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Background: The ongoing rollout of oral TDF-based PrEP has the potential to reduce HIV incidence in Sub-Saharan Africa (SSA) but HIV drug resistance (HIVDR) in PrEP breakthrough infections could threaten [...]

Background: Assisted partner service (APS) is effective for increasing HIV testing services (HTS) uptake among sexual partners of people diagnosed with HIV with rare social harm. The acceptability of APS [...]

Background: In Kenya HIV prevalence among people who inject drugs (PWID) is estimated at 18% versus 5.6% in general population. To reduce opioid addiction and HIV risk, methadone was introduced in Nairobi and Kenya's coastal region in 2013. Studies in high-income countries have shown that methadone is associated with antiretrovira therapy (ART) uptake, however, it is not known whether participation in a methadone program is associated with increased ART use among PWID in Kenya. Methods: Participants were recruited from an ongoing study of Assisted Partner Services (APS) to identify, test and link to care the sexual and injecting partners of HIV-positive PWID in Kenya. Recruitment for index participants was done from NSP programs and methadone clinics in Nairobi, Kilifi and Mombasa countie where they were receiving HIV care. In this study we interviewed all HIV-positive index participants who had injected drugs in the last one year about linkage to care, ART uptake, methadone use and current injecting practices. We used logistic regression to evaluate associations between methadone program participation and current ART use, adjusting for demographic and behavioral characteristics. Results: A total of 668 HIV-positive index participants were enrolled. Of these, 138 (21%) were on methadone and 527 (79%) reported they were taking ART. The majority of participants were male (52%) and median age was 36 years (IQR 31 to 42). Of 138 currently enrolled in methadone programs, 128 (93%) were on ART compared to 399 (75%) of the remaining 530 not taking methadone. After adjusting for age, sex, marital status, and living conditions, those on ART were over 4 times more likely to take methadone (adjusted Odds Ratio [aOR] = 4.21, p < 0.001). Of 346 men 89 (26%) were on methadone compared with 49 (15%) of 322 women (aOR = 0.45, p < 0.001). Women were also less likely to be on ART compared to men although this difference was not statistically significant (aOR = 0.72, p = 0.08). Conclusions: Methadone use was strongly associated with reported ART use amongst PWID in Kenya. Women were significantly less likely than men to take methadone and were also less likely to be taking ART. These findings can guide policies and practices for targeted methadone support programs in Kenya., OA21.02 L. Mbogo (1); A. Monroe-Wise (2); B. Sambai (1); B. Guthrie (2); D. Bukusi (3); W. Sinkele (4); P. Macharia (5); N. Ludwig (6); J. Herbeck (6); M. Dunbar [...]

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. APS providers attempted contacting partners using phone first and, if unsuccessful, in-person in the community. Using log-linear mixed models, we estimated relative risks (RR) between phone being the final contact method and partner characteristics and HIV outcomes., Results: From May 2018-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 vs. in-person (9.8% vs. 15.9%; adjusted RR:0.61, 95%CI: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: Conflicts 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.)

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.

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.)

In Kenya, overdose remains a major public health concern with approximately 40% of persons who inject drugs (PWID) reporting personal overdoses. PWID living with HIV (PWID-LH) are particularly vulnerable to experiencing fatal and non-fatal overdoses because of the surrounding physical, social, economic, and political environments, which are not fully understood in Kenya. Through qualitative inquiry, this study characterizes Kenya's overdose risk environment. Participants were purposively recruited from a larger cohort study from September to December 2018 using the following inclusion criteria: HIV-positive, age ≥18 years, injected drugs in the last year, and completed cohort study visits. Semi-structured interviews explored experiences of personal and observed overdoses, including injection settings, sequence of events (e.g., pre-, during, and post-overdose), safety strategies, and treatment. Interviews were transcribed, translated (Swahili to English), reviewed, and analyzed thematically, applying a risk environment framework. Nearly all participants described personal and/or observed overdose experiences (96%) and heroin was the most frequently reported substance (79%). Overdose precursors included increased consumption, polysubstance use, recent incarceration, and rushed injections. There were also indications of female-specific precursors, including violence and accessing prefilled syringes within occupational settings. Overdose safety strategies included avoiding injecting alone, injecting drugs incrementally, assessing drug quality, and avoiding polysubstance use. Basic first-aid techniques and naloxone use were common treatment strategies; however, naloxone awareness was low (25%). Barriers to treatment included social network abandonment, police discrimination, medical stigma, fatalism/religiosity, medical and transportation costs, and limited access to treatment services. In Kenya, the overdose risk environment highlights the need for comprehensive overdose strategies that address the physical, social, economic, and political environments. Morbidity and mortality from overdose among PWID-LH could be reduced through overdose prevention initiatives that support harm reduction education, naloxone awareness, and access, destigmatization of PWID, and reforming punitive policies that criminalize PWID-LH., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Maurano 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.)

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.)

The co-occurrence of infectious diseases (ID) and non-communicable diseases (NCD) is widespread, presenting health service delivery challenges especially in low-and middle-income countries (LMICs). Integrated health care is a possible solution but may require a paradigm shift to be successfully implemented. This literature review identifies integrated care examples among selected ID and NCD dyads. We searched PubMed, PsycINFO, Cochrane Library, CINAHL, Web of Science, EMBASE, Global Health Database, and selected clinical trials registries. Eligible studies were published between 2010 and December 2022, available in English, and report health service delivery programs or policies for the selected disease dyads in LMICs. We identified 111 studies that met the inclusion criteria, including 56 on tuberculosis and diabetes integration, 46 on health system adaptations to treat COVID-19 and cardiometabolic diseases, and 9 on COVID-19, diabetes, and tuberculosis screening. Prior to the COVID-19 pandemic, most studies on diabetes-tuberculosis integration focused on clinical service delivery screening. By far the most reported health system outcomes across all studies related to health service delivery (n = 72), and 19 addressed health workforce. Outcomes related to health information systems (n = 5), leadership and governance (n = 3), health financing (n = 2), and essential medicines (n = 4)) were sparse. Telemedicine service delivery was the most common adaptation described in studies on COVID-19 and either cardiometabolic diseases or diabetes and tuberculosis. ID-NCD integration is being explored by health systems to deal with increasingly complex health needs, including comorbidities. High excess mortality from COVID-19 associated with NCD-related comorbidity prompted calls for more integrated ID-NCD surveillance and solutions. Evidence of clinical integration of health service delivery and workforce has grown-especially for HIV and NCDs-but other health system building blocks, particularly access to essential medicines, health financing, and leadership and governance, remain in disease silos., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Jackson-Morris 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.)

Competing Interests: Conflicts of interest: none declared.

