HIV Acquisition Research Articles

HIV risks and transactional sex among Swedish-born MSM and foreign-born MSM in Sweden

Abstract Background Transactional sex, which includes exchanging sex for material goods, services, or money, is a key HIV risk factor. Risk patterns associated with transactional sex among men who have sex with men (MSM) in Sweden, where buying sexual services is illegal, have not been examined earlier. This study aims to assess whether transactional sex (both buying and selling), country of birth, and migration-related factors (described by country of origin) are associated with self-reported HIV status among MSM in Sweden. Methods We analyzed secondary data from the 2017 European MSM Internet Survey (EMIS-2017), including participants reporting to live in Sweden (n = 4443). Using multivariate logistic regression analysis, we aimed to understand factors related to involvement in transactional sex and risk of HIV acquisition. Results Among the respondents, 5.4% reported living with HIV, with 8.8% of foreign-born MSM and 4.8% of Swedish-born MSM. The multivariable analysis showed that both selling and buying sex in the past five years increased the odds of reporting a positive HIV serostatus among all participants. Stratifying by transactional sex exposure and country of birth showed an HIV prevalence increase for all groups. Foreign-born selling or buying sex ever in the last five years had the highest prevalence of all groups (ranging from 17.8 to 19.1%). Other factors associated with a positive HIV status were age, outness, sex with a woman in the past twelve months, and condom use. Conclusions The relatively high reported HIV prevalence supports the need for HIV prevention, including the scale-up of access to pre-exposure prophylaxis to foreign-born MSM. A transparent discussion about risk factors and socioeconomic structures contributing to risk behaviors, including transactional sex, is needed. Key messages • Engaging in transactional sex increases the HIV risk among MSM in Sweden, particularly among foreign-born MSM. • HIV prevention needs to address the socioeconomic factors contributing to risky behaviors, such as transactional sex.

Very high HIV prevalence and incidence among men who have sex with men and transgender women in Indonesia: a retrospective observational cohort study in Bali and Jakarta, 2017-2020.

There are no longitudinal HIV incidence data among men who have sex with men (MSM) and transgender women (TGW) in Indonesia. We aimed to estimate HIV prevalence and incidence and identify associated factors among clinic attendees in Jakarta and Bali. We conducted a retrospective cohort study using medical records from five clinics. We reviewed HIV tests among MSM/TGW aged ≥18 years who attended the clinics between 1 January 2018 to 31 December 2020 in Jakarta and 1 January 2017 to 31 December 2019 in Bali. HIV prevalence was measured at the first test. Those with an HIV-negative test and ≥1 follow-up test/s were included in the person-years (PY) at risk to determine HIV incidence. The PY at risk calculation started at the first negative test until the last recorded negative test or seroconversion. Multivariate Poisson regression was used to determine factors associated with HIV acquisition. Among 5203 and 2815 individuals with an HIV test result in Jakarta and Bali, respectively, at the first HIV test, 1205 and 616 were HIV positive (HIV prevalence 23.2% and 21.9%). The longitudinal sample included 1418 and 873 individuals, respectively. The median number of tests among repeat testers was 3 in Jakarta (interquartile range [IQR] = 2-4) and 3 in Bali (IQR = 2-5). At baseline, about one-quarter were aged <25 years, >90% were MSM and >35% had been tested for HIV previously. In Jakarta, there were 127 HIV seroconversions in 1353 PY (incidence 9.39/100 PY, 95% CI = 7.89-11.17), and in Bali, 71 seroconversions in 982 PY (incidence 7.24/100 PY, 95% CI = 5.73-9.13). Compared to those aged 18-24 years, the incidence rate was lower in older patients (Jakarta-30-39 years: aRR = 0.56, 95% CI = 0.34-0.92; 40+ years: aRR = 0.34, 95% CI = 0.14-0.81; Bali-25-29 years: aRR = 0.44, 95% CI = 0.25-0.79; 30-39 years: aRR = 0.33, 95% CI = 0.18-0.61; 40+ years: aRR = 0.06, 95% CI = 0.01-0.48). In Jakarta, incidence was lower in those with university education than in those without (aRR = 0.66, 95% CI = 0.45-0.96). In Bali, those who had been referred by outreach workers had a higher incidence than those who self-presented for testing (aRR = 1.85, 95% CI = 1.12-3.07). We observed very high HIV prevalence and incidence rate estimates. Measures to encourage regular testing and effective use of HIV prevention, including pre-exposure prophylaxis scale-up and demand creation, are needed.

