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In Kenya, persons insufficiently engaged in HIV Testing Services (HTS) are often treated in emergency departments (ED). There are limited data from healthcare workers on ED-HTS. A qualitative study was completed to understand challenges and facilitators for ED-HTS and HIV self-testing (HIVST). Data were collected via six focus groups of healthcare workers. Data were inductively analyzed and mapped to the Capability-Opportunity-Motivation Behavioral Model. Focus groups were completed with 49 healthcare workers: 18 nurses, 15 HIV counselors, 10 physicians and 6 administrators. HTS challenges included staff burdens, resources access, deficiencies in systems integration and illness severity. HTS facilitators included education of healthcare workers and patients, services coordination, and specific follow-up processes. HIVST challenges included accuracy concerns, follow-up barriers and psychosocial risks. HIVST facilitators were patient autonomy and confidentiality, resource utilization and ability to reach higher-risk persons. Mapping to the Capability-Opportunity-Motivation Behavioral Model interventions within the domains of knowledge, decision processes, environmental aspects, social influences and professional identities could support enhanced ED-HTS with integrated HIVST delivery. This study provided insights into challenges and facilitators on ED-HTS and identifies pragmatic approaches to improve healthcare workers' behaviors and abilities to provide services to persons already in contact with healthcare.

Background: Assisted partner services (APS) is an effective strategy for testing people with undiagnosed HIV, but there is limited information on the relative reach and effectiveness of phone versus in-person contact., Methods: We analyzed data from 31 facilities in Western Kenya providing APS to female index clients newly HIV diagnosed, their male partners, and female partners of men newly HIV diagnosed. Assisted partner services providers attempted contacting partners using phone first and, if unsuccessful, in-person in the community. Using log-linear mixed models, we estimated relative risks (RRs) between phone being the final contact method and partner characteristics and HIV outcomes., Results: From May 2018 to March 2020, 2534 female index clients named 7614 male partners, of whom 772 (10.1%) tested positive and named an additional 4956 non-index female partners. Of 11,912 (94.7%) partners reached, 5179 (43.5%) were via phone and 6733 (56.5%) in-person. Of 8076 testing-eligible partners, 99.7% tested and 11.2% first-time tested. Of those tested, 13.1% were newly diagnosed, of whom 87.0% linked to care. Newly diagnosed partners were less likely to have been reached by phone versus in-person (9.8% vs. 15.9%; adjusted relative risk, 0.61; 95% confidence interval, 0.53-0.70). Being reached by phone was not significantly associated with testing, first-time testing, or linkage to care., Conclusions: In an APS program that reached 94% of elicited partners, fewer than half were successfully contacted by phone. A combined phone and in-person approach is likely essential for equitable, effective APS., Competing Interests: Conflict of Interest and Sources of Funding: There are no conflicts of interest to report for all authors. This study was funded by the US National Institute of Allergy and Infectious Diseases of the National Institutes of Health (grant number R01 AI134130). Additional support was provided by the University of Washington/Fred Hutch Center for AIDS Research, an NIH-funded program (P30 AI027757)., (Copyright © 2024 American Sexually Transmitted Diseases Association. All rights reserved.)

Background.: Intervention effectiveness in a randomized controlled trial is attributed to intervention fidelity. Measuring fidelity has increasing significance to intervention research and validity. The purpose of this article is to describe a systematic assessment of intervention fidelity for VITAL Start (Video intervention to Inspire Treatment Adherence for Life)-a 27-minute video-based intervention designed to improve antiretroviral therapy adherence among pregnant and breastfeeding women., Method.: Research Assistants (RAs) delivered VITAL Start to participants after enrolment. The VITAL Start intervention had three components: a pre-video orientation, video viewing, and post-video counseling. Fidelity assessments using checklists comprised self (RA assessment) and observer (Research Officers, also known as ROs) assessment. Four fidelity domains (adherence, dose, quality of delivery, and participant responsiveness) were evaluated. Score scale ranges were 0 to 29 adherence, 0 to 3 dose, 0 to 48 quality of delivery and 0 to 8 participant responsiveness. Fidelity scores were calculated. Descriptive statistics summarizing the scores were performed., Results.: In total, eight RAs delivered 379 VITAL Start sessions to 379 participants. Four ROs observed and assessed 43 (11%) intervention sessions. The mean scores were 28 ( SD = 1.3) for adherence, 3 ( SD = 0) for dose, 40 (SD = 8.6) for quality of delivery, and 10.4 ( SD = 1.3) for participant responsiveness., Conclusion.: Overall, the RAs successfully delivered the VITAL Start intervention with high fidelity. Intervention fidelity monitoring should be an important element of randomized control trial design of specific interventions to ensure having reliable study results.

Background: Oral Pre-exposure prophylaxis (PrEP) is effective in preventing HIV transmission. However, despite high rates of HIV risk behaviors among people who inject drugs (PWID), this population remains underserved by current HIV prevention efforts in the United States. To address this challenge, we conducted an in-depth exploration of perspectives on using oral PrEP among PWID engaged in the HIV Prevention Trials Network (HPTN) 094 INTEGRA Study., Methods: Guided by the Practical, Robust, Implementation, and Sustainability Model (PRISM), our qualitative study drew on semi-structured interviews conducted as part of the embedded implementation science evaluation of HPTN 094 INTEGRA. Seventy-seven PWID participants from five sites across New York City, Houston, Los Angeles, Philadelphia, and Washington DC were interviewed to assess intervention delivery, care access, and engagement sustainability. Audio files were transcribed verbatim and analyzed via an inductive and deductive thematic approach., Results: Most participants (n = 46, 59.7%) discussed oral PrEP during their interview, though not directly prompted. Participants discussing PrEP had a mean age of 41.6 years and were predominantly white (54.3%) and cisgender men (60.9%). Among these, 15 participants described using PrEP. All participants had facilitated access to oral PrEP. Yet, the choice to use PrEP was influenced by personal risk perceptions, (mis)information about PrEP, and external factors (i.e. housing, financial security), which, for some, limited the autonomy to use PrEP. Two key themes emerged among participants using PrEP: ease of access and perceptions of high HIV risk. Those not using PrEP described two themes: low risk perception and prioritizing more urgent needs. Among participants not using PrEP a subgroup commonly described ambivalent interest, PrEP knowledge gaps, and PrEP readiness (i.e., contemplation)., Conclusions: Qualitative findings highlight that facilitated PrEP access was insufficient to motivate use for many participants. Rather, PrEP decision-making process (i.e., choice) was linked to risk perception and individuals' capability to leverage PrEP as a resource based on their circumstances (i.e., autonomy). Participants' descriptions of the centrality of choice and autonomy for PrEP use underscore that ease of access is a necessary pre-condition, but person-centered interventions should also address housing, financial stability, and urgent medical conditions to promote PrEP utilization among PWID., Clinical Trial Registration: NCT04804027., Competing Interests: Declarations. Ethics approval: This trial was approved for all sites by a central institutional review board (Advarra), and specific to the implementation science sub-study University of Toronto Research Ethics Board approval was also obtained. All participants provide written informed consent prior to initiation of any study activities. This manuscript’s content is solely the author’s responsibility and does not necessarily represent the official views of the NIH. JEL has receives research support from Gilead Sciences and Zydus and is a consultant to CytoDyn and Theratechnologies. Competing interests: None to declare., (© 2024. The Author(s).)

Background: Persons seeking emergency injury care are often from higher-risk and underserved key populations (KPs) and priority populations (PPs) for HIV programming. While facility-based HIV Testing Services (HTS) in Kenya are effective, emergency department (ED) delivery is limited, despite the potential to reach underserved persons., Methods: This quasi-experimental prospective study evaluated implementation of the HIV Enhanced Access Testing in Emergency Departments (HEATED) at Kenyatta National Hospital ED in Nairobi, Kenya. The HEATED program was designed as a multi-component intervention employing setting appropriate strategies for HIV care sensitization and integration, task shifting, resource reorganization, linkage advocacy, skills development and education to promote ED-HTS with a focus on higher-risk persons. KPs included sex workers, gay men, men who have sex with men, transgender persons and persons who inject drugs. PPs included young persons (18-24 years), victims of interpersonal violence, persons with hazardous alcohol use and persons never HIV tested. Data were obtained from systems-level records, enrolled injured patient participants and healthcare providers. Systems and patient-level data were collected during a pre-implementation period (6 March - 16 April 2023) and post-implementation (period 1, 1 May - 26 June 2023). Additional, systems-level data were collected during a second post-implementation (period 2, 27 June - 20 August 2023). HTS data were evaluated as facility-based HIV testing (completed in the ED) and distribution of HIV self-tests independently, and aggregated as ED-HTS. Evaluation analyses were completed across reach, effectiveness, adoption, implementation and maintenance framework domains., Results: All 151 clinical staff were reached through trainings and sensitizations on the HEATED program. Systems-level ED-HTS among all presenting patients increased from 16.7% pre-implementation to 23.0% post-implementation periods 1 and 2 (RR = 1.31, 95% CI: 1.21-1.43; p  < 0.001). Among 605 enrolled patient participants, facilities-based HTS increased from 5.7% pre-implementation to 62.3% post-implementation period 1 (RR = 11.2, 95%CI: 6.9-18.1; p  < 0.001). There were 440 (72.7%) patient participants identified as KPs (5.6%) and/or PPs (65.3%). For enrolled KPs/PPs, facilities-based HTS increased from 4.6% pre-implementation to 72.3% post-implementation period 1 (RR = 13.8, 95%CI: 5.5-28.7, p  < 0.001). Systems and participant level data demonstrated successful adoption and implementation of the HEATED program. Through 16 wk post-implementation a significant increase in ED-HTS delivery was maintained as compared to pre-implementation., Conclusions: The HEATED program increased overall ED-HTS and augmented delivery to KPs/PPs, suggesting that broader implementation could improve HIV services for underserved persons already in contact with health systems.

