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Author(s): Aditya Narayan 1, Argita D. Salindri 1, Salmaan Keshavjee 2,3, Monde Muyoyeta 4, Kavindhran Velen 5, Zulma V. Rueda 6,7, Julio Croda 8,9,10, Salome Charalambous 5,11, Alberto L. García-Basteiro [...]

Introduction: "Programme science" deploys scientific methods to address questions that are a priority to support the impact of public health programmes. As such, programme science responds to the challenges of making such studies: (1) feasible to undertake, (2) useful, (3) rigorous, (4) real‐world‐relevant, (5) informative, and undertaken by (6) equitable partnerships. The acronym "FURRIE" is proposed to describe this set of six challenges. This paper discusses selected HIV/STI (sexually transmitted infection) programme science case studies to illustrate how programme science rises to the FURRIE challenges. Discussion: One way in which programme science is made more feasible is through the analysis and interpretation of data collected through service delivery. For some questions, these data can be augmented through methods that reach potential clients of services who have not accessed services or been lost to follow‐up. Process evaluation can enhance the usefulness of programme science by studying implementation processes, programme−client interactions and contextual factors. Ensuring rigour by limiting bias and confounding in the real‐world context of programme science studies requires methodological innovation. Striving for scientific rigour can also have the unintended consequence of creating a gap between what happens in a study, and what happens in the "real‐world." Community‐led monitoring is one approach to grounding data collection in the real‐world experience of clients. Evaluating complex, context‐specific strategies to strengthen health outcomes in a way that is informative for other settings requires clear specification of the intervention packages that are planned and delivered in practice. Programme science provides a model for equitable partnership through co‐leadership between programmes, researchers and the communities they serve. Conclusions: Programme science addresses the FURRIE challenges, thereby improving programme impact and ultimately health outcomes and health equity. The adoption and adaptation of the types of novel programme science approaches showcased here should be promoted within and beyond the HIV/STI field. [ABSTRACT FROM AUTHOR]

Introduction: Optimizing uptake of pre‐exposure prophylaxis (PrEP) for individuals at risk of HIV acquisition has been challenging despite clear scientific evidence and normative guidelines, particularly for key populations (KPs) such as men who have sex with men (MSM), female sex workers (FSWs), transgender (TG) people and persons who inject drugs (PWID). Applying an iterative Programme Science cycle, building on the effective programme coverage framework, we describe the approach used by the Centre for Infectious Disease Research in Zambia (CIDRZ) to scale up PrEP delivery and address inequities in PrEP access for KP in Lusaka, Zambia. Methods: In 2019, CIDRZ partnered with 10 local KP civil society organizations (CSOs) and the Ministry of Health (MOH) to offer HIV services within KP‐designated community safe spaces. KP CSO partners led KP mobilization, managed safe spaces and delivered peer support; MOH organized clinicians and clinical commodities; and CIDRZ provided technical oversight. In December 2021, we introduced a community‐based intervention focused on PrEP delivery in venues where KP socialize. We collected routine programme data from September 2019 to June 2023 using programme‐specific tools and the national electronic health record. We estimated the before‐after effects of our intervention on PrEP uptake, continuation and equity for KP using descriptive statistics and interrupted time series regression, and used mixed‐effects regression to estimate marginal probabilities of PrEP continuity. Results: Most (25,658) of the 38,307 (67.0%) Key Population Investment Fund beneficiaries were reached with HIV prevention services at community‐based venues. In total, 23,527 (61.4%) received HIV testing services, with 15,508 (65.9%) testing HIV negative and found PrEP eligible, and 15,241 (98.3%) initiating PrEP. Across all programme quarters and KP types, PrEP uptake was >90%. After introducing venue‐based PrEP delivery, PrEP uptake (98.7% after vs. 96.5% before, p < 0.001) and the number of initiations (p = 0.014) increased significantly. The proportion of KP with ≥1 PrEP continuation visit within 6 months of initiation was unchanged post‐intervention (46.7%, 95% confidence interval [CI]: 45.7%, 47.6%) versus pre‐intervention (47.2%, 95% CI: 45.4%, 49.1%). Conclusions: Applying Programme Science principles, we demonstrate how decentralizing HIV prevention services to KP venues and safe spaces in partnership with KP CSOs enabled successful community‐based PrEP delivery beyond the reach of traditional facility‐based services. [ABSTRACT FROM AUTHOR]

