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Lissa N Mandell,1 Violeta J Rodriguez,1,2 Deborah L Jones1 1Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA; 2Department of Psychology, University of Georgia, Athens, GA, USACorrespondence: Deborah L Jones Email d.jones3@med.miami.eduIntroduction: With the help of safer conception strategies (SCS), women with HIV (WHIV) can achieve their reproductive goals while minimizing the risk of transmission to their partners or infants. However, interpregnancy intervals of at least 24 months are recommended to optimize maternal and infant health outcomes, so postpartum WHIV need to use contraception to delay subsequent pregnancies. Understanding safer conception and family planning knowledge, attitudes, and practices among WHIV is key to tailoring family planning policy and intervention development in regions with high HIV prevalence.Methods: This study described the safer conception and family planning knowledge, attitudes, and practices of postpartum WHIV (N = 956) in rural Mpumalanga province, South Africa, 12 months after delivery.Results: Almost all women understood the importance of condom use, but most overestimated the risk of sexual transmission. A majority of women reported that their partner’s desires (53%) and the risk of perinatal transmission (58%) were very important factors when making childbearing decisions. Most women (81%) used condoms for HIV prevention and most (83%) used contraception for pregnancy prevention. Many women (33% of contraceptive users) used condoms for both HIV prevention and contraception without using another contraceptive method as well. Only 43% of contraceptive users endorsed dual method use of condoms with hormones, intrauterine devices, or sterilization.Discussion: Results highlight the prominence of condom-based pregnancy and HIV transmission prevention, the influence of male partners in fertility decision-making, and the opportunity for further education and promotion of long acting methods in this setting.Keywords: HIV, family planning, contraception, condoms, pregnancy, safer conception

Imelda K Moise,1,2 Evan de Joya,1 Benjamin Caplan,1 Violeta J Rodriguez,3 Stefani Butts,3 Maureen Chisembele,4 Stephen M Weiss,3 Deborah L Jones,3 Maria L Alcaide3 1Department of Geography and Regional Studies, University of Miami, Coral Gables, FL, USA; 2Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL, USA; 3Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL33136, USA; 4Department of Obstetrics and Gynecology, University of Zambia, Lusaka, Zambia Purpose: In this study, we evaluated the risk behaviors that are drivers of the HIV epidemic among adolescent girls and young women in Zambia using a focus group research technique.Subjects and methods: Eighteen adolescent couples (n=18 females and 18 males) aged 16–24 participated in six focus groups discussions (3 per gender) convened at three health facilities in Lusaka, Zambia. Focus group moderators utilized a set of open-ended questions to guide the 60-minute sessions. The focus group audio recordings were transcribed, coded, and analyzed using qualitative content analysis in Nvivo 11.Results: Three themes and four subthemes were identified relating to adolescent and young adult couples’ knowledge, views, and male partner attitudes toward intravaginal practices (IVPs). The first theme, knowledge and rationale for IVPs, consisted of the subthemes relating to why adolescents and young adult couples engage in IVPs and assessed their knowledge of health risks associated with IVPs. The second theme, attitudes toward IVPs, consisted of the subtheme willingness to stop or support partner to discontinue IVP and practices toward IVP and strategies for changing. The third theme, strategies for changing IVPs, consisted of the subtheme raise awareness.Conclusion: IVPs used for cleaning purposes were perceived as essential to enhancing hygiene, health, and sexual satisfaction for both girls and boys. However, couples expressed concern about the health effects of IVPs used for tightening and a desire for learning more about this practice as well as stopping it. Keywords: bacterial vaginosis, sexually transmitted infection, Zambia, focus groups, HIV

Karl Peltzer,1,2 Sibusiso Sifunda,1 Lissa N Mandell,3 Violeta J Rodriguez,3 Tae Kyoung Lee,4 Ryan Cook,5 Stephen M Weiss,3 Deborah L Jones3 1HIV/AIDS/STIs and TB (HAST) Research Programme, Human Sciences Research Council, Pretoria, South Africa; 2Department of Research and Innovation, University of Limpopo, Sovenga, South Africa; 3Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA; 4Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL, USA; 5School of Public Health, University of California, Los Angeles, Los Angeles, CA, USA Introduction: This study aimed to assess fertility intentions (planning to have more children in the future) and associated factors among pregnant and postpartum HIV positive women in rural South Africa. Methods: In a longitudinal study, as part of a prevention of mother to child transmission (PMTCT) intervention trial, 699 HIV positive prenatal women, were systematically recruited and followed up at 6 months and 12 months postpartum (retention rate = 59.5%). Results: At baseline, 32.9% of the women indicated fertility intentions and at 12 months postnatal, 120 (28.0%) reported fertility intentions. In longitudinal analyses, which included time-invariant baseline characteristics predicting fertility intention over time, not having children, having a partner with unknown/HIV-negative status, and having disclosed their HIV status to their partner, were associated with fertility intentions. In a model with time-varying covariates, decreased family planning knowledge, talking to a provider about a future pregnancy, and increased male involvement were associated with fertility intentions. Conclusion: Results support ongoing perinatal family planning and PMTCT education. Keywords: fertility intentions, family planning, HIV infection, pregnancy, South Africa, male involvement

Stefani A Butts,1 Lauren E Parmley,1 Maria L Alcaide,1 Violeta J Rodriguez,1 Annette Kayukwa,2 Ndashi Chitalu,2 Stephen M Weiss,1 Deborah L Jones1 1Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA; 2Department of Pediatrics, University of Zambia, Lusaka, Zambia Abstract: In Zambia, adolescent girls and young women (AGYW) are disproportionately affected by human immunodeficiency virus (HIV), social, cultural and economic factors making them particularly vulnerable. This study was designed to understand the context in which AGYW are at risk and to identify perceived drivers of the epidemic and potential strategies to reduce HIV risk. Focus group discussions were conducted with AGYW in Zambian districts with the highest HIV prevalence from February through August 2016. The focus group guide addressed HIV risk factors and strategies for HIV prevention in AGYW. Focus group discussions were recorded, translated and transcribed, themes identified and responses coded. Results suggest that gender inequality undermined potentially protective factors against HIV among AGYW. Poverty and stigmatization were major barriers to accessing available HIV prevention services as well as primary risk factors for HIV infection. Sponsorship to support AGYW school attendance, programs for boys and girls to foster gender equality and financial assistance from the government of Zambia to support AGYW most in need were proposed as strategies to reduce HIV risk. Results highlight the utility of using community-based research to guide potential interventions for the affected population. Future research should explore the use of multilevel interventions to combat HIV among AGYW. Keywords: HIV, sub-Saharan Africa, prevention, adolescent girls, women, Zambia

