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Background: When used effectively, oral pre-exposure prophylaxis (PrEP; tenofovir disoproxil fumarate and emtricitabine) prevents maternal HIV acquisition and reduces the risk of vertical transmission. Our study aimed to better understand PrEP initiation, continued use, and adherence in pregnant and postpartum women., Methods: The PrEP in Pregnancy and Postpartum (PrEP-PP) study is a demonstration cohort study that enrolled pregnant women aged 16 years and older without HIV attending their first antenatal care visit in Cape Town, South Africa, between Aug 29, 2019, and Oct 10, 2021. Eligible, consenting women were followed up quarterly up to 12 months postpartum with regular HIV testing and offer of PrEP with ongoing adherence counselling. The primary outcome was distribution of women across the PrEP cascade (ie, initiation and continuation up to 12 months postpartum) with crude and adjusted hazard ratios (HRs). We also report on HIV incidence by pregnancy and postpartum status., Findings: Overall, 1195 pregnant women were recruited and followed up (median age 26 years, IQR 23-31; median gestational age 21 weeks, IQR 15-31); 1009 (84·4%) started PrEP at enrolment. Among women who initiated PrEP at enrolment, 668 (67·5%) of 990 continued PrEP at the 1-month follow-up, 485 (49·9%) of 972 continued at 3 months, 392 (39·4%) of 994 at 6 months, and 275 (27·4%) of 1005 at 12 months. Of 186 women who did not accept PrEP at enrolment, 70 (37·6%) of 186 subsequently initiated PrEP. Overall, 200 (18·6%) of 1076 women continued PrEP at 12 months postpartum. Of 186 women who did not initiate PrEP at baseline, 70 (37·6%) subsequently initiated PrEP during the study. Factors associated with PrEP discontinuation up to 12 months postpartum included being married or cohabiting (adjusted HR 1·32, 95% CI 1·16-1·50), condomless sex since last visit (1·43, 1·23-1·65), reporting intimate partner violence (2·03, 1·59-2·59), or depression in the past 12 months (1·53, 1·14-2·05). Overall, 16 women seroconverted over 1673·8 woman-years (HIV incidence rate 0·96 per 100 woman-years, 95% CI 0·49-1·42); 14 discontinued PrEP use and two never initiated PrEP. HIV incidence was 0·28 per 100 woman-years during pregnancy (95% CI 0·22-0·33), and the incidence rate ratio was 1·77 per 100 woman-years (0·53-5·90) 0-6 months postpartum and 2·19 per 100 woman-years (0·61-7·83) 6-12 months postpartum compared with pregnant women., Interpretation: There is an urgent need for the integration of PrEP into antenatal and postnatal care and interventions that address barriers to continued use, including targeted counselling during pregnancy and postpartum to reduce PrEP discontinuation., Funding: National Institute of Mental Health and Fogarty International, US National Institutes of Health., Translation: For the French translation of the abstract see Supplementary Materials section., Competing Interests: Declaration of interests DLJD reported drug donation from Gilead Sciences and STI tests from Cepheid and a grant for study from Gilead Sciences. L-GB reported honoraria from Gilead Sciences, Merck, and ViiV Healthcare. All other authors declare no competing interests., (Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Objective: To compare pregnancy outcomes using self-reported and objective levels of intracellular tenofovir diphosphate (TFV-DP) in pregnant women using preexposure prophylaxis (PrEP)., Design: We enrolled pregnant women >15 years without HIV at first antenatal care visit in an observational cohort study to compare pregnancy outcomes by PrEP use., Methods: Exposure defined as: any PrEP use [tenofovir disoproxil and emtricitabine (TDF/FTC]) prescription + reported taking PrEP], or objectively-measured TFV-DP in dried blood spots in PrEP-using pregnant women. The primary outcome was a composite of pregnancy loss, preterm birth (<37weeks), low birthweight (<2500 g), small for gestational age ([SGA] ≤ tenth percentile), or neonatal death. Multivariable logistic regression models evaluated individual and composite adverse outcomes by self-reported or objectively measured PrEP use adjusting for age, gestational age, gravidity and socio-economic status., Results: Between August 19 and February 23, we followed 1195 pregnant women and ascertained 1145 pregnancy outcomes (96%); 72% ( n  = 826) reported taking PrEP while pregnant, 16% did not take PrEP ( n  = 178), 12% were unconfirmed ( n  = 141). Overall, 94.5% ( n  = 1082) had singleton live births with a median birthweight of 3.2 kg [interquartile range (IQR) = 2.9-3.5], with no difference in pregnancy loss between self-reported PrEP exposed vs. unexposed [4.0 vs. 5.6%; adjusted odds ratio (aOR) = 0.65, 95% confidence interval (CI) = 0.32-1.47]. Composite adverse outcomes did not differ by reported PrEP use (20% for both groups; aOR = 1.07, 95% CI = 0.71-1.63). Comparing objective PrEP use (any TFV-DP vs. no TFV-DP or not on PrEP), adverse outcomes did not differ (aOR = 0.64, 95% CI = 0.39-1.04), nor did other outcomes including preterm birth nor SGA., Conclusions: Pregnancy outcomes did not differ by PrEP exposure (self-reported or objective), suggesting real-world efficacy that TDF/FTC as PrEP is safe in pregnancy., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.)

Background: Adolescent girls and young women (AGYW) in South Africa are at a higher risk of acquiring HIV. Despite the increasing availability of daily oral pre-exposure prophylaxis (PrEP) for HIV prevention, knowledge on PrEP use during pregnancy and postpartum periods at antenatal care (ANC) facilities remains inadequate., Methods: Data from HIV-uninfected pregnant women in Cape Town, South Africa, were used in this study. These women aged 16-24 years were enrolled in the PrEP in pregnancy and postpartum (PrEP-PP) cohort study during their first ANC visit. Using the PrEP cascade framework, the outcomes of the study were PrEP initiation (prescribed tenofovir disoproxil fumarate and emtricitabine at baseline), continuation (returned for prescription), and persistence [quantifiable tenofovir diphosphate (TFV-DP) in dried blood samples]. The two primary exposures of this study were risk perception for HIV and baseline HIV risk score (0-5), which comprised condomless sex, more than one sexual partner, partner living with HIV or with unknown serostatus, laboratory-confirmed sexually transmitted infections (STIs), and hazardous alcohol use before pregnancy (Alcohol Use Disorders Identification Test for Consumption score ≥ 3). Logistic regression was used to examine the association between HIV risk and PrEP, adjusting for a priori confounders., Results: A total of 486 pregnant women were included in the study, of which 16% were "adolescents" (aged 16-18 years) and 84% were "young women" (aged 19-24 years). The adolescents initiated ANC later than the young women [median = 28 weeks (20-34) vs. 23 weeks (16-34), p  = 0.04]. Approximately 41% of the AGYW were diagnosed with sexually transmitted infection at baseline. Overall, 83% of the AGYW initiated PrEP use during their first ANC. The percentage of PrEP continuation was 63% at 1 month, 54% at 3 months, and 39% at 6 months. Approximately 27% consistently continued PrEP use through 6 months, while 6% stopped and restarted on PrEP use at 6 months. With a higher risk score of HIV (≥2 vs. ≤1), the AGYW showed higher odds of PrEP continuation [adjusted odds ratio: 1.85 (95% CI: 1.12-3.03)] through 6 months, adjusting for potential confounders. Undergoing the postpartum period (vs. pregnant) and having lower sexual risk factors were found to be the barriers to PrEP continuation. TFV-DP concentration levels were detected among 49% of the AGYW, and 6% of these women had daily adherence to PrEP at 3 months., Conclusions: AGYW were found to have high oral PrEP initiation, but just over one-third of these women continued PrEP use through 6 months. Pregnant AGYW who had a higher risk of acquiring HIV (due to condomless sex, frequent sex, and STIs) were more likely to continue on PrEP use through the postpartum period. Pregnant and postpartum AGYW require counseling and other types of support, such as community delivery and peer support to improve their effective PrEP use through the postpartum period., Clinical Trial Number: ClinicalTrials.gov, NCT03826199., 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., (© 2023 Khadka, Gorbach, Nyemba, Mvududu, Mashele, Javanbakht, Nianogo, Aldrovandi, Bekker, Coates, Myer and Joseph Davey.)