Introduction: Pregnant women living with HIV can achieve viral suppression and prevent HIV mother-to-child transmission (MTCT) with timely HIV testing and early ART initiation and maintenance. Although it is recommended that pregnant women undergo HIV testing early in antenatal care in Malawi, many women test positive during breastfeeding because they did not have their HIV status ascertained during pregnancy or they tested negative during pregnancy but seroconverted postpartum. We sought to estimate the association between the timing of last positive HIV test (during pregnancy vs. breastfeeding) and outcomes of maternal viral suppression and MTCT in Malawi's PMTCT programme. Methods: We conducted a two-stage cohort study among mother-infant pairs in 30 randomly selected high-volume health facilities across five nationally representative districts of Malawi between 1 July 2016 and 30 June 2017. Log-binomial regression was used to estimate prevalence ratios (PR) and risk ratios (RR) for associations between timing of last positive HIV test (i.e. breastfeeding vs. pregnancy) and maternal viral suppression and MTCT, controlling for confounding using inverse probability weighting. Results: Of 822 mother-infant pairs who had available information on the timing of the last positive HIV test, 102 mothers (12.4%) had their last positive test during breastfeeding. Women who lived one to two hours (PR = 2.15; 95% CI: 1.29 to 3.58) or >2 hours (PR = 2.36; 95% CI: 1.37 to 4.10) travel time to the nearest health facility were more likely to have had their last positive HIV test during breastfeeding compared to women living Conclusions: MTCT in Malawi occurred disproportionately among women with a last positive HIV test during breastfeeding. Testing delayed until the postpartum period may lead to higher MTCT. To optimize maternal and child health outcomes, PMTCT programmes should focus on early ART initiation and providing targeted testing, prevention, treatment and support to breastfeeding women. Keywords: antiretroviral therapy; mother-to-child transmission; HIV; Option B+; PMTCT; viral suppression, 1 | INTRODUCTION Antiretroviral therapy (ART) for HIV-positive pregnant and breastfeeding women (PBFW) has proved to be life-saving for both mother and infant. As a treatment for HIV, ART improves [...]

Introduction: In the current 'test and treat' era, HIV programmes are increasingly focusing resources on linkage to care and same-day antiretroviral therapy (ART) initiation to meet UNAIDS 95-95-95 targets. After observing sub-optimal treatment indicators in health facilities supported by the Centre for Infectious Disease Research in Zambia (CIDRZ), we piloted a 'linkage assessment' tool in facility-based HIV testing settings to uncover barriers to same-day linkage to care and ART initiation among newly identified people living with HIV (PLHIV) and to guide HIV programme quality improvement efforts. Methods: The one-page, structured linkage assessment tool was developed to capture patient-reported barriers to same-day linkage and ART initiation using three empirically supported categories of barriers: social, personal and structural. The tool was implemented in three health facilities, two urban and one rural, in Lusaka, Zambia from 1 November 2017 to 31 January 2018, and administered to all newly identified PLHIV declining same-day linkage and ART. Individuals selected as many reasons as relevant. We used mixed-effects logistic regression modelling to evaluate predictors of citing specific barriers to same-day linkage and ART, and Fisher's Exact tests to assess differences in barrier citation by socio-demographics and HIV testing entry point. Results: A total of 1278 people tested HIV positive, of whom 126 (9.9%) declined same-day linkage and ART, reporting a median of three barriers per respondent. Of these 126, 71.4% were female. Females declining same-day ART were younger, on average, (median 28.5 years, interquartile range (IQR): 21 to 37 years) than males (median 34.5 years, IQR: 26 to 44 years). The most commonly reported barrier category was structural, 'clinics were too crowded' (n = 33), followed by a social reason, 'friends and family will condemn me' (n = 30). The frequency of citing personal barriers differed significantly across HIV testing point ([chi square] p = 0.03). Significant predictors for citing [greater than or equal to]1 barrier to same-day ART were >50 years of age (OR: 12.59, 95% CI: 6.00 to 26.41) and testing at a rural facility (OR: 9.92, 95% CI: 4.98 to 19.79). Conclusions: Given differences observed in barriers to same-day ART initiation reported across sex, age, testing point, and facility type, new, tailored counselling and linkage to care approaches are needed, which should be rigorously evaluated in routine programme settings. Keywords: Same-day ART; Zambia; HIV care continuum; Africa < Region; testing Stigma; ARV; linkage to care, 1 | INTRODUCTION Treatment programmes are increasingly focusing resources to meet the UNAIDS 'second 95' target such that 95% of all people diagnosed with HIV receive antiretroviral therapy (ART) [1]. [...]