Feasibility of Emergency Department-Initiated HIV Pre-Exposure Prophylaxis

Introduction: Pre-exposure prophylaxis (PrEP) for HIV—using antiretroviral medication in non-infected individuals to prevent HIV—has immense potential to slow the spread of the virus. However, uptake has been insufficient, and stark racial disparities exist in both HIV acquisition and PrEP usage, making PrEP access a health equity issue. A promising venue to engage high-risk populations in PrEP care is the emergency department (ED); however, existing ED PrEP initiatives have been costly or have had limited success. We hypothesize that two strategies could overcome these barriers: prescribing PrEP during an ED visit and providing patients with an initial supply of PrEP medication in the ED. Here, we describe the results of a qualitative study exploring multidisciplinary emergency clinicians and HIV clinicians’ needs and views about the feasibility of such an initiative. Methods: We conducted 22 semi-structured interviews with multidisciplinary clinicians from an urban, safety-net medical center in the ED and the on-site HIV clinic that provides PrEP services.We performed thematic analysis to summarize challenges and potential solutions described by participants. Results: Participants’ responses fell into three thematic categories: operational challenges; patient-level considerations; and potential impacts. Operational challenges highlighted the difficulty of PrEP initiation in a busy ED and clinician support needs. Patient-level considerations included the complex psychosocial needs of ED patients who could benefit from PrEP. Finally, participants anticipated that an ED-based PrEP initiation program could positively impact both individual patients and public health. Conclusion: Interviews with emergency department and HIV clinic staff revealed important considerations and potential solutions for ED-initiated PrEP workflows. Clinicians in both specialties were enthusiastic about such an initiative, which could facilitate its success. This study lays the groundwork for the future design of an efficient and innovative workflow to leverage the ED as an essential entry point into HIV prevention services.

Extragenital self-collection testing for gonorrhea and chlamydia: A feasibility study for expanding STI screening in the Veterans Health Administration.

Rectal and pharyngeal infections with gonorrhea and chlamydia are of concern because they are associated with higher risk of HIV acquisition. Extragenital screening in asymptomatic persons at high risk may have the potential to reduce the incidence of these sexually transmitted infections (STIs). Several testing platforms are available for the testing of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) using nucleic acid amplification tests (NAATs). Self-collected extragenital samples are currently not approved by the US Food and Drug Administration in any NAAT platform. This study compares the analytical performance of self-collected extragenital specimens to that of clinician-collected specimens. We performed a multicenter/multiplatform validation study as a National Veterans Health Administration Pathology and Laboratory Medicine quality improvement project, with 9 different participating sites. Self-collected specimens were obtained at the same time as clinician-collected specimens. Clinician-collected specimens were used as the gold standard to evaluate the sensitivity and specificity of self-collection. A total of 2324 individual tests were analyzed (501 rectal and 661 oropharyngeal). The sensitivity was 94.44% for CT and 100% for NG for rectal specimens, whereas it was 100% for CT and 97.22% for NG for oral specimens. Specificity for oral specimens was 99.85% for CT and 99.36% for NG, whereas for rectal specimens, it was 99% for CT and NG. Self-collected specimens for extragenital CT/NG testing are highly sensitive and specific, with negative predictive values of 100%. Self-collection has the potential to overcome a major barrier for STI screening by providing an accessible, convenient, and patient-centered alternative.

Addressing barriers to implementing and scaling PrEP in carceral settings: Applying insights from implementation science.

Within the United States, individuals experiencing incarceration are at higher risk for HIV acquisition compared to the general population, yet may face additional difficulty engaging in HIV prevention clinical services. HIV pre-exposure prophylaxis (PrEP) is an effective approach to preventing HIV transmission, and the Centers for Disease Control (CDC) recommends that PrEP be offered in carceral settings, particularly during the vulnerable community re-entry period. However, there have been few efforts to scale PrEP in this setting. Based on our experience implementing PrEP in Rhode Island's state carceral system, we have identified potential approaches to overcoming barriers to PrEP use in this unique practice environment by utilizing the implementation research logic model (IRLM). We then evaluated specific implementation determinants and barriers as well as strategies used to overcome those barriers to effectively scale PrEP in this setting. We developed a "toolkit," or 14-step guide, for others in the field to use for implementing PrEP in carceral settings including the development and use of clinical protocols as well as community linkage strategies. Our experiences with barriers in the carceral setting, identifying and leveraging implementation strategies, allowed us to develop a "toolkit" to guide other PrEP implementation projects in carceral settings. We encourage others to scale-out our work to other carceral settings to better reach and engage a group of individuals both at elevated risk for HIV and currently underserved by HIV prevention strategies, including PrEP.

The Role of Natural Killer Cells and Their Metabolism in HIV-1 Infection.

