from integrated and control sites one year after implementation of FP/HIV integration. Data were transcribed and analyzed using grounded theory methods and ATLAS-ti. Providers supported male partner inclusion when choosing FP and emphasized that decisions should be made collaboratively. Providers believed that men have traditionally played a prohibitive role in FP but identified several benefits to partner involvement in FP decision-making including: reducing relationship conflicts, improving FP knowledge and contraceptive continuation, and increasing partner cohesion. Providers suggested that integrated FP/HIV services facilitate male partner involvement in FP decision-making since HIV-positive men are already established patients in HIV clinics. Some providers stated that women had a right to choose and start FP alone if their partners did not agree with using FP. Integrated FP services may be a useful strategy to help increase male participation to reduce the unmet FP need in sub-Saharan Africa. It is important to determine effective ways to engage male partners in FP, without impinging upon women's autonomy and reproductive rights.

'Women now wear trousers': men's perceptions of family planning in the context of changing gender relations in western Kenya.

Gender inequity has been closely linked with unmet need for family planning among women in sub-Saharan Africa but the factors related to male family planning disapproval are not well-understood. This qualitative study explored men's perspectives of gender roles and cultural norms as they pertain to family planning. Twelve small group meetings were held with 106 married men in Nyanza Province, Kenya. Shifting gender relations made the definitions of manhood more tenuous than ever. Men's previous identities as sole breadwinners, which gave them significant control over decision-making, were being undermined by women's increasing labour force participation. While many men viewed family planning positively, fears that family planning would lead to more female sexual agency and promiscuity or that male roles would be further jeopardised were widespread and were major deterrents to male family planning approval. By addressing such fears, gender-sensitive programmes could help more men to accept family planning. Increased family planning education for men is needed to dispel misconceptions regarding family planning side-effects. Focusing on the advantages of family planning, namely financial benefits and reduced conflict among couples, could resonate with men. Community leaders, outreach workers and healthcare providers could help shift men's approval of joint decision-making around family size to other reproductive domains, such as family planning use.

Fertility intentions among HIV-infected, sero-concordant couples in Nyanza province, Kenya.

Research in sub-Saharan Africa has shown significant diversity in how HIV influences infected couples' fertility intentions. Supporting HIV-infected, sero-concordant couples in sub-Saharan Africa to make informed choices about their fertility options has not received sufficient attention. In-depth interviews were conducted among 23 HIV-positive, sero-concordant married couples in Kenya, to better understand how HIV impacted fertility intentions. HIV compelled many to reconsider fertility plans, sometimes promoting childbearing intentions in some individuals but reducing fertility plans among most, largely due to fears of early death, health concerns, stigma, perinatal HIV transmission and financial difficulties (particularly in men). Preferences for sons and large families influenced some couples' intentions to continue childbearing, although none had discussed their intentions with healthcare providers. Additional support and services for HIV-infected, sero-concordant couples are needed. Family planning counselling should be tailored to the unique concerns of HIV-infected couples, addressing perinatal transmission but also individual, couple-level and socio-cultural fertility expectations. Community-level programmes are needed to reduce stigma and make HIV-infected couples more comfortable in discussing fertility intentions with healthcare providers.

Transforming masculine norms to improve men's contraceptive acceptance: results from a pilot intervention with men in western Kenya.

Men's adherence to constraining male gender norms can lead them to resist contraceptive use. Very few interventions have attempted to transform masculine norms to encourage greater contraceptive acceptance and gender equality. We designed and evaluated a small-scale community-based intervention targeting the masculine norms tied to contraceptive resistance among partnered men (N = 150) in two western Kenya communities (intervention vs. control). Pre-post survey data fit to linear and logistic regression models evaluated differences in post-intervention outcomes, accounting for pre-intervention differences. Intervention participation was associated with increases in contraceptive acceptance scores (adjusted coefficient (aß) 1.04; 95% confidence interval (CI) 0.16, 1.91; p = 0.02) and contraceptive knowledge scores (aß 0.22; 95% CI 0.13, 0.31; p < 0.001) and with contraceptive discussions with one's partner (adjusted Odds Ratio (aOR) 3.96; 95% CI 1.21, 12.94; p = 0.02) and with others (aOR 6.13; 95% CI 2.39, 15.73; p < 0.001). The intervention was not associated with contraceptive behavioural intention or use. Our findings demonstrate the promise of a masculinity-driven intervention on increasing men's contraceptive acceptance and positive contraceptive involvement. A larger randomised trial is needed to test the effectiveness of the intervention among men as well as among couples.

