Contribution of men who have sex with men (MSM) attending due to contact tracing to the diagnoses of HIV, syphilis and gonorrhoea in MSM from a clinic-based population

2021 ◽  
pp. sextrans-2021-055169
Author(s):  
Keshinie Samarasekara ◽  
Miriam Ringshall ◽  
Kuhuk Parashar ◽  
Alice Pickering ◽  
Zoe Buss ◽  
...  
Keyword(s):  
Cross Sectional Study ◽  
Sexual Contact ◽  
Health Policies ◽  
Contact Tracing ◽  
Sectional Study ◽  
Cross Sectional ◽  
Public Health Policies ◽  
The Past ◽  
Sexual Contacts ◽  
Sex With Men

ObjectivesRates of HIV, syphilis and gonorrhoea have increased over the past 20 years in men who have sex with men (MSM). Contact tracing strategies have increased the number of MSM attending clinics as sexual contacts. Understanding the outcomes of contact tracing could inform future public health policies to reduce the burden of STIs in MSM.MethodWe aimed to describe the contribution of MSM attending as notified sexual contacts of patients with HIV, syphilis and gonorrhoea to the overall diagnoses of HIV, syphilis and gonorrhoea in MSM in a cross-sectional study. We collected data on all MSM diagnosed with HIV, syphilis and gonorrhoea in 2019 and evaluated which of these MSM were tested due to attending as a sexual contact.ResultsSexual contacts of HIV, syphilis and gonorrhoea contributed to 20% (95% CI=17.3% to 23.7%) of all diagnoses of HIV (3 of 30, 10%), syphilis (28 of 183, 15%) or gonorrhoea (98 of 420, 23%) in the study period. Asymptomatic sexual contacts contributed to 12% (95% CI=9.6% to 14.9%) of all diagnoses of HIV (3 of 30, 10%), syphilis (16 of 183, 9%) and gonorrhoea (57 of 420, 14%). The proportion of MSM diagnosed with gonorrhoea attending as sexual contacts of gonorrhoea (21%) was significantly greater than MSM diagnosed with HIV, attending as sexual contacts of HIV (3%) or MSM diagnosed with syphilis, attending as a sexual contact of syphilis (4%) (p<0.001). Furthermore, the proportion of MSM diagnosed with syphilis, attending as a sexual contact of another STI (11%) was significantly greater than MSM diagnosed with HIV, attending as a contact of another STI (7%) or MSM diagnosed with gonorrhoea, attending as a sexual contact of another STI (2%) (p<0.001).ConclusionContact tracing contributes significantly to the overall diagnoses of HIV, syphilis and gonorrhoea including asymptomatic sexual contacts in our population. Further efforts to increase the yield from contact tracing may continue to reduce the burden of HIV, syphilis and gonorrhoea within sexual networks of MSM.

scholarly journals Prevalence and Factors Associated With HIV Self-testing Uptake Among Men Who Have Sex With Men in Ningbo, China: A Cross-sectional Study

2020 ◽  
Author(s):  
Hang Hong ◽  
Hong-bo Shi ◽  
Hai-bo Jiang ◽  
Hong-jun Dong ◽  
Yun-liang Shen
Keyword(s):  
Hiv Testing ◽  
Cross Sectional Study ◽  
Sexual Contact ◽  
Categorical Variables ◽  
Sectional Study ◽  
Cross Sectional ◽  
Factors Associated ◽  
The Past ◽  
Self Testing ◽  
Sex With Men

Abstract BackgroundHIV testing and early linkage to care are critical for reducing the risk of HIV transmission. HIV self-testing (HIVST) is an useful tool for increasing HIV testing frequency.This study aimed to investigate HIVST rates among men who have sex with men (MSM), the characteristics of MSM who had HIVST, and factors associated with HIVST uptake among MSM in Ningbo, China. MethodsA cross-sectional study was conducted from April to October 2019 in Ningbo,China. Participants were aged at least 18 years and having had sexual contact with men in the past year. Proportions were used for categorical variables. Adjusted Odds Ratio (AOR) and 95% Confidence Interval (CI) for characteristics associated with HIVST uptake was processed by multiple logistic regression models.ResultsAmong a sample of 699 MSM recruited, 38.2% had reported previous use of an HIV self-test kit. A greater proportion of HIVST Users had a higher frequency of HIV testing(≥2 times: 70.0% versus 41.2%, p<0.001) in the past one year. Factor associated with HIVST uptake was gay apps use(AOR=1.86,CI=1.13-3.05), multiple male sex partners (AOR=1.90,CI=1.29-2.80), frequency of male-male sexual contact ≥1 times per week(AOR=1.86, CI=1.30-2.66), syphilis infection(AOR=5.48, CI=2.53-11.88).ConclusionsFurther HIVST education should be strengthened for school-aged children and teenagers, and free HIVST kits may be provided to low-income high-risk MSM through gay apps and NGOs to achieve the increased HIV testing frequency.