Deborah L Jones,1 Marisa Echenique,1 JoNell Potter,2 Violeta J Rodriguez,1 Stephen M Weiss,1 Margaret A Fischl3 1Department of Psychiatry and Behavioral Sciences, 2Department of Obstetrics and Gynecology, 3Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL, USA Background: Rates of pregnancy among women living with HIV are similar to those in the general population. Unintended pregnancies are also common, and among adolescents and young women perinatally infected (PHIV+) or behaviorally infected (BHIV+) with HIV, planning for both conception and contraception is an important element of HIV care that may be neglected. This pilot study examined the influence of intervention strategies targeting fertility planning, safer conception practices and patient-provider communication. It was hypothesized that preconception counseling interventions would enhance reproductive knowledge, planning and practices, as well as stimulate discussion with providers regarding conception. Methods: Adolescent girls and young women (N=34) perinatally (n=21) or behaviorally (n=13) infected with HIV, aged 16–29 years, were recruited from urban South Florida, and completed measures of reproductive knowledge, sexual practices and fertility intentions. Participants were randomized to condition, ie, video presentation plus Motivational Interviewing (MI), MI only, control. Results: The average age of women was 22 years (SD =3.27), and the majority of them were African American. Levels of depression were higher among BHIV+ compared to PHIV+ at baseline and 6 months. Pregnancy knowledge (pregnancy, safe conception and pregnancy planning) and the proportion of those engaging in birth control planning (condom use, long-term birth control, patient-provider discussions on preventing pregnancy and fertility desires) were similar between conditions at post-intervention and 6 months. Bayes factors indicated that the data were insensitive with regard to differences between conditions, limiting support for both the null and alternative hypotheses. Conclusion: The impact of interventions used in this study to stimulate pregnancy planning was inconclusive. Results suggest that pregnancy planning interventions may require greater intensity to influence sexual behavior in this population. Despite adequate reproductive knowledge, HIV-infected adolescent girls and young women may fail to engage in planning behavior. Keywords: adolescents, young women, HIV, reproduction, family planning, safer conception, preconception counseling

Marisa I Echenique,1 Rachel S Bookman,1 Violeta J Rodriguez,1 Richard P LaCabe,1 JoNell Efantis Potter,2 Deborah L Jones1 1Department of Psychiatry and Behavioral Sciences, 2Department of Obstetrics and Gynecology, University of Miami Miller School of Medicine, Miami, FL, USA Abstract: Once expected to not survive childhood, youth with perinatally acquired HIV (YPHIV) have now reached young adulthood and are of reproductive age and sexually active. Given the health impact of pregnancy among YPHIV, understanding reproductive decision making may inform preconception counseling strategies. Most literature regarding reproductive health among YPHIV focuses on women, overlooking one of the most important factors influencing the reproductive decision-making process, male sexual partners. This study examined attitudes, perceptions, and experiences of young men with perinatally acquired HIV (YMPHIV) regarding family planning and relationships, safer sex, disclosure, stigma, and psychological health. Participants (n=21) were YMPHIV aged 18–24 years recruited in Miami, Florida. Focus groups (n=4) were conducted; qualitative data were analyzed using grounded theory. HIV disclosure, stigma, fertility intentions, safer preconception knowledge, attitudes and practices, family planning communication with medical providers and family, and mental health emerged as themes. Results suggest that despite accurate knowledge regarding healthy preconception practices, psychopathology, substance use, and stigma impact the uptake of HIV health care interventions. Effective interventions on preconception counseling may require more tailored approaches than knowledge-based psychoeducation alone, such as inclusion of psychological treatment, which could be offered in HIV health care settings to optimize health outcomes. Keywords: preconception counseling, fertility decision making, young adults, HIV risk reduction, HIV knowledge

Violeta J Rodriguez,1 Ryan R Cook,1 Stephen M Weiss,1 Karl Peltzer,2–4 Deborah L Jones1 1Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA; 2HIV/AIDS/STIs and TB (HAST) Research Programme, Human Sciences Research Council, Pretoria, South Africa; 3ASEAN Institute for Health Development, Mahidol University, Salaya, Thailand; 4Department of Psychology, University of Limpopo, Turfloop, South Africa Abstract: Patient–provider family planning discussions and preconception counseling can reduce maternal and neonatal risks by increasing adherence to provider recommendations and antiretroviral medication. However, HIV-infected women may not discuss reproductive intentions with providers due to anticipation of negative reactions and stigma. This study aimed to identify correlates of patient–provider family planning discussions among HIV-infected women in rural South Africa, an area with high rates of antenatal HIV and suboptimal rates of prevention of mother-to-child transmission (PMTCT) of HIV. Participants were N=673 pregnant HIV-infected women who completed measures of family planning discussions and knowledge, depression, stigma, intimate partner violence, and male involvement. Participants were, on average, 28 ± 6 years old, and half of them had completed at least 10–11 years of education. Most women were unemployed and had a monthly income of less than ~US$76. Fewer than half of the women reported having family planning discussions with providers. Correlates of patient–provider family planning discussions included younger age, discussions about PMTCT of HIV, male involvement, and decreased stigma (p < 0.05). Depression was indirectly associated with patient–provider family planning discussions through male involvement (b = −0.010, bias-corrected 95% confidence interval [bCI] [−0.019, −0.005]). That is, depression decreased male involvement, and in turn, male involvement increased patient–provider family planning discussions. Therefore, by decreasing male involvement, depression indirectly decreased family planning discussions. Study findings point to the importance of family planning strategies that address depression and facilitate male involvement to enhance communication between patients and providers and optimize maternal and neonatal health outcomes. This study underscores the need for longitudinal assessment of men’s impact on family planning discussions both pre- and postpartum. Increasing support for provision of mental health services during pregnancy is merited to ensure the health of pregnant women living with HIV and their infants. Keywords: family planning, women, HIV, South Africa, pregnancy, contraception

Maria L Alcaide,1 Violeta J Rodriguez,2 Margaret A Fischl,1 Deborah L Jones,2 Stephen M Weiss2 1Division of Infectious Diseases, Department of Medicine, University of Miami Miller School of Medicine, 2Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA Abstract: Intravaginal practices (IVPs), include intravaginal cleansing (cleansing the inside of the vagina) or intravaginal insertion of products for hygiene, health or sexuality reasons. IVPs are associated with adverse female health outcomes, development of bacterial vaginosis, HIV acquisition and transmission. A mixed methods approach was used in this study to examine the prevalence of IVP, assess reasons for engagement, and perceptions of IVP among a sample of minority (African-American and Hispanic) women infected, or at-risk, for HIV in Miami, USA, a city with increasing numbers of sexually transmitted infections (STIs) and HIV. Three focus groups (total n=20) and quantitative assessments (n=72) were conducted with women infected or uninfected with HIV. In the qualitative assessments, most women reported engaging in both intravaginal cleansing and intravaginal insertion, and stated the main motivation for IVP was hygiene. The quantitative assessments confirmed that cleansing with water alone, soap with water or using commercial douches was common, as well as intravaginal insertion using a cloth or a rag in both HIV-infected and uninfected women. Women with HIV infection reported less use of water and water and soap for IVPs, and reported learning about the potential harm of IVP from their HIV health care providers. Despite their health risks, IVP appeared common in both HIV-infected and at-risk minority women, and interventions to decrease IVP could have important health implications among populations with high rates of IVP, STIs and HIV. Keywords: focus groups, HIV, vaginal practices, women, mixed methods

