Safety and Immunogenicity of Accelerated Heterologous Two-dose Ebola Vaccine Regimens in Adults With and Without HIV in Africa.

BACKGROUND: Shorter prophylactic vaccine schedules may offer more rapid protection against Ebola in resource-limited settings. METHODS: This randomized, observer-blind, placebo-controlled, phase 2 trial conducted in five sub-Saharan African countries included people without HIV (PWOH, n = 249) and people living with HIV (PLWH, n = 250). Adult participants received one of two accelerated Ebola vaccine regimens (MVA-BN-Filo, Ad26.ZEBOV administered 14 days apart [n = 79] or Ad26.ZEBOV, MVA-BN-Filo administered 28 days apart [n = 322]) or saline/placebo (n = 98). The primary endpoints were safety (adverse events [AEs]) and immunogenicity (Ebola virus [EBOV] glycoprotein-specific binding antibody responses). Binding antibody responders were defined as participants with a > 2.5-fold increase from baseline or the lower limit of quantification if negative at baseline. RESULTS: The mean age was 33.4 years, 52% of participants were female, and among PLWH, the median (interquartile range) CD4+ cell count was 560.0 (418.0-752.0) cells/µL. AEs were generally mild/moderate with no vaccine-related serious AEs or remarkable safety profile differences by HIV status. At 21 days post-dose 2, EBOV glycoprotein-specific binding antibody response rates in vaccine recipients were 99% for the 14-day regimen (geometric mean concentrations [GMCs]: 5168 enzyme-linked immunosorbent assay units (EU)/mL in PWOH; 2509 EU/mL in PLWH), and 98% for the 28-day regimen (GMCs: 6037 EU/mL in PWOH; 2939 EU/mL in PLWH). At 12 months post-dose 2, GMCs in PWOH and PLWH were 635 and 514 EU/mL, respectively, for the 14-day regimen and 331 and 360 EU/mL, respectively, for the 28-day regimen. CONCLUSIONS: Accelerated 14- and 28-day Ebola vaccine regimens were safe and immunogenic in PWOH and PLWH in Africa. TRIAL REGISTRATION: NCT02598388.

SARS-CoV-2 Vaccine-Induced Immune Responses Among Hematopoietic Stem Cell Transplant Recipients.

Background: Although severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination reduces the risk and severity of coronavirus disease 2019 (COVID-19), several variables may impact the humoral response among patients undergoing hematopoietic stem cell transplantation (HSCT). Methods: A retrospective chart review was conducted among SARS-CoV-2-vaccinated HSCT recipients between 2020 and 2022 at a single center in Boston, Massachusetts. Patients age ≥18 years who received doses of Pfizer, Moderna, or J&J vaccines were included. Anti-spike (S) immunoglobulin G (IgG) titer levels were measured using the Roche assay. Responders (≥0.8 U/mL) and nonresponders (<0.8 U/mL) were categorized and analyzed. Multivariable linear and logistic regression were used to estimate the correlation coefficient and odds ratio of response magnitude and status. Results: Of 152 HSCT recipients, 141 (92.8%) were responders, with a median (interquartile range [IQR]) anti-S IgG titer of 2500 (107.9-2500) U/mL at a median (IQR) of 80.5 (36-153.5) days from last dose, regardless of the number of doses received. Higher quantitative titers were associated with receipt of more vaccine doses (coeff, 205.79; 95% CI, 30.10 to 381.47; P = .022), being female (coeff, 343.5; 95% CI, -682.6 to -4.4; P = .047), being younger (<65 years; coeff, 365.2; 95% CI, -711.3 to 19.1; P = .039), and not being on anti-CD20 therapy (coeff, -1163.7; 95% CI, -1717.7 to -609.7; P = .001). Being male (odds ratio [OR], 0.11; 95% CI, 0.01 to 0.93; P = .04) and being on anti-CD20 therapy (OR, 0.16; 95% CI, 0.03 to 0.70; P = .016) were associated with nonresponse. Conclusions: Overall, most HSCT recipients had high SARS-CoV-2 antibody responses. More vaccine doses improved the magnitude of immune responses. Anti-S IgG monitoring may be useful for identifying attenuated vaccine-induced responses.

Food and Water Insecurity in Sexual and Gender Minority Groups Living With HIV in Lagos, Nigeria.

