Impact of coronavirus disease 2019-related clinic closures on HIV incidence in young adult MSM and transgender women in Kenya.

INTRODUCTION: Little is known about the impact that the COVID-19 pandemic had on risk of HIV acquisition in sub-Saharan Africa. We assessed the impact of COVID-19-related clinic closures on HIV incidence in a cohort of gay, bisexual, and other men who have sex with men (MSM) and transgender women in Kenya. METHODS: MSM and transgender women enrolled in a prospective, multicentre cohort study were followed quarterly for HIV testing, behaviour assessments, and risk. We estimated the HIV incidence rate and its 95% credible intervals (CrI) among participants who were HIV-negative before COVID-19-related clinic closure, comparing incidence rate and risk factors associated with HIV acquisition before vs. after clinic reopening, using a Bayesian Poisson model with weakly informative priors. RESULTS: A total of 690 (87%) participants returned for follow-up after clinic reopening (total person-years 664.3 during clinic closure and 1013.3 after clinic reopening). HIV incidence rate declined from 2.05/100 person-years (95% CrI = 1.22-3.26, n  = 14) during clinic closures to 0.96/100 person-years (95% CrI = 0.41-2.07, n  = 10) after clinic reopening (IRR = 0.47, 95% CrI = 0.20-1.01). The proportion of participants reporting hazardous alcohol use and several sexual risk behaviours was higher during clinic closures than after clinic reopening. In multivariable analysis adjusting for study site and participant characteristics, HIV incidence was lower after clinic reopening (IRR 0.57, 95% CrI = 0.23-1.33). Independent risk factors for HIV acquisition included receptive anal intercourse (IRR 1.94, 95% CrI = 0.88-4.80) and perceived risk of HIV (IRR 3.03, 95% CRI = 1.40-6.24). CONCLUSION: HIV incidence during COVID-19-related clinic closures was moderately increased and reduced after COVID-19 restrictions were eased. Ensuring access to services for key populations is important during public health emergencies.

Transgender women in Kenya experience greater stigma, depressive symptoms, alcohol and drug use and risky sexual practices than cis-gendered men who have sex with men.

BACKGROUND: Worldwide, sexual and gender minority individuals have disproportionate burden of HIV. There are limited quantitative data from sub-Saharan Africa on the intersection of risks experienced by transgender women (TGW) in comparison to cis-men who have sex with men (MSM). This analysis addresses this gap by comparing reported stigma, psychosocial measures of health, and sexual risk practices between TGW and cis-MSM in Kenya. METHODS: We analyzed data from the baseline visit of an ongoing prospective cohort study taking place in three diverse metropolitan areas. Eligible participants were HIV-negative, assigned male at birth, ages 18-29 years, and reported anal intercourse in the past 3 months with a man or TGW. Data collected by audio computer assisted self-interview included sociodemographic measures, and sexual practices occurring in the past 3 months. Multivariable regressions assessed differences between TGW and cis-MSM in selected sexual practices, depressive symptoms, alcohol and drug use, and stigma. RESULTS: From September, 2019, through May, 2021, 838 participants were enrolled: 108 (12.9%) TGW and 730 (87.1%) cis-MSM. Adjusting for sociodemographic variables, TGW were more likely than cis-MSM to report: receptive anal intercourse (RAI; adjusted prevalence ratio [aPR] = 1.59, 95% CI: 1.32 - 1.92), engaging in group sex (aPR = 1.15, 95% CI: 1.04 - 1.27), 4 or more male sex partners (aPR = 3.31, 95% CI: 2.52 - 4.35), and 3 or more paying male sex partners (aPR = 1.58, 95% CI: 1.04 - 2.39). TGW were also more likely to report moderate to severe depressive symptoms (aPR = 1.42, 95% CI: 1.01 - 1.55), and had similar alcohol and drug abuse scores as cis-MSM. In sensitivity analysis, similar to TGW, male-identifying individuals taking feminizing gender affirming therapy had an increased likelihood of reporting RAI and group sex, and greater numbers of male sex partners and paying male sex partners relative to cis-MSM. CONCLUSIONS: Across three metropolitan areas in Kenya, TGW were more likely to report depressive symptoms and increased sexual risk taking. We identified a need for research that better characterizes the range of gender identities. Our analysis affirms the need for programmatic gender-affirming interventions specific to transgender populations in Kenya and elsewhere in Africa.

The Effect of the Shikamana Peer-and-Provider Intervention on Depressive Symptoms, Alcohol Use, and Other Drug Use Among Gay, Bisexual, and Other Men Who Have Sex with Men in Kenya.