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: People who inject drugs are at increased risk of both HIV and hepatitis C virus (HCV) infections but face barriers to testing and engagement in care. Assisted partner services are effective in locating people with HIV but are understudied among people who inject drugs. We assessed whether assisted partner services could be used to find, test for HIV and HCV infections, and link to care the partners of people who inject drugs in Kenya., Methods: In this prospective study at eight sites offering harm-reduction services in Kenya, we enrolled people aged 18 years or older who inject drugs and were living with HIV (index participants) between Feb 27, 2018, and Nov 1, 2021. Index participants provided information about their sexual and injecting partners (ie, anyone with whom they had had sexual intercourse or injected drugs in the previous 3 years), and then community-embedded peer educators located partners and referred them for enrolment in the study (partner participants). All participants underwent testing for HCV infection, and partner participants also underwent HIV testing. Index and partner participants with HIV but who were not on antiretroviral therapy (ART) were linked with treatment services, and those positive for HCV were linked to treatment with direct-acting antivirals. We calculated the number of index participants whom we needed to interview to identify partner participants with HIV and HCV infection., Findings: We enrolled 989 people living with HIV who inject drugs, who mentioned 4705 sexual or injecting partners. Of these 4705 partners, we enrolled 4597 participants, corresponding to 3323 unique individuals. 597 (18%) partner participants had HIV, of whom 506 (85%) already knew their status. 358 (71%) of those who knew they were HIV positive were virally suppressed. 393 (12%) partner participants were HCV antibody positive, 213 (54%) of whom had viraemia and 104 (26%) of whom knew their antibody status. 1·66 (95% CI 1·53-1·80) index participants had to be interviewed to identify a partner with HIV, and 4·24 (3·75-4·85) had to be interviewed to find a partner living with HIV who was unaware of their HIV status, not on ART, or not virally suppressed. To find a partner seropositive for HCV who did not know their antibody status, 3·47 (3·11-3·91) index participants needed to be interviewed. Among the 331 index and partner participants living with HIV who were not on ART at enrolment, 238 (72%) were taking ART at 6-month follow-up. No adverse events were attributed to study procedures., Interpretation: Use of assisted partner services among people with HIV who inject drugs was safe and identified partners with HIV and HCV infections. Assisted partner services was associated with increased uptake of ART for both index participants and partners., Funding: US National Institutes of Health., Competing Interests: Declaration of interests AM-W has served as a consultant for WHO and has received financial support from Gilead Sciences. BLG has received financial support from Gilead and has served as an expert witness for the Los Angeles Unified School District. JS has served as a consultant for Gilead, Premera Blue Cross, Guidepoint, and Novo Nordisk, and as an expert witness for the Washington State Medical Commission. All other authors declare no competing interests., (Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Inequities in global health research are well documented. For example, training opportunities for US investigators to conduct research in low-income and middle-income countries (LMIC) have exceeded opportunities for LMIC investigators to train and conduct research in high-income countries. Reciprocal innovation addresses these inequities through collaborative research across diverse global settings.The Fogarty International Center of the US National Institutes of Health (NIH) promotes research capacity building in LMICs. Fogarty K-grants for mentored career development in global health are available for both US and LMIC investigators, whereas the D43 is the standard grant to support institutional training programmes in LMIC. Other NIH institutes fund T32 training grants to support biomedical research training in the USA, but very few have any global health component. Most global health training partnerships have historically focused on research conducted solely in LMIC, with few examples of bidirectional training partnerships. Opportunities may exist to promote global health reciprocal innovation (GHRI) research by twinning K-awardees in the USA with those from LMIC or by intentionally creating partnerships between T32 and D43 training programmes.To sustain independent careers in GHRI research, trainees must be supported through the path to independence known as the K (mentored grantee)-to-R (independent grantee) transition. Opportunities to support this transition include comentorship, research training at both LMIC and US institutions and protected time and resources for research. Other opportunities for sustainability include postdoctoral training before and after the K-award period, absorption of trained researchers into home institutions, South-South training initiatives and innovations to mitigate brain drain., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: In Kenya, violence is common among people who inject drugs (PWID) living with HIV and their sexual and injecting partners and may lead to decreased uptake of HIV services, increased HIV risk behaviors, and increased HIV transmission. Violence is defined as any physical harm, threatened harm, or forced sexual acts inflicted on a person in the past year. Understanding the nature of violence and its correlates among PWID and their partners will inform population-specific public health interventions and policy recommendations., Methods: This is a cross-sectional study nested in a prospective cohort study conducted in eight public health centers, methadone clinics, and needle syringe programs in Nairobi, Kilifi, and Mombasa counties in Kenya. 3,302 sexual and/or injecting partners of PWID living with HIV were recruited through assisted partner services and participated in the study. Prevalence and correlates of violence were identified using the Wald test and negative binomial regression., Results: Out of 3302 study participants, 1439 (44%) had experienced violence within the past year. Physical violence was the most common form of violence experienced (35%), followed by being threatened (23%) or subjected to sexual violence (7%). In an adjusted analysis, female participants reported higher experiences of sexual violence (prevalence ratio [PR] = 2.46; 95% confidence interval [CI] 1.62, 3.74; p < 0.001) compared to male participants. In adjusted analysis, coastal residents had a higher experience of overall violence (PR = 1.48; 95% CI 1.27, 1.72; p < 0.001) than those living in Nairobi. This regional effect was relatively stronger among the female respondents (p interaction  = 0.025). Participants' sex modified the association between region and experiencing violence after adjusting potential confounding factors., Conclusions: The study reveals the prevalence of violence among PWID and identifies high-risk sub-groups, including women, specifically for sexual violence, and coastal residents. Tailored interventions addressing their unique needs are essential. A holistic approach that combines violence prevention and response, comprehensive harm reduction, healthcare access, and community support is crucial to address the complex issue of drug use and HIV burden among PWID in Kenya for improved health outcomes., (© 2023. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)

Background: Malaria and preeclampsia are leading causes of maternal morbidity and mortality in sub-Saharan Africa. They contribute significantly to poor perinatal outcomes like low neonatal weight by causing considerable placental morphological changes that impair placental function. Previous studies have described the effects of either condition on the placental structure but the structure of the placenta in malaria-preeclampsia comorbidity is largely understudied despite its high burden. This study aimed to compare the placental characteristics and neonatal weights among women with malaria-preeclampsia comorbidity versus those with healthy pregnancies., Methodology: We conducted a retrospective cohort study among 24 women with malaria-preeclampsia comorbidity and 24 women with healthy pregnancies at a County Hospital in Western Kenya. Neonatal weights, gross and histo-morphometric placental characteristics were compared among the two groups., Results: There was a significant reduction in neonatal weights (P<0.001), placental weights (P = 0.028), cord length (P<0.001), and cord diameter (P<0.001) among women with malaria-preeclampsia comorbidity compared to those with healthy pregnancies. There was also a significant reduction in villous maturity (P = 0.016) and villous volume density (P = 0.012) with increased villous vascularity (P<0.007) among women with malaria-preeclampsia comorbidity compared to those with healthy pregnancies., Conclusion: Placental villous maturity and villous volume density are significantly reduced in patients with malaria-preeclampsia comorbidity with a compensatory increase in villous vascularity. This leads to impaired placental function that contributes to lower neonatal weights., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Lwamulungi 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: Persons with HIV (PWH) on antiretroviral therapy (ART) have persistent immune activation associated with increased risk for non-AIDS related diseases. Latent tuberculosis infection (LTBI), endemic in Africa, may contribute to this immune dysregulation. We evaluated the impact of HIV and TB co-infection on plasma pro- and anti-inflammatory cytokines among Kenyan adults., Methods: We compared data from 221 PWH on long-term ART and 177 HIV-negative adults examining biomarkers of pro-[sCD14, interleukin (IL)-2, IL-6, interferon gamma (IFN-γ), tumor necrosis factor alpha (TNF-α), IL-12p70, IL-17A] and anti(IL-4, IL-5, IL-13) inflammatory cytokines, by HIV/LTBI status (HIV+LTBI+, HIV+LTBI-, HIV-LTBI+, HIV-LTBI-). LTBI was diagnosed based on a positive QuantiFERON TB Gold-Plus test in the absence of active TB symptoms. Linear regression was used to evaluate the associations of HIV, LTBI, and HIV/LTBI status with biomarkers adjusting for clinical factors including HIV-specific factors., Results: Half of the participants were women and 52% had LTBI. HIV was independently associated with higher sCD14, IL-15, IL-6, IL-4, IL-5. LTBI was independently associated with higher TNF-α, IL-12p70, IL-17A, IL-4, IL-13 in adjusted models ( P  < 0.05). LTBI status was associated with higher IL-4 and IL-12p70 only among PWH, but not HIV-negative participants ( P  < 0.05 for interactions). In multivariate analysis, only HIV+LTBI+ demonstrated elevated levels of TNF-α, IL-6, IL-12p70, IL-15, IL-17A, IL4, IL-5, IL-13 in comparison to the HIV-LTBI- ( P  < 0.05 for all). The effect of LTBI on cytokines among PWH was independent of CD4 + T-cell count and ART duration., Conclusions: Despite viral suppression, persons with HIV and LTBI exhibit abnormal cytokine production accompanied by high concentrations of pro- and anti-inflammatory cytokines., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.)

