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.

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.

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.

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.

A Randomized Controlled Trial of the Shikamana Intervention to Promote Antiretroviral Therapy Adherence Among Gay, Bisexual, and Other Men Who Have Sex with Men in Kenya: Feasibility, Acceptability, Safety and Initial Effect Size.

Gay, bisexual, and other men who have sex with men (GBMSM) living with HIV in rights-constrained settings need support for antiretroviral therapy (ART) adherence due to barriers including stigma. The Shikamana intervention combined modified Next Step Counseling by providers with support from trained peers to improve adherence among GBMSM living with HIV in Kenya. A randomized controlled trial with 6-month follow-up was used to determine feasibility, acceptability, safety, and initial intervention effects. Generalized estimating equations examined differences in self-reported adherence and virologic suppression. Sixty men enrolled, with 27 randomly assigned to the intervention and 33 to standard care. Retention did not differ by arm, and no adverse events occurred. Feedback on feasibility and acceptability was positive based on exit interviews. After adjustment for baseline viral suppression and confounding, the intervention group had a sixfold increased odds of viral suppression during follow-up. A larger trial of a scaled-up intervention is needed.

HIV care engagement and ART adherence among Kenyan gay, bisexual, and other men who have sex with men: a multi-level model informed by qualitative research.

Gay, bisexual, and other men who have sex with men (GBMSM) are highly stigmatized and male-male sex is often criminalized in sub-Saharan Africa, impeding access to quality care for sexual health, HIV prevention, and treatment. To better understand HIV care engagement and antiretroviral therapy (ART) adherence among GBMSM in this context, a conceptual model incorporating sociocultural factors is needed. We conducted a qualitative study of barriers to and facilitators of HIV care engagement and ART adherence among Kenyan GBMSM, informed by a conceptual model based on an access, information, motivation, and behavioral skills (access-IMB) model, with trust in providers and stigma and discrimination as a priori factors of interest. We conducted 30 semi-structured interviews with HIV-positive Kenyan GBMSM, of whom 20 were taking ART and 10 had not yet initiated treatment. A deductive approach was used to confirm the relevance of basic concepts of the access-IMB model, while an inductive approach was used to identify content that emerged from men's lived experiences. Access-related information, motivation, and behavioral skills appeared relevant to HIV care engagement and ART adherence, with stigma and discrimination appearing consistently across discourse exploring facilitators and barriers. Trusted providers and supportive family and friends helped many men, and resilience-related concepts such as selective disclosure of GBMSM status, connection to lesbian, gay, bisexual, and transgender (LGBT) organizations, self-acceptance, goal-setting, social identity and altruism emerged as important facilitators. Findings suggest a need to increase support from providers and peers for Kenyan GBMSM living with HIV infection. In addition, they point toward the potential value of interventions that provide opportunities to build or enhance one's sense of community belonging in order to improve HIV care engagement and promote ART adherence for this vulnerable population.

How intersectional constructions of sexuality, culture, and masculinity shape identities and sexual decision-making among men who have sex with men in coastal Kenya.

Men who have sex with men are increasingly recognised as one of the most vulnerable HIV risk groups in Kenya. Sex between men is highly stigmatised in Kenya, and efforts to provide sexual health services to men who have sex with men require a deeper understanding of their lived experiences; this includes how such men in Kenya construct their sexual identities and how these constructions affect sexual decision-making. Adult self-identified men who have sex with men (n = 26) in Malindi, Kenya, participated in individual interviews to examine sociocultural processes influencing sexual identity construction and decision-making. Four key themes were identified: (1) tensions between perceptions of 'homosexuality' versus being 'African', (2) gender-stereotyped beliefs about sexual positioning, (3) socioeconomic status and limitations to personal agency and (4) objectification and commodification of non-normative sexualities. Findings from this analysis emphasise the need to conceive of same-sex sexuality and HIV risk as context-dependent social phenomena. Multiple sociocultural axes were found to converge and shape sexual identity and sexual decision-making among this population. These axes and their interactive effects should be considered in the design of future interventions and other public health programmes for men who have sex with men in this region.

Public/community engagement in health research with men who have sex with men in sub-Saharan Africa: challenges and opportunities.