Kenyan gay, bisexual, and other men who have sex with men (GBMSM) face stigma and discrimination, which may adversely impact mental health and limit antiretroviral therapy (ART) adherence among GBMSM living with HIV. We evaluated whether the Shikamana peer-and-provider intervention, which improved ART adherence among participants in a small randomized trial, was associated with changes in mental health or substance use. The intervention was associated with a significant decrease in PHQ-9 score between baseline and month 6 (estimated change - 2.7, 95% CI - 5.2 to - 0.2, p = 0.037) compared to standard care. In an exploratory analysis, each one-point increment in baseline HIV stigma score was associated with a - 0.7 point (95% CI - 1.3 to - 0.04, p = 0.037) greater decrease in PHQ-9 score over the study period in the intervention group. Additional research is required to understand factors that influence this intervention's effects on mental health outcomes.

Testing strategies to detect acute and prevalent HIV infection in adult outpatients seeking healthcare for symptoms compatible with acute HIV infection in Kenya: a cost-effectiveness analysis.

BACKGROUND: Detection of acute and prevalent HIV infection using point-of-care nucleic acid amplification testing (POC-NAAT) among outpatients with symptoms compatible with acute HIV is critical to HIV prevention, but it is not clear if it is cost-effective compared with existing HIV testing strategies. METHODS: We developed and parametrised a decision tree to compare the cost-effectiveness of (1) provider-initiated testing and counselling (PITC) using rapid tests, the standard of care; (2) scaled-up provider-initiated testing and counselling (SU-PITC) in which all patients were tested with rapid tests unless they opted out; and (3) opt-out testing and counselling using POC-NAAT, which detects both acute and prevalent infection. The model-based analysis used data from the Tambua Mapema Plus randomised controlled trial of a POC-NAAT intervention in Kenya, supplemented with results from a stochastic, agent-based network model of HIV-1 transmission and data from published literature. The analysis was conducted from the perspective of the Kenyan government using a primary outcome of cost per disability-adjusted life-year (DALY) averted over a 10-year time horizon. RESULTS: After analysing the decision-analytical model, the average per patient cost of POC-NAAT was $214.9 compared with $173.6 for SU-PITC and $47.3 for PITC. The mean DALYs accumulated per patient for POC-NAAT were 0.160 compared with 0.176 for SU-PITC and 0.214 for PITC. In the incremental analysis, SU-PITC was eliminated due to extended dominance, and the incremental cost-effectiveness ratio (ICER) comparing POC-NAAT to PITC was $3098 per DALY averted. The ICER was sensitive to disability weights for HIV/AIDS and the costs of antiretroviral therapy. CONCLUSION: POC-NAAT offered to adult outpatients in Kenya who present for care with symptoms compatible with AHI is cost-effective and should be considered for inclusion as the standard of HIV testing in this population. TRIAL REGISTRATION NUMBER: Tambua Mapema ("Discover Early") Plus study (NCT03508908) conducted in Kenya (2017-2020) i.e., Post-results.

Integrating HIV and mental health interventions to address a global syndemic among men who have sex with men.

In this Series paper, we review evidence on the co-occurring and synergistic epidemics (syndemic) of HIV and mental health problems worldwide among men who have sex with men (MSM). The multilevel determinants of this global syndemic include structural factors that enable stigma, systematic bias, and violence towards MSM across geographical and cultural contexts. Cumulative exposure to these factors over time results in population-level inequities in the burden of HIV infections and mental health problems among MSM. Evidence for this syndemic among MSM is strongest in the USA, Canada, western Europe, and parts of Asia and Latin America, with emerging evidence from sub-Saharan Africa. Integrated interventions are needed to address syndemics of HIV and mental health problems that challenge the wellbeing of MSM populations worldwide, and such interventions should consider various mental health conditions (eg, depression, anxiety, trauma, and suicidality) and their unique expressions and relationships with HIV outcomes depending on cultural contexts. In addition, interventions should identify and intervene with locally relevant structural factors that result in HIV and mental health vulnerabilities among MSM.

Modeling the Impact of HIV-1 Nucleic Acid Testing Among Symptomatic Adult Outpatients in Kenya.

BACKGROUND: Up to 69% of adults who acquire HIV in Kenya seek care before seroconversion, providing an important opportunity for early diagnosis and treatment. The Tambua Mapema Plus (TMP) trial tested a combined HIV-1 nucleic acid testing, linkage, treatment, and partner notification intervention for adults aged 18-39 years with symptoms of acute HIV infection presenting to health facilities in coastal Kenya. We estimated the potential impact of TMP on the Kenyan HIV epidemic. METHODS: We developed an agent-based network model of HIV-1 transmission using TMP data and Kenyan statistics to estimate potential population-level impact of targeted facility-based testing over 10 years. Three scenarios were modeled: standard care [current use of provider-initiated testing and counseling (PITC)], standard HIV rapid testing scaled to higher coverage obtained in TMP (scaled-up PITC), and the TMP intervention. RESULTS: Standard care resulted in 90.7% of persons living with HIV (PLWH) knowing their status, with 67.5% of those diagnosed on treatment. Scaled-up PITC resulted in 94.4% of PLWH knowing their status and 70.4% of those diagnosed on treatment. The TMP intervention achieved 97.5% of PLWH knowing their status and 80.6% of those diagnosed on treatment. The percentage of infections averted was 1.0% (95% simulation intervals: -19.2% to 19.9%) for scaled-up PITC and 9.4% (95% simulation intervals: -8.1% to 24.5%) for TMP. CONCLUSION: Our study suggests that leveraging new technologies to identify acute HIV infection among symptomatic outpatients is superior to scaled-up PITC in this population, resulting in >95% knowledge of HIV status, and would reduce new HIV infections in Kenya.

