Gestational weight gain and adverse birth outcomes in South African women with HIV on antiretroviral therapy and without HIV: a prospective cohort study.

INTRODUCTION: Outside of pregnancy, evidence shows that persons with HIV initiating or switching to dolutegravir (DTG)-based antiretroviral therapy (ART) experience greater weight gain compared to those on other ART classes. However, there are few data on the impact of DTG-based ART on gestational weight gain (GWG) in sub-Saharan Africa where HIV is most common. According to the National Academy of Medicine (NAM), GWG below and above NAM guidelines is associated with adverse birth outcomes. Therefore, the objective of this study was to describe GWG by HIV status and ART regimen, and examine the associations with adverse birth outcomes. METHODS: We enrolled pregnant women with HIV (WHIV) and without HIV (≥18 years) in a peri-urban primary healthcare facility in Cape Town, South Africa between 2019 and 2022. GWG was study-measured at 24-28 (baseline) and 33-38 weeks gestation and converted to GWG rate (kg/week) in accordance with NAM guidelines. GWG z-scores were generated using the INTEGROWTH-21 and US standards to account for differing lengths of gestation. Birth outcome data were obtained from medical records. Associations of GWG z-score with adverse birth outcomes were assessed using multivariable linear or log-binomial regression. RESULTS: Among 292 participants (48% WHIV), median age was 29 years (IQR, 25-33), median pre-pregnancy body mass index (BMI) was 31 kg/m2 (IQR, 26-36) and 20% were primiparous at baseline. The median weekly rate of GWG was 0.30 kg/week (IQR, 0.12-0.50), 35% had GWG below NAM standards (59% WHIV) and 48% had GWG above NAM standards (36% WHIV). WHIV gained weight more slowly (0.25 vs. 0.37 kg/week, p<0.01) than women without HIV. Weekly rate of GWG did not differ by ART regimen (DTG-based ART 0.25 vs. efavirenz-based ART 0.27 kg/week, p = 0.80). In multivariable analyses, GWG z-score was positively associated with continuous birth weight (mean difference = 68.53 95% CI 8.96, 128.10) and categorical high birth weight of >4000 g (RR = 2.18 95% CI 1.18, 4.01). CONCLUSIONS: Despite slower GWG among WHIV, nearly half of all women gained weight faster than recommended by the NAM. GWG was positively associated with infant birth weight. Interventions to support healthy GWG in sub-Saharan Africa are urgently needed.

Cardiometabolic Health in Pregnancy and Postpartum: Findings From a Prospective Cohort Study in South Africa.

Background: The cardiometabolic impact of HIV infection and treatment with antiretroviral therapy (ART) in pregnancy and the postpartum period remains unclear. Methods: We enrolled pregnant persons with (PHIV) and without HIV in Cape Town, South Africa, who were ≥18 years old at 24-28 weeks' gestation and followed them up to 32 months postpartum. We estimated associations between HIV status and cardiometabolic risk including body mass index (BMI), obesity (BMI ≥30 kg/m2), blood pressure (BP; elevated systolic BP ≥130 and/or diastolic ≥85 mmHg), lipid levels, and metabolic syndrome according to the Joint Interim Statement criteria using multivariable log binomial or linear regression models. Subgroup analyses compared PHIV on efavirenz (EFV)- vs dolutegravir (DTG)-based ART. Results: Among 400 participants (n = 200 without HIV, n = 200 PHIV), 52% had prepregnancy obesity and 9% had elevated BP. Postpartum, 57% were classified with obesity, 31% had elevated BP, and 29% had metabolic syndrome. In multivariable analyses, HIV was associated with a lower BMI prepregnancy but not postpartum; however, mean indices were in the obese range regardless of HIV status. Neither BMI nor obesity prepregnancy or postpartum differed by ART regimen. Among PHIV, participants on DTG had higher levels of elevated BP in pregnancy and postpartum, compared with PHIV on EFV. Conclusions: We observed high levels of obesity, elevated BP, and metabolic syndrome in the perinatal period but few differences by HIV status. Participants on DTG may be more likely to have elevated BP in pregnancy and postpartum. Monitoring of cardiometabolic health for pregnant persons on DTG is warranted.

