Describing the effect of COVID-19 on sexual and healthcare-seeking behaviours of men who have sex with men in three counties in Kenya: a cross-sectional study.

BACKGROUND: While the COVID-19 pandemic disrupted HIV preventative services in sub-Saharan Africa, little is known about the specific impacts the pandemic has had on men who have sex with men (MSM) in Kenya. METHODS: Data were from an HIV self-testing intervention implemented in Kisumu, Mombasa and Kiambu counties in Kenya. Baseline data collection took place from May to July 2019, and endline in August-October 2020, coinciding with the lifting of some COVID-19 mitigation measures. Using endline data, this study characterised the impact the pandemic had on participants' risk behaviours, experience of violence and behaviours related to HIV. Logistic regression was used to understand factors related to changes in risk behaviours and experiences of violence; adjusted AORs (AORs) and 95% CIs are reported. RESULTS: Median age was 24 years (IQR: 21-27). Most respondents (93.9%) reported no change or a decrease in the number of sexual partners (median number of male sexual partners: 2, IQR: 2-4). Some participants reported an increase in alcohol (10%) and drug (16%) consumption, while 40% and 28% reported decreases in alcohol and drug consumption, respectively. Approximately 3% and 10% reported an increase in violence from intimate partners and police/authorities, respectively. Compared with those with primary education, those with post-secondary education were 60% less likely to report an increase in the number of male sexual partners per week (AOR: 0.4, 95% CI: 0.2 to 0.9), while those who were HIV positive were at twofold the odds of reporting an increase or sustained levels of violence from intimate partners (AOR: 2.0, 95% CI: 1.1 to 4.0). CONCLUSION: The results of this study demonstrate heterogeneity in participants' access to preventative HIV and clinical care services in Kenya after the onset of the COVID-19 epidemic. These results indicate the importance of responding to specific needs of MSM and adapting programmes during times of crisis.

Implementation fidelity to HIV assisted partner services (aPS) during scale-up in western Kenya: a convergent mixed methods study.

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.

Characteristics of users of HIV self-testing in Kenya, outcomes, and factors associated with use: results from a population-based HIV impact assessment, 2018.

BACKGROUND AND SETTING: About 20% of persons living with HIV aged 15-64 years did not know their HIV status in Kenya, by 2018. Kenya adopted HIV self-testing (HIVST) to help close this gap. We examined the sociodemographic characteristics and outcomes of self-reported users of HIVST as our primary outcome. METHODS: We used data from a 2018 population-based cross-sectional household survey in which we included self-reported sociodemographic and behavioral characteristics and HIV test results. To compare weighted proportions, we used the Rao-Scott χ-square test and Jackknife variance estimation. In addition, we used logistic regression to identify associations of sociodemographic, behavioral, and HIVST utilization. RESULTS: Of the 23,673 adults who reported having ever tested for HIV, 937 (4.1%) had ever self-tested for HIV. There were regional differences in HIVST, with Nyanza region having the highest prevalence (6.4%), p < 0.001. Factors independently associated with having ever self-tested for HIV were secondary education (adjusted odds ratio [aOR], 3.5 [95% (CI): 2.1-5.9]) compared to no primary education, being in the third (aOR, 1.7 [95% CI: 1.2-2.3]), fourth (aOR, 1.6 [95% CI: 1.1-2.2]), or fifth (aOR, 1.8 [95% CI: 1.2-2.7]) wealth quintiles compared to the poorest quintile and having one lifetime sexual partner (aOR, 1.8 [95% CI: 1.0-3.2]) or having ≥ 2 partners (aOR, 2.1 [95% CI: 1.2-3.7]) compared to none. Participants aged ≥ 50 years had lower odds of self-testing (aOR, 0.6 [95% CI: 0.4-1.0]) than those aged 15-19 years. CONCLUSION: Kenya has made progress in rolling out HIVST. However, geographic differences and social demographic factors could influence HIVST use. Therefore, more still needs to be done to scale up the use of HIVST among various subpopulations. Using multiple access models could help ensure equity in access to HIVST. In addition, there is need to determine how HIVST use may influence behavior change towardsaccess to prevention and HIV treatment services.

"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.

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.

Sex Differences in HIV Testing - 20 PEPFAR-Supported Sub-Saharan African Countries, 2019.