Background: Development of a non-sputum test using readily-obtainable biospecimens remains a global priority for tuberculosis (TB) control. We quantified lipoarabinomannan (LAM) concentrations, a pathogen biomarker for Mycobacterium tuberculosis, in urine, plasma and serum for real-world diagnostic accuracy of pulmonary TB among people living with and without HIV., Methods: We conducted a prospective diagnostic study among adults with TB symptoms in South Africa. We measured LAM concentrations in time-matched urine, plasma and serum with an electrochemiluminescence immunoassay using two capture antibodies (FIND 28 and S4-20). From the completed cohort, we randomly selected 210 participants (2 cases: 1 control) based on sensitivity estimates, and we compared diagnostic accuracy of LAM measurements against the microbiological reference standard., Findings: Urine and blood specimens from 210 of 684 adults enrolled were tested for LAM. Among 138 TB-positive adults (41% female), median urine LAM was 137 pg/mL and 52 pg/mL by FIND 28 and S4-20, respectively. Average LAM concentrations were highest in HIV-positive participants with CD4+ T cells <200 cells/mm 3 . Urine LAM by S4-20 achieved diagnostic sensitivity of 62% (95% CI: 53%-70%) and specificity of 99% (95% CI: 96%-100%). Plasma and serum LAM by FIND 28 showed similar sensitivity (70%, 95% CI: 62%-78%) and comparable specificities (90%, 95% CI: 82%-97%; 94%, 95% CI: 88%-99%). Diagnostic sensitivity of urine LAM by S4-20 was higher among participants without HIV (41%, 95% CI: 24%-61%) compared to HIV-positive participants with CD4 ≥200 cells/mm 3 (20%, 95% CI: 8%-39%)., Interpretation: Detection of LAM was achievable in non-sputum specimens for pulmonary TB, but additional analyte concentration or signal amplification may be required to achieve diagnostic accuracy targets., Funding: Bill and Melinda Gates Foundation., Competing Interests: Declaration of interests PKD and DW declare receiving grant funding, paid to the institution, from the Bill and Melinda Gates Foundation. PKD reports receiving consulting fees from ThermoFischer, InBios Internation, and Abbott Diagnostics, and advisory board fees from Abbvie and Cepheid. Rutgers University (AP) has a patent on the use of the A194-01 antibody for diagnosis of TB infections., (Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)

Background: HIV and syphilis are common sexually transmitted infections in sub-Saharan Africa. We aimed to investigate the prevalence and distribution of active syphilis while considering HIV status, demographic characteristics, and behavioural characteristics., Methods: The Population-based HIV Impact Assessment surveys used a cross-sectional, two-stage, stratified cluster sample design to collect data in Ethiopia, Tanzania, Uganda, Zambia, and Zimbabwe from 2015 to 2018. Eligible participants were aged 15 years and older and provided demographic information, behavioural information, and blood specimens for HIV and syphilis testing. Active syphilis was defined as the presence of both treponemal and non-treponemal antibodies, measured using an antigen-based rapid test. Multivariable logistic regression models with survey weights were applied. The estimated number of participants with active syphilis in each country was calculated by multiplying the survey-weighted syphilis prevalence by the corresponding participant population size from the latest national census data. The total burden across the five countries was obtained by summing these estimates., Findings: 102 831 participants enrolled in the five surveys (54 583 [57·6%] participants were female, 48 248 [42·4%] participants were male, 9036 [9·9%] participants were HIV positive). Population-based syphilis prevalence was 0·9% (95% CI 0·7-1·1) in Tanzania and Zimbabwe, 2·1% (1·9-2·4) in Uganda, and 3·0% (2·7-3·4) in Zambia. Overall, an estimated 1 027 615 (95% CI 877 243-1 158 246) participants had active syphilis across the five countries (266 383 HIV-positive and 761 232 HIV-negative individuals). Syphilis prevalence was higher among people living with HIV (range from 2·6% [95% CI 1·1-4·0] in Ethiopia to 9·6% [8·1-11·0] in Zambia) than among those without HIV (range from 0·8% [0·7-1·0] in Tanzania to 2·1% [1·8-2·4] in Zimbabwe). The odds of active syphilis were higher among people living with HIV than in those who were HIV negative (adjusted odds ratio [aOR] range from 2·5 [95% CI 1·8-3·4] in Uganda to 5·9 [3·8-9·2] in Zimbabwe), among divorced, separated, or widowed individuals (aOR range from 1·5 [1·1-2·0] in Uganda to 2·7 [1·7-4·3] in Zimbabwe), and among those reporting two or more sexual partners in the previous 12 months (aOR range from 1·1 [CI 0·8-1·5] in Uganda to 1·9 [1·1-3·3] in Zimbabwe)., Interpretation: This study shows the high burden of syphilis in five sub-Saharan African countries, with a correlation between HIV and active syphilis, underscoring the need for integrated sexual health services and targeted diagnosis, prevention, and treatment strategies to address this public health challenge., Funding: The President's Emergency Plan for AIDS Relief through the US Centers for Disease Control and Prevention., Competing Interests: Declaration of interests We declare no competing interests., (Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Background: Incentives have shown mixed results in increasing HIV testing rates in low-resource settings. We investigated the effectiveness of offering additional self-tests (HIVSTs) as an incentive to increase testing among partners receiving assisted partner services (APS)., Setting: Western Kenya., Methods: We conducted a single-crossover study nested within a cluster-randomized controlled trial. Twenty-four facilities were randomized 1:1 to (1) control: provider-delivered testing or (2) intervention: offered 1 HIVST or provider-delivered testing for 6 months (pre-implementation), then switched to offering 2 HIVSTs for 6 months (post-implementation). A difference-in-differences approach using generalized linear mixed models, accounting for facility clustering and adjusting for age, sex, and income, was used to estimate the effect of the incentive on HIV testing and first-time testing among partners in APS., Results: March 2021-June 2022, 1127 index clients received APS and named 8155 partners, among whom 2333 reported a prior HIV diagnosis and were excluded from analyses, resulting in 5822 remaining partners: 3646 (62.6%) and 2176 (37.4%) in the pre-implementation and post-implementation periods, respectively. Overall, 944/2176 partners (43%) were offered a second HIVST during post-preimplementation, of whom 34.3% picked up 2 kits, of whom 71.7% reported that the second kit encouraged HIV testing. Comparing partners offered 1 vs. two HIVSTs showed no difference in HIV testing (relative risk: 1.01, 95% confidence interval: 0.951 to 1.07) or HIV testing for the first time (relative risk: 1.23, 95% confidence interval: 0.671 to 2.24)., Conclusions: Offering a second HIVST as an incentive within APS did not significantly impact HIV testing or first-time testing, although those opting for 2 kits reported it incentivized them to test., Competing Interests: The authors have no funding or conflicts of interest to disclose., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Previous data suggest a lack of cross-resistance between the gp120-directed attachment inhibitor temsavir (active moiety of fostemsavir) and the CD4-directed post-attachment inhibitor ibalizumab. Recently, analysis of HIV-1 envelopes with reduced sensitivity to both inhibitors was undertaken to determine whether they shared genotypic correlates of resistance. Sequences from 2 envelopes with reduced susceptibility to both agents were mapped onto a temsavir-bound gp120 structure. Residues within 5.0 Å of the temsavir binding site were evaluated using reverse genetics. Broader applicability and contextual determinants of key substitutions were further assessed using envelopes from participants in the phase 3 BRIGHTE study. Temsavir sensitivity was measured by half-maximal inhibitory concentration (IC 50 ) and ibalizumab sensitivity by IC 50 and maximum percent inhibition (MPI). One envelope required substitutions of E113D and T434M for full restoration of temsavir susceptibility. Neither substitution nor their combination affected ibalizumab sensitivity. However, in the second envelope, an E202 substitution (HXB2, T202) was sufficient for observed loss of susceptibility to both inhibitors. One BRIGHTE participant with no ibalizumab exposure had an emergent K202E substitution at protocol-defined virologic failure, with reduced sensitivity to both inhibitors. Introducing T202E into previously susceptible clinical isolates reduced temsavir potency by ≥ 40-fold and ibalizumab MPI from >99% to ∼80%. Interestingly, introduction of the gp120 V5 region from a highly ibalizumab-susceptible envelope mitigated the E202 effect on ibalizumab but not temsavir. A rare HIV-1 gp120 E202 mutation reduced temsavir susceptibility, and depending on sequence context, could result in reduced susceptibility to ibalizumab., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Background: Alcohol use is a major contributor to mortality and morbidity worldwide. Uganda has a high level of alcohol use per capita. Compared to men, women are less likely to consume alcohol globally; however, women who drink have increased risks for co-occurring conditions, including depression, intimate partner violence, and HIV. This study assessed the prevalence of alcohol use and correlates of harmful alcohol use by gender and HIV status in rural Uganda., Methods: We used cross-sectional data from a study among women and men aged 15-59 residing in rural, central Uganda and accepting home-based HIV testing (Nov 2017 to Dec 2020). We estimated the prevalence of levels of alcohol use (categorized as no alcohol use (score 0), low (score 1-3 for men; 1-2 for women), medium (score 4-5 for men; 3-5 for women), high (score 6-7), and very-high (score 8-12) use with the AUDIT-C), stratified by gender and HIV status. We assessed correlates of harmful alcohol use using multivariable logistic regression models for women and men., Results: Among 18,460 participants, 67% (95% CI: 66-67%) reported no alcohol use, 16% (95% CI: 16-17%) reported low, 5% (95% CI: 4.8-5%) reported medium, 5% (95% CI: 4-5%) reported high, and 3% (95% CI: 2.8-3) reported very high alcohol use. Compared to women, men were more likely to report alcohol use (Chi-squared p-value<0.0001). People diagnosed with HIV (both newly diagnosed and previously aware of their status prior to home-based HIV testing) were more likely to report low, medium, high, and very high alcohol use compared to those who were HIV negative (Chi-squared p-value<0.0001). Among women, those who were newly diagnosed were more likely report alcohol use, compared to those who were HIV negative. In multivariable models, being newly diagnosed with HIV (compared to HIV negative) increased the odds of harmful alcohol use among women, but not men., Conclusion: While alcohol use was higher among men and people living with HIV, being newly diagnosed with HIV had a stronger relationship with harmful alcohol use among women than men. More research is needed to understand how alcohol use may increase the risks of HIV acquisition among women and to identify gender-responsive services to address harmful alcohol use and increase access to HIV testing and linkage to care for women who use harmful levels of alcohol., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Wynn et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Introduction: Assisted partner services (APS), or exposure notification and HIV testing for sexual partners of persons diagnosed HIV positive (index clients), is recommended by the World Health Organization. Most APS literature focuses on outcomes among index clients and their partners. There is little data on the benefits of providing APS to partners of partners diagnosed with HIV., Methods: We utilized data from a large-scale APS implementation project across 31 facilities in western Kenya from 2018 to 2022. Females testing HIV positive at facilities were offered APS; those who consented provided contact information for all male sexual partners in the last 3 years. Male partners were notified of their potential HIV exposure and offered HIV testing services (HTS). Males newly testing positive were also offered APS and asked to provide contact information for their female partners in the last 3 years. Female partners of male partners (FPPs) were provided exposure notification and HTS. All participants with HIV were followed up at 12 months post-enrolment to assess linkage-to antiretroviral treatment (ART) and viral suppression. We compared HIV positivity, demographics and linkage outcomes among female index clients and FPPs., Results: Overall, 5708 FPPs were elicited from male partners, of whom 4951 received HTS through APS (87% coverage); 291 FPPs newly tested HIV positive (6% yield), an additional 1743 (35.2%) reported a prior HIV diagnosis, of whom 99% were on ART at baseline. At 12 months follow-up, most FPPs were taking ART (92%) with very few adverse events: <1% reported intimate partner violence or reported relationship dissolution. FPPs were more likely than female index clients to report HIV risk behaviours including no condom use at last sex (45% vs. 30%) and multiple partners (38% vs. 19%)., Conclusions: Providing HIV testing via APS to FPP is a safe and effective strategy to identify newly diagnosed females and achieve high linkage and retention to ART and can be an efficient means of identifying HIV cases in the era of declining HIV incidence. The high proportion of FPPs reporting HIV risk behaviours suggests APS may help interrupt community HIV transmission via increased knowledge of HIV status and linkage to treatment., (© 2024 The Author(s). Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of International AIDS Society.)

