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: Introduction: Antiretroviral therapy (ART) initiation in infants living with HIV before 12 weeks of age can reduce the risk of mortality by 75%. Point‐of‐care (POC) diagnostic testing is critical for prompt ART initiation; however, despite its availability, rates of ART initiation are still relatively low before 12 weeks of age. This systematic review describes the barriers to ART initiation in infants before 12 weeks of age, despite the availability of POC. Methods: This systematic review used a narrative synthesis methodology. We searched PubMed and Scopus using search strategies that combined terms of multiple variants of the keywords “early infant initiation on antiretroviral therapy,” “barriers” and “sub‐Saharan Africa” (initial search 18th January 2023; final search 1st August 2023). We included qualitative, observational and mixed methods studies that reported the influences of early infant initiation on ART. We excluded studies that reported influences on other components of the Prevention of Mother to Child Transmission cascade. Using a deductive approach guided by the updated Consolidated Framework of Implementation Research, we developed descriptive codes and themes around barriers to early infant initiation on ART. We then developed recommendations for interventions for the identified barriers using the action, actor, target and time framework from the codes. Results: Of the 266 abstracts reviewed, 52 full‐text papers were examined, of which 12 papers were included. South Africa had most papers from a single country (n = 3) and the most reported study design was retrospective (n = 6). Delays in ART initiation beyond 12 weeks in infants 0–12 months were primarily associated with health facility and maternal factors. The most prominent barriers identified were inadequate resources for POC testing (including human resources, laboratory facilities and patient follow‐up). Maternal‐related factors, such as limited male involvement and maternal perceptions of treatment and care, were also influential. Discussion: We identified structural barriers to ART initiation at the health system, social and cultural levels. Improvements in the timely allocation of resources for POC testing operations, coupled with interventions addressing social and behavioural barriers among both mothers and healthcare providers, hold a promise for enhancing timely ART initiation in infants. Conclusions: This paper identifies barriers and proposes strategies for timely ART initiation in infants., INTRODUCTION Sub‐Saharan Africa (SSA) harbours the highest burden of HIV and has registered the lowest progress in paediatric antiretroviral therapy (ART) treatment coverage at 74% ( There are several known [...]

: Introduction: HIV diagnosis is the necessary first step towards HIV care initiation, yet many persons living with HIV (PLWH) remain undiagnosed. Employing multiple HIV testing strategies in tandem could increase HIV detection and promote linkage to care. We aimed to assess an intervention to improve HIV detection within socio‐sexual networks of PLWH in two sexually transmitted infections (STI) clinics in Lilongwe, Malawi. Methods: We conducted a randomized controlled trial to evaluate an intervention combining acute HIV infection (AHI) screening, contract partner notification and social contact referral versus the Malawian standard of care: serial rapid serological HIV tests and passive partner referral. Enrolment occurred between 2015 and 2019. HIV‐seropositive persons (two positive rapid tests) were randomized to the trial arms and HIV‐seronegative (one negative rapid test) and ‐serodiscordant (one positive test followed by a negative confirmatory test) persons were screened for AHI with HIV RNA testing. Those found to have AHI were offered enrolment into the intervention arm. Our primary outcome of interest was the number of new HIV diagnoses made per index participant within participants’ sexual and social networks. We also calculated total persons, sexual partners and PLWH (including those previously diagnosed) referred per index participant. Results: A total of 1230 HIV‐seropositive persons were randomized to the control arm, and 561 to the intervention arm. Another 12,713 HIV‐seronegative or ‐serodiscordant persons underwent AHI screening, resulting in 136 AHI cases, of whom 94 enrolled into the intervention arm. The intervention increased the number of new HIV diagnoses made per index participant versus the control (ratio: 1.9; 95% confidence interval (CI): 1.2 to 3.1). The intervention also increased the numbers of persons (ratio: 2.5; 95% CI: 2.0 to 3.2), sexual partners (ratio: 1.7; 95% CI: 1.4 to 2.0) and PLWH (ratio: 2.3; 95% CI: 1.7 to 3.2) referred per index participant. Conclusions: Combining three distinct HIV testing and referral strategies increased the detection of previously undiagnosed HIV infections within the socio‐sexual networks of PLWH seeking STI care. Combination HIV detection strategies that leverage AHI screening and socio‐sexual contact networks offer a novel and efficacious approach to increasing HIV status awareness., INTRODUCTION HIV diagnosis is the essential first step for people living with HIV (PLWH) to access HIV care, which can improve health outcomes and reduce the potential for onward transmission [...]