Despite progress toward controlling the human immunodeficiency virus (HIV) epidemic, testing gaps remain, particularly among men and young persons in sub-Saharan Africa (1). This observational study used routinely collected programmatic data from 20 African countries reported to the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) from October 2018 to September 2019 to assess HIV testing coverage and case finding among adults (defined as persons aged ≥15 years). Indicators included number of HIV tests conducted, number of HIV-positive test results, and percentage positivity rate. Overall, the majority of countries reported higher HIV case finding among women than among men. However, a slightly higher percentage positivity was recorded among men (4.7%) than among women (4.1%). Provider-initiated counseling and testing (PITC) in health facilities identified approximately two thirds of all new cases, but index testing had the highest percentage positivity in all countries among both sexes. Yields from voluntary counseling and testing (VCT) and mobile testing varied by sex and by country. These findings highlight the need to identify and implement the most efficient strategies for HIV case finding in these countries to close coverage gaps. Strategies might need to be tailored for men who remain underrepresented in the majority of HIV testing programs.

Scaling Up Testing for Human Immunodeficiency Virus Infection Among Contacts of Index Patients - 20 Countries, 2016-2018.

In 2017, the Joint United Nations Programme on HIV/AIDS (UNAIDS) estimated that worldwide, 36.9 million persons were living with human immunodeficiency virus (HIV) infection, the virus infection that causes acquired immunodeficiency syndrome (AIDS). Among persons with HIV infection, approximately 75% were aware of their HIV status, leaving 9.4 million persons with undiagnosed infection (1). Index testing, also known as partner notification or contact tracing, is an effective case-finding strategy that targets the exposed contacts of HIV-positive persons for HIV testing services. This report summarizes data from HIV tests using index testing in 20 countries supported by CDC through the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) during October 1, 2016-March 31, 2018. During this 18-month period, 1,700,998 HIV tests with 99,201 (5.8%) positive results were reported using index testing. The positivity rate for index testing was 9.8% among persons aged ≥15 years and 1.5% among persons aged <15 years. During the reporting period, HIV positivity increased 64% among persons aged ≥15 years (from 7.6% to 12.5%) and 67% among persons aged <15 years (from 1.2% to 2.0%). Expanding index testing services could help increase the number of persons with HIV infection who know their status, are initiated onto antiretroviral treatment, and consequently reduce the number of persons who can transmit the virus.

Evaluation of community-based HIV self-testing delivery strategies on reducing undiagnosed HIV infection, and improving linkage to prevention and treatment services, among men who have sex with men in Kenya: a programme science study protocol.

BACKGROUND: HIV prevalence among men having sex with men (MSM) in Kenya is 18.2%. Despite scale-up of HIV testing services, many MSM remain unaware of their HIV status and thus do not benefit from accessing HIV treatment or prevention services. HIV self-testing (HIVST) may help address this gap. However, evidence is limited on how, when, and in what contexts the delivery of HIVST to MSM could increase awareness of HIV status and lead to early linkage to HIV treatment and prevention. METHODS: The study will be embedded within existing MSM-focused community-based HIV prevention and treatment programmes in 3 counties in Kenya (Kisumu, Mombasa, Kiambu). The study is designed to assess three HIV testing outcomes among MSM, namely a) coverage b) frequency of testing and c) early uptake of testing. The study will adopt a mixed methods programme science approach to the implementation and evaluation of HIVST strategies via: (i) a baseline and endline bio-behavioural survey with 1400 MSM; (ii) a socio-sexual network study with 351 MSM; (iii) a longitudinal qualitative cohort study with 72 MSM; (iv) routine programme monitoring in three sites; (v) a programme-specific costing exercise; and (vi) mathematical modelling. This protocol evaluates the impact of community-based implementation of HIV self-testing delivery strategies among MSM in Kenya on reducing the undiagnosed MSM population, and time for linkage to prevention, treatment and care following HIV self-testing. Baseline data collection started in April 2019 and the endline data collection will start in July 2020. DISCUSSION: This study is one of the first programme science studies in Sub-Saharan Africa exploring the effectiveness of integrating HIVST interventions within already existing HIV prevention and treatment programmes for MSM in Kenya at scale. Findings from this study will inform national best approaches to scale up HIVST among MSM in Kenya.

Effectiveness of Using Additional HIV Self-Test Kits as an Incentive to Increase HIV Testing Within Assisted Partner Services.

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.

Providing HIV-assisted partner services to partners of partners in western Kenya: an implementation science study.

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.

Effectiveness of HIV self-testing when offered within assisted partner services in Western Kenya (APS-HIVST Study): a cluster randomized controlled trial.

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.

Association between funding source, methodological quality and research outcomes in randomized controlled trials of synbiotics, probiotics and prebiotics added to infant formula: a systematic review.