Natural killer (NK) cells are multifaceted innate effector cells that critically influence antiviral immunity, and several protective NK cell features that modulate HIV-1 acquisition and viral control have been described. Chronic HIV-1 infection leads to NK cell impairment that has been associated with metabolic dysregulations. Therapeutic approaches targeting cellular immune metabolism represent potential novel interventions to reverse defective NK cell function in people living with HIV.

A Review and Economic Analysis of the Dapivirine Vaginal Ring as HIV Pre-Exposure Prophylaxis for Women, to Inform South African Public-Sector Guidelines.

South Africa has a high HIV incidence and oral pre-exposure prophylaxis (PrEP) is available as public-sector standard of care. Access to alternative prevention methods for women may further reduce HIV acquisition. South African public sector. We performed a systematic search for high-quality up-to-date guidelines recommending dapivirine rings as PrEP using the Grading of Recommendations Assessment, Development, and Evaluation -Adolopment process. We appraised the systematic review and randomized controlled trial (RCT) evidence underpinning the selected guideline's recommendations and conducted a cost-effectiveness analysis. The Grading of Recommendations Assessment, Development, and Evaluation evidence-to-decision framework guided the adaptation of source guideline recommendations, according to our local context. We identified the 2021 World Health Organization PrEP Guidelines, informed by 2 placebo-controlled RCTs, which were included in a contemporaneous systematic review. There were 23 fewer HIV acquisitions per 1000 clients with dapivirine ring vs placebo (95% confidence interval: 10 to 34), with no increase in adverse events (moderate certainty evidence). We found no RCTs comparing dapivirine to oral PrEP or among adolescent/pregnant/breastfeeding clients. Dapivirine is less cost-effective than oral PrEP at $14.59/ring, at the current price. The source guideline recommendation was adapted for the local context. Dapivirine ring seems to be less efficacious than oral PrEP, although comparative studies are lacking. Data on adolescents and pregnancy are also lacking, currently limiting the use of dapivirine as an alternative for women unable to take oral PrEP. At the current price, dapivirine is not cost-effective and unaffordable for inclusion in the South African Essential Medicines List.

A-284 Development of a Low Positive Molecular Control for Mycoplasma genitalium and Trichomonas vaginalis Screening

Abstract Background Mycoplasma genitalium (MG) is a sexually transmitted gram -negative bacteria that infects the urinary and genital tracts. Trichomonas vaginalis (TV) is a protozoan parasite and is the most common curable sexually transmitted infection (STI) worldwide. TV/ MG infections often go unrecognized because infected individuals are either asymptomatic or have symptoms similar to other infections of the urogenital tract (cervicitis in females and urethritis in males). Left untreated, TV/MG can lead to severe health complications including pelvic inflammatory disease, adverse pregnancy outcomes such as preterm delivery and miscarriage, increased risk of HIV acquisition, sexually acquired reactive arthritis, and infertility. The rates of STIs are increasing and differentiating among different STIs is critical to ensure patients receive effective treatment. Amplified nucleic acid based tests (NAATs) have emerged as the gold standard for diagnosis of TV/MG infections due to their high sensitivity and high throughput using a variety of clinical samples including male and female urine. This study describes work to develop a low positive quality control material in human urine for TV/MG amplified nucleic acids tests. Methods A method was developed to eliminate residual enzymatic activity from raw, pooled human urine from both genders to create a homogeneous diluent that supports analyte stability. The urine diluent was tested for viral pathogens (HIV-1, HCV, HBV) and ensure urine proteins and chemistry analytes were within acceptable limits. TaqMan® assays for TV (targeting RNA polymerase Rpb1 gene) and MG (targeting SMC Chromosome segregation gene) were developed and qualified for digital PCR quantitation of these organisms using the BioRad QX200 system. Cultured Trichomonas vaginalis strain C-1:NIH and Mycoplasma genitalium strain G37 were spiked into the urine diluent along with 0.09% sodium azide as a preservative. The concentration of TV and MG was guided by digital PCR quantitation throughout formulation and the final product was tested on Abbott Alinity m STI Panel, Hologic Aptima® Mycoplasma genitalium Assay, and Hologic Aptima® Trichomonas vaginalis Assay. Results Three independent lots were produced that were each detected for both TV and MG on the Abbott Alinity m STI panel. The concentration of the controls targeted a cycle number (CN) of ∼27 for TV and ∼32 for MG and were within acceptable limits. The lots were also positive for TV and MG when tested on the Hologic Aptima TV and MG assays. Accelerated stability studies showed that the product is stable throughout 2 years of shelf life when stored frozen at -20 °C, but is also stable for up to 30 days at 2-8 °C refrigerated storage. Conclusions LGC Clinical Diagnostics is developing a stable, whole organism molecular control material for use with in vitro diagnostic test methods that detect TV and MG. The product will fulfill an unmet need for molecular quality controls for STI testing that are formulated in a true patient-like matrix like urine. This study helps ensure the molecular control will be a low positive on leading diagnostic assays, be consistent batch to batch, and have the needed stability to meet the needs of clinical testing labs.

