Search

Measuring PrEP adherence remains challenging. In 2009-2010, the International AIDS Vaccine Initiative randomized phase II trial participants to daily tenofovir disoproxil fumarate/emtricitabine or placebo in Uganda and Kenya. Adherence was measured by electronic monitoring (EM), self-report (SR), and drug concentrations in plasma and hair. Each adherence measure was categorised as low, moderate, or high and also considered continuously; the incremental value of combining measures was determined. Forty-five participants were followed over 4 months. Discrimination for EM adherence by area under receiver operating curves (AROC) was poor for SR (0.53) and best for hair (AROC 0.85). When combining hair with plasma or hair with self-report, discrimination was improved (AROC > 0.9). Self-reported adherence was of low utility by itself. Hair level was the single best PK measure to predict EM-assessed adherence; the other measurements had lower discrimination values. Combining short-term (plasma) and long-term (hair) metrics could be useful to assess patterns of drug-taking in the context of PrEP.

Broadly neutralizing antibodies (bnAbs) are thought to be a critical component of a protective HIV vaccine. However, designing vaccines immunogens able to elicit bnAbs has proven unsuccessful to date. Understanding the correlates and immunological mechanisms leading to the development of bnAb responses during natural HIV infection is thus critical to the design of a protective vaccine. The IAVI Protocol C program investigates a large longitudinal cohort of primary HIV-1 infection in Eastern and South Africa. Development of neutralization was evaluated in 439 donors using a 6 cross-clade pseudo-virus panel predictive of neutralization breadth on larger panels. About 15% of individuals developed bnAb responses, essentially between year 2 and year 4 of infection. Statistical analyses revealed no influence of gender, age or geographical origin on the development of neutralization breadth. However, cross-clade neutralization strongly correlated with high viral load as well as with low CD4 T cell counts, subtype-C infection and HLA-A*03(-) genotype. A correlation with high overall plasma IgG levels and anti-Env IgG binding titers was also found. The latter appeared not associated with higher affinity, suggesting a greater diversity of the anti-Env responses in broad neutralizers. Broadly neutralizing activity targeting glycan-dependent epitopes, largely the N332-glycan epitope region, was detected in nearly half of the broad neutralizers while CD4bs and gp41-MPER bnAb responses were only detected in very few individuals. Together the findings suggest that both viral and host factors are critical for the development of bnAbs and that the HIV Env N332-glycan supersite may be a favorable target for vaccine design.

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 sexua 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. Keywords: HIV healthcare services; MSM; Kenya; decentralization; health equity, 1 | INTRODUCTION Kenya has among the largest HIV epidemics in the world with an estimated 1.6 million people living with HIV, 46,000 new infections, and 25,000 AIDS-related deaths in [...]

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; [I.sup.2] = 94.9%; five studies); yield varied between studies using targeted strategies (11.1%; 95% CI, 5.9 to 17.6; [I.sup.2] = 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 universa 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. Keywords: acute HIV infection; early HIV infection; men who have sex with men; targeted screening; risk score; mobilization; systematic review, 1 | INTRODUCTION In 2018, sub-Saharan Africa (SSA) faced approximately one million new HIV infections [1]. Although HIV disproportionally affects men who have sex with men (MSM) globally [2,3], HIV [...]

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. Keywords: MSM; attrition; pre-exposure prophylaxis; Kenya; LGBTQ; sub-Saharan Africa; HIV, 1 | INTRODUCTION Men who have sex with men (MSM) are among the populations at highest risk of HIV acquisition globally [1]. Incidence estimates of HIV in MSM in sub-Saharan [...]

Keywords: Africa; men who have sex with men; transgender people; key and vulnerable populations; sexual and gender minorities; sexual behaviour; biomedical research; implementation science; population health management; transgender women, 1 | INTRODUCTION In sub-Saharan Africa, men who have sex with men (MSM) and transgender women (TGW) have been living with, and dying from, HIV since the start of the [...]