Introduction: This study used an unsupervised machine learning algorithm, sidClustering and random forests, to identify clusters of risk behaviors of Bacterial Vaginosis (BV), the most common cause of abnormal vaginal discharge linked to STI and HIV acquisition.  METHODS: Participants were 391 cisgender women in Miami, Florida, with a mean of 30.8 (SD = 7.81) years of age; 41.7% identified as Hispanic; 41.7% as Black and 44.8% as White. Participants completed measures of demographics, risk behaviors [sexual, medical, and reproductive history, substance use, and intravaginal practices (IVP)], and underwent collection of vaginal samples; 135 behavioral variables were analyzed. BV was diagnosed using Nugent criteria., Results: We identified four clusters, and variables were ranked by importance in distinguishing clusters: Cluster 1: nulliparous women who engaged in IVPs to clean themselves and please sexual partners, and used substances frequently [n = 118 (30.2%)]; Cluster 2: primiparous women who engaged in IVPs using vaginal douches to clean themselves (n = 112 (28.6%)]; Cluster 3: primiparous women who did not use IVPs or substances [n = 87 (22.3%)]; and Cluster 4: nulliparous women who did not use IVPs but used substances [n = 74 (18.9%)]. Clusters were related to BV (p < 0.001). Cluster 2, the cluster of women who used vaginal douches as IVPs, had the highest prevalence of BV (52.7%)., Conclusions: Machine learning methods may be particularly useful in identifying specific clusters of high-risk behaviors, in developing interventions intended to reduce BV and IVP, and ultimately in reducing the risk of HIV infection among women., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Despite compelling evidence linking voluntary medical male circumcision (VMMC) with 60-70% HIV risk reduction in sub-Saharan Africa, Zambian men have been especially reluctant to undergo VMMC. The Government of Zambia set targets for VMMC uptake and promoted community-level interventions. Spear & Shield (S&S) is an innovative, evidence-based, service program promoting VMMC uptake while ensuring both VMMC supply and demand. This study assessed the large-scale provincial rollout of the program (S&S2) utilizing the RE-AIM model for translating interventions into the community. The S&S2 study was conducted between November 2015 and December 2020, and sequentially rolled out over four Zambian provinces in 96 clinics; 24 observation clinics received VMMC training only. Local clinic healthcare workers were trained to conduct the VMMC procedure and HIV counselors were trained to lead S&S group sessions. Using the RE-AIM model, primary outcomes were: Reach, the number, proportion, and representativeness of S&S attendees; Effectiveness, the impact of S&S2 on VMMC uptake; Adoption, the number, proportion, and representativeness of clinics implementing S&S2; Implementation, fidelity to the S&S intervention manual; and Maintenance, the extent to which S&S2 became an element of standard care within community clinics. Initially, n = 109 clinics were recruited; 96 were sustained and randomized for activation (Adoption). A total of 45,630 clinic patients (n = 23,236 men and n = 22,394 women) volunteered to attend the S&S sessions (Reach). The S&S2 program ran over 2,866 clinic-months (Implementation). Although the study did not target individual-level VMMCs, ~58,301 additional VMMCs were conducted at the clinic level (Effectiveness). Fidelity to the S&S intervention by group leaders ranged from 42%-95%. Sustainability of the program was operationalized as the number of CHCs initially activated that sustained the program. Intervention delivery ended, however, when study funding ceased (Maintenance). The S&S2 program successfully utilized the RE-AIM model to achieve study goals for implementation and dissemination in four Zambian provinces. Innovative VMMC programs such as S&S2 can improve the uptake of VMMC, one of the most effective strategies in the HIV prevention arsenal., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Weiss et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Competing Interests: The authors have no conflicts of interest to disclose.

Background: Elimination of vertical HIV Transmission (VHT) and maternal deaths are global health priorities. Male involvement is one of the most important factors that influences women's decisions, including the uptake of Prevention of vertical HIV transmission (P-VHT). We sought to understand not knowing a male partner's HIV status (MPHIVs) amongst women using services to prevent vertical HIV transmission in six South African districts with high antenatal HIV burden., Methods: A mixed-methods cross-sectional study was conducted in six South African districts, and data collected through face-to-face interviews with women and focus group discussions (FGDs) with women or male partners. The quantitative data were analyzed using STATA SE-17.0 and an inductive approach was used for qualitative data analysis., Results: Overall, 28.7% of women were unaware of their MPHIVs, while 25.3% and 46.0% knew the MPHIVs was positive or negative, respectively. In multivariable logistic regression, single marital status and unplanned pregnancy increased the odds of not knowing a MPHIVs while a woman's disclosure of her HIV status to the male partner reduced the odds. FDGs highlighted complexities around MPHIVs disclosure, e.g., reluctance to test for HIV and potential interventions including healthcare worker (HCW) assisted HIV disclosure., Conclusion: User-informed interventions to address MPHIVs non-disclosure amongst women of child-bearing age, particularly those at risk of unstable sexual partners and unplanned pregnancies, should be strengthened., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Voluntary Medical Male Circumcision (VMMC) is an effective strategy for HIV prevention in areas with high prevalence of, and risk for, HIV. More than 361,000 male neonates are born each year in Zambia, many of whom could be eligible for Early-Infant Medical Circumcision (EIMC). Building on successful implementation strategies utilized in our Spear & Shield program, this pilot study, "Like Father, Like Son" (LFLS), evaluated the feasibility and acceptability of offering combined EIMC and VMMC services and couple-level behavioral interventions. A total of N = 702 pregnant women and their male partners (n = 351 couples) were recruited and enrolled. Couples were assessed twice pre-birth, 2 weeks post birth, and 6 months post birth. Expectant mothers were an average of 15.05 weeks pregnant (SD = 8.83). Thirty-nine pregnancies did not result in a live birth (11%), 14 couples withdrew from the study or were lost to follow-up prior to delivery (4%), and 148 babies were born female (42%), leaving 150 couples with a male infant in the analytic sample (43%). The LFLS study achieved significantly higher EIMC rates (35%) in comparison with previously observed EIMC study rates in Zambia (11%), and significantly higher than hypothetical comparison rates up to 30%. Relative to baseline rates, odds of VMMC among couples' older sons increased by 31% at post-intervention and by 90% at two-weeks following birth. Overall, this pilot study found the LFLS intervention to be feasible, acceptable, and effective in doubling the rate of EIMC in comparison with a previous longitudinal study in Zambia. Future research should consider a family-centric approach to promotion of male circumcision for infants and adolescents. LFLS may be effective in promoting father-son "bonding" by MC status; a bond that may be a bridge to increase both EIMC and VMMC uptake in newborns and couples' older sons and is a novel leverage point for promotion of this HIV prevention strategy., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Weiss et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Assessing neurodevelopmental functioning in early infancy is essential as this is a critical period for infant development. Infants born to mothers with HIV are at a greater risk of developmental delays than those born to mothers without HIV. In this study, we analyzed differences in early neurodevelopmental functioning for infants with HIV exposure versus HIV infection to inform infant screening and early intervention., Methods: Participants were recruited from community health centers in Mpumalanga Province, South Africa. Prenatally, mothers completed baseline demographic assessment at 8 to 24-week gestation periods. Infant neurodevelopment was assessed using the Bayley Infant Neurodevelopmental Screener (BINS) 12 months postnatally. Five areas of development were assessed: cognition, receptive communication, expressive communication, fine motor ability, and gross motor ability., Findings: Postnatal infant assessment using the BINS revealed that infants were at risk for neurodevelopmental delays across all domains assessed. Notably, infants exposed to HIV, regardless of HIV status, were 'at emerging risk' or 'at clear risk' for cognitive (43.5%), receptive communication (38.2%), expressive communication (53.1%), fine motor (49.9%), and gross motor delays (55.6%). Differences were noted by HIV status in the cognition domain, such that HIV-exposed infants were more likely to be at emerging or clear risk than HIV-infected infants. There was a different trend with gross motor delays, such that HIV-infected infants were at a greater risk for motor delays than HIV-exposed, uninfected infants., Conclusion: Screening tools for this vulnerable population provide valuable early life assessment to determine infant needs for intervention and treatment planning. Such interventions may mitigate the impact of HIV status on neurodevelopmental health generally and cognition., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: This study describes adverse events following immunization (AEFIs) and the development of SARS-COV-2 antibodies after Sputnik V, AstraZeneca, and Sinopharm COVID-19 vaccination in people with HIV (PWH)., Methods: In total, 595 adult PWH at an HIV center in Argentina from March to December 2021 were enrolled. Analysis included participants who received COVID-19 vaccination with Sputnik V, AstraZeneca, and Sinopharm, and did not receive mRNA COVID-19 vaccines. Clinical data, and local or systemic AEFI variables were collected using an online questionnaire after the first dose. Detection of S1-RBD IgG antibodies was performed between days 28 and 60 after the second dose in a subsample (SARS-CoV-2 IgG chemiluminescent immunoassay; Siemens). A multivariable logistic regression and spearman test were used for analyses., Results: Mean age was 46.1 years (SD = 11.8); 70.4% were men; and median CD4 + T cells count was 659 (500-852) cells/μl. AEFIs were reported in 214 (36.0%) participants. More participants reported AEFIs after Sputnik V (29.4%) and AstraZeneca (47.5%) than Sinopharm (13.9%) (χ 2  = 35.85, P  < 0.001). Higher odds of reporting an AEFIs were associated with receiving Sputnik V [aOR = 2.90; 95% confidence interval (95% CI) = 1.40-6.04; P  = 0.004] and AstraZeneca (aOR = 5.38; 95% CI = 2.63-11.01; P  < 0.001) compared with Sinopharm. Lower odds were associated with age (aOR = 0.97; 95% CI = 0.95-0.99; P  < 0.001). Overall, 76 (95.0%) individuals assessed for the presence of SARS-CoV-2 antibody reached S1-RBD IgG antibody titers at least 1 U/ml; mean titer was 51.3 (SD = 51.07) U/ml. Higher antibody titers correlated with higher CD4 + T cells count (Rho = 0.280; P  = 0.012)., Conclusion: NonmRNA vaccines showed a good safety profile and adequate SARS-CoV-2 antibody responses among PWH suggesting adequate protection to SARS-CoV-2., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Biological and psychological mechanisms may be responsible for menstrual irregularities occurring among women during the COVID-19 pandemic., Study Design: From January 2019 to September 2021, women (18- to 45-years-old and not using hormonal contraception) were recruited in Miami-Dade County, Florida. Cross-sectional, self-report surveys collected data on menstrual irregularities, COVID-19 vaccination, stress, depression, and loneliness. A EUA approved rapid test assay using whole blood measured SARS-CoV-2 IgG antibodies. Chi-square and Fisher's exact tests described menstrual irregularities among women recruited before versus after the start of the COVID-19 pandemic and with detectable versus undetectable SARS-CoV-2 IgG antibodies. A logistic regression examined the relationship between the presence of SARS-CoV-2 IgG antibodies and menstrual irregularities controlling for age, stress, depression, and loneliness., Results: Among 182 women enrolled, 73 were enrolled after pandemic onset, and 36 provided vaccination data. Having detectable SARS-CoV-2 IgG antibodies was associated with a higher percentage of menstrual irregularities among unvaccinated women (0% vs. 39%, p = .026) and among all women regardless of vaccination status (31% vs. 5%; p = .005). Adjusting for age and psychological variables, the odds of menstrual irregularities were 7.03 times (95% CI [1.39, 35.60]; p = .019) higher among women with detectable antibodies compared to women without detectable antibodies. Neither enrollment date, age, nor psychological factors were associated to menstrual irregularities., Conclusions: Biological mechanisms related to SARS-CoV-2 infection may be responsible for irregular menstruation and should be further examined to mitigate the impact of the COVID-19 pandemic on women's health., Competing Interests: The authors have declared that no competing interests exist.