Impact of Awareness of Sexual Partners' HIV Serostatus on the HIV Acquisition among Men Who Have Sex with Men in Guangzhou, China: A Nested Case-Control Study.

This study aimed to investigate the impact of sexual partners' HIV serostatus awareness on theHIV acquisition among men who have sex with men (MSM) in Guangzhou, China. A nested case-control study was conducted based on a prospective cohort of MSM in Guangzhou. Within the cohort, individuals who underwent HIV seroconversion were identified as the case group, and each case was matched with four controls from the non-seroconverted participants. Information regarding the awareness of sexual partners' HIV serostatus over the preceding 6months was gathered. Of the 161 participants, 36.0% were aware of the HIV serostatus of all their sexual partners. The practice of engaging in condomless anal sex with partners of unknown HIV serostatus and being aware of the HIV serostatus of only some casual partners were positively correlated with an elevated risk of acquiring HIV. Conversely, being fully aware of the HIV serostatus of all sexual partners, including regular ones, was associated with a diminished risk of HIV incidence.Regular communication with sexual partners regarding HIV testing outcomes, honest disclosure of one's own HIV serostatus, and refusal of sexual contact with partners of unknown HIV serostatus can potentially mitigate the risk of acquiring HIV among MSM.

The effect of protecting women against economic shocks to fight HIV in Cameroon, Africa: The POWER randomised controlled trial.

Women in sub-Saharan Africa are disproportionately affected by the HIV epidemic. Young women are twice as likely to be living with HIV as men of the same age and account for 64% of new HIV infections among young people. Many studies suggest that financial needs, alongside biological susceptibility, are a leading cause of the gender disparity in HIV acquisition. New robust evidence suggests women adopt risky sexual behaviours to cope with economic shocks, the sudden decreases in household's income or consumption power, enhancing our understanding of the link between poverty and HIV. We investigated if health insurance protects against economic shocks, reducing the need for vulnerable women to engage in risky sexual behaviours and reducing HIV and sexually transmitted infection (STI) incidence. We conducted a randomised controlled trial to test the effectiveness of a formal shock coping strategy to prevent HIV among women at high risk of HIV (registration number: ISRCTN 22516548). Between June and August 2021, we recruited 1,508 adolescent girls and women over age 15 years who were involved in transactional sex (n = 753) or commercial sex (n = 755), using snowball sampling. Participants were randomly assigned (1:1) to receive free health insurance for themselves and their economic dependents for 12 months either at the beginning of the study (intervention; n = 579; commercial sex n = 289, transactional sex n = 290) from November 2021 or at the end of the study 12 months later (control; n = 568; commercial sex n = 290, transactional sex n = 278). We collected data on socioeconomic characteristics of participants. Primary outcomes included incidence of HIV and STIs and were measured at baseline, 6 months after randomisation, and 12 months after randomisation. We found that study participants who engaged in transactional sex and were assigned to the intervention group were less likely to become infected with HIV post-intervention (combined result of 6 months post-intervention or 12 months post-intervention, depending on the follow-up data available; odds ratio (OR) = 0.109 (95% confidence interval (CI) [0.014, 0.870]); p = 0.036). There was no evidence of a reduction in HIV incidence among women and girls involved in commercial sex. There was also no effect on STI acquisition among both strata of high-risk sexual activity. The main limitations of this study were the challenges of collecting reliable STI incidence data and the low incidence of HIV in women and girls involved in commercial sex, which might have prevented detection of study effects. The study provides to our knowledge the first evidence of the effectiveness of a formal shock coping strategy for HIV prevention among women who engage in transactional sex in Africa, reinforcing the importance of structural interventions to prevent HIV. The trial was registered with the ISRCTN Registry: ISRCTN 22516548. Registered on 31 July 2021.