Background: Pre-exposure prophylaxis (PrEP) reduces HIV acquisition risk by >90% and is a critical lever to reduce HIV incidence. Identifying individuals most likely to benefit from PrEP and retaining them on PrEP throughout HIV risk is critical to realize PrEP's prevention potential. Individuals with sexually transmitted infections (STIs) are an obvious priority PrEP population, but there are no data from sub-Saharan Africa (SSA) confirming the effectiveness of integrating PrEP into STI clinics. Assisted partner notification may further enhance STI clinic-based PrEP programming by recruiting PrEP users from the pool of named sexual partners of individuals presenting with an incident STI. However, the acceptability, feasibility, and effectiveness of these integrated and enhanced strategies are unknown. Objective: This study aims to describe the implementation outcomes of acceptability, feasibility, and effectiveness (regarding PrEP uptake and persistence) of integrating an enhanced PrEP implementation strategy into an STI clinic in Malawi. Methods: The enhanced PrEP STI study is a prospective cohort study enrolling patients who are eligible for PrEP (aged =15 years) who are seeking STI services at a Lilongwe-based STI clinic. Data collection relies on a combination of in-depth interviews, patient and clinic staff surveys, and clinic record review. All enrolled PrEP users will be screened for acute HIV infection and receive quarterly testing for Neisseria gonorrhea, Chlamydia trachomatis, and syphilis. Participants will be asked to name recent sexual partners for assisted notification; returning partners will be screened for PrEP eligibility and, if interested, enrolled into the cohort of PrEP initiators. We will also enroll patients who are eligible for PrEP but choose not to initiate it, from the STI clinic. Patient participants will be followed for 6 months; we will assess self-reported PrEP use, PrEP refills, sexual behaviors, perceived HIV risk, and incident STIs. Clinic staff participants will be interviewed at baseline and at approximately 6 months and will complete surveys examining the perceived acceptability and feasibility of the integrated and enhanced PrEP strategy. Results: Enrollment began in March 2022 and is projected to continue until February 2023, with patient participant follow-up through August 2023. The results of this study are expected to be reported in 2024. Conclusions: This study will generate important evidence regarding the potential integration of PrEP services into STI clinics in SSA and preliminary data regarding the effectiveness of an enhanced intervention that includes assisted partner notification as a strategy to identify potential PrEP users. Furthermore, this trial will provide some of the first insights into STI incidence among PrEP users recruited from an STI clinic in SSA--critical data to inform the use of etiologic STI testing where syndromic management is the current standard. These findings will help to design future PrEP implementation strategies in SSA. [ABSTRACT FROM AUTHOR]

Background People with human immunodeficiency virus (HIV) and advanced immunosuppression initiating antiretroviral therapy (ART) remain vulnerable to tuberculosis (TB) and early mortality. To improve early survival, isoniazid preventive therapy (IPT) or empiric TB treatment have been evaluated; however, their benefit on longer-term outcomes warrants investigation. Methods We present a 96-week preplanned secondary analysis among 850 ART-naive outpatients (≥13 years) enrolled in a multicountry, randomized trial of efavirenz-containing ART plus either 6-month IPT (n  = 426) or empiric 4-drug TB treatment (n  = 424). Inclusion criteria were CD4 count <50 cells/mm3 and no confirmed or probable TB. Death and incident TB were compared by strategy arm using the Kaplan-Meier method. The impact of self-reported adherence (calculated as the proportion of 100% adherence) was assessed using Cox-proportional hazards models. Results By 96 weeks, 85 deaths and 63 TB events occurred. Kaplan-Meier estimated mortality (10.1% vs 10.5%; P  = .86) and time-to-death (P  = .77) did not differ by arm. Empiric had higher TB risk (6.1% vs 2.7%; risk difference, −3.4% [95% confidence interval, −6.2% to −0.6%]; P  = .02) and shorter time to TB (P  = .02) than IPT. Tuberculosis medication adherence lowered the hazards of death by ≥23% (P  < .0001) in empiric and ≥20% (P  < .035) in IPT and incident TB by ≥17% (P   ≤ . 0324) only in IPT. Conclusions Empiric TB treatment offered no longer-term advantage over IPT in our population with advanced immunosuppression initiating ART. High IPT adherence significantly lowered death and TB incidence through 96 weeks, emphasizing the benefit of ART plus IPT initiation and completion, in persons with advanced HIV living in high TB-burden, resource-limited settings. [ABSTRACT FROM AUTHOR]