Patient and provider perspectives on barriers and facilitators to reproductive healthcare access for women experiencing homelessness with substance use disorders in San Francisco.

BACKGROUND: Women experiencing homelessness with substance use disorders face unique and intersecting barriers to realizing their reproductive goals. OBJECTIVE: This study explored the reproductive aspirations of this population, as well as the barriers to accessing reproductive services from the perspectives of affected individuals, and the healthcare providers who serve them. DESIGN: This mixed-methods study included surveys and interviews with women experiencing homelessness with substance use disorders and healthcare providers. METHODS: We conducted surveys and semi-structured interviews with women recruited from opiate treatment programs and homeless encampments in San Francisco, California in 2018. We also conducted interviews and focus groups with healthcare providers in reproductive health and substance use treatment settings. Interviews were recorded, transcribed, and coded. Descriptive statistics of survey results were performed. RESULTS: Twenty-eight women completed surveys, 96% of whom reported current substance use. Ten women participated in interviews. One-third (9/28) reported desiring pregnancy in the next year; over half (16/28) reported they would be somewhat or very happy to learn they were pregnant. A majority used no contraception at last intercourse (14/28). Twenty-six healthcare providers participated in interviews (n = 15) and focus groups (n = 2). Patients and providers identified similar barriers to care access, including discrimination, logistical and financial challenges, and delayed pregnancy awareness. While providers proposed solutions focused on overcoming logistical challenges, patients emphasized the importance of transforming the healthcare environment to treat patients affected by substance use and homelessness with dignity and respect. CONCLUSION: Women experiencing homelessness with substance use disorders face intersecting and compounding barriers to accessing reproductive health services. For patients, the impact of stigma and bias on treatment experiences are particularly salient, in contrast to logistical barriers emphasized by providers. Improving access will require structural and individual-level solutions to address stigma and create person-centered, trauma-informed, and respectful care environments.

Immediate start of hormonal contraceptives for contraception.

BACKGROUND: Health care providers often tell women to wait until the next menses to begin hormonal contraception. The intent is to avoid contraceptive use during an undetected pregnancy. An alternative is to start hormonal contraception immediately with back-up birth control for the first seven days. Immediate initiation was introduced with combined oral contraceptives (COCs), and has expanded to other hormonal contraceptives. At the time of the initial review, how immediate start compared to conventional menses-dependent start was unclear regarding effectiveness, continuation, and acceptability. The immediate-start approach may improve women's access to, and continuation of, hormonal contraception. OBJECTIVES: This review examined randomized controlled trials (RCTs) of immediate-start hormonal contraception for differences in effectiveness, continuation, and acceptability. SEARCH METHODS: In August 2012, we searched MEDLINE, CENTRAL, POPLINE, LILACS, ClinicalTrials.gov, and ICTRP for trials of immediate-start hormonal contraceptives. We contacted researchers to find other studies. Earlier searches also included EMBASE. SELECTION CRITERIA: We included RCTs that compared immediate start to conventional start of hormonal contraception. Also included were trials that compared immediate start of different hormonal contraceptive methods with each other. DATA COLLECTION AND ANALYSIS: Data were abstracted by two authors and entered into RevMan. The Peto odds ratio (OR) with 95% confidence interval (CI) was calculated. MAIN RESULTS: Five studies were included. No new eligible studies have been found since the review was initially conducted. Method discontinuation was similar between groups in all trials. Bleeding patterns and side effects were similar in trials that compared immediate with conventional start. In a study of depot medroxyprogesterone acetate (DMPA), immediate start of DMPA showed fewer pregnancies than a 'bridge' method before DMPA (OR 0.36; 95% CI 0.16 to 0.84). Further, more women in the immediate-DMPA group were very satisfied versus those with a 'bridge' method (OR 1.99; 95% CI 1.05 to 3.77). A trial of two immediate-start methods showed the vaginal ring group had less prolonged bleeding (OR 0.42; 95% CI 0.20 to 0.89) and less frequent bleeding (OR 0.23; 95% CI 0.05 to 1.03) than COC users. The ring group also reported fewer side effects. Also, more immediate ring users were very satisfied than immediate COC users (OR 2.88; 95% CI 1.59 to 5.22). AUTHORS' CONCLUSIONS: We found limited evidence that immediate start of hormonal contraception reduces unintended pregnancies or increases method continuation. However, the pregnancy rate was lower with immediate start of DMPA versus another method. Some differences were associated with contraceptive type rather than initiation method, i.e., immediate ring versus immediate COC. More studies are needed of immediate versus conventional start of the same hormonal contraceptive.