BACKGROUND: Food and water insecurity are associated with poor health outcomes that may be exacerbated by social marginalization and barriers to health care experienced by sexual and gender minorities (SGM) in resource-limited settings. We explored factors associated with food and water insecurity in SGM with HIV. SETTING: A longitudinal study of 357 men who have sex with men, transgender women, and other gender-identifying people in Lagos, Nigeria. METHODS: Laboratory testing, interviews, food and water assessments, and anthropometry were performed quarterly. Robust Poisson regression with generalized estimating equations was used to evaluate factors potentially associated with food and water insecurity. RESULTS: From 2014 to 2018, 357 SGM with HIV completed either the food or water assessments. At baseline, participants identified as cisgender men who have sex with men 265 (74.2%), transgender women 63 (17.7%), or as nonbinary/other gender 29 (8.1%). Food insecurity and water insecurity were reported by 63/344(18.3%) and 113/357(31.7%), respectively, at any visit. Food and water insecurity each decreased with ongoing study participation. Food insecurity was associated with nonpartnered relationship status, CD4 count <500 cells/mm 3 , and lack of access to piped water. Water insecurity was associated with age 25 years or older, living with a man, transactional sex, and food insecurity. CONCLUSIONS: Food and water insecurity were common among SGM in Nigeria and decreased with continued study participation, suggesting amenability to intervention when SGM are successfully engaged in care. Targeted interventions to support food and water security may improve HIV-related outcomes, such as CD4 count.

Herpes Simplex Virus Type 2 Prevalence and Association with Inflammatory Cytokines Among Sexual and Gender Minorities Living With and Without HIV-1 from Lagos, Nigeria.

Herpes simplex virus type 2 (HSV-2) is common globally and contributes significantly to the risk of acquiring HIV-1, yet these two sexually transmitted infections have not been sufficiently characterized for sexual and gender minorities (SGM) across Sub-Saharan Africa. To help fill this gap, we performed a retrospective study using plasma and serum samples from 183 SGM enrolled at the Lagos site of the TRUST/RV368 cohort in Nigeria, assayed them for HSV-2 antibodies with the Kalon ELISA and plasma cytokines and chemokines with Luminex, and correlated the findings with HIV-1 viral loads (VLs) and CD4 counts. We found an overall HSV-2 prevalence of 36.6% (49.5% and 23.9% among SGM with and without HIV-1, respectively, p < .001). Moreover, HSV-2-positive status was associated with high circulating concentrations of CCL11 among antiretroviral therapy-treated (p = .031) and untreated (p = .015) participants, and with high concentrations of CCL2 in the untreated group (p = .004), independent of VL. Principal component analysis revealed a strong association of cytokines with HIV-1 VL independent of HSV-2 status. In conclusion, our study finds that HSV-2 prevalence among SGM with HIV-1 is twice as high than HSV-2 prevalence among SGM without HIV-1 in Lagos and suggests that this is associated with higher levels of certain systemic cytokines. Additional work is needed to further characterize the relationship between HSV-2 and HIV-1 in SGM and help develop targeted therapies for coinfected individuals.

Associations of gender identity with sexual behaviours, social stigma and sexually transmitted infections among adults who have sex with men in Abuja and Lagos, Nigeria.

INTRODUCTION: Sexual and gender minority populations are disproportionately affected by the global syndemic of HIV and other sexually transmitted infections (STIs). We hypothesized that transgender women (TGW) and non-binary individuals in Nigeria have more STIs than cis-gender men who have sex with men (cis-MSM), and that experiences of stigma and sexual practices differ between these three groups. METHODS: From 2013 to 2020, TRUST/RV368 enrolled adults assigned male sex at birth who reported anal sex with men in Abuja and Lagos, Nigeria. Participants were tested for STIs and completed questionnaires about sexual behaviours and social stigma every 3 months. Participants were categorized as cis-MSM, TGW or non-binary/other based on self-reported gender identity. Gender group comparisons were made of HIV, gonorrhoea and chlamydia prevalence and incidence; stigma indicators; and condom use during anal sex. RESULTS: Among 2795 participants, there were 2260 (80.8%) cis-MSM, 284 (10.2%) TGW and 251 (9.0%) non-binary/other individuals with median age of 23 years (interquartile range 20-27). HIV prevalence among cis-MSM, TGW and non-binary/other participants was 40.8%, 51.5% and 47.6%, respectively (p = 0.002). HIV incidence was 8.7 cases per 100 person-years (PY) (95% confidence interval [CI] 6.9-10.8), 13.1 cases/100 PY (95% CI 6.5-23.4) and 17.6 cases/100 PY (95% CI 9.8-29.0, p = 0.025), respectively. Anorectal gonorrhoea incidence was lower in cis-MSM than TGW (22.2 [95% CI 19.6-25.0] vs. 35.9 [95% CI 27.3-46.3]). TGW were more likely than cis-MSM to report being affected by stigma, including assault (47.2% vs. 32.3%), fear of walking around (32.4% vs. 19.2%) and healthcare avoidance (25.0% vs. 19.1%; all p < 0.05). TGW were more likely to report always using condoms than non-binary/other individuals (35.3% vs. 26.2%, p = 0.041) during receptive anal sex. CONCLUSIONS: Sexual and gender minorities in Nigeria have heterogeneous sexual behaviours and experiences of social stigma that may influence the vulnerability to HIV and other STIs. There is a need for tailored interventions that acknowledge and are informed by gender. Further research is needed, particularly among understudied non-binary individuals, to better understand disparities and inform tailored interventions to improve outcomes among these communities.