Introduction: Assisted partner services (APS), or notification for sexual partners of people diagnosed with HIV, is an efficient, effective, and high yield strategy to identify people living with HIV and is recommended by the World Health Organization (WHO). However, there remains a need to further understand the acceptability of APS qualitatively from a client lens, particularly when APS is integrated into the national health system. We investigated acceptability of APS when integrated into HIV services in Kenya., Methods: Starting in May 2018, APS was implemented in 31 health facilities in Kisumu and Homa Bay counties in western Kenya. From January to December 2019, we conducted in-depth interviews (IDIs) with female index clients (n = 16) and male sexual partners (n = 17) in 10 facilities participating in an APS scale up study. Interviews assessed APS satisfaction, perceived benefits of the intervention, and challenges that may affect delivery or uptake. We applied the Theoretical Framework of Acceptability by Sekhon et al. (2017) as a guide to organize our findings., Results: We find that views of APS are often guided by an individual's trust in the intervention's design and implementation, and an interest to preserve one's health and that of one's family and children. There were strong and consistent acceptable views of APS as "doing good" and "saving a life" and as a means of showing love towards one's partner(s). The initial acceptability framing of individuals engaging with APS was predicated either on a feeling of comfort with the intervention, or a wariness of divulging sex partner personal information. Health care workers (HCWs) were seen to play an important role in mitigating participant fears linked with the intervention, particularly around the sensitive nature of HIV disclosure and sexual partners. Clients noted considerable challenges that affected acceptability, including the risk to the relationship of disclosing one's HIV status, and the risk of intimate partner violence., Discussion: We found that APS is acceptable as a strategy to reach male sexual partners of females diagnosed with HIV, and these findings provide opportunities to inform recommendations for further scale-up. Opportunities such as focusing on intervention confidentiality and appropriate counseling, excluding female clients at risk of IPV from this intervention, and highlighting the altruistic benefits of APS to potential clients. Understanding the perspectives of clients receiving APS in a real-world setting may be valuable to policy-makers and stakeholders interested in scaling up or enhancing APS within health systems., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Naughton 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: HIV assisted partner services (aPS) is an intervention to improve HIV status awareness among sex and drug-injecting partners of people newly diagnosed with HIV (index clients). Implementation fidelity-the degree to which an intervention is conducted as intended - is critical to effectiveness, but there are limited data about aPS fidelity when delivered by HIV testing service (HTS) providers. We explored factors affecting implementation fidelity to aPS in two high-HIV prevalence counties in western Kenya., Methods: We used convergent mixed methods adapting the conceptual framework for implementation fidelity within the aPS scale-up project. This was an implementation study examining scale-up of APS within HTS programs in Kisumu and Homa Bay counties that recruited male sex partners (MSPs) of female index clients. We defined implementation fidelity as the extent to which HTS providers followed the protocol for phone and in-person participant tracing at six expected tracing attempts. Quantitative data were collected from tracing reports in 31 facilities between November 2018 and December 2020, and in-depth interviews (IDIs) were conducted with HTS providers. Descriptive statistics were used to describe tracing attempts. IDIs were analyzed using thematic content analysis., Results: Overall, 3017 MSPs were mentioned of whom 98% (2969/3017) were traced, with most tracing attempts being successful (2831/2969, 95%). Fourteen HTS providers participated in the IDIs-mostly females (10/14, 71%) with a median age of 35 years (range 25-52), who all had post-secondary education (14/14, 100%). The proportion of tracing attempts occurring by phone ranged from 47 to 66%, with the highest proportion occurring on the first attempt and lowest on the sixth attempt. Contextual factors either enhanced or impeded implementation fidelity to aPS. Positive provider attitudes towards aPS and conducive work environment factors promoted implementation fidelity, while negative MSP responses and challenging tracing conditions impeded it., Conclusion: Interactions at the individual (provider), interpersonal (client-provider), and health systems (facility) levels affected implementation fidelity to aPS. As policymakers prioritize strategies to reduce new HIV infections, our findings highlight the importance of conducting fidelity assessments to better anticipate and mitigate the impact of contextual factors during the scale-up of interventions., (© 2023. The Author(s).)

Background: Assisted partner services (APS), or exposure notification and HIV testing for sexual partners of individuals diagnosed with HIV (index clients), have been shown to be safe and effective in clinical trials. We assessed the real-world effectiveness of APS when integrated into HIV clinics in western Kenya., Methods: In this single-arm, hybrid type 2 implementation science study, we facilitated APS implementation in 31 health facilities in Kenya by training existing health-care staff. We focused on male partner outcomes to assess the impact of APS in reaching male individuals in sub-Saharan Africa, who have lower rates of HIV testing than female individuals. Female individuals (aged ≥18 years or emancipated minor) who tested positive for HIV at participating facilities in Kenya were offered APS; consenting female participants provided contact information for all male sexual partners in the past 3 years. Male partners were notified of their potential HIV exposure and offered a choice of community-based or facility-based HIV testing services (HTS). Female index clients and male partners with HIV were followed up at 6 weeks, 6 months, and 12 months after enrolment, to assess linkage to antiretroviral treatment. Viral load was assessed at 12 months., Findings: Between May 1, 2018, and March 31, 2020, 32 722 female individuals received HTS; 1910 (6%) tested positive for HIV, of whom 1724 (90%) received APS. Female index clients named 5137 male partners (median 3 per index [IQR 2-4]), of whom 4422 (86%) were reached with exposure notification and HTS. 524 (12%) of the male partners tested were newly diagnosed with HIV and 1292 (29%) reported a previous HIV diagnosis. At 12 months follow-up, 1512 (88%) female index clients and 1621 (89%) male partners with HIV were taking ART, with few adverse events: 25 (2%) female index clients and seven (<1%) male partners reported intimate partner violence, and 60 (3%) female index clients and ten (<1%) male partners reported relationship dissolution., Interpretation: Evidence from this real-world APS scale-up project shows that APS is a safe, acceptable, and effective strategy to identify males with HIV and retain them in care., Funding: The US National Institutes of Health., Competing Interests: Declaration of interests CF, MS, BJW, and DK report grants from the National Institutes of Health, outside of the submitted work. MS reports grants from the Bill & Melinda Gates Foundation, outside of the submitted work. All other authors declare no competing interests., (Copyright © 2023 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Community-based delivery of oral HIV self-testing (HIVST) may expand access to testing among adolescents and young adults (AYA). Eliciting youth perspectives can help to optimize these services. We conducted nine focus group discussions (FGDs) with HIV negative AYA aged 15-24 who had completed oral HIVST following community-based distribution through homes, pharmacies, and bars. FGDs were stratified by distribution point and age (15-17, 18-24). Participants valued HIVST because it promoted greater autonomy and convenience compared to traditional clinic-based testing. AYA noted how HIVST could encourage positive behavior change, including using condoms to remain HIV negative. Participants recommended that future testing strategies include individualized, ongoing support during and after testing. Support examples included access to trained peer educators, multiple community-based distribution points, and post-test support via phones and websites. Multiple distribution points and trained peer educators' involvement in all steps of distribution, testing, and follow-up can enhance future community-based HIVST programs.