Alcohol use among people living with HIV (PWH) is common and may negatively affect engagement in HIV care. We evaluated the relationships between alcohol use, ART use, and viral suppression among PWH in Uganda. PATH/Ekkubo was a trial evaluating a linkage to HIV care intervention in four Ugandan districts, Nov 2015-Sept 2021. Our analytical sample included: (1) baseline data from individuals not enrolled in the intervention trial (previously diagnosed HIV+); and 12-month follow-up data from the control group (newly diagnosed or previously diagnosed, but not in care). Level of alcohol use was categorized using the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C): none (AUDIT-C = 0), low (women = 1-2, men = 1-3), medium (women = 3-5, men = 4-5), high/very high (6-12). Multivariable logistic regression models evaluated associations between alcohol use, ART use and viral suppression (a viral load of < 20); we also stratified by gender. Among 931 PWH, medium (OR: 0.43 [95% CI 0.25-0.72]) and high/very high (OR: 0.22 [95% CI 0.11-0.42]) levels of alcohol use were associated with lower odds of being on ART. In a sub-sample of 664, medium use (OR: 0.63 [95% CI 0.41-0.97]) was associated with lower odds of viral suppression. However, this association was not statistically significant when restricting to those on ART, suggesting the relationship between alcohol use and viral suppression is explained by ART use. Among men, high/very high, and among women, medium alcohol use levels were associated with lower odds of being on ART and being virally suppressed. Interventions for PWH who use higher levels of alcohol may be needed to optimize the benefits of Uganda's Universal Test and Treat strategy., (© 2024. The Author(s).)

Introduction: Assisted partner services (APS) is an effective strategy for increasing HIV testing, new diagnosis, and linkage to care among sexual partners of people living with HIV (PLWH). APS can be resource intensive as it requires community tracing to locate each partner named and offer them testing. There is limited evidence for the effectiveness of offering HIV self-testing (HIVST) as an option for partner testing within APS., Methods: We conducted a cluster randomized controlled trial comparing provider-delivered HIV testing (Standard APS) versus offering partners the option of provider-delivered testing or HIVST (APS+HIVST) at 24 health facilities in Western Kenya. Facilities were randomized 1:1 and we conducted intent-to-treat analyses using Poisson generalized linear mixed models to estimate intervention impact on HIV testing, new HIV diagnoses, and linkage to care. All models accounted for clustering at the clinic level and new diagnoses and linkage models were adjusted for individual-level age, sex, and income a priori., Results: From March to December 2021, 755 index clients received APS and named 5054 unique partners. Among these, 1408 partners reporting a prior HIV diagnosis were not eligible for HIV testing and were excluded from analyses. Of the remaining 3646 partners, 96.9% were successfully contacted for APS and tested for HIV: 2111 (97.9%) of 2157 in the APS+HIVST arm and 1422 (95.5%) of 1489 in the Standard APS arm. In the APS+HIVST arm, 84.6% (1785/2111) tested via HIVST and 15.4% (326/2111) received provider-delivered testing. Overall, 16.7% of the 3533 who tested were newly diagnosed with HIV (APS+HIVST = 357/2111 [16.9%]; Standard APS = 232/1422 [16.3%]). Of the 589 partners who were newly diagnosed, 90.7% were linked to care (APS+HIVST = 309/357 [86.6%]; Standard APS = 225/232 [97.0%]). There were no significant differences between the two arms in HIV testing (relative risk [RR]: 1.02, 95% CI: 0.96-1.10), new HIV diagnoses (adjusted RR [aRR]: 1.03, 95% CI: 0.76-1.39) or linkage to care (aRR: 0.88, 95% CI: 0.74-1.06)., Conclusions: There were no differences between APS+HIVST and Standard APS, demonstrating that integrating HIVST into APS continues to be an effective strategy for identifying PLWH by successfully reaching and HIV testing >95% of elicited partners, newly diagnosing with HIV one in six of those tested, >90% of whom were linked to care., Clinical Trial Number: NCT04774835., (© 2024 The Author(s). Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of International AIDS Society.)

Background: Pre-Exposure Prophylaxis (PrEP) has demonstrated efficacy in preventing HIV infection. Female Bar Workers (FBWs) often act as informal sex workers, placing them at risk of HIV infection. Despite expressing interest in PrEP, FBWs face barriers to accessing public-sector clinics where PrEP is delivered. We developed a study to compare the effectiveness of workplace-based PrEP provision to standard-of-care facility-based provision for PrEP initiation, retention and adherence among FBWs., Methods: In this double-randomized intervention study, FBWs aged 15 years and above will be screened, consented and initiated on PrEP (emtricitabine/tenofovir disoproxil), and followed for six months. Participants will be randomized at the bar level and offered PrEP at their workplace or at a health facility. Those who are initiated will be independently individually randomized to either receive or not receive an omni-channel PrEP champion intervention (support from an experienced PrEP user) to improve PrEP adherence. We expect to screen 1,205 FBWs to enroll at least 160 HIV negative women in the study. Follow-up visits will be scheduled monthly. HIV testing will be performed at baseline, month 1, 4 and 6; and TDF testing at months 2 and 6. Primary outcomes for this trial are: (1) initiation on PrEP (proportion of those offered PrEP directly observed to initiate PrEP); and (2) adherence to PrEP (detectable urine TDF drug level at 6-months post-enrollment). The primary outcomes will be analyzed using Intention-to-Treat (ITT) analyses., Discussion: Using a randomized trial design, we will evaluate two interventions aiming to reduce barriers to uptake and retention on PrEP among FBWs, a vulnerable population at risk of HIV acquisition and onward transmission. If these interventions prove effective in promoting PrEP among FBWs, they could assist in abating the HIV epidemic in Africa., Trial Registration: Registered with German Clinical Trials Register (www.drks.de) on 29 April 2020; Registration number DRKS00018101., Competing Interests: The authors declare that there are no competing interests exist., (Copyright: © 2024 Chebet et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Viral suppression (VS) in children has remained suboptimal compared to that in adults. We evaluated the impact of transitioning children weighing < 20 kg to a pediatric formulation of dolutegravir (pDTG) on VS in Malawi. We analyzed routine retrospective program data from electronic medical record systems pooled across 169 healthcare facilities in Malawi supported by the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF). We included children who weighed < 20 kg and received antiretroviral therapy (ART) between July 2021-June 2022. Using descriptive statistics, we summarized demographic and clinical characteristics, ART regimens, ART adherence, and VS. We used logistic regression to identify factors associated with post-transition VS. A total of 2468 Children Living with HIV (CLHIV) were included, 55.3% of whom were < 60 months old. Most (83.8%) had initiated on non-DTG-based ART; 71.0% of these had a viral load (VL) test result before transitioning to pDTG, and 62.5% had VS. Nearly all (99.9%) CLHIV transitioned to pDTG-based regimens. Six months after the transition, 52.7% had good ART adherence, and 38.6% had routine VL testing results; 81.7% achieved VS. Post-transition VS was associated with good adherence and pre-transition VS: adjusted odds ratios of 2.79 (95% CI 1.65-4.71), p < 0.001 and 5.32 (95% CI 3.23-9.48), p < 0.001, respectively. After transitioning to pDTG, VS was achieved in most children tested within the first 6 months. However, adherence remained suboptimal post-transition and VL testing at 6 months was limited. Interventions to improve VL testing and enhance ART adherence are still needed in CLHIV on pDTG-based regimens., (© 2024. The Author(s).)