Vaccines to prevent COVID-19: A living systematic review with Trial Sequential Analysis and network meta-analysis of randomized clinical trials.

BACKGROUND: COVID-19 is rapidly spreading causing extensive burdens across the world. Effective vaccines to prevent COVID-19 are urgently needed. METHODS AND FINDINGS: Our objective was to assess the effectiveness and safety of COVID-19 vaccines through analyses of all currently available randomized clinical trials. We searched the databases CENTRAL, MEDLINE, Embase, and other sources from inception to June 17, 2021 for randomized clinical trials assessing vaccines for COVID-19. At least two independent reviewers screened studies, extracted data, and assessed risks of bias. We conducted meta-analyses, network meta-analyses, and Trial Sequential Analyses (TSA). Our primary outcomes included all-cause mortality, vaccine efficacy, and serious adverse events. We assessed the certainty of evidence with GRADE. We identified 46 trials; 35 trials randomizing 219 864 participants could be included in our analyses. Our meta-analyses showed that mRNA vaccines (efficacy, 95% [95% confidence interval (CI), 92% to 97%]; 71 514 participants; 3 trials; moderate certainty); inactivated vaccines (efficacy, 61% [95% CI, 52% to 68%]; 48 029 participants; 3 trials; moderate certainty); protein subunit vaccines (efficacy, 77% [95% CI, -5% to 95%]; 17 737 participants; 2 trials; low certainty); and viral vector vaccines (efficacy 68% [95% CI, 61% to 74%]; 71 401 participants; 5 trials; low certainty) prevented COVID-19. Viral vector vaccines decreased mortality (risk ratio, 0.25 [95% CI 0.09 to 0.67]; 67 563 participants; 3 trials, low certainty), but comparable data on inactivated, mRNA, and protein subunit vaccines were imprecise. None of the vaccines showed evidence of a difference on serious adverse events, but observational evidence suggested rare serious adverse events. All the vaccines increased the risk of non-serious adverse events. CONCLUSIONS: The evidence suggests that all the included vaccines are effective in preventing COVID-19. The mRNA vaccines seem most effective in preventing COVID-19, but viral vector vaccines seem most effective in reducing mortality. Further trials and longer follow-up are necessary to provide better insight into the safety profile of these vaccines.

Individual and partnership characteristics associated with consistent condom use in a cohort of cisgender men who have sex with men and transgender women in Nigeria.

BACKGROUND: This study reports on the individual and partnership characteristics that influence consistent condom use in cisgender men who have sex with men (MSM) and transgender women (TGW) attending trusted community centers that provide HIV prevention and treatment services in Nigeria. METHODS: Adults assigned male at birth who reported anal sex with male partners who enrolled between March 2013-2019 and had information about at least one male sexual partner were included in these analyses. At enrollment and follow-up visits every 3 months for up to 18 months, participants were administered detailed questionnaires that collected information about demographics, sexual practices, HIV risk behaviors, and characteristics and behaviors of their partners in the previous year (at enrollment) or the preceding 3 to 6-months (at follow-up visits). Logistic regression models with generalized estimating equations were used to assess the odds ratio (OR) and 95% confidence intervals (CI) of individual, partner, and partnership characteristics associated with consistent condom use (CCU). A participant was defined as consistently using condom if they reported always using condoms all the time they had insertive, receptive or both types of anal sex with a male partner. RESULTS: At the individual level, CCU was positively associated with higher education, disclosure of key population status to a healthcare worker and negatively associated with poor access to condoms. At the partner and partnership level, CCU was associated with partners with higher education (aOR: 1.36; 95% CI: 1.07-1.72), casual relationships (aOR: 1.22; 95% CI: 1.11-1.34) and relationships in which partners encouraged the participant to use condoms with other partners (aOR: 1.14; 95% CI: 1.02-1.28). Relationships in which the partner was married to a woman and/or the partner's HIV status positive or unknown were negatively associated with CCU. CONCLUSIONS: These findings suggest that individuals in relationships where partners were more open and encouraged safer sex were more likely to consistently use condoms. HIV prevention programs should consider leveraging communication to sexual partners to encourage condom use as this may support condom use with other sexual partners. Given sustained and growing HIV and STI epidemics among MSM and TGW, even with pre-exposure prophylaxis scale-up, it is crucial to continue to study optimal implementation strategies to increase condom use.

Hepatitis B virus infection among men who have sex with men and transgender women living with or at risk for HIV: a cross sectional study in Abuja and Lagos, Nigeria.