BACKGROUND: There is little or no information available on the impact of funding by the food industry on trial outcomes and methodological quality of synbiotics, probiotics and prebiotics research in infants. The objective of this study was to compare the methodological quality, outcomes of food industry sponsored trials versus non industry sponsored trials, with regards to supplementation of synbiotics, probiotics and prebiotics in infant formula. METHODS: A comprehensive search was conducted to identify published and unpublished randomized clinical trials (RCTs). Cochrane methodology was used to assess the risk of bias of included RCTs in the following domains: 1) sequence generation; 2) allocation concealment; 3) blinding; 4) incomplete outcome data; 5) selective outcome reporting; and 6) other bias. Clinical outcomes and authors' conclusions were reported in frequencies and percentages. The association between source of funding, risk of bias, clinical outcomes and conclusions were assessed using Pearson's Chi-square test and the Fisher's exact test. A p-value < 0.05 was statistically significant. RESULTS: Sixty seven completed and 3 on-going RCTs were included. Forty (59.7%) were funded by food industry, 11 (16.4%) by non-industry entities and 16 (23.9%) did not specify source of funding. Several risk of bias domains, especially sequence generation, allocation concealment and blinding, were not adequately reported. There was no significant association between the source of funding and sequence generation, allocation concealment, blinding and selective reporting, majority of reported clinical outcomes or authors' conclusions. On the other hand, source of funding was significantly associated with the domains of incomplete outcome data, free of other bias domains as well as reported antibiotic use and conclusions on weight gain. CONCLUSION: In RCTs on infants fed infant formula containing probiotics, prebiotics or synbiotics, the source of funding did not influence the majority of outcomes in favour of the sponsors' products. More non-industry funded research is needed to further assess the impact of funding on methodological quality, reported clinical outcomes and authors' conclusions.

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.

"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.

Stand-alone model for delivery of oral HIV pre-exposure prophylaxis in Kenya: a single-arm, prospective pilot evaluation.

INTRODUCTION: The delivery of daily, oral HIV pre-exposure prophylaxis (PrEP) at private pharmacies may overcome barriers to PrEP delivery at public healthcare facilities, including HIV-associated stigma, long wait times and overcrowding. METHODS: At five private, community-based pharmacies in Kenya, a care pathway for PrEP delivery (ClinicalTrials.gov: NCT04558554) was piloted-the first of its kind in Africa. Pharmacy providers screened clients interested in PrEP for HIV risk, then used a prescribing checklist to identify clients without medical conditions that might contraindicate PrEP safety, counsel them on PrEP use and safety, conduct provider-assisted HIV self-testing and dispense PrEP. For complex clinical cases, a remote clinician was available for consultation. Clients who did not meet the checklist criteria were referred to public facilities for free services delivered by clinicians. Pharmacy providers dispensed a 1-month PrEP supply at initiation and a 3-month supply thereafter at a client fee of 300 KES (∼$3 USD) per visit. RESULTS: From November 2020 to October 2021, pharmacy providers screened 575 clients, identified 476 who met the prescribing checklist criteria and initiated 287 (60%) on PrEP. Among pharmacy PrEP clients, the median age was 26 years (IQR 22-33) and 57% (163/287) were male. The prevalence of behaviours associated with HIV risk among clients was high; 84% (240/287) reported sexual partners with unknown HIV status and 53% (151/287) reported multiple sexual partners (past 6 months). PrEP continuation among clients was 53% (153/287) at 1 month, 36% (103/287) at 4 months and 21% (51/242) at 7 months. During the pilot observation period, 21% (61/287) of clients stopped and restarted PrEP and overall pill coverage was 40% (IQR 10%-70%). Nearly, all pharmacy PrEP clients (≥96%) agreed or strongly agreed with statements regarding the acceptability and appropriateness of pharmacy-delivered PrEP services. CONCLUSIONS: Findings from this pilot suggest that populations at HIV risk frequently visit private pharmacies and PrEP initiation and continuation at pharmacies is similar to or exceeds that at public healthcare facilities. Private pharmacy-based PrEP delivery, conducted entirely by private-sector pharmacy staff, is a promising new delivery model that has the potential to expand PrEP reach in Kenya and similar settings.

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.

Expanding options for HIV testing: A process evaluation of a community-led HIV self-testing intervention among men who have sex with men in Kenya.

Background: Men who have sex with men (MSM) in Kenya continue to face barriers to HIV testing, which leads to delays in HIV prevention and care. An HIV self-testing (HIVST) intervention was implemented in three Kenyan counties to increase coverage and frequency of HIV testing among MSM communities with high HIV prevalence. The evaluation study examined how HIVST can increase testing among MSM who are unaware of their status by increasing coverage, frequency, and early uptake of testing and support linkages to prevention and treatment. We share results from the process evaluation of the intervention implemented in partnership with MSM-led organizations. Methods: For a 12-month period between August 2019 and July 2020, the project team conducted in-depth interviews with HIVST users, monthly meetings with programme implementation teams, and monthly monitoring data reviews. Polling booth surveys were also conducted with participants. The process evaluation explored the fidelity, feasibility, coverage, acceptability, quality, and effectiveness of the HIVST intervention. Results: An average of 793 MSM received 1,041 HIVST kits on a monthly basis through different distribution channels. Of those who received HIVST kits, 67% were distributed to infrequent testers and non-testers. Testing frequency among users increased to 82% for those who had a recent test during the previous three months, compared to 58% of HIVST non-users. There was a high linkage to care and treatment services (84%) among those who tested reactive for HIV at endline. MSM shared preferring HIVST kits because of its convenience and privacy. During the COVID-19 pandemic, adaptations to the intervention were made to support ongoing HIV testing and linkages to services. Conclusion: The introduction of HIVST in MSM-led HIV prevention programmes was feasible with high acceptability. The involvement of the MSM community in the design, implementation and evaluation of the intervention was a key factor to intervention success.