Background: Critical to efforts to end the HIV epidemic is the identification of persons living with HIV who have yet to be diagnosed and engaged in care. Expanded HIV testing outreach efforts need to be both efficient and ambitious, targeting the social networks of persons living with HIV and those at above-average risk of undiagnosed HIV infection. The ubiquity of mobile phones across many high HIV prevalence settings has created opportunities to leverage mobile health (mHealth) technologies to engage social networks for HIV testing outreach, prevention, and treatment., Objective: The purpose of this study is to evaluate the acceptability and efficacy of a novel mHealth intervention, "Confidential Social Network Referrals for HIV Testing (CONSORT)," to nudge at-risk individuals to test for HIV using SMS text messages., Methods: We will conduct the CONSORT study in Moshi, Tanzania, the commercial center and administrative capital of the Kilimanjaro Region in northern Tanzania. After qualitative formative work and pilot testing, we will enroll 400 clients presenting for HIV counseling and testing and 200 persons living with HIV and receiving care at HIV care and treatment centers as "inviters" into a randomized controlled trial. Eligible participants will be aged 18 years or older and live, work, or regularly receive care in Moshi. We will randomize inviters into 1 of 2 study arms. All inviters will be asked to complete a survey of their HIV testing and risk behaviors and to think of social network contacts who would benefit from HIV testing. They will then be asked to whom they would prefer to extend an HIV testing invitation in the form of a physical invitation card. Arm 1 participants will also be given the opportunity to extend CONSORT invitations in the form of automated confidential SMS text messages to any of their social network contacts or "invitees." Arm 2 participants will be offered physical invitation cards alone. The primary outcome will be counselor-documented uptake of HIV testing by invitees within 30 days of inviter enrollment. Secondary outcomes will include the acceptability of CONSORT among inviters, the number of new HIV diagnoses, and the HIV risk of invitees who present for testing., Results: Enrollment in the randomized controlled trial is expected to start in September 2024. The findings will be disseminated to stakeholders and published in peer-reviewed journals., Conclusions: If CONSORT is acceptable and effective for increasing the uptake of HIV testing, given the minimal costs of SMS text reminders and the potential for exponential but targeted growth using chain referrals, it may shift current practices for HIV testing programs in the area., Trial Registration: ClincalTrials.gov NCT05967208; https://clinicaltrials.gov/study/NCT05967208., International Registered Report Identifier (irrid): PRR1-10.2196/55068., (©Jan Ostermann, Bernard Njau, Marco van Zwetselaar, Thespina Yamanis, Leah McClimans, Rose Mwangi, Melkiory Beti, Amy Hobbie, Salomé-Joelle Gass, Tara Mtuy, Nathan Thielman. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 30.05.2024.)

We evaluated the prevalence and correlates of HIV viral nonsuppression and HIV drug resistance (HIV-DR) in a cohort of people who inject drugs living with HIV (PWID-LH) and their sexual and injecting partners living with HIV in Kenya. HIV-DR testing was performed on participants with viral nonsuppression. Of 859 PWID-LH and their partners, 623 (72.5%) were on antiretroviral therapy (ART) ≥4 months and 148/623 (23.8%) were not virally suppressed. Viral nonsuppression was more common among younger participants and those on ART for a shorter duration. Among 122/148 (82.4%) successfully sequenced samples, 55 (45.1%) had detectable major HIV-DR mutations, mainly to non-nucleoside and nucleotide reverse transcriptase inhibitors (NNRTI and NRTI). High levels of HIV-DR among those with viral nonsuppression suggests need for viral load monitoring, adherence counseling, and timely switching to alternate ART regimens in this key population.

Background: The principal barrier to an HIV cure is the presence of the latent viral reservoir (LVR), which has been understudied in African populations. From 2018 to 2019, Uganda instituted a nationwide rollout of ART consisting of Dolutegravir (DTG) with two NRTI, which replaced the previous regimen of one NNRTI and the same two NRTI., Methods: Changes in the inducible replication-competent LVR (RC-LVR) of ART-suppressed Ugandans with HIV (n = 88) from 2015 to 2020 were examined using the quantitative viral outgrowth assay. Outgrowth viruses were examined for viral evolution. Changes in the RC-LVR were analyzed using three versions of a Bayesian model that estimated the decay rate over time as a single, linear rate (model A), or allowing for a change at time of DTG initiation (model B&C)., Findings: Model A estimated the slope of RC-LVR change as a non-significant positive increase, which was due to a temporary spike in the RC-LVR that occurred 0-12 months post-DTG initiation (p < 0.005). This was confirmed with models B and C; for instance, model B estimated a significant decay pre-DTG initiation with a half-life of 6.9 years, and an ∼1.7-fold increase in the size of the RC-LVR post-DTG initiation. There was no evidence of viral failure or consistent evolution in the cohort., Interpretation: These data suggest that the change from NNRTI- to DTG-based ART is associated with a significant temporary increase in the circulating RC-LVR., Funding: Supported by the NIH (grant 1-UM1AI164565); Gilead HIV Cure Grants Program (90072171); Canadian Institutes of Health Research (PJT-155990); and Ontario Genomics-Canadian Statistical Sciences Institute., Competing Interests: Declaration of interests RR and SLL are employed by BioInfoExperts, LLC. No other authors have any conflicts to report., (Published by Elsevier B.V.)

Background: In settings without etiologic testing for sexually transmitted infections (STIs), programs rely on STI symptom data to inform priorities. To evaluate whether self-reported STI symptoms in household surveys consistently represent the STI burden, we compared symptomatic infection rates between survey self-reporting and health facility case reporting in Malawi., Methods: We analyzed self-reported symptoms and treatment seeking in the past year among sexually active adults from 4 Malawi Demographic and Health Surveys between 2000 and 2015. Bayesian mixed-effects models were used to estimate temporal trends, spatial variation, and sociodemographic determinants. Survey reporting was compared with health facility syndromic diagnoses between 2014 and 2021., Results: In surveys, 11.0% (95% confidence interval, 10.7%-11.4%) of adults reported STI or STI-related symptoms in the last year, of whom 54.2% (52.8%-55.7%) sought treatment. In facilities, the mean annual symptomatic case diagnosis rate was 3.3%. Survey-reported treatment in the last year was 3.8% (95% credible interval, 2.3%-6.1%) for genital ulcer, 3.8% (2.0%-6.7%) for vaginal discharge, and 2.6% (1.2%-4.7%) for urethral discharge. Mean annual diagnosis rates at facilities were 0.5% for genital ulcer, 2.2% for vaginal discharge, and 2.0% for urethral discharge. Both data sources indicated a higher burden of symptoms among women, individuals older than 25 years, and those in Southern Malawi., Conclusions: Survey and facility case reports indicated similar spatial and demographic patterns of STI symptom burden and care seeking, but implied large differences in the magnitude and relative burden of symptoms, particularly genital ulcer, which could affect program priorities. Targeted etiologic surveillance would improve interpretation of these data to enable more comprehensive STI surveillance., Competing Interests: Conflict of Interest and Sources of Funding: The authors have no competing interests to declare., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Sexually Transmitted Diseases Association.)

Early gene therapy studies held great promise for the cure of heritable diseases, but the occurrence of various genotoxic events led to a pause in clinical trials and a more guarded approach to progress. Recent advances in genetic engineering technologies have reignited interest, leading to the approval of the first gene therapy product targeting genetic mutations in 2017. Gene therapy (GT) can be delivered either in vivo or ex vivo. An ex vivo approach to gene therapy is advantageous, as it allows for the characterization of the gene-modified cells and the selection of desired properties before patient administration. Autologous cells can also be used during this process which eliminates the possibility of immune rejection. This review highlights the various stages of ex vivo gene therapy, current research developments that have increased the efficiency and safety of this process, and a comprehensive summary of Human Immunodeficiency Virus (HIV) gene therapy studies, the majority of which have employed the ex vivo approach.

Objective: The aim of the research was to understand what drives and motivates young women living with HIV in their treatment journeys, as well as their key influencers. The findings will assist in appreciating their obstacles to treatment and constructing the most effective ways to convey fresh messages to them. These insights will contribute to the messaging developed for a campaign across sub-Saharan Africa, primarily Malawi and Zimbabwe., Design: This was a qualitative study conducted in order to build an understanding of unknown parts of the HIV treatment journey through in-depth interviews. A hybrid approach was used to conduct thematic analysis., Setting and Participants: Study participants were HIV-positive women, their influencers (eg, parents/partners/siblings/aunts and uncles/religious leaders, etc) and healthcare providers from a range of regions in Zimbabwe and Malawi., Results: A total of 26 young people living with HIV (PLHIV), 29 healthcare providers and 24 influencers such as maternal figures in the community were interviewed. Two main broad insights were drawn, that is, key needs and wider contextual factors. The key needs of young PLHIV to stay on treatment were empathy, support and emotional connection with antiretroviral therapy (ART), while the wider contextual factors impacting their treatment journeys were structural challenges and cultural reference points. Fear of shame and humiliation can also be significant barriers to disclosure and treatment. The fear predisposes the PLHIV to the need for empathy, support and connection with ART. Mental health and anxiety appear to be comorbid with HIV. Some PLHIV have a small and limited support network leading to very few people living openly with HIV. There is no 'one-size-fits-all' approach, and maximising campaign reach will likely need a multifaceted approach., Conclusion: Currently, the relationship between nurses and PLHIV can appear to be transactional. Through learning about the community (including PLHIV), there are more chances of communicating in a way that resonates., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Background: Despite tremendous progress in antiretroviral therapy (ART) and access to ART, many patients have advanced human immunodeficiency virus (HIV) disease (AHD). Patients on AHD, whether initiating ART or providing care after disengagement, have an increased risk of morbidity and mortality. The Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) launched an enhanced care package using a hub-and-spoke model to optimize AHD care in Malawi. This model improves supply availability and appropriate linkage to care. We utilized a hub-and-spoke model to share health facility challenges and recommendations on the AHD package for screening and diagnosis, prophylaxis, treatment, and adherence support., Methods: This qualitative study assessed the facility-level experiences of healthcare workers (HCWs) and lay cadres (LCs) providing AHD services to patients through an intervention package. The study population included HCWs and LCs supporting HIV care at four intervention sites. Eligible study participants were recruited by trained Research Assistants with support from the health facility nurse to identify those most involved in supporting patients with AHD. A total of 32 in-depth interviews were conducted. Thematic content analysis identified recurrent themes and patterns across participants' responses., Results: While HCWs and LCs stated that most medications are often available at both hub and spoke sites, they reported that there are sometimes limited supplies and equipment to run samples and tests necessary to provide AHD care. More than half of the HCWs stated that AHD training sufficiently prepared them to handle AHD patients at both the hub and spoke levels. HCWs and LCs reported weaknesses in the patient referral system within the hub-and-spoke model in providing a linkage of care to facilities, specifically improper referral documentation, incorrect labeling of samples, and inconsistent availability of transportation. While HCWs felt that AHD registers were time-consuming, they remained motivated as they thought they provided better patient services., Conclusions: These findings highlight the importance of offering comprehensive AHD services. The enhanced AHD program addressed weaknesses in service delivery through decentralization and provided services through a hub-and-spoke model, improved supply availability, and strengthened linkage to care. Additionally, addressing the recommendations of service providers and patients is essential to improve the health and survival of patients with AHD., (© 2024. The Author(s).)