Background: Patients disengaged from HIV care, e.g., missed medication pick-ups, not attending physician visits, account for ≥70% of new HIV infections. Re-engaging and sustaining engagement is essential to controlling the HIV pandemic. This study tested a physician-delivered evidence-based intervention, Motivational Interviewing (MI), to improve health outcomes, adherence to antiretroviral therapy (ART), HIV virologic suppression, CD 4 + count, retention in HIV care, and self-efficacy among patients disengaged from care in Argentina., Methods: Regional clinics ( n = 6) were randomised to condition, MI Intervention or Enhanced Standard of Care (ESOC), and recruited N = 360 patients disengaged from HIV care. ART adherence, HIV RNA viral load, CD 4 + count retention, and self-efficacy were assessed at baseline, 6, 12, 18, and 24-months. Indirect effects from condition to main outcomes were examined using patient-provider relationship as a mediator. The study was a cluster-randomised clinical trial entitled Conexiones y Opciones Positivas en la Argentina 2 (COPA 2 ) and was registered at clinicaltrials.gov, NCT02846350., Findings: Participants were an average age of 39·15 ( SD = 10·96), 51% were women; intervention participants were older ( p = ·019), and more ESOC participants were women (60% vs. 42%, p = 0·001). Using mixed models, the intervention had no effect on ART adherence over time by condition on HIV RNA viral load, CD 4 + count retention, or self-efficacy. However, analysing mediated paths, there was an indirect effect of condition on ART adherence ( B = 0·188, p = 0·009), HIV viral load ( B = -0·095, P = 0·027), and self-efficacy ( B = 0·063, P = 0·001), suggesting the intervention was associated with improved patient-provider relationships, which was in turn associated with increased ART adherence, lower HIV viral load, and higher self-efficacy., Interpretation: These findings suggest that physician-delivered MI may enhance the patient-provider relationship, self-efficacy, and ART adherence, and reduced HIV viral load in patients disengaged from HIV care. However, these findings are preliminary due to the small number of clusters randomised, and replication is warranted., Funding: National Institutes of Health., Competing Interests: Declaration of interests The authors declare that they have no conflict of interest.