Womandla Health: development and rationale of a behavioral intervention to support HIV treatment adherence among postpartum women in South Africa.

BACKGROUND: While Option B + has made great strides in eliminating vertical transmission of HIV and improving access to lifelong antiretroviral therapy (ART) for women, the postpartum period remains a risk period for disengagement from HIV care and non-adherence. METHODS: Longitudinal qualitative data was collected from 30 women living with HIV in Cape Town, South Africa from pregnancy through 1 year postpartum to examine key barriers and facilitators to HIV treatment adherence across this transition. Participants were also asked about their preferences for behavioral intervention content, format, and scope. The intervention development process was guided by Fernandez et al.'s Intervention Mapping process and was informed by the qualitative data, the wider literature on ART adherence, and Transition Theory. RESULTS: The Womandla Health Intervention is a multicomponent intervention consisting of four individual sessions with a lay health worker and four peer group sessions, which span late pregnancy and early postpartum. These sessions are guided by Transition Theory and utilize motivational interviewing techniques to empower women to ascertain their own individual barriers to HIV care and identify solutions and strategies to overcome these barriers. CONCLUSIONS: This intervention will be tested in a small scale RCT. If successful, findings will provide an innovative approach to HIV treatment by capitalizing on the transition into motherhood to bolster self-care behaviors, focusing on ART adherence and also women's overall postpartum health and psychosocial needs.

Antiretroviral Therapy Use Was Not Associated with Stillbirth or Preterm Birth in an Analysis of U.S. Medicaid Pregnancies to Persons with HIV.

Background: Using a U.S. based, nationally representative sample, this study compares stillbirth and preterm birth outcomes between women living with HIV (WWH) who did and did not use antiretroviral therapy (ART) during pregnancy, additionally assessing ART duration and regimen type. Methods: Using 2001 to 2012 Medicaid Analytic eXtract (MAX) data from the 14 states with the highest prevalence of HIV. We estimated two, propensity score matched, multivariate logistic regression models for both outcomes of stillbirth and preterm birth: (1) any ART use and (2) the number of months on ART during pregnancy for ART users, adjusting for patient-level covariates. Results: Only 34.6% of pregnancies among WWH had a history of ART use and among those, the proportions of stillbirth and preterm birth were 0.9% and 7.9%, respectively. Any ART use was not significantly associated with either outcome of stillbirth (marginal effects [MEs]: 0.06%, 95% confidence interval [CI]: -0.17 to 0.28) or preterm birth (ME: -0.12%, 95% CI: -0.79 to 0.55). For ART users, duration of ART was not significantly associated with either outcome. Black race was a strong independent predictor in both models (stillbirth: 0.80% and 0.84%, preterm birth: 4.19% and 3.76%). Neither protease inhibitor (PI) nor boosted PI regimens were more strongly associated with stillbirth or preterm birth than nucleoside reverse transcriptase inhibitor-based regimens. Conclusion: ART use during pregnancy was low during this period. Our findings suggest that ART use and ART regimen are not associated, positively or negatively, with stillbirth or preterm birth for mothers with Medicaid. Additionally, our findings highlight a persisting need to address disparities in these outcomes for Black women.

Associations of HIV and antiretroviral therapy with gestational diabetes in South Africa.

