Implementation and Assessment of the HIV Enhanced Access Testing in the Emergency Department (HEATED) Program in Nairobi, Kenya: A Quasi-Experimental Prospective Study.

Background: Persons seeking emergency injury care are often from 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 using setting specific data and utilizes resource reorganization, services integration and HIV sensitization to promote ED-HTS. 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 those never previously 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). 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 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) with a 62.9% relative increase in HIV self-test kit provision. Among 605 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, 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-weeks post-implementation a significant increase in ED-HTS delivery was maintained as compared to pre-implementation. Conclusions: The HEATED program increased 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.

Efficacy of assisted partner services for people who inject drugs in Kenya to identify partners living with HIV and hepatitis C virus infection: a prospective cohort study.

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.

Virologic Nonsuppression and HIV Drug Resistance Among People Who Inject Drugs and Their Sexual and Injecting Partners in Kenya.

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.

Using viral sequence diversity to estimate time of HIV infection in infants.

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.

Passively Acquired Constant Region 5-Specific Antibodies Associated With Improved Survival in Infants Who Acquire Human Immunodeficiency Virus.

Studying vertical human immunodeficiency virus (HIV) transmission enables the impact of passively transferred antibodies on HIV transmission and pathogenesis to be examined. Using phage display of HIV envelope peptides and peptide enzyme-linked immunosorbent assay (ELISA), we found that, in infants who acquired HIV, passive antibody responses to constant region 5 (C5) were associated with improved survival in 2 cohorts. In a combined analysis, C5 peptide ELISA activity was correlated directly with survival and estimated infection time and inversely with set point viral load. These results suggest that preexisting C5-specific antibodies may be correlated with the survival of infants living with HIV, motivating additional research into their protective potential.

"I feel good because I have saved their lives": Acceptability of assisted partner services among female index clients and male sexual partners in Kenya.

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.

Real-world impact of integrating HIV assisted partner services into 31 facilities in Kenya: a single-arm, hybrid type 2 implementation-effectiveness study.

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.

HIV self-testing acceptability among injured persons seeking emergency care in Nairobi, Kenya.

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.

Prevalence of Substance Use and Its Association with Sociodemographic and Behavioral Factors among Women Who Conduct Sex Work in Kenya.

Female sex workers (FSWs) in sub-Saharan Africa are a marginalized group with an increased morbidity risk. Psychoactive substance use among this group is common and increases the risk of adverse health consequences. The type of substance used, extent, and nature of use varies with different settings and regions. We examine the use of specific psychoactive substances among FSWs residing in an urban informal settlement in Nairobi. This cross-sectional study was conducted between April and August 2017. Structured questionnaires were administered in face-to-face interviews. Descriptive statistics and logistic regression were undertaken to examine prevalence, patterns, and factors associated with use of specific substances. Out of 301 FSWs, 98% reported current psychoactive substance use. The most used substance was alcohol with 95.6% of the study population reporting use in the past year. Of these, 151 (50.2%) met criteria for very high-risk drinkers. Reported current use was 61.5% for cannabis, 47.2% for khat, and 30.9% for tobacco. Factors independently associated with hazardous and harmful alcohol use included earning a higher monthly income (>USD50) and disclosure of sex work to close family and friends. There is an urgent need for preventive and curative interventions to address the high prevalence of substance use among FSW residing in high-risk urban informal settlements in Kenya.

"It is a process" - a qualitative evaluation of provider acceptability of HIV assisted partner services in western Kenya: experiences, challenges, and facilitators.

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.

Characteristics associated with HIV and hepatitis C seroprevalence among sexual and injecting partners of HIV positive persons who inject drugs in Nairobi and coastal Kenya.

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.

Cost of integrating assisted partner services in HIV testing services in Kisumu and Homa Bay counties, Kenya: a microcosting study.

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.

Acceptability and uptake of HIV self-testing in emergency care settings: A systematic review and meta-analysis.

BACKGROUND: Emergency departments (ED) interface with large numbers of patients that are often missed by conventional HIV testing approaches. ED-based HIV self-testing (HIVST) is an innovative engagement approach which has potential for testing gains among populations that have failed to be reached. This systematic review and meta-analysis evaluated acceptability and uptake of HIVST, as compared to standard provider-delivered testing approaches, among patients seeking care in ED settings. METHODS: Six electronic databases were systematically searched (Dates: January 1990-May 2021). Reports with data on HIVST acceptability and/or testing uptake in ED settings were included. Two reviewers identified eligible records (κ= 0.84); quality was assessed using formalized criteria. Acceptability and testing uptake metrics were summarized, and pooled estimates were calculated using random-effects models with assessments of heterogeneity. RESULTS: Of 5773 records identified, seven met inclusion criteria. The cumulative sample was 1942 subjects, drawn from three randomized control trials (RCTs) and four cross-sectional studies. Four reports assessed HIVST acceptability. Pooled acceptability of self-testing was 92.6% (95% confidence interval [CI]: 88.0%-97.1%). Data from two RCTs demonstrated that HIVST significantly increased testing uptake as compared to standard programs (risk ratio [RR] = 4.41, 95% CI: 1.95-10.10, I2  = 25.8%). Overall, the quality of evidence was low (42.9%) or very low (42.9%), with one report of moderate quality (14.2%). CONCLUSIONS: Available data indicate that HIVST may be acceptable and may increase testing among patients seeking emergency care, suggesting that expanding ED-based HIVST programs could enhance HIV diagnosis. However, given the limitations of the reports, additional research is needed to better inform the evidence base.