Background: Genital ulcer disease (GUD) is a common clinical syndrome in Africa. Periodic surveillance of GUD causes in countries that rely on syndromic management of sexually transmitted infections (STIs) is important for informing treatment guidelines, which recommend presumptive therapy for syphilis, genital herpes, and chancroid. Approximately 20% of all symptomatic clients presenting to STI clinics in Malawi present with GUD. We evaluated the current distribution of etiologies of GUD in Malawi, since the last review10 years ago. Methods: We recruited men and women ≥18 years of age with wet/moist ulcers at Bwaila STI clinic in Lilongwe, between January 2020 and May 2022. Ulcer swabs were collected and underwent polymerase chain reaction (PCR) testing for Haemophilus ducreyi (HD), Chlamydia trachomatis (CT), herpes simplex virus (HSV), and Treponema pallidum subs. pallidum (TP) (polA); genovar-specific PCR to confirm cases of lymphogranuloma venereum (LGV) PCR was not available so CT results were considered presumptive for LGV. We assessed the distribution of GUD etiologies based on demographic characteristics and HIV status. Results: Of the 742 clients with wet/moist genital ulcers, 568 (77%) had ulcer swab specimens with PCR results. The median age was 27 years (IQR: 23, 34), 61% (345/564) were men and 13% (60/464) were HIV seropositive. Two-thirds (368/568, 65%) of participants had TP, 23% (128/568) had HD, 17% (98/568) had HSV, 6% (36/568) had CT and 8% (46/568) had no etiology identified. Most participants (420/568, 74%) had one pathogen, 96 (17%) had two and 6 (1%) had three pathogens identified. TP and HSV were slightly more common among HIV seropositive patients (TP: 73%, HSV: 25%) compared to HIV seronegative patients (TP: 65%, HSV:16%), respectively. Women had slightly more TP (71%) and CT (11%) compared to men (TP: 61%, CT: 3%), respectively. Conclusion: Since the last etiologic review, there has been a rise in the prevalence of syphilis and chancroid, suggesting a shift in the etiologic burden of GUD in Malawi. Routine point-of-care screening, treatment, and active partner notification of syphilis needs to be intensified among patients with GUD, particularly HIV co-infected patients. Further studies investigating HD will be important for informing syndromic treatment guidelines in Malawi. [ABSTRACT FROM AUTHOR]

Background Prior to the widespread availability of antiretroviral therapy (ART), men living with human immunodeficiency virus (HIV) with urethritis had increased concentrations of HIV in semen. This study aims to better evaluate HIV shedding in men with urethritis receiving ART, and its implications for the cure of HIV. Methods Men living with HIV with urethritis taking ART ≥12 weeks were enrolled at a sexually transmitted infections clinic in Lilongwe, Malawi. Study follow-up included visits at 1, 2, 4, 8, 12, 24, 36, and 48 weeks after urethritis diagnosis and treatment. Matched blood and semen samples were collected at all visits, and all additional episodes of urethritis were followed with extra visits 1, 2, and 4 weeks after treatment. Results There were 111 men enrolled in the study between January 2017–March 2019, and 77 (69%) were suppressed in the blood (<400 copies/mL). Among the 77 men, 87 episodes of urethritis were evaluated during follow-up. Of the 87 episodes, 15 episodes (17%) had instances of seminal viral shedding ≥400 copies/mL despite viral suppression in the blood. During nonurethritis follow-up, ≤6% of men at each visit had a viral load ≥400 copies/mL in the semen while maintaining viral suppression in the blood. Conclusions An HIV cure requires the elimination of HIV from every body compartment, but available ART does not currently accomplish this. Our study highlights the male genital tract as a local source of HIV that can be reversibly activated. A better understanding of this phenomenon is important to advance the HIV cure field. [ABSTRACT FROM AUTHOR]