Background In sub-Saharan Africa, 3 community-facility linkage (CFL) models-Expert Clients, Community Health Workers (CHWs), and Mentor Mothers-have been widely implemented to support pregnant and breastfeeding women (PBFW) living with HIV and their infants to access and sustain care for prevention of mother-to-child transmission of HIV (PMTCT), yet their comparative impact under real-world conditions is poorly understood. Methods and findings We sought to estimate the effects of CFL models on a primary outcome of maternal loss to follow-up (LTFU), and secondary outcomes of maternal longitudinal viral suppression and infant 'poor outcome' (encompassing documented HIV-positive test result, LTFU, or death), in Malawi's PMTCT/ART program. We sampled 30 of 42 high-volume health facilities ('sites') in 5 Malawi districts for study inclusion. At each site, we reviewed medical records for all newly HIV-diagnosed PBFW entering the PMTCT program between July 1, 2016 and June 30, 2017, and, for pregnancies resulting in live births, their HIV-exposed infants, yielding 2,589 potentially eligible mother-infant pairs. Of these, 2,049 (79.1%) had an available HIV treatment record and formed the study cohort. A randomly selected subset of 817 (40.0%) cohort members underwent a field survey, consisting of a questionnaire and HIV biomarker assessment. Survey responses and biomarker results were used to impute CFL model exposure, maternal viral load, and early infant diagnosis (EID) outcomes for those missing these measures to enrich data in the larger cohort. We applied sampling weights in all statistical analyses to account for the differing proportions of facilities sampled by district. Of the 2,049 mother-infant pairs analyzed, 62.2% enrolled in PMTCT at a primary health center, at which time 43.7% of PBFW were [less than or equal to]24 years old, and 778 (38.0%) received the Expert Client model, 640 (31.2%) the CHW model, 345 (16.8%) the Mentor Mother model, 192 (9.4%) [greater than or equal to]2 models, and 94 (4.6%) no model. Maternal LTFU varied by model, with LTFU being more likely among Mentor Mother model recipients (adjusted hazard ratio [aHR]: 1.45; 95% confidence interval [CI]: 1.14, 1.84; p = 0.003) than Expert Client recipients. Over 2 years from HIV diagnosis, PBFW supported by CHWs spent 14.3% (95% CI: 2.6%, 26.1%; p = 0.02) more days in an optimal state of antiretroviral therapy (ART) retention with viral suppression than women supported by Expert Clients. Infants receiving the Mentor Mother model (aHR: 1.24, 95% CI: 1.01, 1.52; p = 0.04) and [greater than or equal to]2 models (aHR: 1.44, 95% CI: 1.20, 1.74; p < 0.001) were more likely to undergo EID testing by age 6 months than infants supported by Expert Clients. Infants receiving the CHW and Mentor Mother models were 1.15 (95% CI: 0.80, 1.67; p = 0.44) and 0.84 (95% CI: 0.50, 1.42; p = 0.51) times as likely, respectively, to experience a poor outcome by 1 year than those supported by Expert Clients, but not significantly so. Study limitations include possible residual confounding, which may lead to inaccurate conclusions about the impacts of CFL models, uncertain generalizability of findings to other settings, and missing infant medical record data that limited the precision of infant outcome measurement. Conclusions In this descriptive study, we observed widespread reach of CFL models in Malawi, with favorable maternal outcomes in the CHW model and greater infant EID testing uptake in the Mentor Mother model. Our findings point to important differences in maternal and infant HIV outcomes by CFL model along the PMTCT continuum and suggest future opportunities to identify key features of CFL models driving these outcome differences., Author(s): Michael E. Herce 1,2,*, Maganizo B. Chagomerana 1,2, Lauren C. Zalla 3, Nicole B. Carbone 1, Benjamin H. Chi 4, Michael T. Eliya 5, Sam Phiri 2,6, Stephanie M. [...]