Background: In South Africa, at least 7.5 million people (age ≥15 years) are living with Human Immunodeficiency Virus (HIV). In 2020, 220,000 new infections occurred, approximately one-third of which were among cisgender adolescent girls and women (age ≥15 years). The perspectives of pregnant adolescent girls and young women (AGYW) as key, targeted end-users of pre-exposure prophylaxis (PrEP) in this setting are not well known., Methods: We purposively recruited participants enrolled in an ongoing cohort study at an urban antenatal clinic in Cape Town, South Africa for in-depth interviews between July-September 2020. We restricted our analysis to pregnant AGYW (age: 16-25 years) who initiated daily oral PrEP (Tenofovir/Emtricitabine) antenatally and self-reported either high PrEP persistence (≥25 days in the past 30 days and no missed PrEP collection), or low PrEP persistence and/or discontinuation (missing >5 days in the last 30 days or missed PrEP collection). The findings were organized thematically, per the adapted Health Behavior Model (2000), using Nvivo -v.1.5., Results: We interviewed 18 AGYW (mean age = 22 years), at a mean of 14 weeks postpartum. Higher self-esteem and high-quality study provider-client relationships, including empathic psychosocial support, facilitated PrEP continuation. Reported barriers included unstable social structure characteristics (i.e., financial hardship) and individual factors (i.e., unintended pregnancy, parental rejection, and inadequate peer- and [non-cohabiting] partner support). Participants self-perceived a need for PrEP, feeling susceptible to non-consensual, forced sex, or considering partners' (presumed) sexual risk-taking. Limited community awareness regarding PrEP availability and/or perceived complexity in navigating health system access to PrEP, impede continuation., Conclusions: PrEP-focused healthcare access pathways for pregnant and postpartum AGYW need to be simplified. Further research is needed on health system determinants (i.e., structural barriers, provider-client interactions, and related outcomes) of oral PrEP utilization. In 2022, South Africa announced regulatory approval of long-acting PrEP options (i.e., the dapivirine ring for non-pregnant women and injectable cabotegravir, respectively); these may mitigate implementation barriers reported in this study. However, the safety and efficacy of long-acting PrEP (e.g., injectables, implants) among pregnant or breastfeeding women, specifically, remains to be confirmed in this setting.

Background: HIV endpoint-driven clinical trials increasingly provide oral pre-exposure prophylaxis (PrEP) as standard of prevention during the trial, however, among participants desiring to continue using PrEP at trial exit, little is known about post-trial PrEP access and continued use., Methods: We conducted one-time, semi-structured, face-to-face, in-depth interviews with 13 women from Durban, South Africa, from November to December 2021. We interviewed women who initiated oral PrEP as part of the HIV prevention package during the Evidence for Contraceptive Options and HIV Outcomes (ECHO) Trial, elected to continue using PrEP at study exit, and were given a 3-month PrEP supply and referred to facilities for PrEP refills at the final trial visit. The interview guide probed for barriers and enablers to post-trial PrEP access, and current and future PrEP use. Interviews were audio-recorded and transcribed. Thematic analysis was facilitated using NVivo., Results: Of the 13 women, six accessed oral PrEP post-trial exit, but five later discontinued. The remaining seven women did not access PrEP. Barriers to post-trial PrEP access and continued use included PrEP facilities having long queues, inconvenient operating hours, and being located far from women's homes. Some women were unable to afford transport costs to collect PrEP. Two women reported visiting their local clinics and requesting PrEP but were informed that PrEP was unavailable at the clinic. Only one woman was still using PrEP at the time of the interview. She reported that the PrEP facility was located close to her home, staff were friendly, and PrEP education and counselling were provided. Most women not on PrEP reported wanting to use it again, particularly if barriers to access could be alleviated and PrEP was easily available at facilities., Conclusions: We identified several barriers to post-trial PrEP access. Strategies to enhance PrEP access such as a reduction in waiting queues, convenient facility operating hours, and making PrEP more widely available and accessible are needed. It is also worth noting that oral PrEP access has expanded in South Africa from 2018 till now and this could improve access to PrEP for participants exiting trials who desire to continue PrEP., (© 2023. The Author(s).)

Introduction : HIV-prevention and endpoint-driven clinical trials enrol individuals at substantial risk of HIV. Recently, these trials have provided oral pre-exposure prophylaxis (PrEP) as HIV-prevention standard of care; however, data on PrEP uptake and use during the trial and post-trial access are lacking. Methods : We conducted once-off, telephonic, in-depth interviews from August 2020 to March 2021, with 15 key stakeholders (including site directors/leaders, principal investigators and clinicians), purposively recruited from research sites across South Africa that are known to conduct HIV-prevention and endpoint-driven clinical trials. The interview guide probed for facilitators and barriers to PrEP uptake and use during the trial, and post-trial PrEP access. Interviews were audio recorded and transcribed. Coding was facilitated using NVivo and emergent themes were identified. Results : Most stakeholders reported incorporating PrEP as part of the HIV-prevention package in HIV-prevention and endpoint-driven clinical trials. Stakeholders identified multiple barriers to PrEP uptake and use, including difficulties with daily pill taking, side effects, stigma, a lack of demand creation and limited knowledge and education about PrEP in communities. Facilitators of PrEP uptake and use included demand-creation campaigns and trial staff providing quality counselling and education. Post-trial PrEP access was frequently challenging as facilities were located a considerable distance from research sites, had long queues and inconvenient operating hours. Conclusions : Strategies to address barriers to PrEP uptake and use during trials and post-trial access, such as PrEP demand creation, education and counselling, addressing stigma, support for daily pill-taking and increased post-trial access, are urgently needed.