A Statistical Model for Inference of Recent and Incident HIV Infection Using Surveillance Data on Individuals Newly Diagnosed With HIV Infection in Scotland

Background: To inform global ambitions to end AIDS, evaluation of progress toward HIV incidence reduction requires robust methods to measure incidence. Although HIV diagnosis date in routine HIV/AIDS surveillance systems are often used as a surrogate marker for incidence, it can be misleading if acquisition of transmission occurred years before testing. Other information present in data such as antibody testing dates, avidity testing result, and CD4 counts can assist, but the degree of missing data is often prohibitive. Methods: We constructed a Bayesian statistical model to estimate the annual proportion of first ever HIV diagnoses in Scotland (period 2015–2019) that represent recent HIV infection (ie, occurring within the previous 3–4 months) and incident HIV infection (ie, infection within the previous 12 months), by synthesizing avidity testing results and surveillance data on the interval since last negative HIV test. Results: Over the 5-year analysis period, the model-estimated proportion of incident infection was 43.9% (95% CI: 40.9 to 47.0), and the proportion of recent HIV infection was 21.6% (95% CI: 19.1 to 24.1). Among the mode of HIV acquisition categories, the highest proportion of recent infection was estimated for people who inject drugs: 27.4% (95% CI: 20.4 to 34.4). Conclusions: The Bayesian approach is appropriate for the high prevalence of missing data that can occur in routine surveillance data sets. The proposed model will aid countries in improving their understanding of the number of people who have recently acquired their infection, which is needed to progress toward the goal of HIV transmission elimination.

Associations of HIV pre-exposure prophylaxis (PrEP) indication, HIV risk perception and unwillingness to use PrEP among people who inject drugs in Baltimore, MD

BackgroundPerceived HIV risk may impact willingness to initiate PrEP among people who inject drugs (PWID). MethodsWe analyzed baseline data from PrEP eligible PWID in Baltimore, MD. Risk perception was assessed by PWID relative to the average risk of their age group categorized as: higher-than, lower-than, or about average. Participants were informed of PrEP for HIV prevention and asked about their willingness to use daily PrEP. Associations of PrEP indication (categorized as injection risk only vs any sexual risk), perceived HIV risk and non-willingness to use PrEP was assessed using generalized linear models. ResultsAmong 489 participants, 61 % were male, 66 % were Black and mean age was 46 years. One-third (35 %) of the participants were aware of PrEP and <1 % had used PrEP in the prior 30 days. Overall, 30 % of PWID reported lower-than-average perceived HIV risk and 18 % reported non-willingness to use PrEP. Participants with injection risk only were more likely (aOR: 2.75; 95 %CI: 1.60 – 4.73) to report having lower-than-average perceived HIV risk compared to those with any sexual risk. Participants with lower-than-average perceived risk were more likely to report non-willingness to use PrEP compared to those with higher perceived risk (adjusted PR: 1.91; 95 %CI: 1.18 – 3.10). ConclusionA considerable proportion of PWID eligible for PrEP reported having low risk of HIV acquisition despite being eligible for PrEP. Consistent and tailored PrEP messaging that addresses drug use HIV risk perception may be critical to increasing PrEP uptake among PWID.

Transcriptional and methylation outcomes of didehydro-cortistatin A use in HIV-1-infected CD4+ T cells.

Ongoing viral transcription from the reservoir of HIV-1 infected long-lived memory CD4+ T cells presents a barrier to cure and associates with poorer health outcomes for people living with HIV, including chronic immune activation and inflammation. We previously reported that didehydro-cortistatin A (dCA), an HIV-1 Tat inhibitor, blocks HIV-1 transcription. Here, we examine the impact of dCA on host immune CD4+ T-cell transcriptional and epigenetic states. We performed a comprehensive analysis of genome-wide transcriptomic and DNA methylation profiles upon long-term dCA treatment of primary human memory CD4+ T cells. dCA prompted specific transcriptional and DNA methylation changes in cell cycle, histone, interferon-response, and T-cell lineage transcription factor genes, through inhibition of both HIV-1 and Mediator kinases. These alterations establish a tolerogenic Treg/Th2 phenotype, reducing viral gene expression and mitigating inflammation in primary CD4+ T cells during HIV-1 infection. In addition, dCA suppresses the expression of lineage-defining transcription factors for Th17 and Th1 cells, critical HIV-1 targets, and reservoirs. dCA's benefits thus extend beyond viral transcription inhibition, modulating the immune cell landscape to limit HIV-1 acquisition and inflammatory environment linked to HIV infection.

Pre-exposure Prophylaxis (PrEP) implementation among latino MSM: a qualitative scoping review of implementation determinants and change methods.