Introduction: Providing outreach HIV prevention services at venues (i.e. 'hotspots') where people meet new sex partners can decrease barriers to HIV testing services (HTS) for key populations (KP) in sub-Saharan Africa (SSA). We offered venue-based HTS as part of bio-behavioural surveys conducted in urban Malawi and Angola to generate regional insights into KP programming gaps and identify opportunities to achieve the 'first 90' for KP in SSA. Methods: From October 2016 to March 2017, we identified and verified 1054 venues in Luanda and Benguela, Angola and Zomba, Malawi and conducted bio-behavioural surveys at 166 using the PLACE method. PLACE interviews community informants to systematically identify public venues where KP can be reached and conducts bio-behavioural surveys at a stratified random sample of venues. We present survey results using summary statistics and multivariable modified Poisson regression modelling to examine associations between receipt of outreach worker-delivered HIV/AIDS education and HTS uptake. We applied sampling weights to estimate numbers of HIV-positive KP unaware of their status at venues. Results: We surveyed 959 female sex workers (FSW), 836 men who have sex with men (MSM), and 129 transgender women (TGW). An estimated 71% of HIV-positive KP surveyed were not previously aware of their HIV status, receiving a new HIV diagnosis through PLACE venue-based HTS. If venue-based HTS were implemented at all venues, 2022 HIV-positive KP (95% CI: 1649 to 2477) who do not know their status could be reached, including 1666 FSW (95% CI: 1397 to 1987), 274 MSM (95% CI: 160 to 374), and 82 TG (95% CI: 20 to 197). In multivariable analyses, FSW, MSM, and TGW who received outreach worker-delivered HIV/AIDS education were 3.15 (95% CI: 1.99 to 5.01), 3.12 (95% CI: 2.17 to 4.48), and 1.80 (95% CI: 0.67 to 4.87) times as likely, respectively, as those who did not to have undergone HTS within the last six months. Among verified venues, Conclusions: Availability of HTS and other HIV prevention services was limited at venues. HIV prevention can be delivered at venues, which can increase HTS uptake and HIV diagnosis among individuals not previously aware of their status. Delivering venue-based HTS may represent an effective strategy to reach the 'first 90' for KP in SSA. Keywords: Key and vulnerable populations; HIV testing; HIV prevention; venue-based outreach; hotspots; sub-Saharan Africa; Malawi; Angola Additional Supporting Information may be found online in the Supporting information tab for this article., 1 | INTRODUCTION Key populations (KP) face a disproportionate HIV burden in sub-Saharan Africa (SSA) [1]. Driven by stigma, discrimination, limited KP-friendly services, and other structural barriers, the HIV prevention, [...]

: Introduction: East African cross‐border areas are visited by mobile and vulnerable populations, such as men, female sex workers, men who have sex with men, truck drivers, fisher folks and young women. These groups may not benefit from traditional HIV prevention interventions available at the health facilities where they live, but may benefit from services offered at public venues identified as places where people meet new sexual partners (e.g. bars, nightclubs, transportation hubs and guest houses). The goal of this analysis was to estimate availability, access and uptake of prevention services by populations who visit these venues. Methods: We collected cross‐sectional data using the Priorities for Local AIDS Control Efforts sampling method at cross‐border locations near or along the land and lake borders of Kenya, Rwanda, Tanzania and Uganda from June 2016–February 2017. This bio‐behavioural survey captured information from a probability sample of 11,428 individuals at 833 venues across all areas. Data were weighted using survey sampling weights and analysed using methods to account for the complex sampling design. Results: Among the 85.6% of persons who had access to condoms, 60.5% did not use a condom at their last anal or vaginal sexual encounter. Venues visited by high percentages of persons living with HIV were not more likely than other venues to offer condoms. In 12 of the 22 cross‐border areas, male or female condoms were available at less than 33% of the venues visited by persons having difficulty accessing condoms. In 17 of the 22 cross‐border areas, education outreach visits in the preceding six months occurred at less than 50% of the venues where participants had low effective use of condoms. Conclusions: Individuals visiting venues in cross‐border areas report poor access to and low effective use of condoms and other prevention services. Availability of HIV prevention services differed by venue and population type and cross‐border area, suggesting opportunities for more granular targeting of HIV prevention interventions and transnational coordination of HIV programming., INTRODUCTION Achieving the UNAIDS 2030 goals to reduce new HIV infections to 200,000 per year will require optimization of HIV prevention and testing [1]. While HIV treatment has been crucial [...]