OBJECTIVE: To estimate associations of HIV status and antiretroviral (ART) regimen with gestational diabetes (GDM) and postpartum glucose metabolism. DESIGN: Prospective cohort study. METHODS: We enrolled pregnant persons with HIV (PWH) and without HIV in Cape Town, South Africa who were at least 18 years of age at 24-28 weeks' gestation and followed up to 26 months postpartum. Participants were tested for GDM in pregnancy and for diabetes postpartum using a 75 g 2 h oral glucose tolerance test (OGTT) and diagnosed via WHO criteria. We estimated associations of HIV status and ART regime [efavirenz (EFV) versus dolutegravir (DTG)] with GDM and postpartum impaired glucose metabolism using multivariable log binomial or linear regression models. RESULTS: Among 397 participants [median age 30 (interquartile range (IQR) 25-34; n  = 198 without HIV, n  = 199 PWH], the prevalence of GDM was 6% (9 PWH versus 3% without HIV). In multivariable analyses, PWH were at higher risk of GDM [risk ratio (RR) 3.9, 95% confidence interval (CI) 1.4-10.7] after adjustment for prepregnancy BMI and other confounders. GDM risk did not differ by ART regimen (unadjusted prevalence 8.1% DTG versus 5.6% EFV, adjusted RR 1.1, 95% CI 0.2-6.6). Few participants had diabetes, impaired glucose tolerance (IGT), or impaired fasting glucose postpartum ( n  = 13, 6%) with no differences by HIV or ART status. CONCLUSION: In a setting of universal GDM testing, PWH had an increased risk of impaired glucose metabolism during pregnancy but not postpartum. Among PWH, GDM risk was similar regardless of EFV or DTG use. Given concerns about DTG and weight gain, diabetes risk should continue to be monitored.

Predictors of PrEP awareness, PrEP discussion and interest in long-acting injectable PrEP among Filipina transfeminine adults.

INTRODUCTION: Transfeminine adults are impacted by the HIV epidemic in the Philippines, and newly approved modalities of pre-exposure prophylaxis (PrEP), including long-acting injectable (LAI-PrEP), could be beneficial for this group. To inform implementation, we analysed PrEP awareness, discussion and interest in taking LAI-PrEP among Filipina transfeminine adults. METHODS: We utilized secondary data from the #ParaSaAtin survey that sampled Filipina transfeminine adults (n = 139) and conducted a series of multivariable logistic regressions with lasso selection to explore factors independently associated with PrEP outcomes, including awareness, discussion with trans friends and interest in LAI-PrEP. RESULTS: Overall, 53% of Filipina transfeminine respondents were aware of PrEP, 39% had discussed PrEP with their trans friends and 73% were interested in LAI-PrEP. PrEP awareness was associated with being non-Catholic (p = 0.017), having previously been HIV tested (p = 0.023), discussing HIV services with a provider (p<0.001) and having high HIV knowledge (p = 0.021). Discussing PrEP with friends was associated with older age (p = 0.040), having experienced healthcare discrimination due to transgender identity (p = 0.044), having HIV tested (p = 0.001) and having discussed HIV services with a provider (p < 0.001). Very interested in LAI-PrEP was associated with living in Central Visayas (p = 0.045), having discussed HIV services with a provider (p = 0.001) and having discussed HIV services with a sexual partner (p = 0.008). CONCLUSIONS: Implementing LAI-PrEP in the Philippines requires addressing systemic improvements across personal, interpersonal, social and structural levels in healthcare access, including efforts to create healthcare settings and environments with providers who are trained and competent in transgender health and can address the social and structural drivers of trans health inequities, including HIV and barriers to LAI-PrEP.

Human Immunodeficiency Virus Type 1 RNA Genital Tract Shedding After Cryotherapy for Cervical Intraepithelial Neoplasia in Western Kenya.

This prospective study of 39 women living with human immunodeficiency virus (HIV) on antiretroviral therapy in Western Kenya aimed to quantify genital tract HIV-1 RNA (GT-HIV RNA) shedding before and after cryotherapy for cervical intraepithelial neoplasia. Most GT-HIV RNA shedding was detected precryotherapy, suggesting that cryotherapy was not the primary cause of shedding.

Characterizing Problematic Drug Use Among Transgender Women and Cisgender Men During the Emerging HIV Crisis in the Philippines: Implications for Policy Research.

Drug use and HIV are key issues for public health interventions in the Philippines. We examined associations of problematic drug use among 320 Filipinx transgender women (trans-WSM) and cisgender men who have sex with men (cis-MSM). The prevalence of exhibited problematic drug use in this sample was 29.38%. Greater odds of problematic drug use were observed among Filipinx participants who recently engaged in sex work (adjusted OR [aOR] = 2.79, 95% CI [1.08, 7.18]), reported having HIV positive and unknown status vs. negative status (aOR = 3.61, 95% CI [1.39, 9.39], and aOR = 13.99, 95% CI [2.04, 29.69], respectively), exhibited low HIV knowledge (aOR = 4.15, 95% CI [1.82, 9.44]), and displayed hazardous drinking (aOR = 2.77, 95% CI [1.21, 6.33]). Given its correlates of HIV-related indicators, integration of HIV and harm reduction services as a public health intervention could potentially decrease problematic drug use.