This study examines baseline associations between alcohol use and HIV sexual risk among a cohort of HIV-uninfected pregnant women (n = 1201) residing in a high HIV burdened community in Cape Town, South Africa. Alcohol use was measured using a modified version of the Alcohol Use Disorder Identification Test (AUDIT). HIV sexual risk was measured through a composite variable of four risk factors: diagnosis with a STI, self-report of > 1 recent sex partners, partner HIV serostatus (unknown or HIV+) and condomless sex at last sex. Any past year alcohol use prior to pregnancy was reported by half of participants (50%); 6.0% reported alcohol use during pregnancy. Alcohol use prior to pregnancy was associated with increased odds of being at high risk of HIV (aOR = 1.33, 95% CI 1.05-1.68, for 2 risks and aOR = 1.47, 95% CI 0.95-2.27 for 3 risks). In addition to reducing alcohol use, several other strategies to address HIV sexual risk were identified. Evidence-based interventions to address alcohol use and other HIV sexual risk behaviors during pregnancy in South Africa are desperately needed. Qualitative work exploring individual and community level drivers of alcohol use among pregnant and breastfeeding women in this setting could support development of a culturally tailored intervention to address these issues in this population., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: Pretreatment HIV drug resistance (PDR) undermines individual treatment success and threatens the achievement of UNAIDS 95-95-95 targets. In many African countries, limited data are available on PDR as detection of recent HIV infection is uncommon and access to resistance testing is limited. We describe the prevalence of PDR among South African women with recent HIV infection from the Evidence for Contraceptive Options and HIV Outcomes (ECHO) Trial., Methods: HIV-uninfected, sexually active women, aged 18-35 years, and seeking contraception were enrolled in the ECHO Trial at sites in South Africa, from 2015 to 2018. HIV testing was done at trial entry and repeated quarterly. We tested stored plasma samples collected at HIV diagnosis from women who seroconverted during follow-up and had a viral load >1000 copies/mL for antiretroviral resistant mutations using a validated laboratory-developed population genotyping assay, which sequences the full protease and reverse transcriptase regions. Mutation profiles were determined using the Stanford Drug Resistance Database., Results: We sequenced 275 samples. The median age was 23 years, and majority (98.9%, n = 272) were infected with HIV-1 subtype C. The prevalence of surveillance drug resistance mutations (SDRMs) was 13.5% (n = 37). Nonnucleoside reverse transcriptase inhibitor (NNRTI) mutations were found in 12.4% of women (n = 34). Few women had NRTI (1.8%, n = 5) and protease inhibitor (1.1%, n = 3) mutations. Five women had multiple NRTI and NNRTI SDRMs., Conclusions: The high levels of PDR, particularly to NNRTIs, strongly support the recent change to the South African national HIV treatment guidelines to transition to a first-line drug regimen that excludes NNRTIs., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.)

Cisgender women, particularly pregnant and postpartum women in Eastern and Southern Africa, face an unacceptably high risk of HIV acquisition. Oral pre-exposure prophylaxis (PrEP) is an effective HIV prevention intervention that can reduce HIV acquisition and vertical transmission. In this qualitative study, we interviewed 21 postpartum women from Cape Town, South Africa who initiated PrEP during pregnancy and who self-reported low PrEP adherence or missed > 1 PrEP follow-up collection. We identified multiple overlapping barriers to PrEP continuation and/or adherence. Individual factors included forgetting to take PrEP daily, being away from home when PrEP should be taken, anticipated stigma and limited disclosure of PrEP use. Women also reported pill-related factors such as side effects and having to take PrEP in addition to other tablets during pregnancy and the postpartum period. Facility-related barriers included logistics around PrEP collection especially when not in antenatal care, as well as transport and financial barriers., (© 2022. The Author(s).)

Background: HIV endpoint-driven clinical trials provide oral pre-exposure prophylaxis (PrEP) as HIV prevention standard of care. We evaluated quantifiable plasma tenofovir among South African women who used oral PrEP during the Evidence for Contraceptive Options and HIV Outcomes (ECHO) Trial., Methods: ECHO, a randomized trial conducted in 4 African countries between 2015 and 2018, assessed HIV incidence among HIV-uninfected women, aged 16-35 years, randomized to 1 of 3 contraceptives. Oral PrEP was offered onsite as part of the HIV prevention package at the South African trial sites. We measured tenofovir in plasma samples collected at the final trial visit among women reporting ongoing PrEP use. We used bivariate and multivariate logistical regression to assess demographic and sexual risk factors associated with plasma tenofovir quantification., Results: Of 260 women included, 52% were ≤24 years and 22% had Chlamydia trachomatis at enrollment. At PrEP initiation, 68% reported inconsistent/nonuse of condoms. The median duration of PrEP use was 90 days (IQR: 83-104). Tenofovir was quantified in 36% (n = 94) of samples. Women >24 years had twice the odds of having tenofovir quantified vs younger women (OR = 2.12; 95% confidence interval = 1.27 to 3.56). Women who reported inconsistent/nonuse of condoms had lower odds of tenofovir quantification (age-adjusted OR = 0.47; 95% confidence interval = 0.26 to 0.83)., Conclusions: Over a third of women initiating PrEP and reporting ongoing use at the final trial visit had evidence of recent drug exposure. Clinical trials may serve as an entry point for PrEP initiation among women at substantial risk for HIV infection with referral to local facilities for ongoing access at trial end., Clinical Trial Number: NCT02550067., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.)

HIV incidence among women in Eastern and Southern Africa remains unacceptably high, highlighting the need for effective HIV prevention options, including pre-exposure prophylaxis (PrEP). The Evidence for Contraceptive Options and HIV Outcomes trial offered daily oral PrEP to participants during the latter part of the clinical trial as an additional HIV prevention choice. We explored daily oral PrEP continuation at trial exit among women enrolled from Durban, South Africa who initiated oral PrEP at the trial site. Of the 132 women initiating oral PrEP, 87% reported continuation of oral PrEP at month 1, 80% at month 3, and 75% continued using oral PrEP at their final trial visit and were referred to off-site facilities for ongoing oral PrEP access. The median duration of oral PrEP use in trial participants who used oral PrEP was 91 days (IQR 87 to 142 days). Women who disclosed their oral PrEP use to someone had increased odds of continuing oral PrEP at trial exit. Women who reported > 1 sex partner and those who felt they would probably or definitely get infected with HIV had reduced odds of continuing oral PrEP at trial exit. Of those discontinuing oral PrEP (n = 32), > 50% discontinued within the first month, and the most common reason for discontinuation was reporting side effects. The high rates of oral PrEP continuation in our study are encouraging and our findings can be utilized by other clinical trials providing oral PrEP as standard of care for HIV prevention and by oral PrEP implementation programmes., (© 2022. The Author(s).)