Adolescents and youth living with HIV (AYLHIV) experience worse health outcomes compared to adults. We aimed to understand the experiences of AYLHIV in care in the youth-focused Red-Carpet program in Kenya to assess the quality of service provision and identify programmatic areas for optimization. We conducted focus group discussions among 39 AYLHIV (15-24 years) and structured analysis into four thematic areas. Within the HIV testing theme, participants cited fear of positive results, confidentiality and stigma concerns, and suggested engaging the community and youth in HIV testing opportunities. Within the HIV treatment adherence theme, participants cited forgetfulness, stigma, adverse side effects, lack of family support, and treatment illiteracy as barriers to adherence. Most participants reported positive experiences with healthcare providers and peer support. In terms of the HIV status disclosure theme, AYLHIV cited concerns about their future capacity to conceive children and start families and discussed challenges with understanding HIV health implications and sharing their status with friends and partners. Youth voices informing service implementation are essential in strengthening our capacity to optimize the support for AYLHIV within the community, at schools and healthcare facilities., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Kose et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Many adolescent girls and young women (AGYW) living with human immunodeficiency virus (HIV) report intimate partner violence (IPV), including emotional IPV and controlling behavior. Yet, few studies have examined the association between these forms of IPV and health outcomes among AGYW living with HIV., Objectives: We conducted an exploratory qualitative study to understand the contexts in which controlling behavior and emotional IPV might impact the health of AGYW living with HIV in Uganda., Design: We used a participatory action research design involving community stakeholders (health workers, program managers of non-governmental organizations serving IPV survivors, and AGYW living with HIV)., Methods: Data were collected through in-depth interviews and focus groups. We analyzed data using an inductive thematic analysis approach., Results: The following four themes related to different dimensions of controlling behavior and emotional IPV among AGYW living with HIV emerged from the data: (1) age-related controlling behavior and emotional IPV; (2) HIV-related controlling behavior and emotional IPV; (3) isolation-type controlling behavior and poor HIV health; (4) financial control and poor HIV health. Embedded throughout the four themes were issues related to male partners' misuse of power., Conclusion: AGYW living with HIV experience unique forms of emotional IPV and controlling behavior that impede their ability to remain healthy. Inequitable gender norms may further increase the risk of emotional IPV and controlling behavior among AGYW living with HIV. Couples-based interventions that build healthy relationship skills and offer social support may help to reduce these forms of IPV.

Background: HIV is hyperendemic among fisherfolk in Sub-Saharan Africa, especially around Lake Victoria, Uganda. Purpose/Research Design: We conducted cross-sectional semi-structured interviews about oral pre-exposure prophylaxis (PrEP) implementation with 35 Ugandan fisherfolk (15 women, 20 men) and 10 key stakeholders (healthcare providers, policymakers, community leaders). We used a directed content analysis approach based on implementation science and social marketing frameworks. Results: Participants showed high acceptability for PrEP. Anticipated barriers among fisherfolk included stigma (due to similar medications/packaging as HIV treatment); misconceptions; mobility, competing needs, poverty, and partner conflict. Anticipated provider barriers included insufficient staffing and travel support. Recommendations included: change PrEP packaging; integrate PrEP with other services; decrease PrEP refill frequency; give transportation resources to providers; train more healthcare workers to provide PrEP to fisherfolk; and use positively framed messages to promote PrEP. Conclusions: Results can inform policymakers and healthcare organizations on how to overcome barriers to PrEP scale-up in most at-risk populations with poor healthcare access., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Uptake of PrEP remains suboptimal, especially in the Southern United States. Same-day or "Rapid PrEP Initiatives" (RPIs) in sexual health centers (SHCs) could facilitate access and overcome barriers to PrEP. We studied the adaptation of an RPI from Denver, Colorado to an SHC in New Orleans, Louisiana. Through focus group discussions (FGDs) with local SHC staff and PrEP providers, we developed a preliminary RPI model. In 5 FGDs with SHC clients referred for or taking PrEP, we gathered adaptation recommendations and feedback on model acceptability, feasibility, and utility. Providers and clients voiced unanimous support for the RPI. Clients favored the ease of same-day PrEP initiation and emphasized a desire for navigational support, financial counseling, and integration of PrEP care with their other clinical needs. Clients recommended that SHC providers discuss PrEP and HIV with all patients, regardless of providers' perception of risk. Next steps include small-scale implementation and evaluation., Competing Interests: Declaration of Conflicting InterestsThe authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: MEC has received research support (grants to institution) from Gilead Sciences and ViiV Healthcare; has received consultancy/advisory board fees from ViiV Healthcare and FHI360; and has received personal fees for educational events from Vindico Medical, Education, Practice Point Communications, and Prime Education. RAL has conducted clinical trials at her institution for Abbott, Becton Dickenson, BioFire, Cepheid, Chembio, Cue, Gilead, Hologic, LabCorp, Merck, QuidelOrtho, Roche, and Visby; has served on a scientific advisory board for Abbott and Roche; and has received personal fees for educational events from Cepheid and Oakstone Publishing.

Background: Emergency department-based HIV self-testing (ED-HIVST) could increase HIV-testing services to high-risk, under-reached populations., Objectives: This study sought to understand the injury patient acceptability of ED-HIVST., Methods: Injury patients presenting to the Kenyatta National Hospital Accident and Emergency Department were enrolled from March to May 2021. Likert item data on HIVST assessing domains of general acceptability, personal acceptability, and acceptability to distribute to social and/or sexual networks were collected. Ordinal regression was performed yielding adjusted odds ratios (aOR) to identify characteristics associated with high HIVST acceptability across domains., Results: Of 600 participants, 88.7% were male, and the median age was 29. Half reported having primary care providers (PCPs) and 86.2% reported prior HIV testing. For each Likert item, an average of 63.5% of the participants reported they 'Agree Completely' with positive statements about ED-HIVST in general, for themselves, and for others. In adjusted analysis for general acceptability, those <25 (aOR = 1.67, 95%CI:1.36-2.08) and with prior HIV testing (aOR = 1.68, 95%CI:1.27-2.21) had greater odds of agreeing completely. For personal acceptability, those with a PCP (aOR = 3.31, 95%CI:2.72-4.03) and prior HIV testing (aOR = 1.83, 95%CI:1.41-2.38) had greater odds of agreeing completely. For distribution acceptability, participants with a PCP (aOR = 2.42, 95%CI:2.01-2.92) and prior HIV testing (aOR = 1.79, 95%CI: 1.38-2.33) had greater odds of agreeing completely., Conclusions: ED-HIVST is perceived as highly acceptable, and young people with prior testing and PCPs had significantly greater favourability. These data provide a foundation for ED-HIVST programme development in Kenya.

Millions of Africans are on dolutegravir-based antiretroviral therapy (ART), but few detailed descriptions of dolutegravir resistance and its clinical management exist. We reviewed HIV drug resistance (HIVDR) testing application forms submitted between June 2019 and October 2022, data from the national HIVDR database, and genotypic test results. We obtained standardized ART outcomes and virological results of cases with dolutegravir resistance, and explored associations with dolutegravir resistance among individuals with successful integrase sequencing. All cases were on two nucleoside reverse transcriptase inhibitors (NRTIs)/dolutegravir, and had confirmed virological failure, generally with prolonged viremia. Among 89 samples with successful integrase sequencing, 24 showed dolutegravir resistance. Dolutegravir resistance-associated mutations included R263K (16/24), E138K (7/24), and G118R (6/24). In multivariable logistic regression analysis, older age and the presence of high-level NRTI resistance were significantly associated with dolutegravir resistance. After treatment modification recommendations, four individuals (17%) with dolutegravir resistance died, one self-discontinued ART, one defaulted, and one transferred out. Of the 17 remaining individuals, 12 had follow-up VL results, and 11 (92%) were <1000 copies/mL. Twenty-four cases with dolutegravir resistance among 89 individuals with confirmed virological failure suggests a considerable prevalence in the Malawi HIV program. Successful management of dolutegravir resistance was possible, but early mortality was high. More research on the management of treatment-experienced individuals with dolutegravir resistance is needed.

Age at HIV acquisition may influence viral pathogenesis in infants, and yet infection timing (i.e. date of infection) is not always known. Adult studies have estimated infection timing using rates of HIV RNA diversification, however, it is unknown whether adult-trained models can provide accurate predictions when used for infants due to possible differences in viral dynamics. While rates of viral diversification have been well defined for adults, there are limited data characterizing these dynamics for infants. Here, we performed Illumina sequencing of gag and pol using longitudinal plasma samples from 22 Kenyan infants with well-characterized infection timing. We used these data to characterize viral diversity changes over time by designing an infant-trained Bayesian hierarchical regression model that predicts time since infection using viral diversity. We show that diversity accumulates with time for most infants (median rate within pol = 0.00079 diversity/month), and diversity accumulates much faster than in adults (compare previously-reported adult rate within pol = 0.00024 diversity/month [1]). We find that the infant rate of viral diversification varies by individual, gene region, and relative timing of infection, but not by set-point viral load or rate of CD4+ T cell decline. We compare the predictive performance of this infant-trained Bayesian hierarchical regression model with simple linear regression models trained using the same infant data, as well as existing adult-trained models [1]. Using an independent dataset from an additional 15 infants with frequent HIV testing to define infection timing, we demonstrate that infant-trained models more accurately estimate time since infection than existing adult-trained models. This work will be useful for timing HIV acquisition for infants with unknown infection timing and for refining our understanding of how viral diversity accumulates in infants, both of which may have broad implications for the future development of infant-specific therapeutic and preventive interventions., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: FAM is an Investigator of the Howard Hughes Medical Institute (HHMI)., (Copyright: © 2023 Russell et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

This study was performed to validate a dried blood spot (DBS) method for the serological screening of HIV, syphilis, hepatitis B and C. It included 250 paired DBS and serum samples and 116 unpaired DBS samples from 366 unique patients from two laboratories between 8 October and 2 November 2021. As determined by original test request, these were tested using a DBS method for HIV Ag/Ab (n=216), anti-treponemal Ab (n=166), hepatitis B sAg (n=100), and hepatitis C Ab (n=100) Elecsys assays on the Roche Cobas automated platform. Using the manufacturer's (serum) cut-off for reactivity ('positivity'), the sensitivity and specificity of DBS testing compared with serum were: for HIV Ag/Ab 100% and 100%, for anti-treponemal Ab 68.3% and 100%, for hepatitis B sAg 95.9% and 100%, and for hepatitis C Ab 84.0% and 100%, respectively. Adjusting the assay cut-off using receiver operator curve analysis increased sensitivity of DBS testing for anti-treponemal Ab to 90.0%, hepatitis B sAg to 97.9% and hepatitis C Ab to 94.0% whilst maintaining specificity of 98.8%, 100% and 100%, respectively. With optimisation of assay cut-off, DBS can perform comparably with serum for serological testing for HIV, syphilis, hepatitis B and C and may be a valuable tool in increasing access to testing in New Zealand., (Copyright © 2023 Royal College of Pathologists of Australasia. Published by Elsevier B.V. All rights reserved.)