Objectives: This study of people with HIV (PWH) and those without HIV conducted during the COVID-19 pandemic in the United States in 2020 examines the impact of posttraumatic stress disorder (PTSD) on COVID-19 burden, defined as pandemic-related disruptions., Methods: Data consisted of survey responses on PTSD among participants (N = 2434) enrolled in the Multicenter AIDS Cohort Study (MACS) and the Women's Interagency HIV (WIHS) cohorts. Unadjusted and adjusted regression models were used to examine the association of PTSD with COVID-19 burden (overall and domain-specific burdens). Quasi-Poisson regression models were used to assess associations with the COVID-19 burden score and 2 domain-specific burdens: (1) changes in resources and (2) interruptions in health care. Analyses was adjusted for age, race/ethnicity, HIV serostatus, current smoking status, number of comorbidities, education, and study regions., Results: Study participants were a median age of 58 (interquartile range, 52-65) years. In both bivariate and multivariable models, PTSD severity was associated with greater overall COVID-19 burden. PTSD severity was associated with the number of resource changes and number of interruptions in medical care. These findings were also consistent across cohorts (MACS/WIHS) and across HIV serostatus, suggesting a greater risk for COVID-19 burden with greater PTSD severity, which remained significant after controlling for covariates., Conclusions: This study builds on emerging literature demonstrating the impact of mental health on the burden and disruption associated with the COVID-19 pandemic, providing context specific to PWH. The ongoing pandemic requires structural and social interventions to decrease disruption to resources and health resource needs among these vulnerable populations., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Background: The concentration and duration of antibodies (Ab) to SARS-CoV-2 infection predicts the severity of the disease and the clinical outcomes. Older people and those with HIV have impaired immune responses, worse outcomes after SARS-CoV-2 infection, and lower antibody responses after viral infection and vaccination. This study evaluated an Ab response to SARS-CoV-2 in people with HIV (PWH) and without HIV (HIV-) and its association with age., Methods: A total of 23 COVID+PWH and 21 COVID+HIV- participants were followed longitudinally for 6 months post-mild COVID-19. Immunoglobin G (IgG) and immunoglobin M (IgM) Ab responses were measured by an in-house developed ELISA. Time points and HIV status interaction were analyzed using Poisson generalized estimating equations, and correlations were analyzed using non-parametric tests., Results: Median age in PWH was 55 years with 28.6% women, while in the HIV- group was 36 years with 60.9% women. The mean time from COVID-19 diagnosis to study enrollment was 16 days for PWH and 11 days for HIV-. The mean CD4+ T-cell count/μl for PWH was 772.10 (±365.21). SARS-CoV-2 IgM and IgG were detected at all time points and Ab response levels did not differ by HIV status ( p > 0.05). At entry, age showed a weak direct association with IgG responses (ρ = 0.44, p < 0.05) in HIV- but did not show any association in PWH. Similar associations between age, IgG, and HIV status emerged at day 14 (T1; ρ = 0.50, p < 0.05), 3 months (T3; ρ = 0.50, p < 0.05), and 6 months visit (T4; ρ = 0.78, p < 0.05) in the HIV- group., Conclusion: The Ab responses in the 6-month post-SARS-CoV-2 infection did not differ by HIV status, though a positive association was found between age and Ab response in older PWH. Results suggest that immune protection and vaccine responses are similar for PWH than for those without HIV infection., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Alcaide, Nogueira, Salazar, Montgomerie, Rodriguez, Raccamarich, Barreto, McGaugh, Sharkey, Mantero, Rodriguez, Beauchamps and Jones.)

'Mother-to-child transmission of HIV' can occur during the period of pregnancy, childbirth, or breastfeeding. 'Prevention of mother-to-child transmission of HIV' (PMTCT) in Mpumalanga Province, South Africa, is especially vital as the prevalence of HIV is 28.2% in women aged 15-49. PMTCT interventions resulted in a drop of MTCT rates in Mpumalanga from ∼2% in 2015 to 1.3% in 2016. This randomised controlled trial in Mpumalanga examined the potential impact of a lay healthcare worker administered intervention, 'Protect Your Family', on maternal and infant adherence, and to assess the relative influence of male partner involvement on infant and maternal adherence. This cluster randomised controlled trial used a two-phase and two-condition (experimental or control) study design where participants ( n  = 1399) did assessments both during pregnancy and post-postpartum. Only women participated in Phase 1, and both female and male partners participated in Phase 2. Results indicated that male involvement was associated with self-reported maternal or infant antiretroviral therapy (ART) adherence, but the intervention was not associated with ART adherence. Self-reported adherence was associated with depression, age, and partner HIV status. The study results provide support for the involvement of men in the antenatal clinic setting during pregnancy. Results also support further research on the meaning and assessment of male involvement and clarification of the constructs underlying the concept in the sub-Saharan African context. Outcomes provide support for male involvement and treatment of depression as adjuncts to improve uptake of both maternal and infant medication as part of the PMTCT protocol.

Background: This study evaluated COVID-19 risk and burden among people with HIV (PWH) in a US city with high rates of HIV and SARS-CoV-2 transmissions and examined the interrelationship between psychosocial factors and COVID-19 risk and burden., Setting: Participants were drawn from an existing consent to contact database of PWH. Database candidates were PWH, adults older than 18 years, people who had received HIV care at the University of Miami HIV clinics, people who spoke English or Spanish, and people who had agreed to be contacted for future research., Methods: An adapted version of the Multicenter AIDS Cohort Study/Women's Interagency HIV Study Combined Cohort Study COVID-19 survey was telephonically administered, requiring 15-30 minutes., Results: Psychological stress was a predictor of COVID-19 burden (financial and social burden) and COVID-19 risk (health factors associated with an increased risk of severe health outcomes due to infection with COVID-19). Having a history of traumatic events was associated with increased COVID-19 risk, and stress was associated with increased COVID-19 burden and COVID-19 risk., Conclusions: Overall, results suggest that the intersection of the HIV and COVID-19 pandemics may be most profound among those who have experienced traumatic events; and traumatic events may be associated with heightened vigilance regarding illness and infection., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and human immunodeficiency virus (HIV) disproportionally affect underrepresented ethnoracial groups in the United States. Medical mistrust and vaccine hesitancy will likely impact acceptability of SARS-CoV-2 vaccines. This study examined SARS-CoV-2 vaccine hesitancy among underrepresented ethnoracial groups with HIV and identified factors that may reduce vaccine uptake., Methods: We conducted a cross-sectional study of adults ≥18 years of age with HIV residing in Miami, Florida. Participants were invited to participate in the ACTION (A Comprehensive Translational Initiative on Novel Coronavirus) cohort study. A baseline survey was administered from April to August 2020 and followed by a coronavirus disease 2019 (COVID-19) vaccine hesitancy survey from August to November 2020. The COVID-19 vaccine hesitancy survey was adapted from the Strategic Advisory Group of Experts survey. Comparisons by race and ethnicity were performed using the Freedman-Haltmann extension of the Fisher exact test., Results: A total of 94 participants were enrolled; mean age was 54.4 years, 52% were female, 60% were Black non-Latinx, and 40% were non-Black Latinx. Black non-Latinx participants were less likely to agree that vaccinations are important for health when compared to non-Black Latinx (67.8% vs 92.1%, P =  .009), less likely to agree that vaccines are effective in preventing disease (67.8% vs 84.2%, P =  .029), less likely to believe that vaccine information is reliable and trustworthy (35.7% vs 71.1%, P =  .002), and less likely to believe vaccines were unnecessary because COVID-19 would disappear soon (11% vs 21%, P =  .049)., Conclusions: Medical mistrust, vaccine hesitancy, and negative sentiments about SARS-CoV-2 vaccines are prevalent among underrepresented ethnoracial groups with HIV, particularly Black non-Latinx. Targeted strategies to increase vaccine uptake in this population are warranted., (© The Author(s) 2021. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)

Despite the efficacy of antiretroviral-based pre-exposure prophylactics (PrEP) in men who have sex with men, studies in women have produced widely varying outcomes. Recent evidence demonstrates that vaginal microbial communities are associated with increased HIV acquisition risk and may impact PrEP efficacy. Here, we investigate the mechanisms underlying how vaginal bacteria alter PrEP drug levels and impact HIV infection rates ex vivo. Using cervicovaginal lavages (CVLs) from women with or without bacterial vaginosis (BV), we identified microbial metabolism of PrEP drugs in BV samples through LC-MS/MS analysis of soluble drug levels and metabolite formation in dual T-cell cultures. CVL samples were assessed for microbiome analysis using sequencing of bacterial 16S rRNA genes. We also observed non-Lactobacillus bacteria that are associated with BV may potentially impact PrEP efficacy through increased HIV infection rates in co-cultures containing Lactobacillus or BV bacteria, PrEP drugs, CEM-GFP cells, and HIV-1LAI virus. Finally, we used these data to develop a novel predictive mathematical simulation modeling system to predict these drug interactions for future trials. These studies demonstrate how dysbiotic vaginal microbiota may impact PrEP drugs and provides evidence linking vaginal bacteria to PrEP efficacy in women., Competing Interests: The authors have declared that no competing interests exist.