Background: HIV incidence among pregnant and postpartum women remains high in South Africa. Pre-exposure prophylaxis (PrEP) use remains suboptimal in this population, particularly during the postpartum period when women's engagement with routine clinic visits outside PrEP decreases. Key barriers to sustained PrEP use include the need for ongoing contact with the health facility and suboptimal counseling around effective PrEP use., Methods: Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum women (SCOPE-PP), is a two-stepped unblinded, individually randomized controlled trial (RCT) that aims to optimize peripartum and postpartum PrEP use by providing a stepped package of evidence-based interventions. We will enroll 650 pregnant women (> 25 weeks pregnant) who access PrEP at a busy antenatal clinic in Cape Town at the time of recruitment and follow them for 15 months. We will enroll and individually randomize pregnant women > 16 years who are not living with HIV who are either on PrEP or interested in starting PrEP during pregnancy. In step 1, we will evaluate the impact of enhanced adherence counselling and biofeedback (using urine tenofovir tests for biofeedback) and rapid PrEP collection (to reduce time required) on PrEP use in early peripartum compared to standard of care (SOC) (n = 325 per arm). The primary outcome is PrEP persistence per urine tenofovir levels and dried blood spots of tenofovir diphosphate (TFV-DP) after 6-months. The second step will enroll and individually randomize participants from Step 1 who discontinue taking PrEP or have poor persistence in Step 1 but want to continue PrEP. Step 2 will test the impact of enhanced counseling and biofeedback plus rapid PrEP collection compared to community PrEP delivery with HIV self-testing on PrEP use (n = up to 325 postpartum women). The primary outcome is PrEP continuation and persistence 6-months following second randomization (~ 9-months postpartum). Finally, we will estimate the cost effectiveness of SCOPE-PP vs. SOC per primary outcomes and disability-adjusted life-years (DALYs) averted in both Step 1 and 2 using micro-costing with trial- and model-based economic evaluation., Discussion: This study will provide novel insights into optimal strategies for delivering PrEP to peripartum and postpartum women in this high-incidence setting., Trial Registration: NCT05322629 : Date of registration: April 12, 2022., (© 2022. The Author(s).)

Introduction: South African men are underrepresented in HIV testing and treatment services. Secondary distribution of oral HIV self-test (HIVST) kits by women living with HIV (WLHIV) to their male partners (i.e. index partner HIVST) may increase men's testing and treatment but has been understudied., Methods: Between March and July 2021, we evaluated the effectiveness of index partner HIVST versus the standard of care (SOC) (invitations for men's facility-based testing) on men's testing in a 1:1 randomized control trial. Eligibility criteria included: WLHIV; ≥18 years of age; attending one of four high-density rural clinics; have a working cell phone; and self-reported having a primary male partner of unknown serostatus. The primary outcome was the proportion of WLHIV reporting that her partner tested for HIV within 3 months after enrolment., Results: We enrolled 180 WLHIV and 176 completed an endline survey (mean age = 35 years, 15% pregnant, 47% unmarried or non-cohabiting). In the HIVST arm, 78% of male partners were reported to have tested for HIV versus 55% in SOC (RR = 1.41; 95% CI = 1.14-1.76). In the HIVST arm, nine men were reactive with HIVST (14% positivity), six were confirmed HIV positive with standard testing (67%) and all of those started antiretroviral therapy (ART), and four HIV-negative men started pre-exposure prophylaxis (PrEP) (5%). In SOC, six men were diagnosed with HIV (12% positivity), 100% started ART and seven HIV-negative men started PrEP (16%). One case of verbal intimate partner violence was reported in the HIVST arm., Conclusions: Secondary distribution of HIVST to partners of WLHIV was acceptable and effective for improving HIV testing among men in rural South Africa in our pilot study. Interventions are needed to link reactive HIVST users to confirmatory testing and ART., (© 2022 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)

Background: Sexually transmitted infections (STIs) during pregnancy may increase the risk of adverse pregnancy outcomes. STI syndromic management is standard of care in South Africa but has its limitations. We evaluated the impact of diagnosing and treating curable STIs during pregnancy on adverse pregnancy and birth outcomes., Methods: We combined data from two prospective studies of pregnant women attending public sector antenatal care (ANC) clinics in Tshwane District and Cape Town, South Africa. Pregnant women were enrolled, tested and treated for STIs. We evaluated the association between any STI at the first ANC visit and a composite adverse pregnancy outcome (miscarriage, stillbirth, preterm birth, early neonatal death, or low birthweight) using modified Poisson regression models, stratifying by HIV infection and adjusting for maternal characteristics., Results: Among 619 women, 61% (n = 380) were from Tshwane District and 39% (n = 239) from Cape Town; 79% (n = 486) were women living with HIV. The prevalence of any STI was 37% (n = 228); C. trachomatis, 26% (n = 158), T. vaginalis, 18% (n = 120) and N. gonorrhoeae, 6% (n = 40). There were 93% (n = 574) singleton live births, 5% (n = 29) miscarriages and 2% (n = 16) stillbirths. Among the live births, there were 1% (n = 3) neonatal deaths, 7% (n = 35) low birthweight in full-term babies and 10% (n = 62) preterm delivery. There were 24% (n = 146) for the composite adverse pregnancy outcome. Overall, any STI diagnosis and treatment at first ANC visit was not associated with adverse outcomes in women living with HIV (adjusted relative risk (aRR); 1.43, 95% CI: 0.95-2.16) or women without HIV (aRR; 2.11, 95% CI: 0.89-5.01). However, C. trachomatis (aRR; 1.57, 95% CI: 1.04-2.39) and N. gonorrhoeae (aRR; 1.69, 95% CI: 1.09-3.08), were each independently associated with the composite adverse outcome in women living with HIV., Conclusion: Treated STIs at the first ANC visit were not associated with adverse pregnancy outcome overall. In women living with HIV, C. trachomatis or N. gonorrhoeae at first ANC were each independently associated with adverse pregnancy outcome. Our results highlights complex interactions between the timing of STI detection and treatment, HIV infection and pregnancy outcomes, which warrants further investigation., (© 2022. The Author(s).)