"Facilitating HIV status adjustment: Qualitative insights from the Tambua Mapema proof-of-concept study in Kenya".

Systematic efforts are needed to prepare persons newly diagnosed with acute or chronic HIV infection to cope. We examined how patients dealt with this news, looking at how readiness to accept an HIV diagnosis impacted treatment outcomes, prevention of transmission, and HIV status disclosure. We examined vulnerability and agency over time and considered implications for policy and practice. A qualitative sub-study was embedded in the Tambua Mapema ("Discover Early") Plus (TMP) study (NCT03508908), conducted in coastal Kenya between 2017 and 2020, which was a stepped wedge trial to evaluate an opt-out HIV-1 nucleic acid testing intervention diagnosing acute and chronic HIV infections. Diagnosed participants were offered antiretroviral therapy (ART), viral load monitoring, HIV partner notification services, and provision of pre-exposure prophylaxis (PrEP) to their uninfected partners. Data were analyzed using thematic approaches. Participants included 24 individuals who completed interviews at four time points (2 weeks and 3, 6, and 9 months after diagnosis), including 18 patients (11 women and 7 men) and 6 partners (1 woman, 5 men, of whom 4 men started PrEP). Acceptance of HIV status was often a long, individualized, and complex process, whereby participants' coping strategies affected day-to-day issues and health over time. Relationship status strongly impacted coping. In some instances, couples supported each other, but in others, couples separated. Four main themes impacted participants' sense of agency: acceptance of diagnosis and commitment to ART; positive feedback after attaining viral load suppression; recognition of partner supportive role and focus on sustained healthcare support whereby religious meaning was often key to successful transition. To support patients with acute or newly diagnosed chronic HIV, healthcare and social systems must be more responsive to the needs of the individual, while also improving quality of care, strengthening continuity of care across facilities, and promoting community support.

Stopping and restarting PrEP and loss to follow-up among PrEP-taking men who have sex with men and transgender women at risk of HIV-1 participating in a prospective cohort study in Kenya.

OBJECTIVE: To assess frequency and predictors of switching between being on and off PrEP and being lost to follow-up (LTFU) among men who have sex with men (MSM) and transgender women (TGW) with access to PrEP services in Sub-Saharan Africa. METHODS: This was a prospective cohort study of MSM and TGW from coastal Kenya who initiated daily oral PrEP from June 2017 to June 2019. Participants were followed monthly for HIV-1 testing, PrEP refill, risk assessment and risk reduction counselling. Follow-up was censored at the last visit before 30 June 2019, or the last HIV-1-negative visit (for those with HIV-1 seroconversion), whichever occurred first. We estimated transition intensities (TI) and predictors of switching: (i) between being off and on PrEP; and (ii) from either PrEP state and being LTFU (i.e. not returning to the clinic for > 90 days) using a multi-state Markov model. RESULTS: In all, 134 participants starting PrEP were followed for a median of 20.3 months [interquartile range (IQR): 7.7-22.1]. A total of 49 (36.6%) people stopped PrEP 73 times [TI = 0.6/person-year (PY), 95% confidence interval (CI): 0.5-0.7] and, of these, 25 (51.0%) restarted PrEP 38 times (TI = 1.2/PY, 95% CI: 0.9-1.7). In multivariable analysis, stopping PrEP was related to anal sex ≤ 3 months, substance-use disorder and travelling. Restarting PrEP was related to non-Christian or non-Muslim religion and travelling. A total of 54 participants were LTFU: on PrEP (n = 47, TI = 0.3/PY, 95% CI: 0.3-0.5) and off PrEP (n = 7, TI = 0.2/PY, 95% CI: 0.1-0.4). In multivariable analysis, becoming LTFU while on PrEP was associated with secondary education or higher, living in the area for ≤ 1 year, residence outside the immediate clinic area and alcohol-use disorder. CONCLUSIONS: Switching between being on and off PrEP or becoming LTFU while on PrEP was frequent among individuals at risk of HIV-1 acquisition. Alternative PrEP options (e.g. event-driven PrEP) may need to be considered for MSM and TGW with PrEP-taking challenges, while improved engagement with care is needed for all MSM and TGW regardless of PrEP regimen.

Pre-exposure prophylaxis for transgender women and men who have sex with men: qualitative insights from healthcare providers, community organization-based leadership and end users in coastal Kenya.