The increasing rates of HIV among Latino men who have sex with men (MSM) necessitate innovative and rigorous studies to evaluate prevention and treatment strategies. Pre-exposure prophylaxis (PrEP) is a highly effective tool in preventing HIV acquisition and plays a crucial role in the Ending the HIV Epidemic in the U.S. initiative. However, there is a scarcity of PrEP research specifically focused on Latino MSM, and the factors influencing its implementation remain largely unknown. To address this gap, we conducted a comprehensive review exploring the determinants (barriers and facilitators) of PrEP implementation among Latino MSM, as well as the change methods (implementation strategies and adjunctive interventions) that have been evaluated to promote its adoption. Our review encompassed 43 peer-reviewed articles examining determinants and four articles assessing change methods. Determinants were coded using the updated Consolidated Framework for Implementation Research (CFIR 2.0) to understand the multilevel barriers and facilitators associated with implementation. The majority of research has focused on PrEP recipients (i.e., patients), primarily examining their awareness and willingness to use PrEP. Fewer studies have explored the factors influencing clinicians and service delivery systems. Additionally, the evaluation of change methods to enhance clinician adoption and adherence to PrEP and recipient adherence to PrEP has been limited. It is evident that there is a need for culturally adapted strategies tailored specifically for Latino MSM, as the current literature remains largely unexplored in this regard. By incorporating principles from implementation science, we can gain a clearer understanding of the knowledge, skills, and roles necessary for effective cultural adaptations. Future research should emphasize factors influencing implementation from a clinician standpoint and focus on innovative change methods to increase PrEP awareness, reach, adoption, and sustained adherence among Latino MSM.

Adolescent Girls and Young Women Overcoming Adherence Challenges with Vaginal and Oral PrEP Use: A Longitudinal Qualitative Study from a Crossover Trial in South Africa, Uganda, and Zimbabwe.

Rates of HIV acquisition remain high among adolescent girls and young women (AGYW) in sub-Saharan Africa. We explored South African, Ugandan, and Zimbabwean AGYW's experiences in a crossover trial of two HIV prevention products: Daily oral pre-exposure prophylaxis pills and a monthly dapivirine vaginal ring. A subset of participants (n = 25) across all sites completed up to three serial in-depth interviews (SIDIs). The SIDIs explored barriers to product use, coping strategies, and the resulting outcomes. Coded textual data were analyzed using a product acceptability conceptual framework. Participants in the SIDIs described managing the array of challenges they encountered through formal adherence support, strategic product disclosure, and personally adapted strategies. For both products, perceived discreetness of the product and decision-making around disclosure was an important component of participants' narratives. Participants tailored their coping strategies based on available personal resources (e.g., cell phone alarms for PrEP reminders, social support through disclosure) or study provided resources (e.g., encouragement from staff, adherence groups). Notably, challenges participants encountered with each product during the crossover period helped inform product selection during the choice period. Our findings suggest that-even in a context where AGYW have access to several options for HIV prevention-challenges to consistent product use remain, but accessible support mechanisms and informed choice can help mitigate these challenges. Enacting that choice may also empower AGYW to reach their short and long-term life goals-including for HIV prevention. (NCT03593655, 20th July 2018).

Trajectories of Adherence to Oral Pre-exposure Prophylaxis and Risks of HIV and Sexually Transmitted Infections.

Pre-exposure prophylaxis (PrEP) effectiveness is highly dependent on medication adherence, which is associated with differential HIV risks and possibly sexually transmitted infection (STI). This retrospective cohort study of PrEP users (01/01/2012-12/31/2021) used the MarketScan database of commercially insured enrollees to examine PrEP adherence trajectory groups' associations with HIV and STI acquisition risks. Distinct PrEP adherence trajectories were identified by group-based trajectory modeling among individuals who used oral PrEP. The primary outcome was HIV acquisition incidence, and secondary was STI rate, compared among trajectory groups. Inverse probability treatment weighting time-varying Cox proportional hazards models assessed HIV acquisition, and Poisson regression models assessed STI. Among 23 258 oral PrEP users, 4 distinct PrEP adherence patterns were identified: minimal use (10.5% of the cohort), rapidly declining (25.4%), gradually declining (24.3%), and consistently high (39.8%). Compared with the minimal use group, the gradually declining (adjusted hazard ratio [AHR], 0.53; 95% CI, 0.31-0.90) and consistently high (AHR, 0.50; 95% CI, 0.30-0.84) PrEP adherence groups showed decreased HIV incidence risks. Compared with the minimal use group, the rapidly declining (adjusted incidence rate ratio [AIRR], 1.35; 95% CI, 1.07-1.72), gradually declining (AIRR, 1.73; 95% CI, 1.38-2.18), and consistently high (AIRR, 2.06; 95% CI, 1.64-2.58) groups were associated with increased STI risk. These findings underscore the benefits of continuing and remaining adherent to PrEP and may also inform public health strategies, clinical guidelines, and interventions aimed at maximizing the effectiveness of PrEP in reducing new HIV infections while developing targeted strategies to prevent STIs with PrEP use.

