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BackgroundBacterial 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.MethodsThis 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).FindingsBetween 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 (β 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.InterpretationVaginal 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.FundingCanadian Institutes of Health Research and the National Institutes of Health National Institute of Allergy and Infectious Diseases.

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 (

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.

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.

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.

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.

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.

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.

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.

ObjectiveTo determine if a health talk on family planning (FP) by community clinic health assistants (CCHAs) will improve knowledge, attitudes and behavioral intentions about contraception in HIV-infected individuals.MethodsA 15-min FP health talk was given by CCHAs in six rural HIV clinics to a sample of 49 HIV-infected men and women. Effects of the health talk were assessed through a questionnaire administered before the health talk and after completion of the participant's clinic visit.ResultsFollowing the health talk, there was a significant increase in knowledge about contraceptives (p

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.

ObjectiveTo evaluate whether HIV-infected women and men in HIV care and not using highly effective methods of contraception thought they would be more likely to use contraception if it were available at the HIV clinic.MethodsA face-to-face survey assessing family-planning knowledge, attitudes, and practices was conducted among 976 HIV-infected women and men at 18 public-sector HIV clinics in Nyanza, Kenya. Data were analyzed using logistic regression and generalized estimating equations.ResultsThe majority of women (73%) and men (71%) thought that they or their partner would be more likely to use family planning if it were offered at the HIV clinic. In multivariable analysis, women who reported making family-planning decisions with their partner (adjusted odds ratio [aOR] 3.22; 95% confidence interval [CI], 1.53-6.80) and women aged 18-25 years who were not currently using family planning (aOR 4.76; 95% CI, 2.28-9.95) were more likely to think they would use contraception if integrated services were available. Women who perceived themselves to be infertile (aOR 0.07; 95% CI, 0.02-0.31) and had access to a cell phone (aOR 0.40; 95% CI, 0.25-0.63) were less likely to think that integrated services would change their contraceptive use. Men who were not taking antiretroviral medications (aOR 3.30; 95% CI, 1.49-7.29) were more likely, and men who were unsure of their partner's desired number of children (aOR 0.36; 95% CI, 0.17-0.76), were not currently using family planning (aOR 0.40; 95% CI, 0.22-0.73), and were living in a peri-urban setting (aOR 0.46; 95% CI, 0.21-0.99) were less likely to think their partner would use contraception if available at the HIV clinic.ConclusionsIntegrating family planning into HIV care would probably have a broad impact on the majority of women and men accessing HIV care and treatment. Integrated services would offer the opportunity to involve men more actively in the contraceptive decision-making process, potentially addressing 2 barriers to family planning: access to contraception and partner uncertainty or opposition.

BackgroundHealth 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.ObjectivesThis review examined randomized controlled trials (RCTs) of immediate-start hormonal contraception for differences in effectiveness, continuation, and acceptability.Search methodsIn 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 criteriaWe 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 analysisData were abstracted by two authors and entered into RevMan. The Peto odds ratio (OR) with 95% confidence interval (CI) was calculated.Main resultsFive 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' conclusionsWe 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.