Introduction: Knowledge of HIV status relies on accurate HIV testing, and is the first step towards access to HIV treatment and prevention programmes. Globally, HIV-status unawareness represents a significant challenge for achieving zero new HIV infections and deaths. In order to enhance knowledge of HIV status, the World Health Organisation (WHO) recommends a testing strategy that includes the use of HIV-specific antibody point-of-care tests (POCT). These POCTs do not detect acute HIV infection, the stage of disease when viral load is highest but HIV antibodies are undetectable. Complicating things further, in the presence of antiretroviral therapy (ART) for pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), other currently available testing technologies, such as viral load detection for diagnosis of acute HIV infection, may yield false-negative results. In this scoping review, we evaluate the evidence and discuss alternative HIV testing algorithms that may mitigate diagnostic dilemmas in the setting of increased utilization of ART for immediate treatment and prevention of HIV infection. Discussion: Missed acute HIV infection prevents people living with HIV (PLHIV) from accessing early treatment, increases likelihood of onward transmission, and allows for inappropriate initiation or continuation of PrEP, which may result in HIV drug resistance. While immediate ART is recommended for all PLHIV, studies have shown that starting ART in the setting of acute HIV infection may result in a delayed or complete absence of development of HIV-specific antibodies, posing a diagnostic challenge that is particularly pertinent to resource-limited, high HIV burden settings where HIV-antibody POCTs are standard of care. Similarly, ART used as PrEP or PEP may supress HIV RNA viralload, complicating current HIV testing algorithms in resource-wealthy settings where viral detection is included. As rollout of PrEP continues, HIV testing algorithms may need to be modified. Conclusions: With increasing use of PrEP and ART in acute infection we anticipate diagnostic challenges using currently available HIV testing strategies. Research and surveillance are needed to determine the most appropriate assays and optimal testing algorithms that are accurate, affordable and sustainable. Keywords: Acute HIV infection; pre-exposure prophylaxis; post-exposure prophylaxis; immediate antiretroviral therapy; HIV testing algorithms; indeterminate HIV test, 1 | INTRODUCTION In the current era of immediate antiretroviral therapy (ART), and pre- or post-exposure prophylaxis, confidently diagnosing HIV is becoming increasingly complex. Cases of diagnostic uncertainty can be [...]

Introduction: There is emerging data on HIV-1 incidence among MSM in sub-Saharan Africa (SSA), but no known estimate of HIV-1 incidence among transgender women (TGW) in the region has yet been reported. We assessed HIV-1 incidence and pre-exposure prophylaxis (PrEP) interest in men who have sex with men exclusively (MSME), men who have sex with men and women (MSMW) and TGW in coastal Kenya. Methods: HIV-1-seronegative individuals who had participated in an HIV testing study in 2016 were traced and retested in 2017 according to Kenyan guidelines. All participants were assigned male sex at birth and had male sex partners; additional data on gender identity and sexual orientation were obtained. We assessed the factors associated with HIV-1 acquisition using Poisson regression and calculated HIV-1 incidence in MSME, MSMW and TGW. PrEP interest was assessed through focus group discussions to characterize subcategories' perceived PrEP needs. Results: Of the 168 cohort participants, 42 were classified as MSME, 112 as MSMW and 14 as TGW. Overall, HIV-1 incidence was 5.1 (95% confidence interval (CI): 2.6 to 9.8) per 100 person-years (PY): 4.5 (95% CI: 1.1 to 17.8] per 100 PY among MSME, 3.4 (95% CI: 1.3 to 9.1) per 100 PY among MSMW and 20.6 (95% CI: 6.6 to 63.8] per 100 PY among TGW. HIV-1 acquisition was associated with exclusive receptive anal intercourse (aIRR 13.0, 95% CI 1.9 to 88.6), history of an STI in preceding six months (aIRR 10.3, 95% CI 2.2 to 49.4) and separated/divorced marital status (aIRR 8.2 (95%: 1.1 to 62.2). Almost all (98.8%) participants were interested in initiating PrEP. MSME and TGW felt that PrEP would lead to increases in condomless anal or group sex. Conclusions: TGW had a very high HIV-1 incidence compared with MSME and MSMW. Subcategories of MSM anticipated different PrEP needs and post-PrEP risk behaviour. Further studies should assess if TGW may have been wrongly categorized as MSM in other HIV-1 incidence studies in the region. Keywords: HIV-1 Incidence; transgender women; TGW; PrEP; men who have sex with men, 1 INTRODUCTION Globally, key populations including men who have sex with men (MSM) are at disproportionate risk for HIV-1 acquisition [1,2]. However, within populations categorized as MSM, there is important [...]