Evaluating the impact of HIV pre-exposure prophylaxis on pregnancy, infant, and maternal health outcomes in Malawi: PrIMO study protocol

BackgroundIncident HIV during the perinatal period significantly impedes elimination of Mother-to-Child HIV Transmission (eMTCT) efforts. Pre-Exposure Prophylaxis (PrEP) effectively reduces HIV acquisition, and new agents like injectable Cabotegravir (CAB-LA) offer potential advantages for pregnant and breastfeeding women. The Pregnancy, Infant, and Maternal health Outcomes (PrIMO) study will compare rates of composite adverse pregnancy outcomes, and infant adverse events, growth and neurodevelopment between mother-infant dyads receiving CAB-LA and those receiving oral PrEP in Malawi.MethodsPrIMO is an observational cohort study involving: (1) the development of a PrEP Pregnancy Registry for longitudinal surveillance of pregnant women on PrEP in Malawi; and (2) the enrolment of a prospective safety cohort of 621 pregnant women initiating oral PrEP or CAB-LA and their subsequent infants. The registry will include all women continuing or initiating PrEP during pregnancy across targeted sites in Lilongwe and Blantyre districts. The safety cohort will enrol a subset of those women and their infants from Bwaila District Hospital in Lilongwe, Malawi. We hypothesize that CAB-LA’s safety will be comparable to daily oral PrEP regarding adverse pregnancy outcomes, maternal/infant adverse events, and infant development. Participants in the cohort will choose either oral PrEP or CAB-LA and will be followed until 52 weeks post-delivery. Safety data will be collected from all mother-infant pairs and qualitative interviews will be conducted with a subset of purposively selected women (n = 50) to assess the acceptability of each PrEP modality.DiscussionThe PrIMO study will provide critical data on the safety of CAB-LA in pregnant and breastfeeding women and their infants. Results will guide clinical recommendations as the Malawi Ministry of Health prepares for the rollout of CAB-LA to this population. Evaluation of Registry implementation will inform its expansion to a nationwide safety monitoring system for PrEP use during pregnancy, with implications for similar systems in the region.Trial Registration numberNCT06158126. The study was prospectively registered (5 December 2023) in ClinicalTrials.gov.

Syphilis among HIV-positive men who have sex with men in Ghana: The 2023 biobehavioral survey.

Apart from HIV acquisition, men who have sex with men are at a higher risk of sexually transmitted infections, especially syphilis. Although the intersection between syphilis and HIV poses a formidable challenge among key populations who are known to be vulnerable to many health threats, there is little known about syphilis infection among MSM living with HIV in Ghana. This study seeks to investigate the burden of syphilis and address the existing knowledge gap by exploring behavioral, healthcare access, and structural factors influencing the syphilis burden within the HIV-positive MSM population. This study was conducted in 2023 as part of the bio-behavioral survey (BBS) among men who have sex with men (MSM) in Ghana. A cross-sectional survey that used a respondent-driven sampling (RDS) approach was conducted in the old ten regions of Ghana. Data was collected on 3,420 participants, however, 857 HIV-positive MSM were included in this study since it focused on syphilis among HIV-positive MSM in Ghana. The study estimated the prevalence of syphilis among MSM living with HIV and provided a 95% confidence interval across different categories of explanatory variables. Bivariate and multivariable logistic regression models were used to identify factors associated with overall syphilis prevalence. All other analyses were weighted due to the complex design of the study. The overall prevalence of syphilis was 23.83% (95% CI: 20.44, 27.58). HIV-positive men who only had sex with men had a 29.77% (95% CI: 23.90, 36.40) prevalence of syphilis compared to a prevalence of 9.50% (95% CI: 2.56, 29.53) recorded by HIV-positive MSM who were attracted to mostly females. Participants who ever had receptive anal sex recorded a higher prevalence 26.79% (95% CI: 22.78, 31.23) than those who never had receptive anal sex 12.86% (95% CI: 8.02, 19.99). The odds of syphilis among HIV-positive MSM who never used condoms with regular sex partners in the last 6 months were 41.08 (aOR: 41.08 at 95% CI 1.24-136.42; p = 0.038). There is a high prevalence of syphilis among HIV-positive men who have sex with men in Ghana, especially among those who engage in unprotected anal sex and have multiple sexual partners. Our findings underscore the dire need for targeted interventions to address the dual brunt of HIV and syphilis among the MSM population in Ghana.