: Introduction: Current healthcare systems fail to provide adequate HIV services to men. In Zambia, 25% of adult men living with HIV were unaware of their HIV status in 2018, and 12% of those who were unaware of their HIV statu were not receiving antiretroviral therapy (ART) due to pervasive barriers to HIV testing services (HTS) and linkage to ART. To identify men and key and priority populations living with HIV in Zambia, and link them to care and treatment, we implemented the Community Impact to Reach Key and Underserved Individuals for Treatment and Support (CIRKUITS) project. We present HTS and ART linkage results from the first year of CIRKUITS. Methods: CIRKUITS aimed to reach beneficiaries by training, mentoring, and deploying community health workers to provide index testing services and targeted community HTS. Community leaders and workplace supervisors were engaged to enable workplace HTS for men. To evaluate the effects of these interventions, we collected age‐ and sex‐disaggregated routinely collected programme data for the first 12 months of the project (October 2018 to September 2019) across 37 CIRKUITS‐supported facilities in three provinces. We performed descriptive statistics and estimated index cascades for indicators of interest, and used Chi square tests to compare indicators by age, sex, and district strata. Results: Over 12 months, CIRKUITS tested 38,255 persons for HIV, identifying 10,974 (29%) new people living with HIV, of whom 10,239 (93%) were linked to ART. Among men, CIRKUITS tested 18,336 clients and identified 4458 (24%) as HIV positive, linked 4132 (93%) to ART. Men who tested HIV negative were referred to preventative services. Of the men found HIV positive, and 13.0% were aged 15 to 24 years, 60.3% were aged 25 to 39, 20.9% were aged 40 to 49 and 5.8% were ≥50 years old. Index testing services identified 2186 (49%) of HIV‐positive men, with a positivity yield of 40% and linkage of 88%. Targeted community testing modalities accounted for 2272 (51%) of HIV‐positive men identified, with positivity yield of 17% and linkage of 97%. Conclusions: Index testing and targeted community‐based HTS are effective strategies to identify men living with HIV in Zambia. Index testing results in higher yield, but lower linkage and fewer absolute men identified compared to targeted community‐based HTS., INTRODUCTION Of the 37.9 million people living with HIV (PLHIV) globally, including the 25.6 million residing in sub‐Saharan Africa (SSA), 21% remain unaware of their HIV status [1]. To address [...]