BACKGROUND: Despite the development of a safe and efficacious hepatitis B vaccine in 1982, the hepatitis B virus (HBV) remains a public health burden in sub-Saharan Africa. Due to shared risk factors for virus acquisition, men who have sex with men (MSM) and transgender women (TGW) living with HIV are at increased risk of HBV. We estimated the prevalence of HBV and associated factors for MSM and TGW living with or without HIV in Nigeria. METHODS: Since March 2013, TRUST/RV368 has recruited MSM and TGW in Abuja and Lagos, Nigeria using respondent driven sampling. Participants with HIV diagnosis, enrollment as of June 2015, and available plasma were selected for a cross-sectional study and retrospectively tested for hepatitis B surface antigen and HBV DNA. Logistic regression models were used to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for factors associated with prevalent HBV infection. RESULTS: A total of 717 MSM and TGW had a median age of 25 years (interquartile range [IQR]: 21-27), 5% self-reported HBV vaccination, 61% were living with HIV, 10% had prevalent HBV infection and 6% were HIV-HBV co-infected. HIV mono-infected as compared to HIV-HBV co-infected had a higher median CD4 T cell count [425 (IQR: 284-541) vs. 345 (IQR: 164-363) cells/mm3, p = 0.03] and a lower median HIV RNA viral load [4.2 (IQR: 2.3-4.9) vs. 4.7 (IQR: 3.9-5.4) log10copies/mL, p < 0.01]. The only factor independently associated with HBV was self-report of condomless sex at last anal intercourse (OR: 2.2, 95% CI: 1.3, 3.6). HIV infection was not independently associated with HBV (OR: 1.0, 95% CI: 0.7-1.6). CONCLUSION: HBV prevalence was moderately high but did not differ by HIV in this cohort of MSM and TGW. Recent condomless sex was associated with elevated HBV risk, reinforcing the need to increase communication and education on condom use among key populations in Nigeria. Evaluating use of concurrent HIV antiretroviral therapy with anti-HBV activity may confirm the attenuated HBV prevalence for those living with HIV.

Disclosure of Same-Sex Sexual Practices to Family and Healthcare Providers by Men Who Have Sex with Men and Transgender Women in Nigeria.

Disclosure of same-sex sexual practices by men who have sex with men (MSM) and transgender women (TGW) may facilitate appropriate healthcare engagement, including risk assessment for HIV and other sexually transmitted infections (STIs), and negotiation of condom use with partners. However, disclosure may also generate stigma. In these cross-sectional analyses, MSM and TGW were categorized based on self-report of disclosure to family members and healthcare providers (HCP) at enrollment into the TRUST/RV368 study of comprehensive HIV and STI care programs in Abuja and Lagos, Nigeria. Multivariable Poisson regression models with robust error variance were used to estimate relative risk of disclosure with 95% confidence intervals. Pearson's chi-squared test was used to compare condom use and stigma indicators by disclosure status. Of 2557 participants who answered baseline questions about disclosure, 384 (15.0%) had ever disclosed to a family member and 733 (28.7%) to HCP, including 192 (7.5%) who disclosed to both. Higher education, prevalent HIV infections, and residence in Lagos were each associated with increased likelihood of disclosure to family and HCP. Older participants were more likely to disclose to HCP but not family. Participants who made a disclosure to family or HCP were more likely to report condom use during anal sex as well as perceived and experienced stigma that included healthcare avoidance, blackmail, assault, and sexual violence as compared to participants who had not disclosed. Improved disclosure practices within safe spaces may enhance engagement of MSM and TGW in healthcare and HIV prevention services.

Factors Associated With Condom Failure in a Longitudinal Cohort of Men Who Have Sex With Men and Transgender Women in Abuja and Lagos, Nigeria.

BACKGROUND: Effective condom use is a critical intervention to limit the spread of HIV and other sexually transmitted infections, particularly among individuals in high-risk networks who practice anal sex. We characterized condom failures in cisgender men who have sex with men and transgender women in Nigeria. SETTING: The TRUST/RV368 cohort provided condoms, compatible lubricants, and safer sex education to men who have sex with men and transgender women at community-engaged health centers in Abuja and Lagos, Nigeria. METHODS: Participants completed structured interview questions about condom usage and failure every 3-6 months. Robust Poisson regression models with generalized estimating equations were used to estimate relative risks and 95% confidence intervals for prespecified factors potentially associated with condom failure in the previous month. RESULTS: From September 2013 to September 2019, 2221 of 2737 participants (81.1%) reported condom use for anal sex with a male partner in the last month, and 305 (13.7%) reported condom failure during this time. Multivariate analyses demonstrated an increased risk of condom failure at postenrollment visits, as well as in participants who reported frequent Internet use, 2 or more casual sexual partners, and 2-4 main sexual partners. Those who cohabited with a woman had reduced risk. CONCLUSIONS: Condom failure was common in this population despite freely available condoms, compatible lubrication, and education. Increased risk of condom failure over time could reflect message fatigue a ceiling for effective condom use, or new uptake of condoms by inexperienced users.