Background: To meet global targets for the elimination of mother-to-child HIV transmission, tailored approaches to HIV testing strategies need prioritizing. Herein, we sought to identify individual-level factors associated with male partner HIV testing., Methods: We conducted a secondary analysis of data from two parallel randomized trials of pregnant women living with HIV and those HIV-negative in Lusaka, Zambia. Across both trials, control groups received partner notification services only, while intervention groups received partner notification services plus HIV self-test kits for their partners. Associations between baseline factors and male partner testing were estimated using a probability difference. The outcome of interest was uptake of male partner HIV testing of any kind within 30 days of randomization., Results: The parent study enrolled 326 participants. Among the 151 women in the control groups, no clear associations were noted between maternal or male partner characteristics and reported uptake of male partner HIV testing. There were positive trends favouring partner testing among women who completed primary school education, had larger households (>2 members), and whose partners were circumcised. Likewise, no clear predictors of male partner testing were identified among the 149 women in the intervention groups. However, negative trends favouring no testing were noted among older, multiparous women from larger households., Conclusion: No consistent predictors for male partner HIV testing across two compared strategies were observed. Our findings suggest that differentiated strategies for male partner HIV testing may not be necessary. Instead, consideration should be given to universal approaches when bringing such services to scale., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: Despite tremendous progress in improving antiretroviral therapy (ART) access, advanced HIV disease (AHD) still remains a challenge globally. Reasons for delayed presentation to care and ART adherence may be affected by gender. We present qualitative study findings on gender differences in decisions for HIV testing and ART initiation/adherence in adults with AHD in Malawi., Methods: We used a qualitative study design, interviewing 16 men and 16 women aged 18 years and above diagnosed with AHD in sites implementing an optimized package of AHD care, from December 2021-February 2022. We included study participants receiving AHD services for at least two months. We also interviewed 16 lay workers and 16 health care workers supporting people living with AHD. In-depths interviews (IDIs) were conducted in English or Chichewa by trained research assistants using semi-structured interview guides. A short-answer analysis was conducted, and findings were interpreted according to thematic areas., Results: Both men and women reported stigma as a main barrier influencing their decision to test for HIV and to initiate and adhere to ART. Fear of side effects, insufficient food, and the need for more information were other barriers reported among men and women as well as perceived as barriers by HCWs. Men appear to have tested later for HIV and stated that they were waiting until experiencing significant symptoms before testing. According to clients and HCWs, men were also less inclined to initiate ART after a HIV diagnosis, whereas women were motivated to start treatment to remain healthy and care for the family. Both genders reported that treatment could be delayed if they were feeling healthy. Treatment fatigue was reported among all groups as the main reason to discontinue treatment., Conclusions: There were similarities and differences between genders in decision-making about HIV care. Concerns about stigma were important reasons for delay in HIV care in both genders. Motivations for accessing HIV treatment and care were different among men and women, pushing the need for gender-tailored counseling services and community messaging that educate both men and women on the benefits of initiating ART early, in turn reducing the number of people presenting with AHD., Trial Registration: NCT05510973, first registration 22/08/2022., (© 2023. The Author(s).)

Background: East Africa's fishing communities experience a high burden of two interrelated and frequently co-occurring health issues: HIV and hazardous alcohol use. Nearly two-thirds of Ugandan fisherfolk men meet the criteria for harmful alcohol use. We developed a multilevel intervention to reduce hazardous alcohol use and improve HIV care engagement among fisherfolk men living with HIV (LWHIV) in Wakiso district, Uganda., Methods: This is a qualitative study of stakeholder perspectives on the appropriateness, acceptability, and feasibility of a multilevel intervention for fisherfolk men LWHIV. The proposed intervention, Kisoboka ("It is possible!"), combines a structural component [changing the mode of work payments from cash to mobile money] with a behavioral component [motivational interviewing-based counseling combined with content using behavioral economic principles to promote behavior change]. We conducted one focus group (n=7) and eight in-depth interviews with fisherfolk men LWHIV and 19 key informant (KI) interviews with health workers, employers, and community leaders. These explored the appropriateness, acceptability, and feasibility of specific key intervention components., Results: Overall, stakeholders' perspectives supported high intervention acceptability and perceived appropriateness of the proposed intervention. It was perceived to be feasible with some caveats of recommendations for overcoming potential implementation challenges identified (e.g., having a friend assist with documenting savings and alcohol use if an individual was unable to write themselves) which are discussed., Conclusion: This work highlights the potential of the Kisoboka intervention and the importance of early engagement of key stakeholders in the intervention development process to ensure appropriateness, acceptability, feasibility, and socio-cultural fit., Competing Interests: Declaration of Competing Interest No conflict declared., (Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.)

This formative study was undertaken between June 2020 and April 2021 to provide evidence to inform the design and delivery of comprehensive sexuality education (CSE) in Malawi for young people living with HIV (YPLHIV) and young people with disabilities (YPWD). The study included a desk review of the situation of these two groups and a mapping of CSE programmes and delivery approaches in Malawi. The study findings show that YPWD and YPLHIV in Malawi are marginalised groups, face stigma and discrimination, and are more vulnerable to abuse, warranting CSE that addresses their needs. Yet, they are often left out of sexuality education such as school-based programmes (due to early school drop-outs) and out-of-school programmes, as well as traditional modes. Furthermore, in instances where they have access to sexuality education, there is little evidence to suggest that the sexuality education that they receive is designed to address their needs, thus raising questions about its relevance. There is need for tailored CSE that addresses the needs of these groups and that is delivered using an approach that is easily accessible to them.

Identifying persons who have newly acquired HIV infections is critical for characterizing the HIV epidemic direction. We analyzed pooled data from nationally representative Population-Based HIV Impact Assessment surveys conducted across 14 countries in Africa for recent infection risk factors. We included adults 15-49 years of age who had sex during the previous year and used a recent infection testing algorithm to distinguish recent from long-term infections. We collected risk factor information via participant interviews and assessed correlates of recent infection using multinomial logistic regression, incorporating each survey's complex sampling design. Compared with HIV-negative persons, persons with higher odds of recent HIV infection were women, were divorced/separated/widowed, had multiple recent sex partners, had a recent HIV-positive sex partner or one with unknown status, and lived in communities with higher HIV viremia prevalence. Prevention programs focusing on persons at higher risk for HIV and their sexual partners will contribute to reducing HIV incidence.

Background: HIV subtype is associated with varied rates of disease progression. The HIV accessory protein, Nef, continues to be present during antiretroviral therapy (ART) where it has numerous immunoregulatory effects. In this study, we analyzed Nef sequences from HIV subtypes A1, B, C, and D using a machine learning approach that integrates functional amino acid information to identify if unique physicochemical features are associated with Nef functional/structural domains in a subtype-specific manner., Methods: 2253 sequences representing subtypes A1, B, C, and D were aligned and domains with known functional properties were scored based on amino acid physicochemical properties. Following feature generation, we used statistical pruning and evolved neural networks (ENNs) to determine if we could successfully classify subtypes. Next, we used ENNs to identify the top five key Nef physicochemical features applied to specific immunoregulatory domains that differentiated subtypes. A signature pattern analysis was performed to the assess amino acid diversity in sub-domains that differentiated each subtype., Results: In validation studies, ENNs successfully differentiated each subtype at A1 (87.2%), subtype B (89.5%), subtype C (91.7%), and subtype D (85.1%). Our feature-based domain scoring, followed by t-tests, and a similar ENN identified subtype-specific domain-associated features. Subtype A1 was associated with alterations in Nef CD4 binding domain; subtype B was associated with alterations with the AP-2 Binding domain; subtype C was associated with alterations in a structural Alpha Helix domain; and, subtype D was associated with alterations in a Beta-Sheet domain., Conclusions: Recent studies have focused on HIV Nef as a driver of immunoregulatory disease in those HIV infected and on ART. Nef acts through a complex mixture of interactions that are directly linked to the key features of the subtype-specific domains we identified with the ENN. The study supports the hypothesis that varied Nef subtypes contribute to subtype-specific disease progression., Competing Interests: Declaration of Competing Interest Susanna Lamers, David Nolan, and Rebecca Rose are employed by BioInfoExperts LLC. Gary Fogel and Enoch Liu are employed by Natural Selection Inc. No other competing interests exist., (Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.)