scholarly journals Prevalence and associated factors of HIV self-testing among men who have sex with men in Ningbo, China: a cross-sectional study

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Hang Hong ◽  
Hong-bo Shi ◽  
Hai-bo Jiang ◽  
Hong-jun Dong ◽  
Yun-liang Shen
Keyword(s):  
Hiv Testing ◽  
Cross Sectional Study ◽  
Sexual Contact ◽  
Categorical Variables ◽  
Sectional Study ◽  
Cross Sectional ◽  
The Past ◽  
Self Testing ◽  
Test Kit ◽  
Sex With Men

Abstract Background HIV testing and early linkage to care are critical for reducing the risk of HIV transmission. HIV self-testing (HIVST) is a useful tool for increasing HIV testing frequency.This study aimed to investigate HIVST rates among men who have sex with men (MSM), the characteristics of MSM who had HIVST, and factors associated with HIVST uptake among MSM in Ningbo, China. Methods A cross-sectional study was conducted from April to October 2019 in Ningbo,China. Participants were aged at least 18 years and having had sexual contact with men in the past year. Proportions were used for categorical variables. Adjusted Odds Ratio (AOR) and 95% Confidence Interval (CI) for characteristics associated with HIVST uptake was processed by multivariable logistic regression models. Results Among a sample of 699 MSM recruited, 38.2% had reported previous use of an HIV self-test kit. A greater proportion of HIVST users had a higher frequency of HIV testing (≥ 2 times: 70.0% versus 41.2%, p < 0.001) in the past 1 year. The odds of older age (30–39 years: AOR = 0.49, CI 0.32–0.76; more than 40 years: AOR = 0.07, CI 0.04–0.14, compared to 18–29 years), bisexual (AOR = 0.49, CI 0.29–0.84) were lower among HIVST users,and were higher among MSM who were higher education level (high school: AOR = 2.82, CI 1.70–4.69, compared to middle school or less), gay apps use (AOR = 1.86, CI 1.13–3.05), multiple male sex partners (AOR = 1.90, CI 1.29–2.80), frequency of male–male sexual contact ≥ 1 times per week (AOR = 1.86, CI 1.30–2.66), syphilis infection (AOR = 5.48, CI 2.53–11.88). Conclusions Further HIVST education should be strengthened for school-aged children and teenagers, and free HIVST kits may be provided to high-risk MSM through gay apps and CBO to achieve the increased HIV testing frequency.

scholarly journals HIV seroprevalence, self-reported STIs and associated risk factors among men who have sex with men: a cross-sectional study in Rwanda, 2015

2018 ◽  
Vol 95 (1) ◽  
pp. 71-74 ◽  
Author(s):  
Roman Saba Ntale ◽  
Gad Rutayisire ◽  
Pierre Mujyarugamba ◽  
Eliah Shema ◽  
Jane Greatorex ◽  
...  
Keyword(s):  
Cross Sectional Study ◽  
High Rate ◽  
Risk Behaviours ◽  
Sectional Study ◽  
Syphilis Infection ◽  
Cross Sectional ◽  
Logistic Regression Models ◽  
The Past ◽  
Hiv Test ◽  
Sex With Men

ObjectivesIn many populations, men who have sex with men (MSM) are at a high risk of HIV infection. This study aimed to estimate the burden of HIV, other STIs and risk behaviours among Rwandan MSM.MethodsIn this cross-sectional study, we recruited through peer referral men aged between 18 and 60 years, who reported sex with men at least once in the 12 months prior to the survey. Representativeness was increased using ‘seeds’ from a variety of sources. Signed informed consent was obtained from all participants. Data on demographics, risk behaviours and self-reported STIs were collected through an interviewer-administered questionnaire. We screened all eligible participants for HIV using the Rwanda-approved protocol for rapid HIV detection.Results504 MSM were recruited from five major cities in Rwanda. Participants were mostly young (median age 23 years, range 18–55 years) and unmarried (484/504, 96.0%). Thirteen per cent (65/504) of the participants reported past gonorrhoea and/or syphilis infection. Of 504 MSM, 53 (10.5%) reported they were diagnosed and treated for gonorrhoea in the past 12 months and 24 (4.8%) tested positive for HIV. A high proportion (232/504, 46%) reported receiving payment for sex by a man, with almost half of these reporting on more than three occasions (107/232, 46%). Many reported having had an HIV test within the past 12 months (385/504, 76.4%). In multivariate logistic regression models controlling for age, being paid for sex was associated with higher odds of past STI (OR 3.36 (1.82–6.43]; P<0.001) and testing HIV positive (OR 3.13, P<0.05).ConclusionFurther research is needed to understand the high rate of payment for sex in this population, which appears to be a major risk factor for STI including HIV.