Association of age with healthcare needs and engagement among Nigerian men who have sex with men and transgender women: cross-sectional and longitudinal analyses from an observational cohort.

INTRODUCTION: Young men who have sex with men (MSM) and transgender women (TGW) face stigmas that hinder access to healthcare. The aim of the study was to understand age-related determinants of healthcare needs and engagement among MSM and TGW. METHODS: The TRUST/RV368 cohort provides integrated prevention and treatment services for HIV and other sexually transmitted infections (STIs) tailored to the needs of sexual and gender minorities. MSM and TGW aged ≥16 years in Abuja and ≥18 years Lagos, Nigeria, completed standardized behavioural questionnaires and were tested for HIV, Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) every three months for up to 18 months. Logistic regression was used to estimate adjusted odds ratios (aORs) for associations of age and other factors with outcomes of interest upon enrolment, including HIV care continuum steps - HIV testing, ART initiation and viral suppression <1000 copies/mL. Cox proportional hazards models were used to calculate adjusted hazard ratios (aHRs) for associations with incident infections. RESULTS: Between March 2013 and February 2019, 2123 participants were enrolled with median age 23 (interquartile range 21 to 27) years. Of 1745 tested, 865 (49.6%) were living with HIV. HIV incidence was 11.6/100 person-years [PY], including 23.1/100PY (95% CI 15.5 to 33.1) among participants aged 16 to 19 years and 23.8/100 PY (95% CI 13.6 to 39.1) among TGW. Compared to participants aged ≥25 years, those aged 16 to 19 years had decreased odds of prior HIV testing (aOR 0.40 [95% CI 0.11 to 0.92]), disclosing same-sex sexual practices to healthcare workers (aOR 0.53 [95% CI 0.36 to 0.77]) and receiving HIV prevention information (aOR 0.60 [95% CI 0.41 to 0.87]). They had increased odds of avoiding healthcare (aOR 1.94 [95% CI 1.3 to 2.83]) and engaging in transactional sex (aOR 2.76 [95% CI 1.92 to 3.71]). Age 16 to 19 years was independently associated with increased incidence of HIV (aHR 4.09 [95% CI 2.33 to 7.49]), NG (aHR 3.91 [95% CI 1.90 to 8.11]) and CT (aHR 2.74 [95% CI 1.48 to 5.81]). CONCLUSIONS: Young MSM and TGW demonstrated decreased healthcare engagement and higher incidence of HIV and other STIs as compared to older participants in this Nigerian cohort. Interventions to address unique obstacles to healthcare engagement by adolescents and young adults are needed to curb the spread of HIV and other STIs among MSM and TGW in Nigeria.

Retention of a cohort of men who have sex with men and transgender women at risk for and living with HIV in Abuja and Lagos, Nigeria: a longitudinal analysis.

INTRODUCTION: Men who have sex with men (MSM), and transgender women (TGW), face specific obstacles to retention in care, particularly in settings with stigmatization such as sub-Saharan Africa. We evaluated the impacts of HIV status and other factors on loss-to-follow-up (LTFU) and visit adherence among MSM and TGW in Abuja and Lagos, Nigeria. METHODS: TRUST/RV368 is an open cohort that provides comprehensive and integrated prevention and treatment services for HIV and sexually transmitted infections (STIs) at community venues supportive of sexual and gender minorities. Recruitment began in March 2013 and participants were followed every three months for up to 18 months. LTFU was defined as not presenting for an expected visit in the past 180 days. Visit adherence was calculated as a rate of completed visits adjusted by the number of three-month intervals elapsed since enrolment. HIV and other factors predictive of LTFU and visit adherence were evaluated using Cox proportional hazards and Poisson regression models, respectively. RESULTS: A total of 1447 participants who completed enrolment evaluations over two visits as of November 2018 were included in these analyses. Their median age was 24 years (interquartile range [IQR]: 21 to 28) and 53% (n = 766) were living with HIV. LTFU occurred in 56% (n = 808) and visit adherence was 0.62 (95% confidence interval: 0.61 to 0.64) visits per three-month interval. Participants at risk and living with HIV had median follow-up times of 12 months (IQR: 6 to 22), and 21 months (IQR: 12 to 30), respectively (p < 0.01). After controlling for other factors, LTFU was less common among participants living with HIV or other STIs and more common among those who did not own a cell phone, sold sex and had never undergone HIV testing prior to enrolment. These factors had parallel associations with visit adherence. CONCLUSIONS: Retention was suboptimal in Nigerian clinics designed to serve MSM and TGW. Particularly high LTFU and low visit adherence among participants at risk for HIV could complicate deployment of HIV prevention interventions. Marketing the benefits of testing, improving access to cell phones and nurturing more trust with clients may improve retention among marginalized communities in Nigeria.