Background DNA plasmids promise a pragmatic alternative to viral vectors for prime-boost HIV-1 vaccines. We evaluated DNA plasmid versus canarypox virus (ALVAC) primes in 2 randomized, double-blind, placebo-controlled trials in southern Africa with harmonized trial designs. HIV Vaccine Trials Network (HVTN) 111 tested DNA plasmid prime by needle or needleless injection device (Biojector) and DNA plasmid plus gp120 protein plus MF59 adjuvant boost. HVTN 100 tested ALVAC prime and ALVAC plus gp120 protein plus MF59 adjuvant boost (same protein/adjuvant as HVTN 111) by needle. Methods and findings The primary endpoints for this analysis were binding antibody (bAb) responses to HIV antigens (gp120 from strains ZM96, 1086, and TV1; variable 1 and 2 [V1V2] regions of gp120 from strains TV1, 1086, and B.CaseA, as 1086 V1V2 and B.CaseA were correlates of risk in the RV144 efficacy trial), neutralizing antibody (nAb) responses to pseudoviruses TV1c8.2 and MW925.26, and cellular responses to vaccine-matched antigens (envelope [Env] from strains ZM96, 1086, and TV1; and Gag from strains LAI and ZM96) at month 6.5, two weeks after the fourth vaccination. Per-protocol cohorts included vaccine recipients from HVTN 100 (n = 186, 60% male, median age 23 years) enrolled between February 9, 2015, and May 26, 2015 and from HVTN 111 (n = 56, 48% male, median age 24 years) enrolled between June 21, 2016, and July 13, 2017. IgG bAb response rates were 100% to 3 Env gp120 antigens in both trials. Response rates to V1V2 were lower and similar in both trials except to vaccine-matched 1086 V1V2, with rates significantly higher for the DNA-primed regimen than the ALVAC-primed regimen: 96.6% versus 72.7% (difference = 23.9%, 95% CI 15.6%-32.2%, p < 0.001). Among positive responders, bAb net mean fluorescence intensity (MFI) was significantly higher with the DNA-primed regimen than ALVAC-primed for 1086 V1V2 (geometric mean [GM] 2,833.3 versus 1,200.9; ratio = 2.36, 95% CI 1.42-3.92, p 98% in both trials, with significantly higher 50% inhibitory dilution (ID.sub.50) among DNA-primed positive responders (n = 53) versus ALVAC-primed (n = 182) to tier 1A MW965.26 (GM 577.7 versus 265.7, ratio = 2.17, 95% CI 1.67-2.83, p < 0.001) and to TV1c8.2 (GM 187.3 versus 100.4, ratio = 1.87, 95% CI 1.48-2.35, p < 0.001). CD4+ T-cell response rates were significantly higher with DNA plasmid prime via Biojector than ALVAC prime (91.4% versus 52.8%, difference = 38.6%, 95% CI 20.5%-56.6%, p < 0.001 for ZM96.C; 88.0% versus 43.1%, difference = 44.9%, 95% CI 26.7%-63.1%, p < 0.001 for 1086.C; 55.5% versus 2.2%, difference = 53.3%, 95% CI 23.9%-82.7%, p < 0.001 for Gag LAI/ZM96). The study's main limitations include the nonrandomized comparison of vaccines from 2 different trials, the lack of data on immune responses to other non-vaccine-matched antigens, and the uncertain clinical significance of the observed immunological effects. Conclusions In this study, we found that further investigation of DNA/protein regimens is warranted given enhanced immunogenicity to the V1V2 correlates of decreased HIV-1 acquisition risk identified in RV144, the only HIV vaccine trial to date to show any efficacy., Author(s): Zoe Moodie 1,*, Stephen R. Walsh 2,3,4, Fatima Laher 5, Lucas Maganga 6, Michael E. Herce 7, Sarita Naidoo 8, Mina C. Hosseinipour 9, Craig Innes 10, Linda-Gail Bekker [...]

: Introduction: Despite the higher risk of HIV among female sex workers (FSWs), men who have sex with men (MSM) and transgender women (TGW), these populations are under‐represented in the literature on HIV in Haiti. Here, we present the first nationally representative estimates of HIV prevalence and the first care and treatment cascade for FSWs, MSM and TGW in Haiti. We also examine the social determinants of HIV prevalence in these groups and estimate FSW and MSM population size in Haiti. Methods: Data were collected between April 2016 and February 2017 throughout the 10 geographical departments of Haiti. The Priorities for Local AIDS Control Efforts (PLACE) method was used to: (1) recruit participants for a behavioural survey; (2) provide rapid testing, counselling and linkage to care for syphilis and HIV; and (3) measure viral load using dried blood spots for participants testing HIV positive. Results: Study participants included 990 FSWs, 520 MSM and 109 TGW. HIV prevalence was estimated at 7.7% (95% CI 6.2%, 9.6%) among FSWs, 2.2% (0.9%, 5.3%) among MSM and 27.6% (5.0%, 73.5%) among TGW. Of participants who tested positive for syphilis, 17% of FSWs, 19% of MSM and 74% of TGW were co‐infected with HIV. Economic instability and intimate partner violence (IPV) were significantly associated with HIV among MSM; food insecurity, economic instability and history of rape were significantly associated with HIV among TGW. Fewer than one‐third of participants living with HIV knew their status, and more than a quarter of those who knew their status were not on treatment. While approximately four in five FSW and MSM participants on treatment for HIV were virally suppressed, viral suppression was less common among TGW participants at only 46%. Conclusions: This study demonstrates a need for targeted interventions to prevent and treat HIV among key populations in Haiti. Potential high‐impact interventions may include venue‐based, peer navigator‐led outreach and testing for HIV and syphilis and improving screening and case management for structural violence and IPV. TGW are in urgent need of such interventions due to our observations of alarmingly high HIV prevalence and low frequency of HIV viral suppression among TGW., Introduction Since 2000, HIV prevalence has remained relatively stable in Haiti, with the most recent data suggesting an HIV prevalence of 2.0% among adults ages 15 to 49. The country [...]