Introduction: Screening for developmental delays during critical periods of infant development is essential for early detection and intervention. Among high-risk infants in resource-limited settings, including those who are HIV exposed, there is a greater need for screening. This study expanded on previous analyses of the Bayley Infant Neurodevelopmental Screener (BINS) by providing psychometric properties to evaluate the appropriateness of using the BINS in a sample of HIV-exposed infants in rural South Africa., Method: A total of 160 mothers with HIV, their infants, and their male partners were recruited. The BINS was administered to the infants, and their weights were recorded. Mothers completed measures of depression, intimate partner violence, male involvement, and adherence. Male partners reported their own involvement in perinatal care., Results: Results demonstrated support for a 5-factor structure consistent with previous transcultural adaptations of the BINS, demonstrating construct validity, and adequate reliability. Convergent validity was partially supported, as shown by associations with intimate partner violence and male involvement as reported by men and women and maternal adherence, although not with birth weight or maternal depression. The BINS showed adequate discriminating power, with only a few low-performing items., Conclusion: In rural South Africa, a resource-limited setting, the BINS seems to be an adequate screening tool for developmental delays in children that may be used to identify those in need of intervention. Considering the high prevalence of delays identified in this study, antiretroviral therapy-exposed and HIV-exposed infants may benefit from further assessment to determine a need for intervention in community-based clinics.

Introduction: Smoking, low education, obesity, and depressive symptoms are all associated with HIV health status, increased blood pressure, and inflammation, and constitute a syndemic burden that may contribute to poor health outcomes. The current study examined syndemic burden and health outcomes among women living with HIV., Methods: Women were participants enrolled in the Women's Interagency HIV Study. Outcomes included blood pressure, HIV health status (HIV-1 RNA viral load and CD4 T-cell counts), and IL-6. Syndemic burden was defined as a count variable of low education, obesity, cigarette use, and depressive symptoms., Results: Women (N = 131) were an average of 60.54 years of age (SD = 8.86), and 49% were non-Hispanic Black. In multivariable analyses, syndemic burden was not significantly associated with SBP (P = 0.342) or DBP (P = 0.763), IL-6 (P = 0.168), or CD4 cell count (P = 0.846). However, syndemic burden was associated with increased viral load (age adjusted β = 0.35, P < 0.001). Comparing women with high versus low syndemic burden, also controlling for women's age, women with high syndemic burden had higher DBP and HIV viral load., Discussion: Syndemic burden appeared to play an important role in HIV health status and could potentially increase the risk of HIV transmission. High syndemic burden, defined as at least two syndemic conditions, had the greatest effects of HIV viral load and DBP. Targeted interventions to address syndemic burden may help improve health outcomes in women living with HIV as well as reduce the risk of hypertension and HIV transmission.

Background: This study evaluated maternal factors associated with infant neurodevelopmental outcomes among HIV-exposed uninfected (HEU) infants in rural South Africa. This study followed pregnant women living with HIV pre- and postpartum and evaluated sociodemographic factors, use of antiretrovirals (ARVs), and mental health factors as predictors of HEU infant developmental outcomes (cognitive, receptive, and expressive communication, fine and gross motor skills)., Methods: Participants were 80 mother-infant dyads. Mothers were assessed during pregnancy, and HEU infant development was assessed at a mean (SD) of 13.36 (1.89) months of age., Results: Women were an average (SD) of 28.9 (5.2) years of age, and infants were on average 13.4 (1.9) months old. An analysis of covariance indicated that infants whose mothers had ARV detected in dry blood spots at 32 weeks of pregnancy had lower functioning scores in the cognitive domain than those with undetected ARV (n = 14; M, 15.3 vs 17.2; P = .048). Antenatal physical intimate partner violence was also associated with delayed cognitive functioning ( F (1, 74), 4.96; P = .029)., Conclusions: This study found risks for delayed infant cognitive development to be associated with the use of ARV during pregnancy and intimate partner violence, although findings merit replication due to the low sample size. Given the growing number of HEU infants, the necessity to better understand the potential toxicity of ARV exposure in utero is apparent. Similarly, the need for preventing intimate partner violence and screening for, and managing, developmental delays among these infants is increasing., (© The Author(s) 2019. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: The Sub-Saharan Africa region still remains the epicentre of the global HIV/AIDS epidemic. With regards to new paediatric HIV infections, almost 90% of new HIV infections are among children (aged 0-14 years), largely through mother to child transmission. Male Partner Involvement in Prevention of Mother to Child Transmission programmes is now strongly advocated as being key in improving infant outcomes. This study describes the role of Male Partner Involvement on infant HIV infection and mortality survival in the first year among HIV-exposed infants born from HIV positive mothers., Methods: This study was a two-phase, two condition (intervention or control) longitudinal study as part of a clinic-randomized Prevention of Mother to Child Transmission controlled trial. For Phase 1, female participants were recruited without their male partners. In Phase 2, both female and male participants were enrolled in the study as couples in order to encourage active Male Partner Involvement during pregnancy. Participants had two assessments prenatally (8-24 weeks and 32 weeks) and three assessments postnatally (6 weeks, 6 months, and 12 months)., Results: About 1424 women were eligible for recruitment into the study and 18 eligible women declined to participate. All women had a partner; 54% were unmarried, 26% were cohabiting, and 20% were married. Just over half (55%) of the women had been diagnosed with HIV during the current pregnancy. Phase 1 had significantly more HIV-infected infants than Phase 2 at 12-months postpartum (aOR = 4.55 [1.38, 15.07]). Increased depressive symptoms were associated with infant HIV infection at 12-months (aOR = 1.06 [1.01, 1.10]). Phase 1 also had a significantly greater proportion of dead and HIV-infected infants than Phase 2 at 12-months (aOR = 1.98 [1.33, 2.94])., Conclusion: Male partner involvement in antenatal care is critical in ensuring infant survival and HIV infection among children born to HIV-positive mothers. This study highlights the high risk of ante-and-post natal depression and underscores the need of screening for depression during pregnancy., Trial Registration: ClinicalTrials.Gov; Trial Number NCT02085356., Competing Interests: The authors have declared that no competing interests exist.

This study evaluated the reasons for not taking antiretroviral treatment (ART) among women of reproductive age who are disengaged from HIV care (have missed pharmacy pickups and physician visits), with the goal of identifying strategies for reengagement in HIV care. Participants were cisgender women (n = 162), 18 to 49 years of age, and who completed sociodemographic, medical history, reasons why they were not taking ART, mental health, motivation, and self-efficacy assessments. Latent class analysis was used for analysis. Women who reported avoidance-based coping (avoid thinking about HIV) had higher depression ( U = 608.5, z = -2.7, P = .007), lower motivation ( U = 601, z = -2.8, P = .006), and lower self-efficacy ( U = 644.5, z = -2.4, P = .017) than those not using this maladaptive strategy. As women living with HIV experience a disproportionate burden of poor health outcomes, interventions focused on the management of depression may improve HIV outcomes and prevent HIV transmission.