Oral sex practices among men who have sex with men and transgender women at risk for and living with HIV in Nigeria.

BACKGROUND: Men who have sex with men (MSM) and transgender women (TGW) are at risk for sexually transmitted infections (STIs), including those of the oropharynx. We estimated the prevalence and factors associated with oral sex practices and characterized oropharyngeal STIs among a cohort of MSM and TGW in Nigeria. METHODS: From 2013 to 2018, TRUST/RV368 recruited MSM and TGW into HIV/STI diagnosis and treatment at community-based clinics in Nigeria. Participants who completed HIV testing and oral sex questions at enrollment were selected. Cross-sectional analyses with bivariate and multivariable logistic regression models estimated odds ratios (ORs) and 95% confidence intervals (CIs). Oropharyngeal swab testing for Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) began in 2014 and for those with diagnostic results at enrollment, the unadjusted association of oral sex practices with oropharyngeal STIs was conducted. RESULTS: A total of 1342 participants had a median age of 25 years (interquartile range: 22-29), 58% were living with HIV, and 69% reported oral sex practices. Factors associated with increased odds of engaging in oral sex included living with HIV (adjusted [a]OR: 1.4, 95% CI: 1.1-1.8), self-identifying as a woman (aOR:1.8, 95% CI: 1.1-2.8), mobile phone ownership (aOR:2.3, 95% CI: 1.3-3.9), receptive anal sex (aOR:1.7, 95% CI:1.3-2.3) and multiple male sexual partners (2 to 4 vs. ≤1, aOR:1.5, 95% CI: 1.0-2.2; 5+ vs ≤1, aOR:2.9, 95% CI:1.9-4.3). Oropharyngeal STI prevalence was 7% (52/752) and higher among those who engaged in oral sex compared to those who did not (unadjusted OR: 2.5, 95% CI:1.2-5.3). CONCLUSIONS: Oral sex was common and associated with an increased odds of oropharyngeal STIs among MSM and TGW from Nigeria. In the absence of screening and treatment guidelines, condoms continue to be the mainstay for oral STI prevention. A pre-exposure prophylaxis for bacterial STIs would complement current prevention strategies to curb transmission.

HIV status disclosure by Nigerian men who have sex with men and transgender women living with HIV: a cross-sectional analysis at enrollment into an observational cohort.

BACKGROUND: Men who have sex with men (MSM) and transgender women (TGW) are disproportionately impacted by HIV and may face barriers to HIV status disclosure with negative ramifications for HIV prevention and care. We evaluated HIV status disclosure to sexual partners, HIV treatment outcomes, and stigma patterns of MSM and TGW in Abuja and Lagos, Nigeria. METHODS: Previously-diagnosed MSM and TGW living with HIV who enrolled in the TRUST/RV368 cohort from March 2013 to August 2018 were asked, "Have you told your (male/female) sexual partners (MSP/FSP) that you are living with HIV?" In separate analyses, robust Poisson regression models were used to estimate risk ratios (RRs) and 95% confidence intervals (95% CIs) for characteristics associated with HIV status disclosure to MSP and FSP. Self-reported stigma indicators were compared between groups. RESULTS: Of 493 participants living with HIV, 153 (31.0%) had disclosed their HIV status to some or all MSP since being diagnosed. Among 222 with FSP, 34 (15.3%) had disclosed to some or all FSP. Factors independently associated with disclosure to MSP included living in Lagos (RR 1.58 [95% CI 1.14-2.20]) and having viral load < 50 copies/mL (RR 1.67 [95% CI 1.24-2.25]). Disclosure to FSP was more common among participants who were working in entertainment industries (RR 6.25 [95% CI 1.06-36.84]) or as drivers/laborers (RR 6.66 [95% CI 1.10-40.36], as compared to unemployed) and also among those married/cohabiting (RR 3.95 [95% CI 1.97-7.91], as compared to single) and prescribed ART (RR 2.27 [95% CI 1.07-4.83]). No differences in self-reported stigma indicators were observed by disclosure status to MSP but disclosure to FSP was associated with a lower likelihood of ever having been assaulted (26.5% versus 45.2%, p = 0.042). CONCLUSIONS: HIV status disclosure to sexual partners was uncommon among Nigerian MSM and TGW living with HIV but was associated with improved HIV care outcomes. Disclosure was not associated with substantially increased experiences of stigma. Strategies to encourage HIV status disclosure may improve HIV management outcomes in these highly-marginalized populations with a high burden of HIV infection.

Seizing opportunities for intervention: Changing HIV-related knowledge among men who have sex with men and transgender women attending trusted community centers in Nigeria.

