Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis.

BACKGROUND: Bacterial vaginosis affects 15 to 50% of women of reproductive age, and recurrence is common after treatment with an antibiotic agent. The high incidence of recurrence suggests the need for new treatments to prevent recurrent bacterial vaginosis. METHODS: We conducted a randomized, double-blind, placebo-controlled, phase 2b trial to evaluate the ability of Lactobacillus crispatus CTV-05 (Lactin-V) to prevent the recurrence of bacterial vaginosis. Women 18 to 45 years of age who had received a diagnosis of bacterial vaginosis and who had completed a course of vaginal metronidazole gel as part of the eligibility requirements were randomly assigned, in a 2:1 ratio, to receive vaginally administered Lactin-V or placebo for 11 weeks; follow-up occurred through week 24. The primary outcome was the percentage of women who had a recurrence of bacterial vaginosis by week 12. RESULTS: A total of 228 women underwent randomization: 152 to the Lactin-V group and 76 to the placebo group; of these participants, 88% in the Lactin-V group and 84% in the placebo group could be evaluated for the primary outcome. In the intention-to-treat population, recurrence of bacterial vaginosis by week 12 occurred in 46 participants (30%) in the Lactin-V group and in 34 participants (45%) in the placebo group (risk ratio after multiple imputation for missing responses, 0.66; 95% confidence interval [CI], 0.44 to 0.87; P = 0.01). The risk ratio for recurrence by week 24 (also calculated with multiple imputation for missing responses) was 0.73 (95% CI, 0.54 to 0.92). At the 12-week visit, L. crispatus CTV-05 was detected in 79% of participants in the Lactin-V group. The percentage of participants who had at least one adverse event related to Lactin-V or placebo by week 24 did not differ significantly between the groups. The percentage of participants with local or systemic adverse events was similar in the two groups. CONCLUSIONS: The use of Lactin-V after treatment with vaginal metronidazole resulted in a significantly lower incidence of recurrence of bacterial vaginosis than placebo at 12 weeks. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT02766023.).

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.

Cultural considerations and beliefs surrounding preterm birth in Kenya and South Africa.

BACKGROUND: Preterm birth (PTB) is a global health epidemic, sub-Saharan Africa is severely impacted due to its limited healthcare resources. Pregnancy knowledge, cultural beliefs and practices play a role in the identification of risk and management of PTB. This study explored knowledge, understandings, cultural beliefs and attitudes to pregnancy and PTB, as well as cultural considerations for the introduction of an intravaginal device which could be used to identify PTB risk. METHODS: Qualitative research was conducted in South Africa and Kenya. In-depth interviews were conducted using semi-structured guides with women with a history of PTB (n = 10), healthcare providers (n = 16) and health systems experts (n = 10); and 26 focus group discussions with pregnant women seeking antenatal care (n = 132) and community male partners/fathers (n = 54). Interviews/discussions were transcribed, translated, and analysed thematically. RESULTS: Pregnancy knowledge, especially for first time pregnancies was poor, with many reporting late entry to antenatal care. Knowledge about PTB was understood in terms of gestational age, weight or small size of baby, with concerns about long term health and stigma. Various risk factors for PTB were described, including those related to traditions and beliefs of witchcraft/curses. Cultural practices, such as the use of traditional medicines and pica, and religion and its impact on health seeking behaviour were also viewed as risk factors. Although insertion of intravaginal devices was not widely acceptable in traditional communities, especially during pregnancy, it was felt that the use of one to detect risk of PTB would be accepted if proven effective in reducing PTB risk. CONCLUSIONS: Various culturally-informed beliefs exist which explain understandings of and attitudes toward pregnancy, pregnancy risk, and PTB. An inclusive exploratory process is critical to facilitate an understanding of the beliefs and traditions which could impact the introduction and design of a product to detect the risk of PTB.

Toward an intravaginal device to detect risk of preterm labor: a user-centered design approach in Sub-Saharan Africa.