Transgender women (TW) and men who have sex with men (MSM) in Kenya are disproportionately affected by human immunodeficiency virus (HIV) and would benefit substantially from pre-exposure prophylaxis (PrEP). We conducted focus group discussions (FGDs) with healthcare providers (HCPs) and TW/MSM leadership and in-depth interviews (IDIs) with PrEP-experienced MSM and TW to learn about perceived and actual barriers to PrEP programming. Eleven HCP and 10 TW/MSM leaders participated in FGDs before PrEP roll-out (January 2018) and 12 months later. Nineteen PrEP end-users (11 MSM and 8 TW) participated in IDIs. Topic guides explored PrEP knowledge, HIV acquisition risk, gender identity, motivation for PrEP uptake and adherence and PrEP-dispensing venue preferences. Braun and Clarke thematic analysis was applied. Four themes emerged: limited preparedness of HCPs to provide PrEP to TW and MSM, varied motivation for PrEP uptake and persistence among end users, lack of recognition of TW by HCPs and suggestions for PrEP programming improvement from all stakeholders. Providers' reluctance to prescribe PrEP to TW and distrust of TW towards providers calls for interventions to improve the capacity of service environments and staff HIV preventive care. Alternative locations for PrEP provision, including community-based sites, may be developed with TW/MSM leaders.

Effect of an opt-out point-of-care HIV-1 nucleic acid testing intervention to detect acute and prevalent HIV infection in symptomatic adult outpatients and reduce HIV transmission in Kenya: a randomized controlled trial.

BACKGROUND: In sub-Saharan Africa, adult outpatients with symptoms of acute infectious illness are not routinely tested for prevalent or acute HIV infection (AHI) when seeking healthcare. METHODS: Adult symptomatic outpatients aged 18-39 years were evaluated by a consensus AHI risk score. Patients with a risk score ≥ 2 and no previous HIV diagnosis were enrolled in a stepped-wedge trial of opt-out delivery of point-of-care (POC) HIV-1 nucleic acid testing (NAAT), compared with standard provider-initiated HIV testing using rapid tests in the observation period. The primary outcome was the number of new diagnoses in each study period. Generalized estimating equations with a log-binomial link and robust variance estimates were used to account for clustering by health facility. The trial is registered with ClinicalTrials.gov NCT03508908. RESULTS: Between 2017 and 2020, 13 (0.9%) out of 1374 participants in the observation period and 37 (2.5%) out of 1500 participants in the intervention period were diagnosed with HIV infection. Of the 37 newly diagnosed cases in the intervention period, two (5.4%) had AHI. Participants in the opt-out intervention had a two-fold greater odds of being diagnosed with HIV (odds ratio = 2.2, 95% confidence interval: 1.39-3.51) after adjustment for factors imbalanced across study periods. CONCLUSIONS: Among symptomatic adults aged 18-39 years targeted by our POC NAAT intervention, we identified one chronic HIV infection for every 40 patients and one AHI patient for every 750 patients tested. Although AHI yield was low in this population, routinely offered opt-out testing could diagnose twice as many patients as an approach relying on provider discretion.

Peer Mobilization and Human Immunodeficiency Virus (HIV) Partner Notification Services Among Gay, Bisexual, and Other Men Who Have Sex With Men and Transgender Women in Coastal Kenya Identified a High Number of Undiagnosed HIV Infections.

BACKGROUND: Human immunodeficiency virus (HIV) partner notification services (HPN), peer mobilization with HIV self-testing, and acute and early HIV infection (AEHI) screening among gay, bisexual, and other men who have sex with men (GBMSM) and transgender women (TGW) were assessed for acceptability, feasibility, and linkage to antiretroviral therapy (ART) and preexposure prophylaxis (PrEP) services. METHODS: Between April and August 2019, peer mobilizers mobilized clients by offering HIV oral self-tests and immediate clinic referral for clients with AEHI symptoms. Mobilized participants received clinic-based rapid antibody testing and point-of-care HIV RNA testing. Newly diagnosed participants including those derived from HIV testing services were offered immediate ART and HPN. Partners were recruited through HPN. RESULTS: Of 772 mobilized clients, 452 (58.5%) enrolled in the study as mobilized participants. Of these, 16 (3.5%) were HIV newly diagnosed, including 2 (0.4%) with AEHI. All but 2 (14/16 [87.5%]) initiated ART. Thirty-five GBMSM and TGW were offered HPN and 27 (77.1%) accepted it. Provider referral identified a higher proportion of partners tested (39/64 [60.9%] vs 5/14 [35.7%]) and partners with HIV (27/39 [69.2%] vs 2/5 [40.0%]) than index referral. Of 44 enrolled partners, 10 (22.7%) were newly diagnosed, including 3 (6.8%) with AEHI. All 10 (100%) initiated ART. PrEP was initiated among 24.0% (103/429) mobilized participants and 28.6% (4/14) partners without HIV. CONCLUSIONS: HPN, combined with a peer mobilization-led self-testing strategy and AEHI screening for GBMSM and TGW, appears to be acceptable and feasible. These strategies, especially HPN provider referral, effectively identified undiagnosed HIV infections and linked individuals to ART and PrEP services.