BACKGROUND: Knowledge of HIV risk factors and reduction strategies is essential for prevention in key populations such as men who have sex with men (MSM) and transgender women (TGW). We evaluated factors associated with HIV-related knowledge among MSM and TGW and the impact of engagement in care at trusted community health centers in Nigeria. METHODS: The TRUST/RV368 cohort recruited MSM and TGW in Lagos and Abuja, Nigeria via respondent driven sampling. During study visits every three months, participants underwent structured interviews to collect behavioral data, received HIV education, and were provided free condoms and condom compatible lubricants. Five HIV-related knowledge questions were asked at enrollment and repeated after 9 and 15 months. The mean number of correct responses was calculated for each visit with 95% confidence intervals (CIs). Multivariable Poisson regression was used to calculate adjusted risk ratios and CIs for factors associated with answering more knowledge questions correctly. RESULTS: From March 2013 to April 2018, 2122 persons assigned male sex at birth were enrolled, including 234 TGW (11.2%). The mean number of correct responses at enrollment was 2.36 (95% CI: 2.31-2.41) and increased to 2.95 (95% CI: 2.86-3.04) and 3.06 (95% CI: 2.97-3.16) after 9 and 15 months in the study, respectively. Among 534 participants who completed all three HIV-related knowledge assessments, mean number of correct responses rose from 2.70 (95% CI: 2.60-2.80) to 3.02 (95% CI: 2.93-3.13) and then 3.06 (95% CI: 2.96-3.16). Factors associated with increased overall HIV-related knowledge included longer duration of study participation, HIV seropositivity, higher education level, and more frequent internet use. CONCLUSIONS: There was suboptimal HIV-related knowledge among Nigerian MSM and TGW at that improved modestly with engagement in care. These data demonstrate unmet HIV education needs among Nigerian MSM and TGW and provide insights into modalities that could be used to address these needs.

Genetic clustering analysis for HIV infection among MSM in Nigeria: implications for intervention.

BACKGROUND: The HIV epidemic continues to grow among MSM in countries across sub-Saharan Africa including Nigeria. To inform prevention efforts, we used a phylogenetic cluster method to characterize HIV genetic clusters and factors associated with cluster formation among MSM living with HIV in Nigeria. METHODS: We analyzed HIV-1 pol sequences from 417 MSM living with HIV enrolled in the TRUST/RV368 cohort between 2013 and 2017 in Abuja and Lagos, Nigeria. A genetically linked cluster was defined among participants whose sequences had pairwise genetic distance of 1.5% or less. Binary and multinomial logistic regressions were used to estimate adjusted odds ratios (AORs) and 95% confidence intervals (CIs) for factors associated with HIV genetic cluster membership and size. RESULTS: Among 417 MSM living with HIV, 153 (36.7%) were genetically linked. Participants with higher viral load (AOR = 1.72 95% CI: 1.04-2.86), no female partners (AOR = 3.66; 95% CI: 1.97-6.08), and self-identified as male sex (compared with self-identified as bigender) (AOR = 3.42; 95% CI: 1.08-10.78) had higher odds of being in a genetic cluster. Compared with unlinked participants, MSM who had high school education (AOR = 23.84; 95% CI: 2.66-213.49), were employed (AOR = 3.41; 95% CI: 1.89-10.70), had bacterial sexually transmitted infections (AOR = 3.98; 95% CI: 0.89-17.22) and were not taking antiretroviral therapy (AOR = 6.61; 95% CI: 2.25-19.37) had higher odds of being in a large cluster (size > 4). CONCLUSION: Comprehensive HIV prevention packages should include behavioral and biological components, including early diagnosis and treatment of both HIV and bacterial sexually transmitted infections to optimally reduce the risk of HIV transmission and acquisition.

Anorectal and Urogenital Mycoplasma genitalium in Nigerian Men Who Have Sex With Men and Transgender Women: Prevalence, Incidence, and Association With HIV.

Among 413 Nigerian men who have sex with men and transgender women, retrospective testing for Mycoplasma genitalium revealed mostly asymptomatic infections of the anorectum (prevalence, 36.8%; incidence, 18.4 cases/100 person-years) and urogenital tract (12.4%, 4.0 cases/100 person-years). Risk factors included HIV and increasing number of sex partners.

New Subtype B Containing HIV-1 Circulating Recombinant of sub-Saharan Africa Origin in Nigerian Men Who Have Sex With Men.