Fertility intentions and interest in integrated family planning services among women living with HIV in Nyanza Province, Kenya: a qualitative study.

Despite increasing efforts to address the reproductive health needs of people living with HIV, a high unmet need for contraception exists among HIV+ women in sub-Saharan Africa. This study explores the fertility intentions and family planning (FP) preferences of Kenyan women accessing HIV treatment. We conducted 30 semistructured interviews and qualitatively analyzed the data with a grounded theory approach. Fears of premature death, financial hardship, and perinatal HIV transmission emerged as reasons for participants' desire to delay/cease childbearing. Participants strongly identified FP needs, yet two-thirds were using male condoms alone or no modern method of contraception. Women preferred the HIV clinic as the site of FP access for reasons of convenience, provider expertise, and a sense of belonging, though some had privacy concerns. Our findings support the acceptability of integrated FP and HIV services. Efforts to empower women living with HIV to prevent unintended pregnancies must expand access to contraceptive methods, provide confidential services, and take into account women's varied reproductive intentions.

Sustained effect of LACTIN-V (Lactobacillus crispatus CTV-05) on genital immunology following standard bacterial vaginosis treatment: results from a randomised, placebo-controlled trial.

BACKGROUND: Bacterial vaginosis might increase HIV risk by eliciting genital inflammation and epithelial barrier disruption, whereas vaginal Lactobacillus crispatus is associated with immune quiescence and HIV protection. We investigated the effect of a live biotherapeutic containing L crispatus CTV-05 (LACTIN-V) on genital immunology and key vaginal bacteria. METHODS: This substudy included women aged 18-45 years who participated in the randomised, placebo-controlled, phase 2b trial of LACTIN-V to reduce bacterial vaginosis recurrence, conducted at four universities and hospitals in the USA. Women with negative results for sexually transmitted infection, pregnancy, and urinary tract infection were provided a 5-day course of vaginal metronidazole 0·75% gel. Those who met at least three of four clinical Amsel criteria for bacterial vaginosis and had a Nugent score of 4-10 from Gram staining were eligible. Participants in the LACTIN-V trial were randomly assigned (2:1) to receive either LACTIN-V or placebo, applied vaginally once per day for 5 days during the first week and then twice per week for 10 more weeks. Follow-up visits occurred 4, 8, 12, and 24 weeks after enrolment. Soluble immune factors and the absolute abundance of bacterial taxa were assayed by mutliplex ELISA and quantitative PCR. The primary outcomes were vaginal levels of IL-1α and soluble E-cadherin at 24 weeks (ie, 13 weeks after treatment cessation). FINDINGS: Between Feb 21, 2020 and March 18, 2021, we characterised genital immune parameters and the vaginal microbiota in a subset of 66 highly adherent participants who were randomly selected, with no exclusion criteria, from those who had attended all study follow-up visits (n=166) in the larger LACTIN-V clinical trial (n=288). 32 (48%) participants received LACTIN-V and 34 (52%) received placebo. LACTIN-V treatment was significantly associated with lower concentrations of the proinflammatory cytokine IL-1α (ß coefficient 0·310, SE 0·149; p=0·042) and soluble E-cadherin (0·429, 0·199; p=0·035), a biomarker of epithelial barrier disruption. INTERPRETATION: Vaginal administration of LACTIN-V following standard bacterial vaginosis therapy resulted in a sustained reduction in genital inflammation and a biomarker of epithelial integrity. The potential of LACTIN-V to reduce HIV susceptibility merits further investigation. FUNDING: Canadian Institutes of Health Research and the National Institutes of Health National Institute of Allergy and Infectious Diseases.