Correlation of APOE polymorphism, expression, and plasma levels with cardiac comorbidities among lipodystrophy in HIV-infected patients

Lipodystrophy in HIV-infected patients (LDHIV) includes morphological and metabolic abnormalities, including lipid and glucose metabolism. ApoE plays a role in the transport and clearance of lipoprotein. In the general population, ApoE 112 (rs429358) and 158 (rs7412) polymorphisms were linked to severe dyslipidemia. Therefore, we investigated ApoE polymorphism using PCR-RFLP in 200 HIV patients (100 with HIV-associated lipodystrophy (HIVLD), 100 without HIVLD), as well as 100 healthy controls. We also assessed ApoE expression using qRT-PCR and measured its level using ELISA. The APOE 4/4, 3/4, and 2/4 genotypes have been associated with a decreased risk of HIV-1 infection. (P = 0.0001, OR = 0.18; P = 0.006, OR = 0.87; P = 0.006, OR = 0.09) when compared between HIV-positive individuals and healthy controls. Conversely, APOE allele 2 was linked to a higher risk of acquiring HIV-1 (P = 0.03, OR = 3.02). APOE allele 2 was linked to a higher likelihood of HIVLD severity when compared between patients with and without HIVLD (P = 0.05, OR = 2.82). When comparing patients with HIVLD to healthy controls, the APOE 4/4 and 2/4 genotypes as well as allele 4 were linked with the reduced risk of LDHIV (P = 0.0006, OR = 0.21; P = 0.01, OR = 0.18; P = 0.0002, OR = 0.40). When compared to patients without HIVLD from healthy controls, the ApoE 4/4 genotype, 2 and 4 alleles, were linked to a reduced risk of developing HIVLD (P = 0.0009, OR = 0.14; P = 0.0001, OR = 0.17; P = 0.00001, OR = 0.39). When comparing impaired to normal cholesterol levels in patients without HIVLD, the ApoE 3/4 genotype was linked with the increased risk of impaired cholesterol levels (P = 0.02, OR = 3.37). When comparing impaired and normal glucose levels in patients without HIVLD, the ApoE 4/4 genotype was associated to an elevated risk of impaired glucose levels (P = 0.03, OR = 8.27). In multivariate analysis, independent impaired cholesterol, LDL, and glucose levels were associated with a higher risk of lipodystrophy severity (P = 0.04, OR = 2.33; P = 0.001, OR = 4.05; P = 0.05, OR = 2.63). ApoE expression was up-regulated in LDHIV with a fold change value of 4.02 compared to those without HIVLD. ApoE protein level was found to be higher in patients of the HIVLD group (3.01 mg/dL) compared to those without HIVLD group (2.83 mg/dL). In conclusion, individuals with ApoE allele 2 were at higher risk for HIV-1 acquisition and severity of HIVLD, whereas those with ApoE allele 4 were at reduced HIVLD severity and development risk. It’s possible that ApoE’s increased level and its overexpression are related to the ApoE allele 2 in HIVLD patients. The development of LDHIV may be facilitated by the APOE 3/4 and 4/4 genotypes as well as abnormal glucose and cholesterol levels.

An optimized strategy triggered at the 2nd immunization visit to prevent HIV acquisition by breastfeeding: a phase 2 trial in Burkina Faso (PREVENIR-PEV)

BackgroundMother-to-child transmission of HIV during breastfeeding remains a challenge in low- and middle-income countries (LMIC). A prevention package was initiated during the highly attended 2nd visit of the Expanded Program of Immunisation (EPI-2) to identify the undiagnosed infants living with HIV and reduce the postnatal transmission of infant exposed to HIV.MethodsPREVENIR-PEV is a non-randomized phase II clinical trial conducted at two health centres in Bobo Dioulasso (Burkina Faso). The study recruited mothers living with HIV aged 15 years and older with their singleton breastfed infants. During EPI-2 (at 8 weeks) and upon signature of the informed consent, a point-of-care early infant diagnosis (EID) was performed. HIV exposed uninfected (HEU) infants were followed-up until 12 months of age. High risk HEU infants (i.e., whose maternal viral load ≥ 1000 cp/mL at EPI-2 or M6) received an extended postnatal prophylaxis (PNP) with lamivudine until end of follow-up or the end of breastfeeding.ResultsBetween 4 December 2019 and 4 December 2020, 118 mothers living with HIV-1 were identified, and 102 eligible mother/infant pairs had their infants tested for HIV EID. Six infants were newly diagnosed with HIV, and 96 HEU infants were followed-up for 10 months. Among the participants followed-up, all mothers were prescribed antiretrovirals. All 18 infants eligible for PNP at either EPI-2 or 6 months (M6) were initiated on lamivudine. No HIV transmission occurred, and no serious adverse events were reported in infants receiving lamivudine.ConclusionsThe PREVENIR-PEV prevention package integrated into existing care is safe and its implementation is feasible in a LMIC with a low HIV prevalence. More research is needed to target mother/infant pairs not adhering to the intervention proposed in this trial.Trial registrationNCT03869944; first registered on 11/03/2019.