Methamphetamine and HIV impair thyroid function, but few studies have investigated their combined effects on thyroid dysregulation. This study examined the associations of methamphetamine use alone and in combination with HIV on thyroid function among men in South Florida. Measures of thyroid function in methamphetamine-using, HIV-infected (METH+HIV+; n = 127) and HIV-negative (METH+HIV-; n = 46) men who have sex with men (MSM) were compared to non-methamphetamine-using, HIV-negative men (METH-HIV-; n = 136). Thyroid function was dysregulated in methamphetamine-using MSM, irrespective of HIV status. Both meth-using groups had greater odds of abnormal thyroid stimulating hormone levels and significantly higher mean free triiodothyronine (T3) levels. Elevated free T3 was associated with greater depressive symptoms. Overall, outcomes have important implications for assessment of thyroid function in methamphetamine users, particularly among those presenting with depression.

Background: We evaluate the impact a multicomponent, behavioural, prevention of mother to child transmission (PMTCT), cluster randomised controlled trial on HIV stigma reduction among perinatal HIV infected women in rural South Africa., Methods: In a cluster randomised controlled trial, twelve community health centres (CHCs) in Mpumalanga Province, South Africa, were randomised; pregnant women living with HIV enrolled received either: A Standard Care (SC) condition plus time-equivalent attention-control on disease prevention (SC; 6 CHCs; n =357), or an Enhanced Intervention (EI) condition of SC PMTCT plus the 'Protect Your Family' intervention (EI; 6 CHCs; n =342). HIV-infected pregnant women in the SC attended four antenatal and two postnatal video sessions; those in the EI, four antenatal and two postnatal group PMTCT sessions, including stigma reduction, led by trained lay health workers. Maternal PMTCT, HIV knowledge and HIV related stigma were assessed. The impact of the EI was ascertained on stigma reduction (baseline, 12 months postnatally). A series of logistic regression and latent growth curve models were developed to test the impact of the intervention., Results: In all, 699 women living with HIV were recruited during pregnancy (8-24 weeks), and assessments were completed prenatally at baseline and at 12 months (59.5%) postnatally. Baseline scores of overall HIV related stigma and the four scale factors (personalised stigma, disclosure concerns, negative self-image, and concern public attitudes) decreased at follow-up in the intervention group, while baseline scores of overall stigma and three scale factors (personalised stigma, negative self-image, and concern public attitudes) increased at follow-up in the control group. Using longitudinal analyses, Model 1, which included time-invariant predictors of stigma assessed over the two time periods of baseline and 12 months, increases in stigma from baseline to 12 months were associated with being unemployed, having been diagnosed with HIV before the current pregnancy, and alcohol use. In Model 2, which included time-varying predictors, lower stigma scores were associated with participation in the intervention, greater male partner involvement, and consistent condom use., Conclusion: The enhanced PMTCT intervention, including stigma reduction, administered by trained lay health workers had a significant effect on the reduction of HIV related stigma., Trial Registration: clinicaltrials.gov: number NCT02085356.

Disclosure of HIV status remains one of the major challenges to the effectiveness of the prevention of mother to child transmission of HIV in rural areas in South Africa. This study aimed at assessing the determinants of HIV status disclosure among HIV infected pregnant women who have disclosed their HIV status to someone, as well as among those who have disclosed to their partners. Cross-sectional data was collected from 673 HIV sero-positive pregnant women receiving antenatal care services at 12 Community Health Centers in Mpumalanga province. Results indicated that over two-thirds (72.1%) disclosed their status to someone, while just over half (58.4%) disclosed to their partners. Multivariate analysis showed that both disclosure of ones HIV status to someone and to their male partners was significantly associated with increase in antiretroviral therapy (ART) adherence, the known HIV positive status of their partner, and male involvement during pregnancy. Participants who were diagnosed HIV positive during this current pregnancy were less likely to disclose their HIV status to someone. Non-disclosure during current pregnancy highlights a need for interventions that will encourage disclosure among HIV positive women, with a particular focus on those who are newly diagnosed. The findings also need to integrate male partner involvement and partner disclosure during pregnancy.

Background: We evaluate the impact of clinic-based PMTCT community support by trained lay health workers in addition to standard clinical care on PMTCT infant outcomes., Methods: In a cluster randomized controlled trial, twelve community health centers (CHCs) in Mpumalanga Province, South Africa, were randomized to have pregnant women living with HIV receive either: a standard care (SC) condition plus time-equivalent attention-control on disease prevention (SC; 6 CHCs; n  = 357), or an enhanced intervention (EI) condition of SC PMTCT plus the "Protect Your Family" intervention (EI; 6 CHCs; n  = 342). HIV-infected pregnant women in the SC attended four antenatal and two postnatal video sessions and those in the EI, four antenatal and two postnatal PMTCT plus "Protect Your Family" sessions led by trained lay health workers. Maternal PMTCT and HIV knowledge were assessed. Infant HIV status at 6 weeks postnatal was drawn from clinic PCR records; at 12 months, HIV status was assessed by study administered DNA PCR. Maternal adherence was assessed by dried blood spot at 32 weeks, and infant adherence was assessed by maternal report at 6 weeks. The impact of the EI was ascertained on primary outcomes (infant HIV status at 6 weeks and 12 months and ART adherence for mothers and infants), and secondary outcomes (HIV and PMTCT knowledge and HIV transmission related behaviours). A series of logistic regression and latent growth curve models were developed to test the impact of the intervention on study outcomes., Results: In all, 699 women living with HIV were recruited during pregnancy (8-24 weeks), and assessments were completed at baseline, at 32 weeks pregnant (61.7%), and at 6 weeks (47.6%), 6 months (50.6%) and 12 months (59.5%) postnatally. Infants were tested for HIV at 6 weeks and 12 months, 73.5% living infants were tested at 6 weeks and 56.7% at 12 months. There were no significant differences between SC and EI on infant HIV status at 6 weeks and at 12 months, and no differences in maternal adherence at 32 weeks, reported infant adherence at 6 weeks, or PMTCT and HIV knowledge by study condition over time., Conclusion: The enhanced intervention administered by trained lay health workers did not have any salutary impact on HIV infant status, ART adherence, HIV and PMTCT knowledge. Trial registration clinicaltrials.gov: number NCT02085356.

The Joint United Nations Programme on HIV and AIDS proposed to reduce the vertical transmission of HIV from ∼72,200 to ∼8300 newly infected children by 2015 in South Africa (SA). However, cultural, infrastructural, and socio-economic barriers hinder the implementation of the prevention of mother-to-child transmission (PMTCT) protocol, and research on potential solutions to address these barriers in rural areas is particularly limited. This study sought to identify challenges and solutions to the implementation, uptake, and sustainability of the PMTCT protocol in rural SA. Forty-eight qualitative interviews, 12 focus groups discussions (n = 75), and one two-day workshop (n = 32 participants) were conducted with district directors, clinic leaders, staff, and patients from 12 rural clinics. The delivery and uptake of the PMTCT protocol was evaluated using the Consolidated Framework for Implementation Research (CFIR); 15 themes associated with challenges and solutions emerged. Intervention characteristics themes included PMTCT training and HIV serostatus disclosure. Outer-setting themes included facility space, health record management, and staff shortage; inner-setting themes included supply use and availability, staff-patient relationship, and transportation and scheduling. Themes related to characteristics of individuals included staff relationships, initial antenatal care visit, adherence, and culture and stigma. Implementation process themes included patient education, test results delivery, and male involvement. Significant gaps in care were identified in rural areas. Information obtained from participants using the CFIR framework provided valuable insights into solutions to barriers to PMTCT implementation. Continuously assessing and correcting PMTCT protocol implementation, uptake and sustainability appear merited to maximize HIV prevention.