Pregnant and breastfeeding populations are at substantial risk of acquiring HIV in some settings, yet are underrepresented in clinical trials of new pre-exposure prophylaxis (PrEP) agents. Several PrEP formulations are in development (eg, vaginal rings, long-acting injectables, and other modalities). Pregnant and breastfeeding populations are typically excluded from initial clinical trials. We identified 14 PrEP trials of novel agents in non-pregnant or non-breastfeeding populations, and six phase 1-3 trials and open label extensions among pregnant and breastfeeding populations, that are currently ongoing or complete. A framework shift is needed to consider the ethical costs of excluding pregnant and breastfeeding populations at risk for HIV in PrEP clinical trials and promote inclusion to maximise the benefits from PrEP tools in the pipeline. Research on new PrEP agents should include pregnant and breastfeeding populations to avoid delays in reaching those who could benefit from PrEP after efficacy is established., Competing Interests: Declaration of interests DLJD received funding from the US National Institutes of Health (K01TW01187 from the Fogarty International Center and National Institute of Mental Health R01MH116771), an honorarium for a meeting on long-acting PrEP by ViiV, donations of the study drug (Truvada) from Gilead, and donations of the STI test kits from Cepheid. NM has an investigator initiated trial from Merck. ADL declared funding for the PHASES Project (grant number R01 AI108368-05; principal investigator) and The FAIRER Project (grant number R01 HG 011480), and is the chair and on the data safety monitoring board for TNF-alpha Blockade with Certolizumab to Prevent Pregnancy Complications in High-Risk Patients with APS, is a member and on the interim review panel for MTN/042-DELIVER, is a member and on the external advisory board for the Infectious Diseases Clinical Research Consortium, and is a member and on the data safety monitoring board for the MOMPOD Study. CS is on the NIAID drug safety monitoring board for several HIV vaccine trials and has received an honorarium, is on a Clover biopharmaceuticals drug safety monitoring board for a COVID-19 vaccine trial and has received an honorarium, and is a member of the Coalition to Advance and Support Prevention Research funded by USAID. LMN received funding to their institution (the Magee-Womens Research Institute) from the US National Institutes of Health and funding from USAID and PEPFAR through a cooperative agreement (7200AA19CA00003; Jhpiego, Johns Hopkins University, Baltimore, MD, USA). The Microbicide Trials Network is funded by the National Institute of Allergy and Infectious Diseases (UM1AI068633, UM1AI068615, and UM1AI106707), with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health, all components of the US National Institutes of Health. All other authors declare no competing interests., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Introduction: Pre-exposure prophylaxis (PrEP) is a safe and effective prevention strategy to reduce women's risk of HIV in pregnancy and postpartum. Effective PrEP protection requires daily PrEP adherence, but little is known about maternal PrEP continuation and factors that influence PrEP use., Methods: The PrEP in pregnancy and postpartum (PrEP-PP) study enrolled consenting pregnant, HIV-negative women at first antenatal care (ANC) visit with follow-up through 12 months postpartum. Eligible and consenting women and girls ≥16 years received HIV prevention counselling and were offered PrEP. Interviewers collected socio-demographic and behavioural data from participants at each visit. We analysed the proportion of women who initiated PrEP and the proportion who continued PrEP after 3 months with associated correlates by estimating the prevalence ratio adjusting for a priori confounders., Results: Between August 2019 and October 2021, we enrolled 1201 pregnant women (median gestation 21 weeks; age 26 years); 84% of women initiated PrEP at their first ANC visit (n = 1014); 55% were married or cohabiting. Overall, 66% of women on PrEP returned for a repeat prescription at 1 month; 58% returned at 3 months (n = 493 of 844). Almost one-half of women on PrEP reported a side effect at 1 month, mostly nausea/vomiting. Women on PrEP in the first and second trimesters had higher odds of reporting side effects (aOR 2.61; 95% CI 1.17-5.84) versus postpartum women. Women who reported side effects continued with PrEP less than those who did not report side effects (aPR = 0.87; 95% CI 0.77-0.97). Women with ≥1 previous pregnancy (aPR = 0.76; 95% CI 0.57-1.01) or were postpartum (aPR 0.85; 95% CI 0.75-0.97) were less likely to continue PrEP compared to women who were primigravid or pregnant. Women who reported having an HIV+ partner (aPR = 1.45; 95% CI 1.13-1.85) or high HIV risk perception (aPR = 1.20, 95% CI = 1.01-1.41) were more likely to continue on PrEP than those who had HIV-negative partners or low risk perception., Conclusions: PrEP initiation and early continuation were high in this setting, compared to other studies in women. Being postpartum and experiencing side effects were associated with lower PrEP continuation, presenting opportunities for counselling on early transient side effects. Interventions for postpartum women on PrEP are needed., (© 2022 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)

In settings with a high burden of HIV, pregnant women often experience a cluster of risk factors, including alcohol use and intimate partner violence (IPV). These interrelated risks are poorly understood among pregnant women at risk of HIV in sub-Saharan Africa. We aim to determine cross-sectional associations between pregnant women's alcohol use and victimization due to IPV in the HIV-Unexposed-Uninfected Mother-Infant Cohort Study in Cape Town, South Africa. Women who tested HIV-negative at first antenatal care (ANC) visit were followed to delivery. Trained interviewers collected demographic and psychosocial information, including recent alcohol use and experiences of IPV victimization. We assess the prevalence of alcohol use and associations with IPV using multivariable logistic regression. In 406 HIV-uninfected pregnant women (mean age = 28 years; mean gestational age = 21 weeks), 41 (10%) reported alcohol consumption in the past 12 months; 30/41 (73%) of these at hazardous levels. Any and hazardous alcohol use were associated with greater odds of reporting past year IPV (adjusted odds ratio [aOR] for hazardous use: 3.24, 95% CI = 1.11, 7.56; aOR for any alcohol use: 2.97, 95% CI = 1.19, 7.45). These data suggest the occurrence of overlapping HIV risk factors among pregnant women and may help design improved health interventions in this population.

Background: Pre-exposure prophylaxis (PrEP) is safe and effective in postpartum women. Human immunodeficiency virus self-testing (HIVST) for male partners combined with biofeedback counseling through real-time adherence measures may improve PrEP use among postpartum women., Methods: Between August 2020 and April 2021, we randomized postpartum women who initiated PrEP in pregnancy 1:1 to the intervention group (HIVST + biofeedback counseling after urine tenofovir test) or to standard of care ([SOC] facility-based human immunodeficiency virus [HIV] tests and routine counseling without biofeedback). The outcomes of interest were PrEP adherence in the past 48-72 hours via urine tenofovir tests and partner HIV testing, measured 1-month after randomization. Secondary outcomes included the proportion of partners who tested for HIV and the discrepancy between self-reported PrEP adherence and urine tenofovir result., Results: We enrolled 106 women (median age = 26 years). At enrollment, 72% of women reported missing <2 doses in the past 7 days; 36% of women had tenofovir present in her urine. One month after enrollment, 62% (n = 33) of women in the intervention arm had tenofovir present in their urine compared to 34% (n = 18) in SOC (risk ratio [RR] = 1.83; 95% confidence interval [CI] = 1.19-2.82; P  = .001). Two thirds of women in the intervention arm reported that her partner tested for HIV (66%; n = 35), compared to 17% (n = 9) in SOC (RR = 3.89; 95% CI = 2.08-7.27; P  < .001). Self-reported PrEP adherence (took PrEP >5 of last week) with no tenofovir in urine test was lower in the intervention group (17% vs 46%; RR = 0.33; 95% CI = 0.17-0.67; P  = .03). No social or clinical adverse events were reported in the intervention arm., Conclusions: The HIVST for partners and biofeedback counseling increased levels of recent PrEP adherence, pointing to the importance of these interventions to support PrEP use in this population., (© The Author(s) 2021. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)