High patient acceptability but low coverage of provider-initiated HIV testing among adult outpatients with symptoms of acute infectious illness in coastal Kenya.

BACKGROUND: Only approximately one in five adults are offered HIV testing by providers when seeking care for symptoms of acute illness in Sub-Saharan Africa. Our aims were to estimate testing coverage and identify predictors of provider-initiated testing and counselling (PITC) and barriers to PITC implementation in this population. METHODS: We assessed HIV testing coverage among adult outpatients 18-39 years of age at four public and two private health facilities in coastal Kenya, during a 3- to 6-month surveillance period at each facility. A subset of patients who reported symptoms including fever, diarrhoea, fatigue, body aches, sore throat or genital ulcers were enrolled to complete a questionnaire independently of PITC offer. We assessed predictors of PITC in this population using generalised estimating equations and identified barriers to offering PITC through focus group discussion with healthcare workers (HCW) at each facility. RESULTS: Overall PITC coverage was 13.7% (1600 of 11,637 adults tested), with 1.9% (30) testing positive. Among 1,374 participants enrolled due to symptoms, 378 (27.5%) were offered PITC and 352 (25.6%) were tested, of whom 3.7% (13) tested positive. Among participants offered HIV testing, 93.1% accepted it; among participants not offered testing, 92.8% would have taken an HIV test if offered. The odds of completed PITC were increased among older participants (adjusted odds ratio [aOR] 1.7, 95% confidence interval [CI] 1.4-2.1 for 30-39 years, relative to 18-24 years), men (aOR 1.3, 95% CI 1.1-1.7); casual labourers (aOR 1.3, 95% CI 1.0-1.7); those paying by cash (aOR 1.2, 95% CI 1.0-1.4) or insurance (aOR 3.0, 95% CI 1.5-5.8); participants with fever (aOR 1.5, 95% CI 1.2-1.8) or genital ulcers (aOR 4.0, 95% CI 2.7-6.0); and who had tested for HIV >1 year ago (aOR 1.4, 95% CI 1.0-2.0) or had never tested (aOR 2.2, 95% CI 1.5-3.1). Provider barriers to PITC implementation included lack of HCW knowledge and confidence implementing guidelines, limited capacity and health systems constraints. CONCLUSION: PITC coverage was low, though most patients would accept testing if offered. Missed opportunities to promote testing during care-seeking were common and innovative solutions are needed.

"I wish to remain HIV negative": Pre-exposure prophylaxis adherence and persistence in transgender women and men who have sex with men in coastal Kenya.

BACKGROUND: Transgender women (TGW) and men who have sex with men (MSM) in sub-Saharan Africa have high HIV acquisition risks and can benefit from daily pre-exposure prophylaxis (PrEP). We assessed PrEP adherence by measuring tenofovir-diphosphate (TFV-DP) levels and explore motives for PrEP persistence in TGW and MSM. METHODS: Participants were enrolled in a one-year PrEP programme and made quarterly visits irrespective of whether they were still using PrEP. At their month 6 visit, participants provided a dried blood spot to test for TFV-DP levels; protective levels were defined as those compatible with ≥4 pills per week (700-1249 fmol/punch). Before TFV-DP levels were available, a sub-set of these participants were invited for an in-depth interview (IDI). Semi-structured IDI topic guides were used to explore motives to uptake, adhere to, and discontinue PrEP. IDI data were analyzed thematically. RESULTS: Fifty-three participants (42 MSM and 11 TGW) were enrolled. At month 6, 11 (20.7%) participants (8 MSM and 3 TGW) were lost to follow up or stopped taking PrEP. Any TFV-DP was detected in 62.5% (5/8) of TGW vs. 14.7% of MSM (5/34, p = 0.01). Protective levels were detected in 37.5% of TGW (3/8), but not in any MSM. Nineteen IDI were conducted with 7 TGW and 9 MSM on PrEP, and 1 TGW and 2 MSM off PrEP. Unplanned or frequent risky sexual risk behaviour were the main motives for PrEP uptake. Among participants on PrEP, TGW had a more complete understanding of the benefits of PrEP. Inconsistent PrEP use was attributed to situational factors. Motives to discontinue PrEP included negative reactions from partners and stigmatizing healthcare services. CONCLUSION: While MSM evinced greater adherence challenges in this PrEP programme, almost 40% of TGW were protected by PrEP. Given high HIV incidences in TGW these findings hold promise for TGW PrEP programming in the region.

Socio-economic condition and lack of virological suppression among adults and adolescents receiving antiretroviral therapy in Ethiopia.