Metronidazole treatment rapidly reduces genital inflammation through effects on bacterial vaginosis-associated bacteria rather than lactobacilli.

BackgroundBacterial vaginosis (BV) causes genital inflammation and increases HIV risk, whereas a vaginal microbiota dominated by Lactobacillus species is associated with immune quiescence and relative HIV protection. BV treatment reduces genital inflammation, but it is unclear whether this reduction is driven by a decrease in BV-associated bacteria or an increase in Lactobacillus species.METHODSTo evaluate the short-term effect of standard BV treatment on genital immunology and the vaginal microbiota, vaginal swabs were collected immediately before and after metronidazole treatment for BV and analyzed with multiplex ELISA, metagenomic sequencing, and quantitative PCR.RESULTSTopical metronidazole treatment rapidly reduced vaginal levels of proinflammatory cytokines, chemokines, and soluble immune markers of epithelial barrier disruption. Although the vaginal microbiota shifted to dominance by L. iners or L. jensenii, this proportional shift was primarily driven by a 2 to 4 log10-fold reduction in BV-associated bacteria absolute abundance. BV treatment induced no change in the absolute abundance of L. crispatus or L. iners and only minor (<1 log10-fold) increases in L. gasseri and L. jensenii that were not independently associated with reduced inflammation in multivariable models.CONCLUSIONThe genital immune benefits that are associated with Lactobacillus dominance after BV treatment were not directly attributable to an absolute increase in lactobacilli, but rather to the loss of BV-associated bacteria.Trial REGISTRATIONParticipants were recruited as part of a randomized controlled trial (ClinicalTrials.gov NCT02766023) from 2016 to 2019.FUNDINGCanadian Institutes of Health Research (PJT-156123) and the National Institute of Allergy and Infectious Diseases (HHSN2722013000141 and HHSN27200007).

Cervical preparation for second trimester dilation and evacuation.

BACKGROUND: Abortion during the second trimester of pregnancy accounts for 10-15% of abortions performed worldwide. Dilation and evacuation (D&E) is the preferred method of second-trimester abortion in most parts of the developed world. Cervical preparation is recommended for dilation and curettage (D&C) after 12 weeks gestation and is standard practice for D&E beyond 14 weeks gestation. Prostaglandins, osmotic dilators, and Foley balloon catheters have been used and studied as cervical preparation prior to second-trimester D&E. However, no consensus exists as to which cervical preparation method is superior with regards to safety, procedure time, need for additional dilation, ability to perform the procedure, or patient and provider acceptability. Despite the fact that the advent of osmotic dilation has improved the safety of the D&E procedure during the second trimester, it is unclear whether a certain type of osmotic dilator is superior to another or whether osmotic dilation with adjuvant prostaglandin is superior to osmotic dilation alone or to prostaglandins alone. OBJECTIVES: This review evaluates cervical preparation methods for second-trimester surgical abortion with respect to differences in procedure time, dilation achieved, need for additional dilation, complications, ability to complete the procedure, patient pain scores, and patient and provider acceptability and satisfaction. SEARCH STRATEGY: We searched for trials of cervical preparation prior to second-trimester D&E. SELECTION CRITERIA: We included all randomized controlled trials that compared osmotic, mechanical, antiprogesterone, prostaglandin, or other medical agents of cervical preparation for second-trimester surgical abortion from 14-24 weeks of gestation. DATA COLLECTION AND ANALYSIS: Data were abstracted by two authors and data entry was verified by a third author. Mean difference and Peto Odds Ratio were calculated. MAIN RESULTS: Osmotic dilators were found to be superior to prostaglandins with respect to cervical dilation throughout the second trimester and with respect to procedure time within the early second trimester. Addition of prostaglandins to osmotic dilators was not found to increase cervical dilation, except after 19 weeks gestation, however, no impact was seen on procedure time. Addition of Mifepristone to misoprostol was found to improve cervical dilation, yet increase procedure time and frequency of pre-procedural expulsions. Two-day cervical preparation was found to produce greater cervical preparation than one-day, but had no impact on procedure time. Serious complication rates or ability to complete the procedure did not differ significantly between any of the preparation methods reviewed. AUTHORS' CONCLUSIONS: Cervical preparation with osmotic dilators and/or misoprostol before second-trimester D&E is safe and effective. Osmotic dilators appear to provide superior cervical dilation when compared to prostaglandins alone or when combined with prostaglandins, however this difference in cervical dilation does not appear to result in differences in procedure time or complication rates. There does not appear to be clear clinical benefit from two days of cervical preparation compared to one-day prior to second-trimester D&E below 19 weeks gestational duration. Mifepristone plus misoprostol was associated with high rates of pre-procedural expulsions and does not appear to be a useful method of cervical preparation before second-trimester dilation and evacuation. Same-day procedures appear to be a safe and reasonable option in the early second trimester, however, more research is needed to assess the effectiveness and safety of same-day procedures in the later second trimester.