PrEP is safe and effective but requires adherence during potential HIV exposure, yet the facilitators of long-term maternal adherence are not well understood. We conducted semi-structured interviews with 25 postpartum women who reported high adherence (PrEP use ≥ 25 days in last 30-days and never missed a PrEP prescription in pregnancy/postpartum period) within a PrEP service for pregnant and postpartum women. A thematic approach guided an iterative process of coding and analysis. Themes identified as drivers of optimal PrEP use were HIV risk perception, mainly because of partner's behaviors and unknown serostatus, and a strong desire to have a baby free of HIV. Reported disclosure of PrEP use facilitated PrEP adherence. Women discussed having partner and family support, which included reminders to take PrEP daily. Primary barriers were anticipated or experienced stigma, overcome through education of partners and family about PrEP. Pregnant women experienced transient side-effects, but found ways to continue, including taking PrEP at night. PrEP programs for pregnant and postpartum women should integrate strategies to assist women with realistic appraisals of risk and teach skills for disclosure and securing support from significant others., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Daily antiretroviral therapy (ART) suppresses viral replication, rendering HIV undetectable through viral load (VL) testing. People living with HIV (PLWH) who have an undetectable VL cannot transmit HIV to sexual partners or through giving birth, a message commonly referred to as U = U (undetectable equals untransmittable). To increase knowledge and understanding of U = U among men, who have poorer HIV testing and treatment outcomes than women, we engaged men from high HIV burden communities in Cape Town in two interactive human-centered design cocreation workshops to develop local U = U messaging for men. Two trained workshop facilitators, explained the U = U message to 39 adult men (in two separate workshops), and asked them how to effectively communicate U = U to other men in the local language (isiXhosa). Participant-designed messages sought to inform men about U = U to help assuage fears of testing HIV positive (by removing the stigma of living with HIV and being a vector of disease), and to explain that ART enables PLWH to live normal healthy lives, making HIV "untransmittable" to sex partners. Participants' messages emphasized that when virally suppressed, " I cannot spread HIV to the other person " and " (the pill) keeps on killing the virus so I can live a normal life for the rest of my life. " Men cocreated simple local U = U messages to address fears of testing HIV positive and emphasizing ART's positive effects. Cocreated tailored messaging may reduce stigma associated with living with HIV and improve the uptake of HIV testing and treatment among South African men. This study was registered at clinicaltrials.gov under NCT04364165.

Pre-exposure prophylaxis (PrEP) in pregnancy can reduce HIV incidence and vertical transmission. Healthcare providers (HCPs) play a critical role in delivering PrEP in antenatal care but little is known about HCP knowledge and attitudes about PrEP in pregnancy. We conducted a qualitative study in two healthcare facilities to assess HCPs' PrEP knowledge and perspectives relating to HIV prevention in pregnant women. Between January-March'19, we administered in-depth interviews among antenatal HCPs. We utilized a constant comparison approach to identify major qualitative findings. We enrolled 35 female HCPs (median age=43yrs. Fewer than half of HCPs had heard of PrEP before. Of those who had heard of PrEP, most felt that it was safe to take during pregnancy. Most HCPs described inaccurate PrEP knowledge regarding effectiveness, and most who knew about PrEP lacked clinical detail. HCPs highlighted important potential barriers to maternal PrEP use including: fear that PrEP may be unsafe, or belief that women must talk to partners/parents before initiating PrEP. Facilitators include good knowledge about serodiscordancy and vulnerability to seroconversion in pregnancy and desire to help women gain control overHIV prevention. We recommend integrating PrEP training into HIV testing and PMTCT nurse training to improve counseling and maternal PrEP delivery.

Introduction: HIV incidence is high during pregnancy and breastfeeding with HIV acquisition risk more than doubling during pregnancy and the postpartum period compared to when women are not pregnant. The World Health Organization recommends offering pre-exposure prophylaxis (PrEP) to pregnant and postpartum women at substantial risk of HIV infection. However, maternal PrEP national guidelines differ and most countries with high maternal HIV incidence are not offering PrEP. We conducted a systematic review of recent research on PrEP safety in pregnancy to inform national policy and rollout., Methods: We used a standard Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) approach to conduct a systematic review by searching for completed, ongoing, or planned PrEP in pregnancy projects or studies from clinicaltrials.gov, PubMed and NIH RePORTER from 2014 to March 2019. We performed a systematic review of studies that assess tenofovir disoproxil fumarate (TDF)-based oral PrEP safety in pregnant and breastfeeding HIV-uninfected women., Results and Discussion: We identified 14 completed (n = 5) and ongoing/planned (n = 9) studies that evaluate maternal and/or infant outcomes following PrEP exposure during pregnancy or breastfeeding. None of the completed studies found differences in pregnancy or perinatal outcomes associated with PrEP exposure. Nine ongoing studies, to be completed by 2022, will provide data on >6200 additional PrEP-exposed pregnancies and assess perinatal, infant growth and bone health outcomes, expanding by sixfold the data on PrEP safety in pregnancy. Research gaps include limited data on (1) accurately measured PrEP exposure within maternal and infant populations including drug levels needed for maternal protection; (2) uncommon perinatal outcomes (e.g. congenital anomalies); (3) infant outcomes such as bone growth beyond one year following PrEP exposure; (4) outcomes in HIV-uninfected women who use PrEP during pregnancy and/or lactation., Conclusions: Expanding delivery of PrEP is an essential strategy to reduce HIV incidence in pregnancy and breastfeeding women. Early safety studies of PrEP among pregnant women without HIV infection are reassuring and ongoing/planned studies will contribute extensive new data to bolster the safety profile of PrEP use in pregnancy. However, addressing research gaps is essential to expanding PrEP delivery for women in the context of pregnancy., (© 2020 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)