Male partner involvement (MPI) can contribute to the success of programs aimed at preventing mother-to-child transmission (PMTCT) of HIV. However, the definition and measures of MPI differ according to context. This study utilized secondary cross-sectional data to investigate the prevalence and determinants of MPI among 463 male partners of HIV-infected pregnant women in rural South Africa. Results indicated that 44.1% of male partners reported involvement in most or all specified male partner involvement activities (i.e., scores of 7 to 9). Descriptive, correlation and multiple linear-regression analyses were conducted. Positive predictors of MPI included relationship status, own HIV status, awareness of female partner's positive HIV status, female partner's desire to have more children, having family planning discussions with provider, condom use to prevent HIV and sexually transmitted infections (STIs), and partner reasoning skills. Negative predictors included partner verbal aggression. Overall, although MPI is low, the study underlines important information that could be used to develop interventions aimed at improving maternal and infant health in PMTCT programs in South Africa., Competing Interests: The authors declare no conflict of interest

Background: Intravaginal practices (IVP) (cleansing or introducing products inside the vagina for hygiene, health or to please sexual partners) are common among women with HIV. IVP increase the risk of developing bacterial Vaginosis (BV), the most common genital infection associated with transmission of sexually transmitted infections and HIV. This study tested a pilot intervention to reduce IVP and BV in HIV infected women in Zambia., Methods: One hundred twenty-eight HIV infected women engaging in IVP were randomized to two conditions: enhanced standard of care (n = 70) and experimental (n = 58) from May 1, 2013 to February 28, 2014. All participants received a brief educational counseling session on discontinuation of IVP, and those with BV, were provided with medical treatment for BV. Women in the experimental condition received an additional group-based, culturally tailored intervention. Participants completed questionnaires assessing sexual risk factors and IVP and were assessed for BV using Nugent criteria at baseline, 6 months and 12 months., Results: At 12-month, the proportion of self-reported use of IVPs decreased in the experimental condition: soap (28% vs. 47%); cloth or a rag (19% vs. 38%); and traditional medicines (22% vs. 42%) (all p < 0.05)) compared with the enhanced standard of care condition. The prevalence of BV at 6 and 12 months did not differ by study condition but averaging over study condition, prevalence of BV decreased from 64.2% at baseline to 15.6% at 6 months (p < 0.01) and to 23.6% at 12 months (p = 0.15). Using an enhanced standard of care approach and an enhanced standard of care + a group intervention, IVP and BV decreased over time, but the experimental condition had greater reduction in self-reported use of IVP., Conclusions: Future studies should address interventions in communities with high burden of IVP, BV and HIV. Interventions that could be administered during routine medical care and decrease IVP and BV are needed, and should be considered part of women's health programs., Trial Registration Number: NCT03134924 (retrospectively registered 21st April 2017).

Background: Desires to have children are not lessened by a woman's HIV status. Couples may lack information to conceive safely, and men may be especially uninformed. This study examined reproductive intentions, practices, and attitudes among men in HIV-infected couples, including attitudes regarding the perceived risk of vertical and horizontal transmission, safer conception, and preconception planning., Methods: Men ( n = 12) in HIV-infected couples were interviewed regarding reproductive intentions, attitudes, and knowledge and qualitative assessments were coded for dominant themes., Results: Themes primarily addressed concerns about the health of the baby, men's involvement in pregnancy, safer conception, concerns about HIV transmission and antiretroviral therapy, and HIV infection. Men lacked information on safer conception and newer HIV prevention strategies, such as pre-exposure prophylaxis (PrEP)., Discussion: Gaps in knowledge regarding preconception practices among men in HIV-infected couples were identified. Results highlight men's desire for involvement in preconception planning, and opportunities for providers to facilitate this practice and to increase patient education and the use of PrEP are discussed.

Male partner involvement (MPI) during antenatal care has been promoted as an effective intervention to improve maternal and newborn health outcomes. Although MPI is commonly defined as men attending antenatal clinic visits with their female partner, few men attend antenatal clinic visits in rural communities in the province of Mpumalanga, South Africa. The study aimed to qualitatively explore the meaning and understanding of MPI as perceived by men visiting primary health care clinics in rural communities in Mpumalanga. Six focus groups discussions ( n = 53) were conducted, digitally recorded, simultaneously transcribed, and translated verbatim into English. Data were analyzed using thematic content analysis. Perceptions of male roles during and after pregnancy differed among men. Male involvement was understood as giving instrumental support to female partners through financial help, helping out with physical tasks, and providing emotional support. Accompanying female partners to the clinic was also viewed as partner support, including behaviors such as holding a spot for her in the clinic queues. Community attitudes, traditional beliefs, and negative experiences in health facilities were barriers for MPI. This study provides support for concerted efforts to work with both men and women within the cultural context to explore the important roles of all members of the family in working together to provide the best possible health outcomes for mother and infant. In particular, future interventions should focus on making antenatal care services more responsive to male partners, and improving male partner accessibility in health care facilities.

This study aimed to assess the prevalence of depressed symptoms and associated factors in prenatal HIV-positive women in primary care facilities in rural South Africa. In a cross-sectional study, 663 HIV-positive prenatal women in 12 community health centres in Mpumalanga province, South Africa, were recruited by systematic sampling (every consecutive patient after HIV post-test counselling). Results indicate that overall, 48.7% [95% CI: 44.8, 52.6] of women during the prenatal period reported depressed mood (scores of ≥ 13 on the Edinburgh Postnatal Depression Scale 10). In multivariate analysis, not being employed, unplanned pregnancy, not having an HIV-positive child, poor antiretroviral therapy adherence, non-condom use at last sex, and intimate partner violence were associated with depressive symptoms. Potential risk factors among HIV-infected prenatal women were identified which could be utilized in interventions. Routine screening for depression may be integrated into prenatal care settings.

Bacterial vaginosis (BV) is the most common female reproductive tract infection and is associated with an increased risk of acquiring and transmitting HIV by a mechanism that is not well understood. Gamma delta (GD) T cells are essential components of the adaptive and innate immune system, are present in the female reproductive tract, and play an important role in epithelial barrier protection. GD1 cells predominate in the mucosal tissue and are important in maintaining mucosal integrity. GD2 cells predominate in peripheral blood and play a role in humoral immunity and in the immune response to pathogens. HIV infection is associated with changes in GD T cells frequencies in the periphery and in the female reproductive tract. The objective of this study is to evaluate if changes in vaginal flora occurring with BV are associated with changes in endocervical GD T cell responses, which could account for increased susceptibility to HIV. Seventeen HIV-infected (HIV+) and 17 HIV-uninfected (HIV-) pre-menopausal women underwent collection of vaginal swabs and endocervical cytobrushes. Vaginal flora was assessed using the Nugent score. GD T cells were assessed in cytobrush samples by flow cytometry. Median Nugent score was 5.0 and 41% of women had abnormal vaginal flora. In HIV uninfected women there was a negative correlation between Nugent score and cervical GD1 T cells (b for interaction = - 0.176, p<0.01); cervical GD1 T cells were higher in women with normal vaginal flora than in those with abnormal flora (45.00% vs 9.95%, p = 0.005); and cervical GD2 T cells were higher in women with abnormal flora than in those with normal flora (1.70% vs 0.35%, p = 0.023). GD T cells in the genital tract are protective (GD1) and are targets for HIV entry (GD2). The decrease in cervical GD1 and increase in GD2 T cells among women with abnormal vaginal flora predisposes women with BV to HIV acquisition. We propose to use GD T cell as markers of female genital tract vulnerability to HIV.