Background: In sub-Saharan Africa many people who inject drugs (PWID) are living with undiagnosed or untreated HIV and experience high levels of poverty and conditions that can contribute to worse outcomes from SARS-CoV-2 infection. Identifying the burden of SARS-CoV-2 infection in marginalized populations like PWID may contribute to controlling the pandemic., Methods: This is a nested cross-sectional study within an ongoing cohort study that recruits PWID living with HIV and their injecting and/or sexual partners at needle and syringe program sites and methadone clinics in Kenya. Blood samples were collected from consenting participants at enrollment to determine SARS-CoV-2 antibodies using a Platellia BioRad SARS-CoV-2 total antibody enzyme-linked immunosorbent assay. Baseline data were collected on HIV status, antiretroviral therapy and methadone adherence. We used logistic regression to identify factors associated with antibody positivity and descriptive statistics to report SARS-CoV-2 antibody prevalence., Results: One thousand participants were enrolled between April and July 2021, of whom 323 (32.3%) were women and 677 (67.7%) were men. Median age of participants was 36 years (interquartile range: 30, 42). SARS-CoV-2 antibody positivity was found in 309 (30.9%) participants. Disruption in obtaining methadone service was reported by 106 (24.3%) of the participants. Men were significantly less likely than women to have SARS-CoV-2 antibodies (adjusted odds ratio [aOR] = 0.68, 95% confidence interval [CI] 0.51, 0.95; p < 0.01) Participants who reported a sexual or injecting partner diagnosed with SARS-CoV-2 were twofold more likely to have SARS-CoV-2 antibodies detected (aOR = 2.21, 95% CI 1.06, 4.58; p < 0.032). Living with HIV was not associated with presence of SARS-CoV-2 antibodies., Conclusion: The seroprevalence of SARS-CoV-2 of 30.9% in this cohort suggests high transmission rates within this population. SARS-CoV-2 seroprevalence was similar for people living with and without HIV. A large portion of this population was noted to have had disruption in access to harm reduction services., (© 2023. The Author(s).)

Prevalence of hypertension (HTN) and human immunodeficiency virus (HIV) are high among men while screening rates are low. Assisted partner notification service is a strategy recommended by the World Health Organization that aims to increase HIV testing and treatment uptake and may present an opportunity to offer integrated HIV/HTN screening and treatment services. In this prospective cohort study, we assessed the feasibility of integrating HTN screening for male sexual partners of females newly tested HIV-positive in 10 health facilities in Kenya. Participants were notified of the exposure and offered HIV testing and HTN screening; if they accepted and tested positive for either HTN, HIV, or both, they were referred for care. HTN was defined as systolic blood pressure ≥ 140 mm Hg, diastolic blood pressure ≥ 90, or the use of antihypertensive medication. Among 1313 male partners traced, 99% accepted HIV testing and HTN screening. Overall, 4% were found to have HTN, 29% were in the pre-HTN stage, and 9% were HIV-positive. Only 75% had previously been screened for HTN compared to 95% who had previously tested for HIV. A majority preferred non-facility-based screening. The participants who refused HTN screening noted time constraints as a significant hindrance. HIV and HTN screening uptake was high in this hard-to-reach population of men aged 25 to 50. Although HTN rates were low, an integrated approach provided an opportunity to detect those with pre-HTN and intervene early. Strategic integration of HTN services within assisted partners services may promote and normalize testing by offering inclusive and accessible services to men., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2023 the Author(s). Published by Wolters Kluwer Health, Inc.)

Assisted partner service (aPS) augments HIV case-finding among sex partners to individuals newly diagnosed with HIV. In 2016, aPS was incorporated into the national HIV testing services (HTS) program in Kenya. We evaluated the extent of, barriers to, and facilitators of aPS integration into HTS. We conducted semi-structured in-depth interviews (IDIs) with 32 stakeholders selected using purposive sampling at national, county, facility, and community levels. IDIs were conducted at two timepoints, at baseline from August-September 2018 in Kisumu and January-June 2019 in Homa Bay, and at follow-up from May-August 2020 to understand changes in aPS integration over time. We defined integration as the creation of linkages between the new intervention (aPS) and the existing HTS program. Data were analyzed using thematic content analysis. We found varying degrees of aPS integration, highest in procurement/logistics and lowest in HTS provider recruitment/training. At baseline, aPS integration was low and activities were at an introductory phase. At follow-up, aPS was integrated in almost the entire HTS program with the exception of low community awareness, which was noted at both baseline and follow-up. There was increasing routinization with establishment of clear aPS cycles, e.g., quarterly data review meetings, annual budget cycles and work-plans. Major barriers included limited government funding, staff constraints, and inadequate community-level sensitization, while key facilitators included increased resources for aPS, and community health volunteer (CHV) facilitated awareness of aPS. Varying degrees of aPS integration across different units of the national HTS program highlights challenges in funding, human resource, and public awareness. Policymakers will need to address these barriers to ensure optimal provision of aPS., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Wamuti 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: Assisted partner service (APS) is effective for increasing HIV testing services (HTS) uptake among sexual partners of people diagnosed with HIV with rare social harm. The acceptability of APS to HTS providers is important for the quality and effectiveness of APS delivery. Within a larger ongoing implementation science study of APS in western Kenya, we qualitatively evaluated the provider acceptability of APS., Methods: From May-June 2020, we conducted virtual, semi-structured in-depth interviews with 14 HTS providers recruited from 8 of 31 study health facilities in Homa Bay and Kisumu counties. Participants were selected using criteria-based purposive sampling to maximize variation on patient volume (assessed by the number of index clients tested for HIV) and APS performance (assessed by sexual partners elicitation and enrollment). Interviews inquired providers' experiences providing APS including challenges and facilitators and the impact of contextual factors. Data were analyzed using an inductive approach., Results: Overall, HTS providers found APS acceptable. It was consistently reported that doing APS was a continuous process rather than a one-day job, which required building rapport and persistent efforts. Benefits of APS including efficiency in HIV case finding, expanded testing coverage in men, and increased HIV status awareness and linkage to care motivated the providers. Provider referral was perceived advantageous in terms of independent contact with partners on behalf of index clients and efficiency in partner tracing. Challenges of providing APS included protecting clients' confidentiality, difficulty obtaining partners' accurate contact information, logistic barriers of tracing, and clients' refusal due to fear of being judged for multiple sexual partners, fear of breach of confidentiality, and HIV stigma. Building rapport with clients, communicating with patience and nonjudgmental attitude and assuring confidentiality were examples of facilitators. Working in rural areas and bigger facilities, training, supportive supervision, and community awareness of APS promoted APS delivery while low salaries, lack of equipment, and high workload undermined it., Conclusions: HTS providers found APS acceptable. Delivering APS as a process was the key to success. Future scale-up of APS could consider encouraging provider referral instead of the other APS methods to improve efficiency and reduce potential harm to clients., (© 2022. The Author(s).)