HIV-Positive and HIV-Negative Women with Medicaid Have Similar Rates of Stillbirth and Preterm Birth.

Introduction: Women living with human immunodeficiency virus (WLHIV) may face additional challenges and differential birth outcomes when compared with women without human immunodeficiency virus (HIV). There is limited research to date studying birth outcomes among a nationally representative sample of WLHIV. This study compares stillbirth and prematurity rates between HIV-positive (HIV+) and HIV-negative (HIV-) mothers in the Medicaid program. Methods: We used 12 years (2001-2012) of Medicaid Analytic eXtract data. We included Medicaid claims from the 14 states with the highest prevalence of HIV: California, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Texas, and Virginia. Primary outcomes were stillbirth and preterm birth. We used logistic regression models adjusting for age, race, Medicaid coverage, eligibility, substance use, rurality, comorbidities, and state fixed effects to compare differences in rates for women with and without HIV. Results: Our study included a total of 33,078 HIV+ and 7,663,758 HIV- pregnancies from Medicaid enrollees between 2001 and 2012. The proportions of stillbirths and preterm births were higher for HIV+ when compared with HIV- mothers (0.9% vs. 0.7% and 8.0% vs. 6.6%, p < 0.0001). After adjusting for covariates, being HIV+ was not significantly associated with both stillbirth (odds ratio [OR]: 1.05) or prematurity (OR: 1.01). Black race was a strong independent predictor of both stillbirth and prematurity (OR: 1.99 and 1.51, p < 0.01). Rurality and substance abuse were not associated with either outcome. Conclusions: After adjustment for relevant covariates, maternal HIV infection was not associated with increased rates of stillbirth or preterm birth in the Medicaid program in the United States. It is imperative that we understand and eliminate the clinical, social, and contextual factors that are responsible for the strong association between black race and poor perinatal outcomes that we observe.

Characterizing Awareness of Pre-Exposure Prophylaxis for HIV Prevention in Manila and Cebu, Philippines: Web-Based Survey of Filipino Cisgender Men Who Have Sex With Men.

BACKGROUND: The Philippines is experiencing an HIV crisis and is considering implementing pre-exposure prophylaxis (PrEP) as a national public health strategy for HIV prevention for cisgender men who have sex with men (cis-MSM). However, critical information on the awareness of PrEP among cis-MSM is needed to roll out this public health initiative. OBJECTIVE: This study aims to assess PrEP awareness and related correlates (ie, sociodemographic variables, social factors, and health care access and use) among Filipino cis-MSM. METHODS: We conducted a web-based survey with Filipino cis-MSM (n=179) residing in the cities of Manila and Cebu, Philippines. Multivariable analysis procedures were performed to examine the factors associated with PrEP awareness. RESULTS: Our sample demonstrated high awareness (134/179, 74.9%) and interest (159/179, 88.8%) in taking PrEP. The adjusted model showed that greater odds of PrEP awareness were associated with having a college education or higher versus a high school education or lower (adjusted odds ratio [aOR] 7.30, 95% CI 1.01-52.47), earning between PHP 10,000 (US $198.6) and PHP 20,000 (US $397.2) versus

Designing Dual Compartment HIV Prevention Products: Women's Sensory Perceptions and Experiences of Suppositories for Rectal and Vaginal Use.