Objectives: Sexually transmitted infections (STIs) are associated with adverse outcomes in pregnancy, including mother-to-child HIV transmission. Yet there are limited data on the prevalence and correlates of STI in pregnant women by HIV status in low- and middle-income countries, where syndromic STI management is routine., Methods: Between November 2017 and July 2018, we conducted a cross-sectional study of consecutive pregnant women making their first visit to a public sector antenatal clinic (ANC) in Cape Town. We interviewed women ≥18 years and tested them for Chlamydia trachomatis (CT), Neisseria gonorrhoea (NG) and Trichomonas vaginalis (TV) using Xpert assays (Cepheid, USA); results of syphilis serology came from routine testing records. We used multivariable logistic regression to identify correlates of STI in pregnancy., Results: In 242 women (median age 29 years [IQR = 24-34], median gestation 19 weeks [IQR = 14-24]) 44% were HIV-infected. Almost all reported vaginal sex during pregnancy (93%). Prevalence of any STI was 32%: 39% in HIV-infected women vs. 28% in HIV-uninfected women (p = 0.036). The most common infection was CT (20%) followed by TV (15%), then NG (5.8%). Of the 78 women diagnosed with a STI, 7 (9%) were identified and treated syndromically in ANC. Adjusting for age and gestational age, HIV-infection (aOR = 1.89; 95% CI = 1.02-3.67), being unmarried or not cohabiting with the fetus' father (aOR = 2.19; 95% CI = 1.16-4.12), and having STI symptoms in the past three days (aOR = 6.60; 95% CI = 2.08-20.95) were associated with STI diagnosis., Conclusion: We found a high prevalence of treatable STIs in pregnancy among pregnant women, especially in HIV-infected women. Few women were identified and treated in pregnancy., Competing Interests: The authors have declared that no competing interests exist.

Objective: HIV-uninfected pregnant and breastfeeding women are at high risk of HIV acquisition, contributing to vertical transmission of HIV. Preexposure prophylaxis (PrEP) is safe in pregnancy, but PrEP in pregnancy is not policy in many countries including South Africa. We evaluated the potential impact of providing PrEP for pregnant/breastfeeding women using a HIV model for South Africa., Methods: Our model considers two scenarios: a conservative scenario that matches the experience reported in the Kenyan PrEP programme for pregnant women (probability of uptake = 32% and 11% in high-risk and low-risk women, respectively); and an optimistic scenario with PrEP initiated by 80% of all pregnant women. We compared this with PrEP for female sex workers, MSM and adolescent girls/young women. Women are assumed to remain on PrEP throughout pregnancy and breastfeeding, and an equivalent average PrEP duration (2 years) is assumed in other scenarios., Results: Between 2020 and 2030, if PrEP is provided to pregnant/breastfeeding mothers, we project a 2.5% reduction in total HIV transmission [95% credibility interval (CI): 2.4-2.6%] in the conservative scenario and 7.2% (95% CI: 6.8-7.5%) in the optimistic scenario, which is similar to that in the female sex worker and MSM PrEP scenarios (1.9% and 3.0%, respectively). Without PrEP, 76 000 (95% CI: 64 000-90 000) new cases of vertical transmission are expected; PrEP provision may reduce these infections by 13% (95% CI: 13-14%) in the conservative scenario and 41% (95% CI: 39-44%) in the optimistic scenario., Conclusion: High levels of uptake of and adherence to PrEP among pregnant/breastfeeding women could substantially reduce maternal and infant HIV acquisition in South Africa.

Introduction: Attempts to conceive and pregnancy may increase HIV transmission to sex partners and infants. Our study evaluated the association between fertility intentions and HIV acquisition among Zambian HIV-serodiscordant couples., Methods: We collected demographic, behavioral, clinical exposures, and data on fertility intentions in a cohort of HIV-serodiscordant couples in Lusaka, Zambia from 2005 to 2012. We evaluated factors associated with fertility intentions stratified by gender using multivariable logistic regression. Multivariable Cox proportional hazard models were used to evaluate the associations between fertility intentions and HIV acquisition controlling for a priori confounders and covariates that substantially (>10%) changed the effect estimates in univariate analyses., Results: Among 1,029 serodiscordant couples, 311 agreed that they wanted children in the future (30%), 368 agreed they did not want children (36%), and 344 couples disagreed about having children (34%), with men more likely than women to want children. Women wanting child(ren) was associated with increased odds of baseline pregnancy (adjusted odds ratio [aOR] = 4.80 (95% confidence interval [CI] = 2.93, 7.85)), fewer previous pregnancies (aOR = 0.85 per additional pregnancy (95% CI = 0.78, 0.93)), and partner fertility intention (aOR = 2.89 (95% CI = 2.14, 3.91)) adjusting for woman's age, literacy, years cohabiting and HIV status. Men wanting child(ren) was associated with younger age (aOR = 0.96 per year (95% CI = 0.93, 0.99)), fewer years cohabiting (aOR = 0.95 (95% CI = 0.92, 0.98)), number of previous partners' pregnancies (aOR = 0.90 (95% CI = 0.82, 0.98)), and partner fertility intention (aOR = 3.00 (95% CI = 2.21, 4.07)) adjusting for partner's age, literacy, HIV status and partner's baseline pregnancy. In adjusted survival analyses, HIV-negative women were more likely to seroconvert if they themselves wanted children (aHR = 2.36 (95% CI = 1.41, 3.96)) vs. did not want children, or if their partner wanted children (aHR = 2.34 (95% CI = 1.33, 4.11)) vs. did not want children, or if the couple agreed that they wanted children (aHR = 2.08 (95% CI = 1.01, 4.30)), adjusting for women's age, women's literacy, previous pregnancies and time in study. HIV-negative men were more likely to seroconvert if their female partner wanted a child in the next 12-months (aHR = 1.94 (95% CI = 1.02, 3.68)) vs. did not want children, and when both partners wanted children (aHR = 2.02 (CI = 1.09, 3.73)) vs. they did not want children, adjusting for men's age and literacy, couple income, number of live children, male circumcision status and time in study., Conclusion: Women had increased risk of HIV acquisition if they and/or their partner wanted a child, while men had increased risk of HIV acquisition when their partner or if both partners agreed that they wanted children. Safer-conception interventions are needed to protect HIV uninfected women and men from HIV acquisition in HIV-serodiscordant couples who want children.