Background: Evidence of HIV drug resistance (HIVDR) in individuals using oral pre-exposure prophylaxis (PrEP) who acquire HIV is limited to clinical trials and case studies. More data are needed to understand the risk of HIVDR with oral PrEP during PrEP rollout. Mechanisms to collect these data vary, and are dependent on cost, scale of PrEP distribution, and in-country infrastructure for the identification, collection, and testing of samples from PrEP seroconverters., Methods: The Global Evaluation of Microbicide Sensitivity (GEMS) project, in collaboration with country stakeholders, initiated HIVDR monitoring among new HIV seroconverters with prior PrEP use in Eswatini, Kenya, South Africa, and Zimbabwe. Standalone protocols were developed to assess HIVDR among a national sample of PrEP users. In addition, HIVDR testing was incorporated into existing demonstration projects for key populations., Lessons Learned: Countries are supportive of conducting a time-limited evaluation of HIVDR during the early stages of PrEP rollout. As PrEP rollout expands, the need for long-term HIVDR monitoring with PrEP will need to be balanced with maintaining national HIV drug resistance surveillance for pretreatment and acquired drug resistance. Laboratory capacity is a common obstacle to setting up a monitoring system., Conclusions: Establishing HIV resistance monitoring within PrEP programs is feasible. Approaches to drug resistance monitoring may evolve as the PrEP programs mature and expand. The methods and implementation support offered by GEMS assisted countries in developing methods to monitor for drug resistance that best fit their PrEP program needs and resources., (© Levy et al.)

Oral HIV self-testing (HIVST) may expand access to testing among hard-to-reach reach adolescents and young adults (AYA). We evaluated community-based HIVST services for AYA in an urban settlement in Kenya. Peer-mobilizers recruited AYA ages 15-24 through homes, bars/clubs, and pharmacies. Participants were offered oral HIVST, optional assistance and post-test counseling. Outcomes were HIVST acceptance and completion (self-report and returned kits). Surveys were given at enrollment, post-testing, and 4 months. Log-binomial regression evaluated HIVST preferences by venue. Among 315 reached, 87% enrolled. HIVST acceptance was higher in bars/clubs (94%) than homes (86%) or pharmacies (75%). HIVST completion was 97%, with one confirmed positive result. Participants wanted future HIVST at multiple locations, include PrEP, and cost ≤ $5USD. Participants from bars/clubs and pharmacies were more likely to prefer unassisted testing and peer-distributers compared to participants from homes. This differentiated community-based HIVST strategy could facilitate engagement in HIV testing and prevention among AYA., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: HIV prevalence among people who inject drugs (PWID) in Kenya is estimated to be 18% compared to 4.5% in the general population. Studies from high-income countries have demonstrated that methadone use is associated with increased uptake of antiretroviral therapy (ART) and higher rates of viral suppression among PWID with HIV. However, it is unclear whether methadone use has the same effect among African PWID living with HIV., Methods: We performed a cross-sectional study to evaluate associations between methadone program participation and ART uptake and viral suppression (HIV RNA viral load <1000 copies/ml) among PWID with HIV in Kenya. Participants were recruited from needle and syringe programs and methadone clinics, interviewed on site, and samples were obtained and assayed for HIV viral loads. Univariate and multiple logistic regression were used to determine associations., Results: Among 679 participants, median age was 37 years, 48% were female, and 24% were in a methadone program. We observed higher proportions of ART use (96% vs. 87%, p = 0.001) and HIV viral suppression (78% vs. 65%, p = 0.012) among PWID on methadone compared to those not on methadone treatment. PWID who were not participating in a methadone program were 3-fold more likely to be off ART and approximately twice as likely to be viremic compared to those in methadone programs (adjusted odds ratio [aOR] = 3.35, 95% confidence interval [CI]: 1.35-8.35 and aOR = 1.90, 95% CI: 1.03-3.52, respectively)., Conclusions: In this study, Kenyan PWID living with HIV participating in a methadone treatment program were more likely to be on ART and to have achieved viral suppression. Scale-up of methadone programs may have a positive impact on HIV epidemic control for this key population., (Copyright © 2021. Published by Elsevier Inc.)

Background: Persons who inject drugs (PWID) have higher HIV and hepatitis C virus (HCV) seroprevalence than the general population in many parts of sub-Saharan Africa (SSA). The seroprevalences of HIV and HCV are also higher in coastal Kenya than in Nairobi. Understanding drivers of regional HIV and HCV variation among PWID in Kenya may inform population-specific prevention interventions., Methods: Using a cross-sectional study, we defined HIV and HCV seroprevalence among persons identified as sexual or injecting partners of HIV positive PWID in two regions of Kenya and used logistic regression to identify demographic and behavioral characteristics associated with higher seroprevalence., Results: Among 2386 partners, 469 (19.7%) tested HIV positive and 297(12.4%) tested HCV antibody positive. Partners on the Coast were more likely to live with HIV (seroprevalences: Coast = 23.8%, Nairobi = 17.1%; p < 0.001) and be HCV antibody positive (seroprevalences: Coast = 17.0%, Nairobi = 8.6%; p < 0.001). After adjusting for sex, age, and years injecting and accounting for clustering by site, the higher prevalence of both diseases in the Coast remained significant for HIV (OR 1.68, 95% CI 1.13-2.51) but not for HCV (OR 1.72, 95% CI 0.84-3.74). Compared to those recruited in Nairobi, partners on the Coast were older (Coast = 35 years, Nairobi = 31 years; p < 0.001), more likely to be male (Coast = 77.6%, Nairobi = 61.7%; p < 0.001), to have paid (Coast = 59.2%, Nairobi = 32.8%; p < 0.001) or received (Coast = 44.2%, Nairobi 35.4%; p < 0.001) money for sex, or to have had sex with someone they knew to be HIV positive (Coast 22.0%, Nairobi 10.8%; p < 0.001). Partners who had injected for five or more years had 1.48 times greater odds (95% CI 1.20-1.82) of living with HIV compared to partners who injected less than 5 years and more than twice the odds of HCV (95% CI 1.84-4.11)., Conclusion: HIV and HCV seroprevalence among sexual and injecting partners of PWID was, respectively, 5 times and > 12 times greater than is reported among the general population in Kenya (4% and < 1%, respectively). Providing resources and education will be crucial to reduce exposure and to maintain the lower needle and equipment sharing that we observed compared to other studies., (© 2022. The Author(s).)

Background: HIV assisted partner services (aPS), or provider notification and testing for sexual and injecting partners of people diagnosed with HIV, is shown to be safe, effective, and cost-effective and was scaled up within the national HIV testing services (HTS) program in Kenya in 2016. We estimated the costs of integrating aPS into routine HTS within an ongoing aPS scale-up project in western Kenya., Methods: We conducted microcosting using the payer perspective in 14 facilities offering aPS. Although aPS was offered to both males and females testing HIV-positive (index clients), we only collected data on female index clients and their male sex partners (MSP). We used activity-based costing to identify key aPS activities, inputs, resources, and estimated financial and economic costs of goods and services. We analyzed costs by start-up (August 2018), and recurrent costs one-year after aPS implementation (Kisumu: August 2019; Homa Bay: January 2020) and conducted time-and-motion observations of aPS activities. We estimated the incremental costs of aPS, average cost per MSP traced, tested, testing HIV-positive, and on antiretroviral therapy, cost shares, and costs disaggregated by facility., Results: Overall, the number of MSPs traced, tested, testing HIV-positive, and on antiretroviral therapy was 1027, 869, 370, and 272 respectively. Average unit costs per MSP traced, tested, testing HIV-positive, and on antiretroviral therapy were $34.54, $42.50, $108.71 and $152.28, respectively, which varied by county and facility client volume. The weighted average incremental cost of integrating aPS was $7,485.97 per facility per year, with recurrent costs accounting for approximately 90% of costs. The largest cost drivers were personnel (49%) and transport (13%). Providers spent approximately 25% of the HTS visit obtaining MSP contact information (HIV-negative clients: 13 out of 54 min; HIV-positive clients: 20 out of 96 min), while the median time spent per MSP traced on phone and in-person was 6 min and 2.5 hours, respectively., Conclusion: Average facility costs will increase when integrating aPS to HTS with incremental costs largely driven by personnel and transport. Strategies to efficiently utilize healthcare personnel will be critical for effective, affordable, and sustainable aPS., (© 2022. The Author(s).)