BackgroundDetection 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. ObjectiveThe 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. MethodsA 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. ResultsEnrollment 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. ConclusionsThe 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 RegistrationClinicalTrials.gov NCT03508908; https://clinicaltrials.gov/ct2/show/NCT03508908 International Registered Report Identifier (IRRID)DERR1-10.2196/16198

Background Evidence on the distribution of pre-treatment HIV-1 drug resistance (HIVDR) among risk groups is limited in Africa. We assessed the prevalence, trends and transmission dynamics of pre-treatment HIVDR within and between MSM, people who inject drugs (PWID), female sex workers (FSWs), heterosexuals (HETs) and perinatally infected children in Kenya. Methods HIV-1 partial pol sequences from antiretroviral-naive individuals collected from multiple sources between 1986 and 2020 were used. Pre-treatment reverse transcriptase inhibitor (RTI), PI and integrase inhibitor (INSTI) mutations were assessed using the Stanford HIVDR database. Phylogenetic methods were used to determine and date transmission clusters. Results Of 3567 sequences analysed, 550 (15.4%, 95% CI: 14.2–16.6) had at least one pre-treatment HIVDR mutation, which was most prevalent amongst children (41.3%), followed by PWID (31.0%), MSM (19.9%), FSWs (15.1%) and HETs (13.9%). Overall, pre-treatment HIVDR increased consistently, from 6.9% (before 2005) to 24.2% (2016–20). Among HETs, pre-treatment HIVDR increased from 6.6% (before 2005) to 20.2% (2011–15), but dropped to 6.5% (2016–20). Additionally, 32 clusters with shared pre-treatment HIVDR mutations were identified. The majority of clusters had R0 ≥ 1.0, indicating ongoing transmissions. The largest was a K103N cluster involving 16 MSM sequences sampled between 2010 and 2017, with an estimated time to the most recent common ancestor (tMRCA) of 2005 [95% higher posterior density (HPD), 2000–08], indicating propagation over 12 years. Conclusions Compared to HETs, children and key populations had higher levels of pre-treatment HIVDR. Introduction of INSTIs after 2017 may have abrogated the increase in pre-treatment RTI mutations, albeit in the HET population only. Taken together, our findings underscore the need for targeted efforts towards equitable access to ART for children and key populations in Kenya. [ABSTRACT FROM AUTHOR]

Introduction: The impact of exposure to endemic infections on basal immunity and susceptibility to HIV-1 acquisition remains uncertain. We hypothesized that exposure to infections such as cytomegalovirus (CMV), malaria and sexually transmitted infections (STIs) in high-risk individuals may modulate immunity and subsequently increase susceptibility to HIV-1 acquisition. Methods: A case-control study nested in an HIV-1 negative high-risk cohort from Coastal Kenya was used. Cases were defined as volunteers who tested HIV-1 positive during follow-up and had a plasma sample collected 3 ± 2 months prior to the estimated date of HIV-1 infection. Controls were individuals who remained HIV-1 negative during the follow-up and were matched 2:1 to cases by sex, age, risk group and follow-up time. STI screening was performed using microscopic and serologic tests. HIV-1 pre-infection plasma samples were used to determined exposure to CMV and malaria using enzyme-linked immunosorbent assays and to quantify forty-one cytokines and soluble factors using multiplexing assays. Multiplexing data were analyzed using principal component analysis. Associations between cytokines and soluble factors with subsequent HIV-1 acquisition were determined using conditional logistic regression models. Results and discussion: Overall, samples from 47 cases and 94 controls were analyzed. While exposure to malaria (p=0.675) and CMV (p=0.470) were not associated with HIV-1 acquisition, exposure to STIs was (48% [95% CI, 33.3 - 63] vs. 26% [95% CI, 17.3 - 35.9]. Ten analytes were significantly altered in cases compared to controls and were clustered into four principal components: PC1 (VEGF, MIP-1β, VEGF-C and IL-4), PC2 (MCP-1, IL-2 and IL-12p70), PC3 (VEGF-D) and PC4 (Eotaxin-3). PC1, which is suggestive of a Th2-modulatory pathway, was significantly associated with HIV-1 acquisition after controlling for STIs (adjusted odds ratio, (95% CI), p-value: 1.51 [1.14 - 2.00], p=0.004). Elevation of Th2-associated pathways may dampen responses involved in viral immunity, leading to enhanced susceptibility to HIV-1 acquisition. Immunomodulatory interventions aimed at inhibiting activation of Th2-associated pathways may be an additional strategy to STI control for HIV-1 prevention and may reduce dampening of immune responses to vaccination. [ABSTRACT FROM AUTHOR]

We appreciate the letter in response to the recent JIAS supplement on engaging African men who have sex with men (MSM) and transgender women (TGW) who have sex with men [...]

: 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., INTRODUCTION Kenya has among the largest HIV epidemics in the world with an estimated 1.6 million people living with HIV, 46,000 new infections, and 25,000 AIDS‐related deaths in 2018 [1], [...]

: 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., INTRODUCTION Men who have sex with men (MSM) are among the populations at highest risk of HIV acquisition globally [1]. Incidence estimates of HIV in MSM in sub‐Saharan Africa (SSA) [...]