Dual compartment suppositories are being developed to prevent HIV and other sexually transmitted infections. Such products, for use in the rectum, the vagina, or both, could have a significant public health impact by decreasing global incidence of these diseases. In this study, 16 women each used two rheologically distinct suppositories in their vagina and rectum. User Sensory Perception and Experience (USPE) scales assessed sensory experiences during sexual activity to understand whether, and how, women perceive formulation properties in the vagina and rectum. Qualitative data from individual in-depth interviews captured women's descriptions and comparisons of the experiences. Significant differences and large Cohen's d effect sizes between vaginal and rectal experiences of suppository-A were found for three scales: Application (APP): Product Awareness, SEX: Initial Penetration; and SEX: Effortful. Qualitative data provided user experience details that credibly align with these score differences. Near significant differences and large effect sizes were found for two additional scales: SEX: Perceived Wetness with suppository-A and SEX: Messiness with suppository-B. In addition, other scale scores showed medium-to-large effect sizes that correspond to hypothesized sensations associated with biophysical properties of the suppositories. Statistical significance combined with large effect sizes and qualitative data accurately represent the hypothesized perceptibility of suppository properties and identifies performance characteristics relevant to acceptability and adherence; together these data provide discernment of factors that can guide the development of dual compartment products. The Clinical Trial Registration number: NCT02744261.

Responsive Medical Providers and Recent HIV Medical Services Engagement Among Transgender Women and Cisgender Men Who Have Sex With Men in the Philippines.

Transgender women and cisgender men who have sex with men (trans-WSM and cis-MSM) comprise the majority of new HIV infections in the Philippines. There is limited research in the Philippines on the relationship between having a provider responsive to the needs of these populations and recent engagement in HIV medical services such as HIV testing and treatment. We used multivariate logistic regression to examine the relationship between having a responsive medical provider and engagement in HIV medical services in the past 12 months among an online sample of 318 trans-WSM and cis-MSM in the Philippines. Participants without a responsive medical provider had lower adjusted odds of recent HIV medical service engagement than those who did (aOR = 0.32, 95% CI [0.16, 0.62], p = .00). In stratified analyses, this relationship was significant for trans-WSM but not cis-MSM. Increasing access to responsive providers in the Philippines could bolster recent engagement with HIV medical services.

Protozoan-Viral-Bacterial Co-Infections Alter Galectin Levels and Associated Immunity Mediators in the Female Genital Tract.

Co-infections with sexually transmittable pathogens are common and more likely in women with disturbed vaginal bacteriome. Among those pathogens, the protozoan parasite Trichomonas vaginalis (TV) is most common after accounting for the highly persistent DNA viruses human papillomavirus (HPV) and genital herpes. The parasitic infection often concurs with the dysbiotic syndrome diagnosed as bacterial vaginosis (BV) and both are associated with risks of superimposed viral infections. Yet, the mechanisms of microbial synergisms in evading host immunity remain elusive. We present clinical and experimental evidence for a new role of galectins, glycan-sensing family of proteins, in mixed infections. We assessed participants of the HIV Epidemiology Research Study (HERS) at each of their incident TV visits (223 case visits) matched to controls who remained TV-negative throughout the study. Matching criteria included age, race, BV (by Nugent score), HIV status, hysterectomy, and contraceptive use. Non-matched variables included BV status at 6 months before the matched visit, and variables examined at baseline, within 6 months of and/or at the matched visit e.g. HSV-2, HPV, and relevant laboratory and socio-demographic parameters. Conditional logistic regression models using generalized estimating equations calculated odds ratios (OR) for incident TV occurrence with each log10 unit higher cervicovaginal concentration of galectins and cytokines. Incident TV was associated with higher levels of galectin-1, galectin-9, IL-1ß and chemokines (ORs 1.53 to 2.91, p <0.001). Galectin-9, IL-1ß and chemokines were up and galectin-3 down in TV cases with BV or intermediate Nugent versus normal Nugent scores (p <0.001). Galectin-9, IL-1ß and chemokines were up in TV-HIV and down in TV-HPV co-infections. In-vitro, TV synergized with its endosymbiont Trichomonasvirus (TVV) and BV bacteria to upregulate galectin-1, galectin-9, and inflammatory cytokines. The BV-bacterium Prevotella bivia alone and together with TV downregulated galectin-3 and synergistically upregulated galectin-1, galectin-9 and IL-1ß, mirroring the clinical findings of mixed TV-BV infections. P. bivia also downregulated TVV+TV-induced anti-viral response e.g. IP-10 and RANTES, providing a mechanism for conducing viral persistence in TV-BV co-infections. Collectively, the experimental and clinical data suggest that galectin-mediated immunity may be dysregulated and exploited by viral-protozoan-bacterial synergisms exacerbating inflammatory complications from dysbiosis and sexually transmitted infections.