Assessing awareness and use of HIV self-testing kits after the introduction of a community-based HIV self-testing programme among men who have sex with men in Kenya.

Men who have sex with men (MSM) bear a disproportionate burden of new HIV infections in Kenya, while experiencing discrimination, leading to suboptimal levels of HIV care. HIV self-testing (HIVST) is a tool to increase HIV screening and earlier diagnosis; however, questions remain regarding how best to scale-up HIVST to MSM in Kenya. The main objective of this study was to examine changes in knowledge and use of HIVST after implementation of a community-led HIVST project. Participants were MSM recruited from Kisumu, Mombasa, and Kiambu counties. Data were collected from two rounds (Round 1: 2019; Round 2: 2020) of serial cross-sectional integrated biological and behavioural assessments (IBBA), pre-, and post-project implementation. Two main outcomes were measured: 1) whether the respondent had ever heard of HIVST; and 2) whether they had ever used HIVST kits. Changes in outcomes between IBBA rounds were examined using modified multivariable Poisson regression models; adjusted prevalence ratios (aPR) and 95% confidence intervals (95% CI) are reported. A total of 2,328 respondents were included in main analyses. The proportion of respondents who had heard of HIVST increased from 75% in Round 1 to 94% in Round 2 (aPR: 1.2, 95% CI: 1.2-1.3), while those reporting using an HIVST kit increased from 20% to 53% (aPR: 2.3, 95% CI: 2.0-2.6). Higher levels of education and HIV programme awareness were associated with both outcomes. Awareness and use of HIVST kits increased after implementation of a community-led HIVST implementation project, demonstrating the importance of integration with existing community groups.

Probiotics, prebiotics infant formula use in preterm or low birth weight infants: a systematic review.

BACKGROUND: Previous reviews (2005 to 2009) on preterm infants given probiotics or prebiotics with breast milk or mixed feeds focused on prevention of Necrotizing Enterocolitis, sepsis and diarrhea. This review assessed if probiotics, prebiotics led to improved growth and clinical outcomes in formula fed preterm infants. METHODS: Cochrane methodology was followed using randomized controlled trials (RCTs) which compared preterm formula containing probiotic(s) or prebiotic(s) to conventional preterm formula in preterm infants. The mean difference (MD) and corresponding 95% confidence intervals (CI) were reported for continuous outcomes, risk ratio (RR) and corresponding 95% CI for dichotomous outcomes. Heterogeneity was assessed by visual inspection of forest plots and a chi² test. An I² test assessed inconsistencies across studies. I²> 50% represented substantial heterogeneity. RESULTS: Four probiotics studies (N=212), 4 prebiotics studies (N=126) were included. Probiotics: There were no significant differences in weight gain (MD 1.96, 95% CI: -2.64 to 6.56, 2 studies, n=34) or in maximal enteral feed (MD 35.20, 95% CI: -7.61 to 78.02, 2 studies, n=34), number of stools per day increased significantly in probiotic group (MD 1.60, 95% CI: 1.20 to 2.00, 1 study, n=20). Prebiotics: Galacto-oligosaccharide/Fructo-oligosaccharide (GOS/FOS) yielded no significant difference in weight gain (MD 0.04, 95% CI: -2.65 to 2.73, 2 studies, n=50), GOS/FOS yielded no significant differences in length gain (MD 0.01, 95% CI: -0.03 to 0.04, 2 studies, n=50). There were no significant differences in head growth (MD -0.01, 95% CI: -0.02 to 0.00, 2 studies, n=76) or age at full enteral feed (MD -0.79, 95% CI: -2.20 to 0.61, 2 studies, n=86). Stool frequency increased significantly in prebiotic group (MD 0.80, 95% CI: 0.48 to 1.1, 2 studies, n=86). GOS/FOS and FOS yielded higher bifidobacteria counts in prebiotics group (MD 2.10, 95% CI: 0.96 to 3.24, n=27) and (MD 0.48, 95% CI: 0.28 to 0.68, n=56). CONCLUSIONS: There is not enough evidence to state that supplementation with probiotics or prebiotics results in improved growth and clinical outcomes in exclusively formula fed preterm infants.