Introduction: The burden of cardiovascular disease (CVD) is increasing in sub-Saharan Africa with untreated hypertension being a major contributing factor. Understanding the magnitude of the problem and risk factors associated with HIV and long-term antiretroviral therapy (ART) is critically important for designing effective programs for diagnosing and treating hypertension in Kenya., Methods: In this cross-sectional study, we enrolled 300 persons with HIV (PWH) on long term ART (≥6 months) and 298 HIV-negative adults seeking care at the Kisumu County Hospital between September 2017 and May 2018. Hypertension was defined as blood pressure of ≥140/90mmHg or a previous hypertension diagnosis. Multivariate regression was used to assess the association between hypertension and HIV adjusting for age, sex, and known CVD risk factors., Results: Overall prevalence of hypertension was 22%. PWH had a lower prevalence of hypertension than HIV-negative persons (16% vs 27% respectively; p<0.002). In multivariate analyses, persons with HIV were 37% less likely to have hypertension compared to HIV-negative individuals (adjusted prevalence ratio 0.63; 95% confidence interval: 0.46-0.86). Other factors that were associated with hypertension in all participants included older age >40 years, body mass index (BMI) >25 kg/m2 and low-density lipoproteins ≥130mg/dL. Among PWH, being older than 40 years and higher BMI >30 kg/m2 were associated with hypertension., Conclusion: Prevalence of hypertension was high, affecting nearly one in every 4 adults, and associated with older age, higher BMI and high low-density lipoproteins. PWH on long-term ART had significantly lower prevalence of hypertension compared to HIV-negative individuals, potentially due to increased access to healthcare services and interaction with prevention messaging. Interventions to increase screening for and prevention of hypertension in the community for all adults are warranted., Competing Interests: The authors declare that they have no conflicts of interest or competing financial interests.

Objectives: Heightened systemic inflammation is common in obese individuals and persons with HIV (PWH) and is independently associated with an increased risk of cardiovascular diseases (CVDs). We investigated the combined effect of central obesity, a surrogate measure of visceral fat and HIV on circulating levels of inflammatory cytokines among Kenyan adults., Design: A cross-sectional study., Methods: We analysed and compared data from 287 virally suppressed PWH and 277 noninfected Kenyan adults, including biomarkers of gut epithelial dysfunction (intestinal fatty acid binding protein), monocyte activation (soluble CD163 and CD14) and inflammation [interleukin (IL)-1β, IL-6, TNF-α and hsCRP] by HIV/central obesity status (HIV-positive/obese, HIV-negative/obese, HIV-positive/nonobese and HIV-negative/nonobese). Central obesity was defined as waist circumference more than 80 cm for women and more than 94 cm for men. We assessed the association of HIV/obesity status with elevated biomarkers (>75th percentile) using logistic regression., Results: Median age for participants was 44 years and 37% were centrally obese. Levels of all biomarkers were higher among the HIV-positive/obese compared with the HIV-negative/nonobese (P < 0.05 for all comparisons). The HIV-positive/obese group had the greatest odds of having elevated inflammatory biomarkers compared with other groups even after adjustment of age, BMI and other conventional CVD risk factors (P < 0.05 for all). Additional adjustment for sCD163 in the multivariate model substantially attenuated the association for HIV-positive/obesity with IL-1β, IL-6 and TNF-α but not hsCRP. The contribution of HIV-positive/obesity to inflammation was independent of the degree of immunosuppression., Conclusion: Central obesity is prevalent among virally suppressed African PWH and is associated with greater inflammation and monocyte activation independent of other comorbidities and HIV-specific factors., (Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.)

Background: In 2017, the Kenyan Ministry of Health integrated provision of pre-exposure prophylaxis (PrEP) into public HIV-1 care clinics as a key component of the national HIV-1 prevention strategy. Estimates of the cost of PrEP provision are needed to inform the affordability and cost-effectiveness of PrEP in Kenya., Methods: We conducted activity-based micro-costing from the payer perspective to estimate both the financial and economic costs of all resources and activities required to provide PrEP in Kenya's public sector. We estimated total and unit costs in 2019 United States dollars from a combination of project expense reports, Ministry of Health training reports, clinic staff interviews, time-and-motion observations, and routinely collected data from PrEP recipient files from 25 high-volume HIV-1 care clinics., Results: In the first year of programmatic PrEP delivery in 25 HIV-1 care clinics, 2,567 persons initiated PrEP and accrued 8,847 total months of PrEP coverage, accounting for 2 % of total outpatient clinic visits. The total financial cost to the Ministry of Health was $91,175, translating to an average of $10.31 per person per month. The majority (69 %) of financial costs were attributable to PrEP medication, followed by administrative supplies (17 %) and training (9 %). Economic costs were higher ($188,584 total; $21.32 per person per month) due to the inclusion of the opportunity cost of staff time re-allocated to provide PrEP and a proportional fraction of facility overhead. The vast majority (88 %) of the annual $80,811 economic cost of personnel time was incurred during activities to recruit new clients (e.g., discussion of PrEP within HIV-1 testing and counselling services), while the remaining 12 % was for activities related to both initiation and maintenance of PrEP provision (e.g., client consultations, technical advising, support groups)., Conclusions: Integration of PrEP provision into existing public health HIV-1 care service delivery platforms resulted in minimal additional staff burden and low incremental costs. Efforts to improve the efficiency of PrEP provision should focus on reductions in the cost of PrEP medication and extra-clinic demand creation and community sensitization to reduce personnel time dedicated to recruitment-related activities., Trial Registration: ClinicalTrials.gov registration NCT03052010 . Retrospectively registered on February 14, 2017., (© 2021. The Author(s).)

Background: Despite the effective scale-up of HIV testing and treatment programs, only 75% of people living with HIV (PLWH) globally know their status, and this rate is lower among men. This highlights the importance of implementing HIV testing and linkage interventions with a high uptake in this population. In a cluster randomized controlled trial conducted in Kenya between 2013 and 2015, we found that assisted partner services (APS) for HIV-exposed partners of newly diagnosed PLWH safely reached more HIV-exposed individuals with HIV testing compared with client referral alone. However, more data are needed to evaluate APS implementation in a real-world setting., Objective: This study aims to evaluate the effectiveness, acceptability, fidelity, and cost of APS when integrated into existing HIV testing services (HTS) in Western Kenya., Methods: Our study team from the University of Washington and PATH is integrating APS into 31 health facilities in Western Kenya. We are enrolling females newly diagnosed with HIV (index clients) who consent to receiving APS, their male sexual partners, and female sexual partners of male sexual partners who tested HIV positive. Female index clients and sexual partners testing HIV positive will be followed up at 6 weeks, 6 months, and 12 months postenrollment to assess linkage to care, antiretroviral therapy initiation, and HIV viral load suppression. We will evaluate the acceptability, fidelity, and cost of real-world implementation of APS via in-depth interviews conducted with national, county, and subcounty-level policy makers responsible for HTS. Facility health staff providing HTS and APS, in addition to staff working with the study project team, will also be interviewed. We will also conduct direct observations of facility infrastructure and clinical procedures and extract data from the facilities and county and national databases., Results: As of March 2020, we have recruited 1724 female index clients, 3201 male partners, and 1585 female partners. We have completed study recruitment as well as 6-week (2936/2973, 98.75%), 6-month (1596/1641, 97.25%), and 12-month (725/797, 90.9%) follow-up visits. Preliminary analyses show that facilities scaling up APS identify approximately 12-18 new HIV-positive males for every 100 men contacted and tested. We are currently completing the remaining follow-up interviews and incorporating an HIV self-testing component into the study in response to the COVID-19 pandemic., Conclusions: The results will help bridge the gap between clinical research findings and real-world practice and provide guidance regarding optimal strategies for APS integration into routine HIV service delivery., International Registered Report Identifier (irrid): DERR1-10.2196/27262., (©Edward Kariithi, Monisha Sharma, Emily Kemunto, Harison Lagat, George Otieno, Beatrice M Wamuti, David A Katz, Christopher Obong'o, Paul Macharia, Rose Bosire, Sarah Masyuko, Mary Mugambi, Carol E Levin, Wenjia Liu, Unmesha Roy Paladhi, Bryan J Weiner, Carey Farquhar. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 20.05.2021.)