Participation in methadone programs improves antiretroviral uptake and HIV viral suppression among people who inject drugs in Kenya.

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.

Assessment of standard HIV testing services delivery to injured persons seeking emergency care in Nairobi, Kenya: A prospective observational study.

Emergency departments (EDs) in Africa are contact points for key groups for HIV testing services (HTS) but understanding of ED-testing delivery is limited which may impeded program impacts. This study evaluated the offering and uptake of standard HTS among injured persons seeking ED care at Kenyatta National Hospital (KNH) in Nairobi, Kenya. An ED population of adult injured persons was prospectively enrolled (1 March-25 May 2021) and followed through ED disposition. Participants requiring admission were followed through hospital discharge and willing participants were contacted at 28-days for follow up. Data on population characteristics and HTS were collected by personnel distinct from clinicians responsible for standard HTS. Descriptive analyses were performed and prevalence values with 95% confidence intervals (CI) were calculated for HIV parameters. The study enrolled 646 participants. The median age was 29 years with the majority male (87.8%). Most ED patients were discharged (58.9%). A prior HIV diagnosis was reported by 2.3% of participants and 52.7% reported their last testing as >6 months prior. Standard ED-HTS were offered to 49 or 8.6% of participants (95% CI: 5.8-9.9%), among which 89.8% accepted. For ED-tested participants 11.4% were newly diagnosed with HIV (95% CI: 5.0-24.0%). Among 243 participants admitted, testing was offered to 6.2% (95% CI: 3.9-9.9%), with 93.8% accepting. For admitted participants tested 13.3% (95% CI: 4.0-35.1%) were newly diagnosed (all distinct from ED cases). At 28-day follow up an additional 22 participants reported completing testing since ED visitation, with three newly diagnosed. During the full follow-up period the HIV prevalence in the population tested was 10.3% (95% CI: 5.3-19.0%); all being previously undiagnosed. Offering of standard HTS was infrequent, however, when offered, uptake and identification of new HIV diagnoses were high. These data suggest that opportunities exist to improve ED-HTS which could enhance identification of undiagnosed HIV.

Improved HIV-positive infant survival is correlated with high levels of HIV-specific ADCC activity in multiple cohorts.

Defining immune responses that protect humans against diverse HIV strains has been elusive. Studying correlates of protection from mother-to-child transmission provides a benchmark for HIV vaccine protection because passively transferred HIV antibodies are present during infant exposure to HIV through breast milk. A previous study by our group illustrated that passively acquired antibody-dependent cellular cytotoxicity (ADCC) activity is associated with improved infant survival whereas neutralization is not. Here, we show, in another cohort and with two effector measures, that passively acquired ADCC antibodies correlate with infant survival. In combined analyses of data from both cohorts, there are highly statistically significant associations between higher infant survival and passively acquired ADCC levels (p = 0.029) as well as dimeric FcγRIIa (p = 0.002) or dimeric FcγRIIIa binding (p < 0.001). These results suggest that natural killer (NK) cell- and monocyte antibody-mediated effector functions may contribute to the observed survival benefit and support a role of pre-existing ADCC-mediating antibodies in clinical outcome.

Using Assisted Partner Services for HIV Testing and the Treatment of Males and Their Female Sexual Partners: Protocol for an Implementation Science Study.

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.

Peer-mediated HIV assisted partner services to identify and link to care HIV-positive and HCV-positive people who inject drugs: a cohort study protocol.

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.

Women's Autonomy in Infant Feeding Decision-Making: A Qualitative Study in Nairobi, Kenya.

BACKGROUND: Exclusive breastfeeding (EBF) is the optimal way to feed young infants. Guidelines recommend that women living with HIV on antiretroviral therapy should EBF for 6 months and continue breastfeeding for up to 24 months or longer. Parents may face social or logistical barriers creating challenges to EBF. OBJECTIVES: To explore barriers, facilitators and community norms influencing EBF practices in Kenya. METHODS: This qualitative research was nested within a longitudinal study of intensive maternal counseling to increase EBF among HIV-positive mothers. HIV-negative and HIV-positive mothers were recruited from four public clinics in Nairobi. Women participated in focus group discussions (FGDs) that explored beliefs about and experiences with infant feeding. Conventional content analysis was used to describe and compare barriers and facilitators influencing HIV-positive and HIV-negative women's EBF experiences. RESULTS: We conducted 17 FGDs with 80 HIV-positive and 53 HIV-negative women between 2009 and 2012. Overall, women agreed that breastmilk is good for infants. However, early mixed feeding was a common cultural practice. HIV-positive women perceived that infant feeding methods and durations were their decision. In contrast, HIV-negative women reported less autonomy and more mixed feeding, citing peer pressure and lack of HIV transmission concerns. Autonomy in decision-making was facilitated by receiving EBF counseling and family support, especially from male partners. Low milk production was a barrier to EBF, regardless of HIV status, and perceived to represent poor maternal nutrition. CONCLUSIONS: Despite challenges, counseling empowered women living with HIV to advocate for EBF with spouses and family.