Background: The World Health Organization recommends Pre-Exposure Prophylaxis (PrEP) for all populations at substantial risk of HIV infection. Understanding PrEP awareness and interest is crucial for designing PrEP programs; however, data are lacking in sub-Saharan Africa. In Malawi, oral PrEP was introduced in 2018. We analyzed data from the 2020 Malawi Population-based HIV Impact Assessment (MPHIA) to assess PrEP awareness and factors associated with PrEP interest in Malawi., Methods: MPHIA 2020 was a national cross-sectional household-based survey targeting adults aged 15 + years. Oral PrEP was first described to the survey participants as taking a daily pill to reduce the chance of getting HIV. To assess awareness, participants were asked if they had ever heard of PrEP and to assess interest, were asked if they would take PrEP to prevent HIV, regardless of previous PrEP knowledge. Only sexually active HIV-negative participants are included in this analysis. We used multivariable logistic regression to assess sociodemographic factors and behaviors associated with PrEP interest. All results were weighted., Results: We included 13,995 HIV-negative sexually active participants; median age was 29 years old. Overall, 15.0%, 95% confidence interval (CI): 14.2-15.9% of participants were aware of PrEP. More males (adjusted odds ratio (aOR): 1.3, 95% CI: 1.2-1.5), those with secondary (aOR: 1.5, 95% CI: 1.2-2.0) or post-secondary (aOR: 3.4, 95% CI: 2.4-4.9) education and the wealthiest (aOR: 1.6, 95% CI: 1.2-2.0) were aware of PrEP than female, those without education and least wealthy participants, respectively. Overall, 73.0% (95% CI: 71.8-74.1%) of participants were willing to use PrEP. Being male (aOR: 1.2; 95% CI: 1.1-1.3) and having more than one sexual partner (aOR: 1.7 95% CI: 1.4-1.9), were associated higher willingness to use PrEP., Conclusions: In this survey, prior PrEP knowledge and use were low while PrEP interest was high. High risk sexual behavior was associated with willingness to use PrEP. Strategies to increase PrEP awareness and universal access, may reduce HIV transmission., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Background: Patients without human immunodeficiency virus (HIV) are increasingly recognized as being at risk for cryptococcosis. Knowledge of characteristics of cryptococcosis in these patients remains incomplete., Methods: We conducted a retrospective study of cryptococcosis in 46 Australian and New Zealand hospitals to compare its frequency in patients with and without HIV and describe its characteristics in patients without HIV. Patients with cryptococcosis between January 2015 and December 2019 were included., Results: Of 475 patients with cryptococcosis, 90% were without HIV (426 of 475) with marked predominance in both Cryptococcus neoformans (88.7%) and Cryptococcus gattii cases (94.3%). Most patients without HIV (60.8%) had a known immunocompromising condition: cancer (n = 91), organ transplantation (n = 81), or other immunocompromising condition (n = 97). Cryptococcosis presented as incidental imaging findings in 16.4% of patients (70 of 426). The serum cryptococcal antigen test was positive in 85.1% of tested patients (319 of 375); high titers independently predicted risk of central nervous system involvement. Lumbar puncture was performed in 167 patients to screen for asymptomatic meningitis, with a positivity rate of 13.2% where meningitis could have been predicted by a high serum cryptococcal antigen titer and/or fungemia in 95% of evaluable cases. One-year all-cause mortality was 20.9% in patients without HIV and 21.7% in patients with HIV (P = .89)., Conclusions: Ninety percent of cryptococcosis cases occurred in patients without HIV (89% and 94% for C. neoformans and C. gattii, respectively). Emerging patient risk groups were evident. A high level of awareness is warranted to diagnose cryptococcosis in patients without HIV., Competing Interests: Potential conflicts of interest . T. S. has received consulting fees for serving on advisory boards and steering committees from Biogen. O. M. has received grants from Gilead Sciences and Merck, Sharp and Dohme Australia and honoraria from Gilead Sciences; support for attending meetings from F2G; and participated on data and safety monitoring boards (DSMB) or advisory boards for Gilead Sciences and Merck, Sharp and Dohme Australia. K. J. K. has received payment for expert testimony at the 46th Society of Hospital Pharmacists of Australia National Conference. A. R. T. has received honoraria from the Medical Journal of Australia, paid to institution, and reports grants or contracts from CTRA with the University of Melbourne (reimbursement of costs paid to institution). B. W. T. is supported by a Medical Research Future Fund Investigator Fellowship; has received grants from MSD and Seqirus; has received honoraria from Pfizer, Alexion, and Janssen; and participated on DSMBs or advisory boards for CSL­Behring, Takeda, and Moderna. S. C. A. C. has received educational grants from F2G and MSD Australia; reports untied educational grants from MSD Australia and F2G Pty Ltd; and reports a role as editor-in-chief for Medical Mycology (journal of ISHAM). M. A. S. has received grants from Gilead Sciences, Merck, and F2G; has received honoraria from F2G; and participated on DSMBs or advisory boards for Pfizer, Cidara, and Roche. R. J. L. reports paid participation on a GSK advisory board. S. A. L. reports grants or contracts as principal investigator on 3 projects funded through a Hot North fund grant and a UK Government Fleming Fund Grant (as part of broader funding for the Menzies School of Health Research; no salary, project costs remunerated only); unpaid participation on a DSMB or advisory board for the Australian Academy of Science and the Australian Academy of Health and Medical Sciences roundtable of experts for the House of Representatives Committee on Health and Ageing; and an unpaid role as a National Tuberculosis Advisory Committee member. M. T. B. reports an unpaid role as an Advanced Training Committee member for General Medicine for the Royal Australasian College of Physicians and an unpaid member of the Vocational Training Committee for Medical Registrars in the Auckland region for the Northern Region Alliance. C. L. K. reports an unpaid role on the Australian Society of Infectious Diseases Board of Directors. E. W. reports a role as a committee member of the Australasian Society for Infectious Diseases Equity and Diversity Committee (unpaid). K. C. G. reports a role as a member of the New Zealand Committee of the Australasian Society for Infectious Diseases. All other authors report no potential conflicts. All authors have submitted the International Committee of Medical Journal Editors Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Differentiated care delivery aims to simplify care of people living with HIV, reflect their preferences, reduce burdens on the healthcare system, maintain care quality and preserve resources. However, assessing program effectiveness using observational data is difficult due to confounding by indication and randomized trials may be infeasible. Also, benefits can reach patients directly, through enrollment in the program, and indirectly, by increasing quality of and accessibility to care. Low-risk express care (LREC), the program under evaluation, is a nurse-centered model which assigns patients stable on ART to a nurse every two months and a clinician every third visit, reducing annual clinician visits by two thirds. Study population is comprised of 16,832 subjects from 15 clinics in Kenya. We focus on patient retention in care based on whether the LREC program is available at a clinic and whether the patient is enrolled in LREC. We use G-estimation to assess the effect on retention of two "strategies": (i) program availability but no enrollment; (ii) enrollment at an available program; versus no program availability. Compared to no availability, LREC results in a non-significant increase in patient retention, among patients not enrolled in the program (indirect effect), while enrollment in LREC is associated with a significant extension of the time retained in care (direct effect). G-estimation provides an analytical framework useful to the assessment of similar programs using observational data., (© 2023 Walter de Gruyter GmbH, Berlin/Boston.)

Introduction: Support groups for people living with HIV (PLHIV) are essential for increasing adherence, retention, addressing their psychosocial needs and improving patient literacy. However, factors that influence participation of caregivers living with HIV (LHIV) in these groups are scarcely documented, particularly for those caring for orphans and vulnerable children (OVC)., Methods: This study used baseline data collected between 1st October 2021 and 30th September 2022 from the PEPFAR/USAID-funded Adolescents and Children HIV Incidence Reduction, Empowerment and Virus Elimination (ACHIEVE) project in Tanzania to investigate factors that affect participation of caregivers LHIV in support groups for PLHIV. A total of 74,249 HIV-positive OVC caregivers who were already receiving antiretroviral therapy (ART) and had a confirmed care and treatment centre identification number were included in the analysis. Factors affecting group participation were identified through multilevel analysis using multivariable mixed-effects logistic regression., Results: Results showed that 84.2% of the caregivers were participants in the support groups for PLHIV. Their mean age was 36 years, and the majority (82.1%) were female. Multivariable analysis revealed that participation in the groups was more likely among caregivers living in urban areas (aOR = 1.39 [1.24, 1.55]), with primary education (aOR = 1.17 [1.07, 1.28]), and without disabilities (aOR = 0.62 [0.47, 0.82]). However, participation was less likely among widowed (aOR = 0.91 [0.84, 0.999]), single or unmarried (aOR = 0.86 [0.78, 0.95]), and those with secondary education or higher levels than never attended (aOR = 0.69 [0.60, 0.80]), moderate hunger (aOR = 0.86 [0.79, 0.93]), and those aged 30 years or older ( p < 0.001)., Discussion: A sizeable proportion (15.8%) of the caregivers were not in support groups for PLHIV, ranging from 12.3% among those in households with severe hunger to 29.7% among disabled ones. The study highlights the need for tailored interventions to increase participation in support groups for PLHIV, particularly for caregivers who are disabled, live in rural areas, are older, widowed, and/or unmarried, and those in poor households., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Kikoyo, Exavery, Charles, Temu, Barankena, Ally, Mseya, Mbwambo, Fovo, Tarimo, Mubyazi, Balampama, Kuhlik, Ventimiglia and Lema.)