Introduction: Targeted, tailored interventions to test high-risk individuals for HIV and hepatitis C virus (HCV) are vital to achieving HIV control and HCV microelimination in Africa. Compared with the general population, people who inject drugs (PWID) are at increased risk of HIV and HCV and are less likely to be tested or successfully treated. Assisted partner services (APS) increases HIV testing among partners of people living with HIV and improves case finding and linkage to care. We describe a study in Kenya examining whether APS can be adapted to find, test and link to HIV care the partners of HIV-positive PWID using a network of community-embedded peer educators (PEs). Our study also identifies HCV-positive partners and uses phylogenetic analysis to determine risk factors for onward transmission of both viruses., Methods: This prospective cohort study leverages a network of PEs to identify 1000 HIV-positive PWID for enrolment as index participants. Each index completes a questionnaire and provides names and contact information of all sexual and injecting partners during the previous 3 years. PEs then use a stepwise locator protocol to engage partners in the community and bring them to study sites for enrolment, questionnaire completion and rapid HIV and HCV testing. Outcomes include number and type of partners per index who are mentioned, enrolled, tested, diagnosed with HIV and HCV and linked to care., Ethics and Dissemination: Potential index participants are screened for intimate partner violence (IPV) and those at high risk are not eligible to enrol. Those at medium risk are monitored for IPV following enrolment. A community advisory board engages in feedback and discussion between the community and the research team. A safety monitoring board discusses study progress and reviews data, including IPV monitoring data. Dissemination plans include presentations at quarterly Ministry of Health meetings, local and international conferences and publications., Trial Registration Number: NCT03447210, Pre-results stage., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Patient-reported outcome measures (PROMs) assess patients' perspectives on their health status, providing opportunities to improve the quality of care. While PROMs are increasingly used in high-income settings, limited data are available on PROMs use for diabetes and hypertension in low-and middle-income countries (LMICs). This scoping review aimed to determine how PROMs are employed for diabetes and hypertension care in LMICs., Methods: We searched PubMed, EMBASE, and ClinicalTrials.gov for English-language studies published between August 2009 and August 2019 that measured at least one PROM related to diabetes or hypertension in LMICs. Full texts of included studies were examined to assess study characteristics, target population, outcome focus, PROMs used, and methods for data collection and reporting., Results: Sixty-eight studies met the inclusion criteria and reported on PROMs for people diagnosed with hypertension and/or diabetes and receiving care in health facilities. Thirty-nine (57%) reported on upper-middle-income countries, 19 (28%) reported on lower-middle-income countries, 4 (6%) reported on low-income countries, and 6 (9%) were multi-country. Most focused on diabetes (60/68, 88%), while 4 studies focused on hypertension and 4 focused on diabetes/hypertension comorbidity. Outcomes of interest varied; most common were glycemic or blood pressure control (38), health literacy and treatment adherence (27), and acute complications (22). Collectively the studies deployed 55 unique tools to measure patient outcomes. Most common were the Morisky Medication Adherence Scale (7) and EuroQoL-5D-3L (7)., Conclusion: PROMs are deployed in LMICs around the world, with greatest reported use in LMICs with an upper-middle-income classification. Diabetes PROMs were more widely deployed in LMICs than hypertension PROMs, suggesting an opportunity to adapt PROMs for hypertension. Future research focusing on standardization and simplification could improve future comparability and adaptability across LMIC contexts. Incorporation into national health information systems would best establish PROMs as a means to reveal the effectiveness of person-centered diabetes and hypertension care., Competing Interests: The authors have declared that no competing interests exist.

Background: Assisted partner services (aPS) involves notification and HIV testing for sexual partners of persons diagnosed HIV-positive (index clients). Because the impact of aPS is contingent on high acceptance, we assessed characteristics and reasons for nonenrollment among female index clients in an ongoing scale-up project., Methods: We analyzed data from HIV-positive females offered aPS in 31 facilities from May 2018 to August 2019. We compared sociodemographic characteristics by aPS enrollment (accepted, refused, and ineligible) and used multivariate binomial regression to assess associations between demographics and refusal., Results: Twenty-four thousand four hundred eighteen females received HIV testing and 1050 (4.3%) tested HIV-positive; 839 females enrolled in aPS (80%), 59 refused (6%), and 152 were ineligible (14%). APS uptake did not differ by age, testing history, or testing type (provider initiated vs. client initiated). Females refusing aPS were more likely to have completed secondary school [adjusted relative risk (aRR) 2.03, 95% confidence interval (CI): 1.13 to 2.82] and be divorced/separated (aRR: 3.09, 95% CI: 1.39 to 6.86) or single (aRR: 2.66, 95% CI: 1.31 to 5.42) compared with married/cohabitating. Reasons for refusing aPS included not feeling emotionally ready (31%) and reporting no sexual partners in past 3 years (22%). Reasons for ineligibility included fear or risk of intimate partner violence (9%), previous HIV diagnosis (9%), or insufficient time for aPS provision (3%)., Conclusions: APS has high acceptability among HIV-positive females regardless of age or testing history. More counseling may be needed to increase uptake among females with higher education and those who are separated/single. Follow-up for females not emotionally ready or who had insufficient time for aPS in their clinic visit can improve coverage.

Introduction: Markers of monocyte/macrophage activation and vascular inflammation are associated with HIV-related cardiovascular diseases (CVD) and mortality. We compared these markers among African people living with HIV (PLWH) and HIV-negative adults, and examined risk factors associated with elevated biomarkers (>75th percentile) in PLWH on antiretroviral therapy (ART)., Design: Cross-sectional study., Methods: We measured serum concentrations of a gut integrity biomarker (intestinal-fatty acid binding protein), monocyte/macrophage activation biomarkers (soluble CD14 and CD163), and vascular inflammation biomarkers [soluble intercellular adhesion molecule 1 (sICAM-1) and soluble vascular adhesion molecule 1 (sVCAM-1)]. We assessed the relationship of these inflammatory parameters with HIV, using logistic regression adjusting for traditional CVD risk factors., Results: Among the 541 participants, median age was 43 years and half were female. Among 275 PLWH, median CD4 T-cell count and duration of ART use was 509 cells/μl and 8 years, respectively. PLWH had significantly higher prevalence of elevated inflammatory biomarkers compared with HIV-negative individuals even after adjustment for traditional CVD risk factors. Compared with individuals without HIV, the prevalence of elevated biomarkers was highest among persons with detectable viral load and CD4 T-cell counts 200 cells/μl or less. In a subanalysis among PLWH, nadir CD4 T-cell count 200 cells/μl or less was associated with elevated soluble CD14 (sCD14); dyslipidemia with elevated sCD14, sICAM-1, and sVCAM-1; and overweight/obesity with reduced sCD14. Longer ART exposure (>4 years) was associated with reduced sVCAM-1 and sICAM-1., Conclusion: HIV and not traditional CVD risk factors is a primary contributor of monocyte/macrophage activation and inflammation despite ART. Anti-inflammatory therapies in addition to ART may be necessary to reduce these immune dysregulations and improve health outcomes of African PLWH.