INTRODUCTION: The potential impact of socio-economic condition on virological suppression during antiretroviral treatment (ART) in sub-Saharan Africa is largely unknown. In this case-control study, we compared socio-economic factors among Ethiopian ART recipients with lack of virological suppression to those with undetectable viral load (VL). METHODS: Cases (VL>1000 copies/ml) and controls (VL<150 copies/ml) aged ≥15years, with ART for >6 months and with available VL results within the last 3 months, were identified from registries at public ART clinics in Central Ethiopia. Questionnaire-based interviews on socio-economic characteristics, health condition and transmission risk behavior were conducted. Univariate variables associated with VL>1000 copies/ml (p<0.25) were added to a multivariable logistic regression model. RESULTS: Among 307 participants (155 cases, 152 controls), 61.2% were female, and the median age was 38 years (IQR 32-46). Median HIV-RNA load among cases was 6,904 copies/ml (IQR 2,843-26,789). Compared to controls, cases were younger (median 36 vs. 39 years; p = 0.004), more likely to be male (46.5% vs. 30.9%; p = 0.005) and had lower pre-ART CD4 cell counts (170 vs. 220 cells/µl; p = 0.009). In multivariable analysis of urban residents (94.8%), VL>1000 copies/ml was associated with lower relative wealth (adjusted odds ratio [aOR] 2.98; 95% CI 1.49-5.94; p = 0.016), geographic work mobility (aOR 6.27, 95% CI 1.82-21.6; p = 0.016), younger age (aOR 0.94 [year], 95% CI 0.91-0.98; p = 0.011), longer duration of ART (aOR 1.19 [year], 95% CI 1.07-1.33; p = 0.020), and suboptimal (aOR 3.83, 95% CI 1.33-10.2; p = 0.048) or poor self-perceived wellbeing (aOR 9.75, 95% CI 2.85-33.4; p = 0.012), after correction for multiple comparisons. High-risk sexual behavior and substance use was not associated with lack of virological suppression. CONCLUSION: Geographic work mobility and lower relative wealth were associated with lack of virological suppression among Ethiopian ART recipients in this predominantly urban population. These characteristics indicate increased risk of treatment failure and the need for targeted interventions for persons with these risk factors.

Risk factors for loss to follow-up among at-risk HIV negative men who have sex with men participating in a research cohort with access to pre-exposure prophylaxis in coastal Kenya.

INTRODUCTION: Retention in preventive care among at-risk men who have sex with men (MSM) is critical for successful prevention of HIV acquisition in Africa. We assessed loss to follow-up (LTFU) rates and factors associated with LTFU in an HIV vaccine feasibility cohort study following MSM with access to pre-exposure prophylaxis (PrEP) in coastal Kenya. METHODS: Between June 2017 and June 2019, MSM cohort participants attending a research clinic 20 km north of Mombasa were offered daily PrEP and followed monthly for risk assessment, risk reduction counselling and HIV testing. Participants were defined as LTFU if they were late by >90 days for their scheduled appointment. Participants who acquired HIV were censored at diagnosis. Cox proportional hazards models were used to estimate adjusted Hazard Ratio (aHR) of risk factors for LTFU. RESULTS AND DISCUSSION: A total of 179 participants with a median age of 25.0 years (interquartile range [IQR]: 23.0 to 30.0) contributed a median follow-up time of 21.2 months (IQR: 6.5 to 22.1). Of these, 143 (79.9%) participants started PrEP and 76 (42.5%) MSM were LTFU, for an incidence rate of 33.7 (95% confidence interval [CI], 26.9 to 42.2) per 100 person-years. Disordered alcohol use (aHR: 2.3, 95% CI, 1.5 to 3.7), residence outside the immediate clinic catchment area (aHR: 2.5, 95% CI, 1.3 to 4.6 for Mombasa Island; aHR: 1.8, 95% CI, 1.0 to 3.3 for south coast), tertiary education level or higher (aHR: 2.3, 95% CI, 1.1 to 4.8) and less lead-in time in the cohort prior to 19 June 2017 (aHR: 3.1, 95% CI, 1.8 to 5.6 for zero to three months; aHR: 2.4, 95% CI, 1.2 to 4.7 for four to six months) were independent predictors of LTFU. PrEP use did not differ by LTFU status (HR: 1.0, 95% CI, 0.6 to 1.5). Psychosocial support for men reporting disordered alcohol use, strengthened engagement of recently enrolled participants and focusing recruitment on areas close to the research clinic may improve retention in HIV prevention studies involving MSM in coastal Kenya. CONCLUSIONS: About one in three participants became LTFU after one year of follow-up, irrespective of PrEP use. Research preparedness involving MSM should be strengthened for HIV prevention intervention evaluations in coastal Kenya.

A more responsive, multi-pronged strategy is needed to strengthen HIV healthcare for men who have sex with men in a decentralized health system: qualitative insights of a case study in the Kenyan coast.