Objective: Evaluate the incidence and predictors of HIV acquisition from outside partners in serodiscordant couples., Methods: Demographic, behavioral, and clinical exposures were measured quarterly in a cohort of serodiscordant cohabiting couples in Zambia from 1995 to 2012 (n = 3049). Genetic analysis classified incident infections as those acquired from the study partner (linked) or acquired from an outside partner (unlinked). Factors associated with time to unlinked HIV infection were evaluated using multivariable Cox proportional hazards regression stratified by sex., Results: There were 100 unlinked infections in couples followed for a median of 806 days. Forty-five infections occurred in women [1.85/100 couple-years; 95% confidence interval (CI): 1.35 to 2.47]. Risk of female unlinked infection (vs. nonseroconverting females) was associated with reporting being drunk weekly/daily vs. moderate/nondrinkers at baseline [adjusted hazard ratio (aHR) = 5.44; 95% CI: 1.03 to 28.73], genital ulcers (aHR = 6.09; 95% CI: 2.72 to 13.64), or genital inflammation (aHR = 11.92; 95% CI: 5.60 to 25.37) during follow-up adjusting for age, years cohabiting, income, contraceptive use, previous pregnancies, history of sexually transmitted infections, and condomless sex with study partner. Fifty-five infections occurred in men (1.82/100 couple-years; 95% CI: 1.37 to 2.37). Risk of male unlinked infection was associated with genital inflammation (aHR = 8.52; 95% CI: 3.82 to 19.03) or genital ulceration (aHR = 2.31; 95% CI: 2.05 to 8.89), reporting ≥1 outside sexual partner (aHR = 3.86; 95% CI: 0.98 to 15.17) during follow-up, and reporting being drunk weekly/daily vs. moderate/nondrinkers at baseline (aHR = 3.84; 95% CI: 1.28 to 11.55), controlling for age, income, circumcision status, and history of sexually transmitted infection., Conclusions: Predictors of unlinked infection in serodiscordant relationships were alcohol use, genital inflammation, and ulceration. Causes of genital inflammation and ulceration should be screened for and treated in HIV-negative individuals. Counseling on risk of alcohol use and sex with outside partners should be discussed with couples where 1 or both are HIV-negative, including in counseling on use of pre-exposure prophylaxis to prevent HIV acquisition in the HIV-negative partner (when feasible and affordable).

Background: Men who have sex with men (MSM) and male-to-female transgender women (transwomen) are disproportionately at risk of syphilis infection in Peru., Methods: From 2013 to 2014, MSM and transwomen seeking human immunodeficiency virus (HIV) or sexually transmitted infection (STI) testing and/or treatment were recruited into a 2-year observational cohort study to determine predictors of recently acquired syphilis infection (defined as a rapid plasma reagin [RPR] titer ≥1:16 and a reactive treponemal antibody test) in Lima, Peru. At baseline, interviewers collected sociodemographic, behavioral, and medical characteristics from participants. All cohort participants were tested for syphilis, HIV, Chlamydia trachomatis (CT), and Neisseria gonorrhoeae (NG) infection. Using cross-sectional analyses, bivariate and multivariate models were used to determine factors associated with recently acquired syphilis infection and calculate adjusted prevalence ratios., Results: We recruited 401 participants, 312 MSM and 89 transwomen, with median ages of 29.0 and 32.5 years old (interquartile ranges: 23.3, 37.4 and 27.2, 39.5, respectively). The prevalence of recently acquired syphilis infection at baseline was 16.8% for MSM and 6.7% for transwomen. Among MSM and transwomen, 30.1 and 33.7% were infected with HIV, 18.6 and 24.7% were infected with CT, and 14.2 and 19.1% were infected with NG, respectively. Co-infection rates among MSM with recently acquired syphilis infection included: 44.2% with HIV, 40.4% with CT (32.7% with anal CT and 7.7% with pharyngeal CT), and 19.2% with NG (11.5% with anal NG and 7.7% with pharyngeal NG). Co-infection rates among transwomen with recently acquired syphilis infection included: 66.7% with HIV, 0% with CT, and 16.7% with anal NG. In multivariate analysis among the entire cohort, recently acquired syphilis infection was independently associated with younger age (adjusted prevalence ratio [aPR] = 0.96, 95% confidence interval [CI] = 0.93-0.99), receptive role during anal sex (aPR = 2.56, 95% CI = 1.05-6.25), prior HIV diagnosis (aPR = 1.70, 95% CI = 1.11-2.61), anal CT or NG infection (aPR = 1.69, 95% CI = 1.09-2.60), and prior syphilis diagnosis (aPR = 3.53, 95% CI = 2.20-5.68)., Conclusions: We recruited a cohort of MSM and transwomen who had a high prevalence of recently acquired syphilis infection in Lima, Peru. Recently acquired syphilis infection was associated with socio-demographic characteristics, sexual risk, and sexually transmitted co-infections.

The aim of the study was to identify factors associated with undiagnosed human immunodeficiency virus (HIV) infection among men who have sex with men (MSM) and male-to-female transgender women in Lima, Peru.We analyzed characteristics of 378 MSM and transgender women recruited from 2 sexually transmitted infection (STI) clinics in Lima, Peru. Descriptive analyses compared: (A) HIV-uninfected, (B) previously undiagnosed HIV-infected, and (C) previously diagnosed HIV-infected participants. Multivariable logistic regression models identified: (1) correlates of previously undiagnosed HIV-infection among participants thought to be HIV-uninfected (B vs A); and (2) correlates of previously undiagnosed HIV-infection among HIV-infected participants (B vs C). Subanalysis identified correlates of frequent HIV testing among participants thought to be HIV-uninfected.Among participants, 31.0% were HIV-infected; of those, 35.0% were previously undiagnosed. Among participants thought to be HIV-uninfected (model 1), recent condomless receptive anal intercourse and last HIV test being over 1-year ago (compared to within the last 6-months) were associated with increased odds of being previously undiagnosed HIV-infected (adjusted odds ratio [aOR] = 2.43, 95% confidence interval [95%CI] = 1.10-5.36; aOR = 2.87, 95%CI = 1.10-7.53, respectively). Among HIV-infected participants (model 2), recent condomless receptive anal intercourse was again associated with previously undiagnosed HIV-infection (aOR = 2.54, 95%CI = 1.04-6.23). Achieving post-secondary education and prior syphilis infection were associated with lower odds of having previously undiagnosed HIV-infection (aOR = 0.35, 95%CI = 0.15-0.81; aOR = 0.32, 95%CI = 0.14-0.75, respectively).Reporting semiannual testing was associated with higher educational attainment, identifying as a transgender woman, or reporting a history of syphilis (aOR = 1.94, 95%CI = 1.11-3.37; aOR = 2.40, 95%CI = 1.23-4.70; aOR = 2.76, 95%CI = 1.62-4.71, respectively). Lower odds of semiannual testing were associated with recent condomless insertive anal intercourse or reporting a moderate or high self-perceived risk of acquiring HIV (aOR = 0.56, 95%CI = 0.33-0.96; aOR = 0.32, 95%CI = 0.18-0.59 and aOR = 0.43, 95%CI = 0.21-0.86, respectively).In our study, undiagnosed HIV-infection was associated with recent condomless receptive anal intercourse, infrequent HIV testing, lower education, and absence of prior syphilis diagnosis. Infrequent HIV testing was associated with lower education, not identifying as transgender, recent condomless insertive anal intercourse, absence of prior syphilis diagnosis, and higher self-perceived risk of HIV. Further efforts to decrease HIV transmission and increase HIV-serostatus awareness should be directed towards effectively promoting condom use and frequent HIV testing, integrated with STI management., Competing Interests: The authors have no conflicts of interest to disclose.