Background: Residual monocyte activation may contribute to increased risk for endothelial dysfunction and subsequent atherosclerotic cardiovascular diseases (CVDs) among people with HIV (PWH) on antiretroviral therapy (ART). We examined the relationship between monocyte activation and endothelial activation in PWH in Kenya., Methods: Serum levels of markers of endothelial activation (soluble/circulating intercellular [sICAM-1] and vascular [sVCAM-1] cell adhesion molecule-1), intestinal barrier dysfunction (intestinal fatty acid binding protein [I-FABP]), and monocyte activation (soluble CD14 [sCD14]) were measured in 275 PWH on ART and 266 HIV-negative persons. Linear regression was used to evaluate associations, adjusting for demographic and traditional CVD risk factors., Results: Among 541 participants, the median age was 43 years, 50% were female, and most PWH were virally suppressed (97%). sICAM-1 and sVCAM-1 levels were significantly higher in PWH than in HIV-negative participants ( P  < .001 for both). After further adjustment for traditional CVD risk factors, HIV infection remained associated with 49% (95% CI, 33% to 67%) greater sICAM-1 and 30% (95% CI, 14% to 48%) greater sVCAM-1 relative to uninfected controls. Adjustment for sCD14 substantially attenuated the difference between PWH and HIV-negative individuals. In a stratified analysis of PWH, both sICAM-1 and sVCAM-1 were positively associated with sCD14 ( P  < .001)., Conclusions: Despite viral suppression, African PWH have evidence of enhanced endothelial activation associated with sCD14, suggesting that monocyte activation plays a role in atherosclerotic plaque development. Future studies are needed to determine mechanistic pathways leading to monocyte activation in this population., (© The Author(s) 2020. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)

To catalyse national scale up of PrEP for HIV serodiscordant couples in public health facilities in Kenya, the Partners Scale-Up Project, using a two-day case-based interactive curriculum, trained health care providers working in 24 high volume facilities in central and western Kenya on PrEP service delivery. Using a standardised test with questions about PrEP and antiretroviral-based HIV prevention we assessed gain in knowledge and confidence gain by comparing pre-and post-training test scores. We explored experiences of the training through key informant interviews after clinics started delivering PrEP. Of 716 health care providers trained, 235 (32.9%) were nurses, 144 (20.2%) were clinical officers and 155 (21.7%) were HIV counsellors. There was a significant improvement between the means of pre-test and post-test scores (61.7% (SD 17.4) vs 86.4% (SD 12.7) p  < 0.001). The proportion of those who reported being 'very comfortable' providing care to HIV serodiscordant couples increased from 22.8% to 67.3% ( p  < 0.001). Key themes that training increasing both knowledge of PrEP and confidence to deliver PrEP to HIV serodiscordant couples emerged from interviews. This short, standardised training resulted in a substantial increase in knowledge of PrEP and in the confidence of the health providers to provide PrEP to HIV serodiscordant couples. Trial registration ClinicalTrials.gov NCT03052010.

Purpose of Review: This review offers an operational definition of systems engineering (SE) as applied to public health, reviews applications of SE in the field of HIV, and identifies opportunities and challenges of broader application of SE in global health., Recent Findings: SE involves the deliberate sequencing of three steps: diagnosing a problem, evaluating options using modeling or optimization, and providing actionable recommendations. SE includes diverse tools (from process improvement to mathematical modeling) applied to decisions at various levels (from local staffing decisions to planning national-level roll-out of new interventions). Contextual factors are crucial to effective decision-making, but there are gaps in understanding global decision-making processes. Integrating SE into pre-service training and translating SE tools to be more accessible could increase utilization of SE approaches in global health. SE is a promising, but under-recognized approach to improve public health response to HIV globally.

Background While advances have been made in HIV prevention and treatment, new HIV infections continue to occur. The introduction of pre-exposure prophylaxis (PrEP) as an additional HIV prevention option for those at high risk of HIV may change the landscape of the HIV epidemic, especially in sub-Saharan Africa, which bears the greatest HIV burden., Methods: This paper details Kenya's experience of PrEP rollout as a national public sector program. The process of a national rollout of PrEP guidance, partnerships, challenges, lessons learnt and progress related to national scale up of PrEP in Kenya, as of 2018, is described. National rollout of PrEP was strongly lead by the government, and work was executed through a multidisciplinary, multi-organisation dedicated team. This required reviewing available evidence, providing guidance to health providers, integration into existing logistic and health information systems, robust communication and community engagement. Mapping of the response showed that subnational levels had existing infrastructure but required targeted resources to catalyse PrEP provision. Rollout scenarios were developed and adopted, with prioritisation of 19 counties focusing on high incidence area and high potential PrEP users to maximise impact and minimise costs., Results: PrEP is now offered in over 900 facilities countrywide. There are currently over 14000 PrEP users 1 year after launching PrEP., Conclusions: Kenya becomes the first African country to rollout PrEP as a national program, in the public sector. This case study will provide guidance for low- and middle-income countries planning the rollout of PrEP in response to both generalised and concentrated epidemics.

Background: Antiretroviral therapy (ART) for HIV-infected persons and pre-exposure prophylaxis (PrEP) for uninfected persons are extraordinarily effective strategies for HIV prevention. In Africa, the region which shoulders the highest HIV burden, HIV care is principally delivered through public health HIV care clinics, offering an existing platform to incorporate PrEP delivery and maximize ART and PrEP synergies. However, successfully bringing this integrated approach to scale requires an implementation science evaluation in public health settings., Methods: The Partners Scale Up Project is a prospective, pragmatic implementation evaluation, designed as a stepped-wedge, cluster-randomized trial, operating at 24 clinics in Kenya. In collaboration with the Kenya Ministry of Health, we are catalyzing scaled implementation of PrEP delivery integrated in HIV care clinics. The intervention package includes staff training, clinic streamlined access to PrEP commodity from the Kenya Medical Supply Authority, and ongoing intensive technical assistance to rigorously assess how PrEP delivery is implemented. PrEP service delivery including retention efforts are conducted by the clinic staff with no additional resources from the project. Guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework and Consolidated Framework for Implementation Science Research, project progress and learning are documented through ongoing monitoring and process evaluations, including chart abstraction and individual and key informant interviews, to evaluate pragmatic rollout and understand barriers and facilitators for successful PrEP delivery in this setting. In this staged rollout design, each step provides data for both pre-implementation (baseline) and implementation periods, and we will compare time points across steps in the baseline versus implementation periods., Discussion: Cost-effective delivery models are urgently needed to maximize the public health impact of PrEP and ART. The Partners Scale Up Project will set the stage for full-scale PrEP implementation fully run and owned by the Kenya Ministry of Health. The work combines nationally sponsored PrEP delivery with technical support and implementation science from academic partners, defining a new but sustainable paradigm for public health collaboration., Trial Registration: Registered with ClinicalTrials.gov on February 14, 2017: NCT03052010 .