BACKGROUND: HIV-1 circulating recombinant forms (CRF) containing subtype B are uncommon in sub-Saharan Africa. Prevalent infections observed during enrollment of a prospective study of men who have sex with men (MSM) from Lagos, Nigeria, revealed the presence of a family of subtype B and CRF02_AG recombinants. This report describes the HIV-1 genetic diversity within a high-risk, high-prevalence, and previously undersampled cohort of Nigerian MSM. METHODS: Between 2013 and 2016, 672 MSM were enrolled at the Lagos site of the TRUST/RV368 study. Prevalent HIV-1 infections were initially characterized by pol sequencing and phylogenetic subtyping analysis. Samples demonstrating the presence of subtype B were further characterized by near full-length sequencing, phylogenetic, and Bayesian analyses. RESULTS: Within this cohort, HIV-1 prevalence was 59%. The major subtype was CRF02_AG (57%), followed by CRF02/B recombinants (15%), subtype G (13%), and smaller amounts of A1, B, and other recombinants. Nine clusters of closely related pol sequences indicate ongoing transmission events within this cohort. Among the CRF02_AG/B, a new CRF was identified and termed CRF95_02B. Shared risk factors and Bayesian phylogenetic inference of the new CRF95_02B and the similarly structured CRF56_cpx indicate a Nigerian or West African origin of CRF56_cpx before its observation in France. CONCLUSION: With high HIV-1 prevalence, new strains, and multiple transmission networks, this cohort of Nigerian MSM represents a previously hidden reservoir of HIV-1 strains, including the newly identified CRF95_02B and closely related CRF56_cpx. These strains will need to be considered during vaccine selection and development to optimize the design of a globally effective HIV-1 vaccine.

Time to change the paradigm: limited condom and lubricant use among Nigerian men who have sex with men and transgender women despite availability and counseling.

PURPOSE: This study characterized availability and uptake of condoms and condom-compatible lubricants (CCLs) at community-engaged condom education and distribution programs serving cisgender men who have sex with men and transgender women in Abuja and Lagos, Nigeria. METHODS: Condoms and water-based CCLs were freely available to participants in the TRUST/RV368 cohort. Factors associated with their consistent use were assessed using Poisson regression with robust error variance to estimate relative risks (RRs) and 95% confidence intervals (CIs). RESULTS: From March 2013-November 2017, 2090 cisgender men who have sex with men and transgender women enrolled with HIV prevalence 40.4% and incidence 12.8 cases per 100 person-years. Fifteen months after enrollment, the proportion who reported consistent condom and CCL use increased during receptive anal sex (21.7%-67.1%, P < .001) and insertive anal sex (25.4%-67.8%, P < .001). Multivariable analyses demonstrated independent impact of 15 months in care on uptake during both receptive (RR 2.62 [95% CI 2.29-3.00]) and insertive (RR 2.27 [95% CI 2.01-2.57]) sex. CONCLUSIONS: Engagement in care improved condom and CCL uptake over time but inconsistent use remained common. Novel approaches to further increase uptake must be pursued alongside complementary strategies, such as sustained access to antiretroviral therapy for those living with HIV and provision of pre and postexposure prophylaxis for those at risk.

Transmitted, pre-treatment and acquired antiretroviral drug resistance among men who have sex with men and transgender women living with HIV in Nigeria.

BACKGROUND: Across sub-Saharan Africa, men who have sex with men (MSM) and transgender women (TGW) have disproportionately poor HIV treatment outcomes. Stigma and criminalization create barriers to health-care engagement and adherence to antiretroviral therapy (ART), potentially promoting the development of HIV drug resistance (HIVDR). We evaluated transmitted, pre-treatment and acquired HIVDR among MSM and TGW in Lagos and Abuja, Nigeria. METHODS: Adults with HIV RNA ≥1,000 copies/ml in the TRUST/RV368 cohort, including incident cases diagnosed via 3-monthly screening, underwent HIVDR testing using the Sanger sequencing method. Major mutations conferring resistance to nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs) and protease inhibitors (PIs) were identified from the 2017 IAS-USA list. World Health Organization surveillance drug resistance mutations (SDRMs) were identified in ART-naive participants. RESULTS: From March 2013 to June 2017, 415 participants with median age 24 (interquartile range [IQR] 21-27) years, CD4+ T-cell count 370 (IQR 272-502) cells/mm3, and HIV RNA 4.73 (IQR 4.26-5.15) log10 copies/ml underwent HIVDR testing. SDRMs were observed in 36 of 373 ART-naive participants (9.7%, 95% confidence interval [95% CI 6.8, 13.1%]), including 8 of 39 incident cases (20.5%, [95% CI] 9.3, 36.5%). Among 42 ART-experienced participants, NNRTI resistance was detected in 18 (42.9%, 95% CI 27.7, 59.0%) and NRTI resistance in 10 (23.8%, 95% CI 12.0, 39.4%). No PI resistance was detected. CONCLUSIONS: The high prevalence of transmitted and acquired drug resistance among Nigerian MSM and TGW living with HIV suggests the need for programmatic solutions to improve uninterrupted access to ART and timely switch to second-line regimens in cases of viral failure.