The development and evaluation of an HIV implementation science network in New England: lessons learned.

BACKGROUND: Describe and evaluate an implementation science network focused on HIV prevention and treatment in New England. METHODS: In 2014, we established a partnership among university researchers and community stakeholders to stimulate and support HIV-related implementation research. We solicited information from Network members through surveys, interviews at Network events, and dialog with participants. In 2017, we conducted a sociocentric network assessment of collaborations on research projects, grants, manuscripts, and consultations. RESULTS: We identified 988 connections made through the Network that resulted in 185 manuscripts published and 15 grants funded. Our experience indicated that eight factors were instrumental in building and sustaining the Network: (1) acknowledging different perspectives, (2) balancing content and expertise, (3) encouraging consistent engagement, (4) providing seed funding, (5) membership flexibility, (6) maintenance of Network interactions, (7) supporting local HIV prevention and treatment efforts, and (8) maintaining productive relationships with health departments and community-based organizations. CONCLUSIONS: Developing and maintaining a regional network on implementation science for HIV prevention and treatment is feasible and can facilitate new and productive partnerships among researchers and community organizations and members.

Transgender-specific developmental milestones and associated experiences of violence, discrimination, and stigma among Filipinx transgender women who are sexually active with men.

BACKGROUND: For transgender people, reaching transgender (trans)-specific developmental milestones, including recognizing and expressing one's identity, plays an integral role in overall health, wellbeing, and the pursuit of gender affirmation. Yet trans people continue to face minority stressors, including structural violence (i.e., discrimination, violence, and stigma), which may interfere with the achievement of these milestones. Among trans women specifically, however, potential associations between gender developmental milestones and structural violence are not well characterized in the literature. In a sample of Filipinx (i.e., an inclusive term for describing non-binary genders in the Philippines) trans women who are sexually active with men (trans-WSM), we thus sought to: (a) describe the mean ages at which gender developmental milestones occur and (b) examine the associations between structural violence and mean ages at which at which Filipinx trans-WSM experience trans-specific developmental milestones. METHODS: Using data from Project #ParaSaAtin, an online survey of Filipinx trans-WSM (n = 139), we mapped age-estimates per trans-specific milestones and then tested whether structural violence is associated with the mean age at which trans women experience trans-specific developmental milestones. RESULTS: Overall, participants who reported higher levels of discrimination, stigma, and violence also experienced a later age for nearly each milestone (i.e., initial self-awareness of transfeminine identity, transfeminine expression in private, transfeminine expression in public, first consensual oral/vaginal/anal sex with a cisgender male partner, first consensual oral/vaginal/anal sex with a cisgender male partner as a trans women, and hormone integration) (all p-values <0.05). Of note, the single exception to this pattern was the non-significant association between stigma and initial disclosure of transfeminine identification to another person. CONCLUSION: Results are consistent with psychological literature outlining a temporal sequence of developmental milestones among young trans-WSM. For young trans-WSM in the Philippines, data from this study demonstrate significant associations between structural violence and the achievement of developmental milestones. These findings highlight the need for trauma-informed, strengths-based programming and institutional policies that measure and mitigate anti-trans violence.

Safety, acceptability, and pharmacokinetics of a monoclonal antibody-based vaginal multipurpose prevention film (MB66): A Phase I randomized trial.