INTRODUCTION: HIV healthcare services for men who have sex with men (MSM) in Kenya have not been openly provided because of persistent stigma and lack of healthcare capacity within Kenya's decentralized health sector. Building on an evaluation of a developed online MSM sensitivity training programme offered to East and South African healthcare providers, this study assessed views and responses to strengthen HIV healthcare services for MSM in Kenya. METHODS: The study was conducted between January and July 2017 in Kilifi County, coastal Kenya. Seventeen policymakers participated in an in-depth interview and 59 stakeholders, who were purposively selected from three key groups (i.e. healthcare providers, implementing partners and members of MSM-led community-based organizations) took part in eight focus group discussions. Discussions aimed to understand gaps in service provision to MSM from different perspectives, to identify potential misconceptions, and to explore opportunities to improve MSM HIV healthcare services. Interviews and focus group discussions were recorded, transcribed verbatim and analysed using Braun and Clarke's thematic analysis. RESULTS: Participants' responses revealed that all key groups navigated diverse challenges related to MSM HIV health services. Specific challenges included priority-setting by county government staff; preparedness of leadership and management on MSM HIV issues at the facility level; data reporting at the implementation level and advocacy for MSM health equity. Strong power inequities were observed between policy leadership, healthcare providers and MSM, with MSM feeling blamed for their sexual orientation. MSM agency, as expressed in their actions to access HIV services, was significantly constrained by county context, but can potentially be improved by political will, professional support and a human rights approach. CONCLUSIONS: To strengthen HIV healthcare for MSM within a decentralized Kenyan health system, a more responsive, multi-pronged strategy adaptable and relevant to MSM's healthcare needs is required. Continued engagement with policy leadership, collaboration with health facilities, and partnerships with different community stakeholders are critical to improve HIV healthcare services for MSM.

From general to specific: moving past the general population in the HIV response across sub-Saharan Africa.

INTRODUCTION: As the HIV field evolves to better serve populations which are diverse in risk and access to services, it is crucial to understand and adapt the conceptual tools used to make sense of the HIV pandemic. In this commentary, we discuss the concept of general population. Using a synthetic and historical review, we reflect on the genesis and usage of the general population in HIV research and programme literature, pointing to its moral connotations and its impact on epidemiologic reasoning. DISCUSSION: From the early days of the HIV pandemic, the category of general population has carried implicit normative meanings. General population represented those people considered to be undeserving of HIV acquisition, and therefore deserving of a response. Framing the HIV epidemic in sub-Saharan Africa as a generalized epidemic primarily affecting the general population has contributed to the exclusion of men who have sex with men from epidemic responses. The usage of this category has also masked heterogeneity among those it includes; the increasing focus on the use of interventions such as circumcision and HIV treatment as general population HIV prevention approaches has been marked by a lack of attention to heterogeneity among beneficiaries. CONCLUSIONS: We recommend that the term general population be retired from the field's lexicon. HIV programmes should strengthen their capacity to describe the heterogeneity of those they serve and plan their interventions accordingly. To increase the efficiency and impact of the HIV response, it is urgent to stratify the category of general population by risk. Sexual networks are a promising basis for this stratification.

Acute and early HIV infection screening among men who have sex with men, a systematic review and meta-analysis.

INTRODUCTION: Screening for acute and early HIV infections (AEHI) among men who have sex with men (MSM) remains uncommon in sub-Saharan Africa (SSA). Yet, undiagnosed AEHI among MSM and subsequent failure to link to care are important drivers of the HIV epidemic. We conducted a systematic review and meta-analysis of AEHI yield among MSM mobilized for AEHI testing; and assessed which risk factors and/or symptoms could increase AEHI yield in MSM. METHODS: We systematically searched four databases from their inception through May 2020 for studies reporting strategies of mobilizing MSM for testing and their AEHI yield, or risk and/or symptom scores targeting AEHI screening. AEHI yield was defined as the proportion of AEHI cases among the total number of visits. Study estimates for AEHI yield were pooled using random effects models. Predictive ability of risk and/or symptom scores was expressed as the area under the receiver operator curve (AUC). RESULTS: Twenty-two studies were identified and included a variety of mobilization strategies (eight studies) and risk and/or symptom scores (fourteen studies). The overall pooled AEHI yield was 6.3% (95% CI, 2.1 to 12.4; I2  = 94.9%; five studies); yield varied between studies using targeted strategies (11.1%; 95% CI, 5.9 to 17.6; I2  = 83.8%; three studies) versus universal testing (1.6%; 95% CI, 0.8 to 2.4; two studies). The AUC of risk and/or symptom scores ranged from 0.69 to 0.89 in development study samples, and from 0.51 to 0.88 in validation study samples. AUC was the highest for scores including symptoms, such as diarrhoea, fever and fatigue. Key risk score variables were age, number of sexual partners, condomless receptive anal intercourse, sexual intercourse with a person living with HIV, a sexually transmitted infection, and illicit drug use. No studies were identified that assessed AEHI yield among MSM in SSA and risk and/or symptom scores developed among MSM in SSA lacked validation. CONCLUSIONS: Strategies mobilizing MSM for targeted AEHI testing resulted in substantially higher AEHI yields than universal AEHI testing. Targeted AEHI testing may be optimized using risk and/or symptom scores, especially if scores include symptoms. Studies assessing AEHI yield and validation of risk and/or symptom scores among MSM in SSA are urgently needed.

PrEP uptake and adherence in relation to HIV-1 incidence among Kenyan men who have sex with men.