People living with HIV face multiple psychosocial challenges. In a large, predominantly rural Ethiopian region, 1799 HIV patients new to care were enrolled from 32 sites in a cluster randomized trial using trained community support workers with HIV to provide individual health education, counseling and social support. Participants received annual surveys through 36 months using items drawn from the Centre for Epidemiologic Studies Depression Scale-10, Medical Outcome Study Social Support Survey, and HIV/AIDS Stigma Instrument-PLWA. At 12 months (using linear mixed effects regression models controlling for enrollment site clustering), intervention participants had greater emotional/informational and tangible assistance social support scores, and lower scores assessing depression symptoms and negative self-perception due to HIV status. A significant treatment effect at 36 months was also seen on scores assessing emotional/informational social support, depression symptoms, and internalized stigma. An intervention using peer community support workers with HIV to provide individualized informational and psychological support had a positive impact on the emotional health of people living with HIV who were new to care.(ClinicalTrials.gov protocol ID: 1410S54203, May 19, 2015)., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Introduction: There is an urgent need for more efficient models of differentiated antiretroviral therapy (ART) delivery for people living with HIV (PLHIV), with the World Health Organization calling for evidence to guide whether annual ART prescriptions and consultations (12M scripts) should be recommended in global guidelines. We assessed the association between 12M scripts (allowed temporarily during the COVID-19 pandemic) versus standard 6-month prescriptions and consultations (6M scripts) and clinical outcomes., Methods: We performed a retrospective cohort study using routine, de-identified data from 59 public clinics in KwaZulu-Natal, South Africa. We included PLHIV aged ≥18 years with a recent suppressed viral load (VL) who had been referred for community ART delivery with 6M or 12M scripts. We used modified Poisson regression to compare 12-month retention-in-care (≤90 days late for all visits) and viral suppression (<50 copies/ml) between prescription groups., Results: Among 27,148 PLHIV referred for community ART during Jun-Dec 2020, 57.4% received 12M scripts. The median age was 39 years and 69.4% were women. Age, sex, prior community ART use and time on ART were similar across groups. However, more of the 12M script group had dolutegravir-based regimens (60.0% vs. 46.3%). The median (interquartile range) number of clinic visits in the year of follow-up was 1(1-1) in the 12M group and 2(2-3) in the 6M group. Retention was 94.6% (95% confidence interval [CI]: 94.2%-94.9%) among those receiving 12M scripts and 91.8% (95% CI: 91.3%-92.3%) among those with 6M scripts. 17.1% and 16.9% of clients in the 12M and 6M groups were missing follow-up VL data, respectively. Among those with VLs, 92.4% (95% CI: 92.0%-92.9%) in the 12M group and 91.4% (95% CI: 90.8%-92.0%) in the 6M group were suppressed. After adjusting for age, sex, ART regimen, time on ART, prior community ART use and calendar month, retention (adjusted risk ratio [aRR]: 1.03, 95% CI: 1.01-1.05) and suppression (aRR: 1.00, 95% CI: 0.99-1.01) were similar across groups., Conclusions: Among PLHIV referred for community ART with a recent suppressed VL, the use of 12M scripts reduced clinic visits without impacting short-term clinical outcomes. 12M scripts should be considered for differentiated service delivery programmes., (© 2023 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of International AIDS Society.)

Background: A trial found that a community health worker (CHW) strategy using "Health Scouts" improved HIV care uptake and ART coverage. To better understand outcomes and areas for improvement, we conducted an implementation science evaluation., Methods: Using the RE-AIM framework, quantitative methods included analyses of a community-wide survey (n = 1903), CHW log books, and phone application data. Qualitative methods included in-depth interviews (n = 72) with CHWs, clients, staff, and community leaders., Results: Thirteen Health Scouts logged 11,221 counseling sessions; 2532 unique clients were counseled. 95.7% (1789 of 1891) of residents reported awareness of the Health Scouts. Overall, reach (self-reported receipt of counseling) was 30.7% (580 of 1891). Unreached residents were more likely to be male and HIV seronegative ( P < 0.05). Qualitative themes included the following: (1) reach was promoted by perceived usefulness but deterred by busy client lifestyles and stigma, (2) effectiveness was enabled through good acceptability and consistency with the conceptual framework, (3) adoption was facilitated by positive impacts on HIV service engagement, and (4) implementation fidelity was initially promoted by the CHW phone application but deterred by mobility. Maintenance showed consistent counseling sessions over time. The findings suggested the strategy was fundamentally sound but had suboptimal reach. Future iterations could consider adaptations to improve reach to priority populations, testing the need for mobile health support, and additional community sensitization to reduce stigma., Conclusions: A CHW strategy to promote HIV services was implemented with moderate success in an HIV hyperendemic setting and should be considered for adoption and scale-up in other communities as part of comprehensive HIV epidemic control efforts., Trial Registration: ClinicalTrials.gov Trial Number NCT02556957., Competing Interests: emocha Mobile Health Inc. developed and supported the smartphone application used in this study. L.W.C. and R.C.B. are entitled to royalties on certain nonresearch revenue generated by this company and own company equity. Specific to this study, L.W.C. and R.C.B. have and will receive no royalties or compensation from emocha Mobile Health Inc. M.J.W. and R.H.G. have previously received consulting fees from the Rakai Health Sciences Program. These consultancies are unrelated to this manuscript under review. All these arrangements have been reviewed and approved by Johns Hopkins University in accordance with its conflict of interest policies. All other authors have no conflicts of interest to disclose., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Background: In 2014, UNAIDS set the goal of ending the AIDS epidemic by 2030 through the achievement of testing and treatment cascade targets. To evaluate progress achieved and highlight persisting gaps in HIV epidemic control in Malawi, we aimed to compare key indicators (prevalence, incidence, viral load suppression, and UNAIDS 95-95-95 targets) from the 2015-16 and 2020-21 Malawi Population-based HIV Impact Assessment (PHIA) survey results., Methods: The Malawi PHIAs were nationally representative, cross-sectional surveys with a two-stage cluster sampling design. The first survey was conducted between Nov 27, 2015, and Aug 26, 2016; the second survey was conducted between Jan 15, 2020, and April 26, 2021. Our analysis included survey participants aged 15-64 years. Participants were interviewed and a 14 mL blood sample was collected and tested for HIV infection using the national rapid testing algorithm. For each survey, we estimated key HIV epidemic indicators and achievement of 95-95-95 targets. The risk ratio (RR) of the indicators between surveys were computed and considered significant at a confidence level of 0·05. All results were weighted, and self-reported awareness and treatment status were adjusted to account for detection of antiretrovirals., Findings: Our analysis included 17 187 participants aged 15-64 years in 2015-16 and 21 208 in 2020-21 who participated in the surveys and blood draw. In the 2020-21 survey, 88·4% (95% CI 86·7-90·0) of people living with HIV were aware of their HIV-positive status; of those aware, 97·8% (97·1-98·5) were on antiretroviral therapy; and of those on treatment, 96·9% (95·9-97·7) were virally suppressed. Between surveys, the national HIV prevalence decreased significantly from 10·6% (10·0-11·2) to 8·9% (8·4-9·5) with RR 0·85 (95% CI 0·78-0·92; p<0·0001). The annual HIV incidence decreased from 0·37% (0·20-0·53) to 0·22% (0·11-0·34) with RR 0·61 (95% CI 0·31-1·20; p=0·15). The population viral load suppression increased from 68·3% (66·0-70·7) in 2015-16 to 87·0% (85·3-88·5) in 2020-21 (RR 1·27 [95% CI 1·22-1·32]; p<0·0001)., Interpretation: These results suggest that Malawi had already surpassed the UNAIDS viral load suppression target for 2030 (85·7%) by 2020-21. Through strategies and evidence-informed interventions implemented in the last half decade, especially scale-up of effective HIV treatment, Malawi has made tremendous progress, including decreasing HIV prevalence and incidence and achieving both the second and third 95 targets ahead of 2030. To address the first 95, efforts in HIV diagnosis should focus on males and younger age groups. There is a continued need for effective linkage to care, retention on antiretroviral therapy, and adherence support to maintain and build on progress., Funding: US President's Emergency Plan for AIDS Relief through the US Centers for Disease Control and Prevention., Competing Interests: Declaration of interests We declare no competing interests., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

HIV stigma is a critical barrier to HIV prevention and care. This study evaluates the psychometric properties of the HIV Stigma Mechanisms Scale (HIV-SMS) among people living with HIV (PLHIV) in central Uganda and tests the underlying framework. Using data from the PATH/Ekkubo study, (n = 804 PLHIV), we assessed the HIV-SMS' reliability and validity (face, content, construct, and convergent). We used multiple regression analyses to test the HIV-SMS' association with health and well-being outcomes. Findings revealed a more specific (5-factor) stigma structure than the original model, splitting anticipated and enacted stigmas into two subconstructs: family and healthcare workers (HW). The 5-factor model had high reliability (α = 0.92-0.98) and supported the convergent validity (r = 0.12-0.42, p < 0.01). The expected relationship between HIV stigma mechanisms and health outcomes was particularly strong for internalized stigma. Anticipated-family and enacted-family stigma mechanisms showed partial agreement with the hypothesized health outcomes. Anticipated-HW and enacted-HW mechanisms showed no significant association with health outcomes. The 5-factor HIV-SMS yielded a proper and nuanced measurement of HIV stigma in central Uganda, reflecting the importance of family-related stigma mechanisms and showing associations with health outcomes similar to and beyond the seminal study., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Awareness of HIV status in Malawi is 88.3% and lowest among 15-24-year-olds (76.2%). There is a need to understand HIV testing history and transmission in this age group. We analyzed pooled HIV surveillance data to describe testing history and HIV recent infection among 8,389 HIV-positive 15-24-year-olds from 251 sites in Malawi between 2019 and 2022. Most HIV-positive 15-24-year-olds were female; aged 23-24 years; rural residents; and diagnosed at voluntary counseling and testing. No prior HIV testing was reported in 43.5% and 32.9% of 15-19-year-olds and males, respectively. Overall, 4.9% of HIV-positive diagnoses were classified as recent HIV infections, with the highest proportions among breastfeeding women (8.2%); persons tested at sexually transmitted infection clinics (9.0%); persons with a prior negative test within 6 months (13.0%); and 17-18-year-olds (7.3%). Tailored and innovative HIV prevention and testing strategies for young adolescents, young males, and pregnant and breastfeeding women are needed for HIV epidemic control.

Gender-based violence (GBV) is a complex issue deeply rooted in social structures, making its eradication challenging. GBV increases the risk of HIV transmission and is a barrier to HIV testing, care, and treatment. Quality clinical services for GBV, which includes the provision of HIV postexposure prophylaxis (PEP), vary, and service delivery data are lacking. We describe GBV clinical service delivery in 15 countries supported by the President's Emergency Plan for AIDS Relief (PEPFAR) through the U.S. Centers for Disease Control and Prevention. Through a descriptive statistical analysis of PEPFAR Monitoring, Evaluation, and Reporting (MER) data, we found a 252% increase in individuals receiving GBV clinical services, from 158,691 in 2017 to 558,251 in 2021. PEP completion was lowest (15%) among 15-19-year-olds. Understanding GBV service delivery is important for policy makers, program managers, and providers to guide interventions to improve the quality of service delivery and contribute to HIV epidemic control.

Using data from 67 Ugandan human immunodeficiency virus (HIV) clinics (July 2019-January 2022), we report a 40% (1005/1662) reduction in the number of people with HIV presenting to care after August 2021 compared to prepandemic levels, with a greater proportion presenting with advanced HIV disease (20% vs 16% in the pre-coronavirus disease 2019 period)., Competing Interests: Potential conflicts of interest. The authors: No reported conflicts of interest. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest., (© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)