BACKGROUND: MB66 film is a multipurpose prevention technology (MPT) product with monoclonal antibodies (mAbs) against HIV-1 (VRC01-N) and HSV-1 and 2 (HSV8-N). The mAbs were produced by transient expression in Nicotiana benthamiana (N). We conducted a Phase I clinical trial to assess the safety, pharmacokinetics (PK), and ex vivo efficacy of single and repeated doses of MB66 when used intravaginally. METHODS AND FINDINGS: The clinical trial enrolled healthy reproductive-aged, sexually abstinent women. In Segment A, 9 women received a single MB66 film which was inserted into the vaginal posterior fornix by a clinician. In Segment B, 29 women were randomly assigned to MB66 (Active) or Placebo film groups and were instructed to insert 1 film vaginally for 7 consecutive days. Visits and clinical sampling occurred predose and at various time points after single and repeated film doses. The primary endpoint was number of adverse events (AEs) Grade 2 or higher related to product use. Secondary endpoints included film dissolution rate, Nugent score (a Gram stain scoring system to diagnose bacterial vaginosis), vaginal pH, post-use survey results, cytokine concentrations in cervicovaginal lavage (CVL) specimens (assessed by Luminex assay), mAb concentrations in vaginal fluid collected from 4 sites (assessed by ELISA), and HIV and HSV neutralization activity of CVL samples ex vivo (assessed by TZM-bl and plaque reduction assay, respectively). The product was generally safe and well tolerated, with no serious AEs recorded in either segment. The AEs in this study were primarily genitourinary in nature with the most commonly reported AE being asymptomatic microscopic hematuria. There were no differences in vaginal pH or Nugent scores or significant increases in levels of proinflammatory cytokines for up to 7 days after film insertion in either segment or between Active and Placebo groups. Acceptability and willingness to use the product were judged to be high by post-use surveys. Concentrations of VRC01-N and HSV8-N in vaginal secretions were assessed over time to generate pharmacokinetic curves. Antibody levels peaked 1 hour postdosing with Active film (median: 35 µg/mL) and remained significantly elevated at 24 hours post first and seventh film (median: 1.8 µg/mL). Correcting for sample dilution (1:20), VRC01-N concentrations ranged from 36 to 700 µg/mL at the 24-hour time point, greater than 100-fold the IC50 for VRC01 (0.32 µg/mL); HSV8-N concentrations ranged from 80 to 601 µg/mL, well above the IC50 of 0.1 µg/m. CVL samples collected 24 hours after MB66 insertion significantly neutralized both HIV-1 and HSV-2 ex vivo. Study limitations include the small size of the study cohort, and the fact that no samples were collected between 24 hours and 7 days for pharmacokinetic evaluation. CONCLUSIONS: Single and repeated intravaginal applications of MB66 film were safe, well tolerated, and acceptable. Concentrations and ex vivo bioactivity of both mAbs in vaginal secretions were significantly elevated and thus could provide protection for at least 24 hours postdose. However, further research is needed to evaluate the efficacy of MB66 film in women at risk for HIV and HSV infection. Additional antibodies could be added to this platform to provide protection against other sexually transmitted infections (STIs) and contraception. TRIAL REGISTRATION: ClinicalTrials.gov NCT02579083.

Differences in HIV risk and healthcare engagement factors in Filipinx transgender women and cisgender men who have sex with men who reported being HIV negative, HIV positive or HIV unknown.