Society of Family Planning clinical recommendations: Cervical preparation for dilation and evacuation at 20-24 weeks' gestation.

Although only 1.3% of abortions in the United States are between 20 and 24 weeks' gestation, these procedures are associated with elevated risks of morbidity and mortality. Adequate cervical preparation before dilation and evacuation (D&E) at 20-24 weeks' gestation reduces procedural risk. For this gestational range, at least one day of cervical preparation with osmotic dilators is recommended before D&E. The use of overnight osmotic dilators alone is sufficient for most D&Es at 20-24 weeks' gestation. Dilapan-S® dilators require a shorter time to achieve maximum dilation, may be more effective than laminaria and may increase the likelihood of success on the first D&E attempt. The use of adjunctive mifepristone administered one-day pre-operatively at the time of osmotic dilator placement, should be considered because evidence demonstrates that it makes D&E subjectively easier at 20-24 weeks without increasing side effects. While older studies suggest that two-days of serial osmotic dilators provide greater dilation than one day of dilators, adjunctive mifepristone may be comparable to a second day of dilators. Adjunctive misoprostol administered on the day of D&E does not appear to affect initial cervical dilation and procedure time and compared with mifepristone is associated with more side effects, such as pain and nausea. Using overnight mifepristone and same-day misoprostol without osmotic dilators at 20-24 weeks' gestation lengthens D&E procedure time and appears to increase immediate complications, at least among less experienced providers. Some evidence shows the feasibility of same-day cervical preparation before D&E at 20-24 weeks using Dilapan-S® with adjunctive misoprostol or serial repeat dosing of misoprostol, but same-day preparation should be limited to providers with significant experience with these regimens. The Society of Family Planning recommends preoperative cervical preparation before D&E at 20-24 weeks' gestation. Further studies are needed to clarify the best means of preparing the cervix in order to minimize abortion complications and improve outcomes in this gestational range.

Integration of family planning services into HIV care clinics: Results one year after a cluster randomized controlled trial in Kenya.

OBJECTIVES: To determine if integration of family planning (FP) and HIV services led to increased use of more effective contraception (i.e. hormonal and permanent methods, and intrauterine devices) and decreased pregnancy rates. DESIGN: Cohort analysis following cluster randomized trial, when the Kenya Ministry of Health led integration of the remaining control (delayed integration) sites and oversaw integrated services at the original intervention (early integration) sites. SETTING: Eighteen health facilities in Kenya. SUBJECTS: Women aged 18-45 receiving care: 5682 encounters at baseline, and 11628 encounters during the fourth quarter of year 2. INTERVENTION: "One-stop shop" approach to integrating FP and HIV services. MAIN OUTCOME MEASURES: Use of more effective contraceptive methods and incident pregnancy across two years of follow-up. RESULTS: Following integration of FP and HIV services at the six delayed integration clinics, use of more effective contraception increased from 31.7% to 44.2% of encounters (+12.5%; Prevalence ratio (PR) = 1.39 (1.19-1.63). Among the twelve early integration sites, the proportion of encounters at which women used more effective contraceptive methods was sustained from the end of the first to the second year of follow-up (37.5% vs. 37.0%). Pregnancy incidence including all 18 integrated sites in year two declined in comparison to the control arm in year one (rate ratio: 0.72; 95% CI 0.60-0.87). CONCLUSIONS: Integration of FP services into HIV clinics led to a sustained increase in the use of more effective contraceptives and decrease in pregnancy incidence 24 months following implementation of the integrated service model. TRIAL REGISTRATION: ClinicalTrials.gov NCT01001507.