BACKGROUND: Data on HIV-1 incidence following programmatic pre-exposure prophylaxis (PrEP) uptake by men who have sex with men (MSM) are limited in sub-Saharan Africa. METHODS: Since June 2017, MSM participating in an ongoing cohort study in Kenya were offered daily PrEP, assessed for PrEP uptake and adherence, and evaluated for HIV-1 acquisition monthly. We determined tenofovir-diphosphate (TFV-DP) concentrations in dried blood spots 6-12 months after PrEP initiation, and tenofovir (TFV) concentrations and genotypic drug resistance in plasma samples when HIV-1 infection occurred. We assessed HIV-1 incidence by reported PrEP use. FINDINGS: Of 172 MSM, 170 (98·8%) were eligible for PrEP, 140 (82·4%) started it, and 64 (57·7%) reported PrEP use at end of study. Of nine MSM who acquired HIV-1 [incidence rate: 3·9 (95% confidence interval (CI), 2·0-7·4) per 100 person-years (PY)], five reported PrEP use at the time of HIV-1 acquisition [incidence rate: 3·6 (95% CI, 1·5-8·6) per 100 PY)] and four had stopped or had never started PrEP [incidence rate: 4·3 (95% CI, 1·6-11·3) per 100 PY]. Among 76 MSM who reported PrEP use, 11 (14·5%) had protective TFV-DP concentrations of ≥700 fmol/punch (≥4 tablets a week). Among the five MSM who acquired HIV-1 while reporting PrEP use, only one had detectable but low TFV concentrations in plasma and none had genotypic HIV-1 resistance. INTERPRETATION: HIV-1 incidence among MSM with access to programmatic PrEP was high and did not differ by reported PrEP use. Only one in seven MSM taking PrEP had protective tenofovir concentrations and four out of five MSM who acquired HIV-1 while reporting PrEP use had not taken it. Strengthened PrEP adherence support is required among MSM in Kenya. FUNDING: This work was supported by the International AIDS Vaccine Initiative (IAVI).

A Novel HIV-1 RNA Testing Intervention to Detect Acute and Prevalent HIV Infection in Young Adults and Reduce HIV Transmission in Kenya: Protocol for a Randomized Controlled Trial.

BACKGROUND: Detection and management of acute HIV infection (AHI) is a clinical and public health priority, and HIV infections diagnosed among young adults aged 18 to 39 years are usually recent. Young adults with recent HIV acquisition frequently seek care for symptoms and could potentially be diagnosed through the health care system. Early recognition of HIV infection provides considerable individual and public health benefits, including linkage to treatment as prevention, access to risk reduction counseling and treatment, and notification of partners in need of HIV testing. OBJECTIVE: The Tambua Mapema Plus study aims to (1) test 1500 young adults (aged 18-39 years) identified by an AHI screening algorithm for acute and prevalent (ie, seropositive) HIV, linking all newly diagnosed HIV-infected patients to care and offering immediate treatment; (2) offer assisted HIV partner notification services to all patients with HIV, testing partners for acute and prevalent HIV infection and identifying local sexual networks; and (3) model the potential impact of these two interventions on the Kenyan HIV epidemic, estimating incremental costs per HIV infection averted, death averted, and disability-adjusted life year averted using data on study outcomes. METHODS: A modified stepped-wedge design is evaluating the yield of this HIV testing intervention at 4 public and 2 private health facilities in coastal Kenya before and after intervention delivery. The intervention uses point-of-care HIV-1 RNA testing combined with standard rapid antibody tests to diagnose AHI and prevalent HIV among young adults presenting for care, employs HIV partner notification services to identify linked acute and prevalent infections, and follows all newly diagnosed patients and their partners for 12 months to ascertain clinical outcomes, including linkage to care, antiretroviral therapy (ART) initiation and virologic suppression in HIV-infected patients, and pre-exposure prophylaxis uptake in uninfected individuals in discordant partnerships. RESULTS: Enrollment started in December 2017. As of April 2020, 1374 participants have been enrolled in the observation period and 1500 participants have been enrolled in the intervention period, with 13 new diagnoses (0.95%) in the observation period and 37 new diagnoses (2.47%), including 2 AHI diagnoses, in the intervention period. Analysis is ongoing and will include adjusted comparisons of the odds of the following outcomes in the observation and intervention periods: being tested for HIV infection, newly diagnosed with prevalent or acute HIV infection, linked to care, and starting ART by week 6 following HIV diagnosis. Participants newly diagnosed with acute or prevalent HIV infection in the intervention period are being followed for outcomes, including viral suppression by month 6 and month 12 following ART initiation and partner testing outcomes. CONCLUSIONS: The Tambua Mapema Plus study will provide foundational data on the potential of this novel combination HIV prevention intervention to reduce ongoing HIV transmission in Kenya and other high-prevalence African settings. TRIAL REGISTRATION: ClinicalTrials.gov NCT03508908; https://clinicaltrials.gov/ct2/show/NCT03508908. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/16198.