INTRODUCTION: Understanding HIV risk and healthcare engagement of at-risk individuals by HIV status is vital to informing HIV programmes in settings where the HIV epidemic is rapidly expanding like the Philippines. This study examined differences in HIV risk and healthcare engagement factors among Filipinx transgender women and cisgender men who have sex with men (trans-WSM and cis-MSM respectively) who self-reported being HIV negative, HIV positive or HIV unknown. METHODS: Between 2018 and 2019, we conducted Project #ParaSaAtin, an online cross-sectional survey that examined the structural, social and behavioural factors impacting HIV services among Filipinx trans-WSM and cis-MSM (n = 318). We performed multinomial regression procedures to determine factors associated with HIV status (with HIV-negative referent). Co-variates included participant demographics, experiences of social marginalization, HIV risk, healthcare engagement and alcohol and substance problems. RESULTS: Self-reported HIV status of the sample was as follows: 38% HIV negative, 34% HIV positive and 28% HIV unknown. Relative to HIV-negative respondents, HIV-positive respondents were more likely to be older (25- to 29-year-old adjusted risk ratio [aRRR]=5.08, 95% Confidence Interval [95% CI] = 1.88 to 13.72; 30- to 34-year-old aRRR = 4.11, 95% CI = 1.34 to 12.58; and 35 + years old aRRR = 8.13, 95% CI = 2.40 to 27.54, vs. 18 to 25 years old respectively), to live in Manila (aRRR = 5.89, 95% CI = 2.20 to 15.72), exhibit hazardous drinking (aRRR = 2.87, 95% CI = 1.37 to 6.00) and problematic drug use (aRRR = 2.90, 95% CI = 1.21 to 7.13). HIV-positive respondents were less likely to identify as straight (aRRR = 0.13, 95% CI = 0.02 to 0.72), and were more likely to avoid HIV services due to lack of anti-lesbian, gay, bisexual and transgender (LGBT) discrimination policies (aRRR = 0.37, 95% CI = 0.14 to 0.90). Relative to HIV-negative respondents, HIV-unknown respondents were less educated (some college aRRR = 0.10, 95% CI = 0.02 to 0.37, beyond college aRRR = 0.31, 95% CI = 0.09 to 0.99, vs. high school or below respectively), had lower HIV knowledge (aRRR = 0.30, 95% CI = 0.20 to 0.71), and were less communicative about safer sex (ARR = 0.29, 95% CI = 0.09 to 0.92). Moreover, HIV-unknown respondents were also more likely to have avoided HIV services due to cost (aRRR = 4.46, 95% CI = 1.73 to 11.52). CONCLUSIONS: This study highlights differences in HIV risks and healthcare engagement by HIV status. These findings show different barriers exist per HIV status group, and underscore the need to address Filipinx trans-WSM and cis-MSM's poor engagement in HIV services in the Philippines.

Characterizing PrEP Awareness and Interest Among Filipina Transgender Women.

Pre-exposure prophylaxis (PrEP) can efficaciously avert HIV acquisition for individuals at risk, including transgender individuals (trans) in the Philippines. We conducted multivariate logistic regression procedures in an online sample of Filipina trans women (n = 139) to examine associations of PrEP awareness. In this sample, 53% of Filipina trans women were unaware of PrEP, but almost all (93%) expressed interest in taking PrEP once learning about it. Greater odds of PrEP awareness was associated with discussion of HIV services with their health care providers, higher HIV knowledge, and discussion of PrEP among trans friends. Lower odds of PrEP awareness was associated with reporting being currently unemployed. The findings underscore a subset of trans women who might be early adopters of PrEP, and highlight PrEP inequities among trans women most marginalized, including those who are unemployed and have engaged in sex work.

Detection of types of HPV among HIV-infected and HIV-uninfected Kenyan women undergoing cryotherapy or loop electrosurgical excision procedure.

OBJECTIVE: To assess the baseline types of HPV infection among HIV-positive and HIV-negative women in western Kenya undergoing cryotherapy or loop electrosurgical excision procedure (LEEP) for cervical intraepithelial neoplasia. METHODS: A prospective observational study was conducted of baseline HPV characteristics of women undergoing visual inspection with acetic acid (VIA) and cryotherapy or LEEP. After a positive VIA in HIV-positive and HIV-negative women, data on demographics, CD4 count, and use of antiretroviral therapy and a cervical swab were collected. HPV typing was performed using the Roche Linear Array. RESULTS: Of 175 participants, 86 (49.1%) were HIV-positive and had a higher prevalence of low-risk HPV types (odds ratio [OR] 5.28, P=0.005) compared with HIV-negative women. The most common high-risk (HR)-HPV types in HIV-positive women were HPV 16 (13.9%) and HPV 18 (11.1%). HIV-positive women requiring LEEP were more likely to have HR-HPV types (OR 6.67, P=0.012) and to be infected with multiple HR-HPV types (OR 7.79, P=0.024) compared to those undergoing cryotherapy. CONCLUSION: HIV-positive women requiring LEEP versus cryotherapy had a higher prevalence of any HR-HPV type and multiple HR-HPV types. There were no such differences in HPV types identified among HIV-negative women.