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]

Introduction: HIV‐associated Kaposi sarcoma (HIV‐KS) is the most common cancer in Malawi. In 2008, the non‐governmental organization, Partners In Health, and the Ministry of Health established the Neno Kaposi Sarcoma Clinic (NKSC) to treat HIV‐KS in rural Neno district. We aimed to evaluate 12‐month clinical outcomes and retention in care for HIV‐KS patients in the NKSC, and to describe our implementation model, which featured protocol‐guided chemotherapy, integrated antiretroviral therapy (ART) and psychosocial support delivered by community health workers. Methods: We conducted a retrospective cohort study using routine clinical data from 114 adult HIV‐KS patients who received ART and ≥1 chemotherapy cycle in the NKSC between March 2008 and February 2012. Results: At enrolment 97% of patients (n/N=103/106) had advanced HIV‐KS (stage T1). Most patients were male (n/N=85/114, 75%) with median age 36 years (interquartile range, IQR: 29–42). Patients started ART a median of 77 days prior to chemotherapy (IQR: 36–252), with 97% (n/N=105/108) receiving nevirapine/lamivudine/stavudine. Following standardized protocols, we treated 20 patients (18%) with first‐line paclitaxel and 94 patients (82%) with bleomycin plus vincristine (BV). Of the 94 BV patients, 24 (26%) failed to respond to BV requiring change to second‐line paclitaxel. A Division of AIDS grade 3/4 adverse event occurred in 29% of patients (n/N=30/102). Neutropenia was the most common grade 3/4 event (n/N=17/102, 17%). Twelve months after chemotherapy initiation, 83% of patients (95% CI: 74–89%) were alive, including 88 (77%) retained in care. Overall survival (OS) at 12 months did not differ by initial chemotherapy regimen (p=0.6). Among patients with T1 disease, low body mass index (BMI) (adjusted hazard ratio, aHR=4.10, 95% CI: 1.06–15.89) and 1 g/dL decrease in baseline haemoglobin (aHR=1.52, 95% CI: 1.03–2.25) were associated with increased death or loss to follow‐up at 12 months. Conclusions: The NKSC model resulted in infrequent adverse events, low loss to follow‐up and excellent OS. Our results suggest it is safe, effective and feasible to provide standard‐of‐care chemotherapy regimens from the developed world, integrated with ART, to treat HIV‐KS in rural Malawi. Baseline BMI and haemoglobin may represent important patient characteristics associated with HIV‐KS survival in rural sub‐Saharan Africa., Introduction Kaposi sarcoma (KS) is a major cause of morbidity and mortality in sub‐Saharan Africa (SSA), resulting in 25,000 deaths each year [1]. In Malawi, KS is the most common [...]

Background The Pox-Protein Public-Private Partnership is performing a suite of trials to evaluate the bivalent subtype C envelope protein (TV1.C and 1086.C glycoprotein 120) vaccine in the context of different adjuvants and priming agents for human immunodeficiency virus (HIV) type 1 (HIV-1) prevention. Methods In the HIV Vaccine Trials Network 111 trial, we compared the safety and immunogenicity of DNA prime followed by DNA/protein boost with DNA/protein coadministration injected intramuscularly via either needle/syringe or a needle-free injection device (Biojector). One hundred thirty-two healthy, HIV-1–uninfected adults were enrolled from Zambia, South Africa, and Tanzania and were randomized to 1 of 6 arms: DNA prime, protein boost by needle/syringe; DNA and protein coadministration by needle/syringe; placebo by needle/syringe; DNA prime, protein boost with DNA given by Biojector; DNA and protein coadministration with DNA given by Biojector; and placebo by Biojector. Results All vaccinations were safe and well tolerated. DNA and protein coadministration was associated with increased HIV-1 V1/V2 antibody response rate, a known correlate of decreased HIV-1 infection risk. DNA administration by Biojector elicited significantly higher CD4+ T-cell response rates to HIV envelope protein than administration by needle/syringe in the prime/boost regimen (85.7% vs 55.6%; P =.02), but not in the coadministration regimen (43.3% vs 48.3%; P =.61). Conclusions Both the prime/boost and coadministration regimens are safe and may be promising for advancement into efficacy trials depending on whether cellular or humoral responses are desired. Clinical Trials Registration South African National Clinical Trials Registry (application 3947; Department of Health [DoH] no. DOH-27–0715–4917) and ClinicalTrials.gov (NCT02997969). [ABSTRACT FROM AUTHOR]