BACKGROUND: Prematurity and its complications are the leading cause of death and disability in children under five in Africa and North America, affecting as many as one in ten pregnancies. Screening tests to predict preterm birth (PTB) are insensitive, costly, and often unavailable in low resource settings. In parallel with early-stage U.S.-based testing of a novel self-placed intravaginal device to predict PTB risk, we elicited key stakeholder input from two sub-Saharan African countries to ensure local contextual factors inform future development of the device and its acceptability. METHODS: A qualitative study was conducted in Kiambu County, Kenya and KwaZulu-Natal Province, South Africa. We conducted 26 focus group discussions with pregnant women (n = 132) and males from the community (n = 54); in-depth interviews with women who had a history of PTB (n = 10), healthcare providers (n = 16), and health system experts (n = 10). Interviews were transcribed and thematic analysis was performed using an iterative coding technique. In addition, we facilitated user-centered design sessions to generate prototype preferences. RESULTS: Women with a personal history of PTB were almost unanimous in support of the proposed device, whereas those with no experience of PTB expressed the greatest degree of reservation. Healthcare providers anticipated that women with a history of PTB would accept the device. However, various potential challenges were identified, including potential discomfort with device insertion, hygiene, and sexual activity, as well as need for provider training, and attention to country-specific regulatory processes. Both community participants and providers expressed a preference for a provider inserted device. Design recommendations included preference for a small, soft, pliable device, with a shape that could facilitate easy removal. CONCLUSIONS: Use of an intravaginal device to detect risk of PTB was generally acceptable, however stakeholders expressed a notable preference for insertion by providers. This reflects the significance of end-user consultation in device design and use. Recommended device modifications as well as educational messaging and provider technical assistance may facilitate utilization.

Prematurity and its complications are the leading cause of death and disability in children under 5 years of age. Up to ten percent of pregnancies in North America and Africa are affected. Screening tests to predict preterm birth (PTB) are insensitive, costly, and often unavailable in low resource settings. A U.S.-based study has developed an intravaginal device to detect preterm labor. In order to assess acceptability and guide development for a low-resource setting, a qualitative study was conducted in Kenya and South Africa. We conducted focus group discussions and interviews with pregnant women, male community members, health care providers and health systems experts. Participants with a personal history of PTB were almost unanimous in support of the proposed device; women with no experience of PTB expressed the greatest degree of reservation. Various potential challenges were identified: discomfort, hygiene, and sexual activity, the need for provider training and attention to country-specific regulatory processes. Design recommendations included preference for a small, soft, pliable device, with a shape that could facilitate easy removal. Stakeholders expressed a strong preference for insertion by providers. These findings reflect the significance of end-user consultation in device design and 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.

Homelessness, housing instability, and abortion outcomes at an urban abortion clinic in the United States.

BACKGROUND: Adverse reproductive health outcomes are well documented among people experiencing homelessness or housing instability. Little is known about abortion outcomes among this population. OBJECTIVE: This study aimed to investigate the relationship between housing status and abortion outcomes and whether gestational age mediates this relationship. STUDY DESIGN: Our sample comprised 1903 individuals who had abortions at an urban clinic in San Francisco, CA, from 2015 to 2017. We defined homelessness or housing instability as a binary exposure, which included staying outside, with friends and/or family, or in a tent, vehicle, shelter, transitional program, or hotel. We evaluated gestational duration of ≥20 weeks as a mediator variable. Our primary outcome was any abortion complication. Logistic regression models were adjusted for age, race, substance use, mental health diagnoses, and previous vaginal and cesarean deliveries. RESULTS: Approximately 19% (n=356) of abortions were among people experiencing homelessness or housing instability. Compared with those with stable housing, people experiencing homelessness or housing instability presented later in pregnancy (mean gestational duration, 13.3 vs 9.5 weeks; P<.001) and had more frequent complications (6.5% vs 2.8%; P<.001; odds ratio, 2.2; 95% confidence interval, 1.2-3.9). Adjusting for race, substance use, mental health diagnoses, and previous cesarean deliveries, individuals experiencing homelessness or housing instability were more likely to have abortion complications (odds ratio, 2.3; 95% confidence interval, 1.3-4.0). However, the relationship was attenuated after adjusting for gestational duration (odds ratio, 1.4; 95% confidence interval, 0.7-2.6), suggesting that gestational duration mediates the relationship between housing status and abortion complications. CONCLUSION: Patients experiencing homelessness or housing instability presented later in gestation, which seems to contribute to the increased frequency of abortion complications.

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.