BACKGROUND: Community engagement, incorporating elements of the broader concepts of public and stakeholder engagement, is increasingly promoted globally, including for health research conducted in developing countries. In sub-Saharan Africa, community engagement needs and challenges are arguably intensified for studies involving gay, bisexual and other men who have sex with men, where male same-sex sexual interactions are often highly stigmatised and even illegal. This paper contextualises, describes and interprets the discussions and outcomes of an international meeting held at the Kenya Medical Research Institute-Wellcome Trust in Kilifi, Kenya, in November 2013, to critically examine the experiences with community engagement for studies involving men who have sex with men. DISCUSSION: We discuss the ethically charged nature of the language used for men who have sex with men, and of working with 'representatives' of these communities, as well as the complementarity and tensions between a broadly public health approach to community engagement, and a more rights based approach. We highlight the importance of researchers carefully considering which communities to engage with, and the goals, activities, and indicators of success and potential challenges for each. We suggest that, given the unintended harms that can emerge from community engagement (including through labelling, breaches in confidentiality, increased visibility and stigma, and threats to safety), representatives of same-sex populations should be consulted from the earliest possible stage, and that engagement activities should be continuously revised in response to unfolding realities. Engagement should also include less vocal and visible men who have sex with men, and members of other communities with influence on the research, and on research participants and their families and friends. Broader ethics support, advice and research into studies involving men who have sex with men is needed to ensure that ethical challenges - including but not limited to those related to community engagement - are identified and addressed. Underlying challenges and dilemmas linked to stigma and discrimination of men who have sex with men in Africa raise special responsibilities for researchers. Community engagement is an important way of identifying responses to these challenges and responsibilities but itself presents important ethical challenges.

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.

Cross-sectional survey of treatment practices for urethritis at pharmacies, private clinics and government health facilities in coastal Kenya: many missed opportunities for HIV prevention.

BACKGROUND: While bacterial sexually transmitted infections (STIs) are important cofactors for HIV transmission, STI control has received little attention in recent years. The aim of this study was to assess STI treatment and HIV testing referral practices among health providers in Kenya. METHODS: In 2011 we assessed quality of case management for male urethritis at pharmacies, private clinics and government health facilities in coastal Kenya using simulated visits at pharmacies and interviews at pharmacies and health facilities. Quality was assessed using Ministry of Health guidelines. RESULTS: Twenty (77%) of 26 pharmacies, 20 (91%) of 22 private clinics and all four government facilities in the study area took part. The median (IQR) number of adult urethritis cases per week was 5 (2-10) at pharmacies, 3 (1-3) at private clinics and 5 (2-17) at government facilities. During simulated visits, 10% of pharmacies prescribed recommended antibiotics at recommended dosages and durations and, during interviews, 28% of pharmacies and 27% of health facilities prescribed recommended antibiotics at recommended dosages and durations. Most regimens were quinolone-based. HIV testing was recommended during 10% of simulated visits, 20% of pharmacy interviews and 25% of health facility interviews. CONCLUSIONS: In an area of high STI burden, most men with urethritis seek care at pharmacies and private clinics. Most providers do not comply with national guidelines and very few recommend HIV testing. In order to reduce the STI burden and mitigate HIV transmission, there is an urgent need for innovative dissemination of up-to-date guidelines and inclusion of all health providers in HIV/STI programmes.

Adherence to antiretroviral therapy and clinical outcomes among young adults reporting high-risk sexual behavior, including men who have sex with men, in coastal Kenya.

African men who have sex with men (MSM) face significant stigma and barriers to care. We investigated antiretroviral therapy (ART) adherence among high-risk adults, including MSM, participating in a clinic-based cohort. Survival analysis was used to compare attrition across patient groups. Differences in adherence, weight gain, and CD4 counts after ART initiation were assessed. Among 250 HIV-1-seropositive adults, including 108 MSM, 15 heterosexual men, and 127 women, patient group was not associated with attrition. Among 58 participants who were followed on ART, 40 % of MSM had less than 95 % adherence, versus 28.6 % of heterosexual men and 11.5 % of women. Although MSM gained less weight after ART initiation than women (adjusted difference -3.5 kg/year), CD4 counts did not differ. More data are needed on barriers to adherence and clinical outcomes among African MSM, to ensure that MSM can access care and derive treatment and prevention benefits from ART.

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.

"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.

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.

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.

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.

"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.

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.

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.

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.