scholarly journals Comparison of depression and anxiety between HIV-negative men who have sex with men and women (MSMW) and men who have sex with men only (MSMO): a cross-sectional study in Western China

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e023498 ◽  
Author(s):  
Ying Hu ◽  
Xiao-ni Zhong ◽  
Bin Peng ◽  
Yan Zhang ◽  
Hao Liang ◽  
...  
Keyword(s):  
Cross Sectional Study ◽  
Western China ◽  
Depression And Anxiety ◽  
Sectional Study ◽  
Cross Sectional ◽  
Men And Women ◽  
The Past ◽  
Prevalence Of Depression ◽  
Sex With Men ◽  
Hiv Negative

ObjectiveTo compare the prevalence of depression, anxiety and comorbidity between HIV-negative men who have sex with men and women (MSMW) and men who have sex with men only (MSMO) and examine the associated factors with depression and anxiety separately.DesignA cross-sectional study.SettingThe study was conducted in Western China.ParticipantsFrom April 2013 to October 2014, 2422 participants aged 18–65 years, who were male at birth, had engaged in sex with male partners in the past 6 months, self-reported negative or unknown HIV status, were willing to participate and provided informed consent were recruited using non-probability sampling. An anonymous self-administered questionnaire was used to collect the data. A total of 1809 HIV-negative men who have sex with men (MSM) were eligible for the final analysis.ResultsOf 1809 MSM, 16.1% were MSMW and 83.9% were MSMO. The prevalence of depression, anxiety and comorbidity was 50.86%, 36.43% and 32.65%, respectively, for MSMW; these results were higher than those for MSMO (35.18%, 23.52% and 18.91%, respectively). After adjusting for potential confounding factors, the prevalence of depression and anxiety was higher among MSMW than among MSMO. The prevalence of depression and/or anxiety was associated with young age, lower educational level, lower monthly income, lower HIV score and some risky sexual behaviour (had never engaged in HIV counselling, had obtained commercial sexual services in the past 6 months and sometimes/always looked for sexual partners through the internet). The prevalence of depression and anxiety was lower for those who drank less than once a week than for those who never drank.ConclusionOur findings suggest the need to address mental health among MSMW. Future health intervention strategies should integrate mental health services and traditional HIV prevention programmes and should consider the differences between MSMW and MSMO.Trial registration numberChiCTR-TRC-13003849; Pre-results.

scholarly journals Relationship between gay app use and HIV testing among men who have sex with men in Shenzhen, China: a serial cross-sectional study

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e028933
Author(s):  
Lan Wei ◽  
Lin Chen ◽  
Haibo Zhang ◽  
Zhengrong Yang ◽  
Shaochu Liu ◽  
...  
Keyword(s):  
Hiv Testing ◽  
Cross Sectional Study ◽  
Sectional Study ◽  
Cross Sectional ◽  
The Past ◽  
Hiv Test ◽  
Related Service ◽  
Sex With Men ◽  
Group Sex ◽  
High Level

ObjectivesTo investigate the relationship between gay app use and HIV testing among men who have sex with men (MSM).DesignSerial cross-sectional study.SettingA newly well-developed city in China.Participants4935 MSM were recruited through offline sampling methods from 2015 to 2017.Primary and secondary outcomesThe primary outcome is the difference in HIV testing between app and non-app users.Results2872 (58.2%) and 2159 (43.7%) participated MSM had been tested for HIV within lifetime and the past year, respectively. Compared with non-app-using MSM, app-using MSM had a significantly higher prevalence of HIV testing within lifetime (adjusted OR (AOR): 1.48, 95% CI 1.27 to 1.72) and the past year (AOR: 1.36, 95% CI 1.18 to 1.57). App-using MSM were more likely to take an HIV test at the Centers for Disease Control and Prevention (AOR: 1.48, 95% CI 1.24 to 1.76) and community-based organisations (AOR: 1.71, 95% CI 1.44 to 2.03), but less often at gay venues (AOR: 0.49, 95% CI 0.37 to 0.63). Meanwhile, app-using MSM were more likely to take self-testing (AOR: 1.61, 95% CI 1.21 to 2.14). Predictors of HIV testing in the past year were: having an education level of college or higher (AOR: 1.29, 95% CI 1.01 to 1.65), being self-identified as a homosexual (AOR: 1.23, 95% CI 1.02 to 1.46), being recruited through clinic-based sampling (AOR: 1.30, 95% CI 1.06 to 1.60), using gay app (AOR: 1.49, 95% CI 1.21 to 1.83), engaging in group sex (AOR: 1.64, 95% CI 1.23 to 2.19), having received HIV-related service (AOR: 5.49, 95% CI 4.57 to 6.60), having a high level of HIV-related knowledge (AOR: 1.33, 95% CI 1.10 to 1.61) and high-risk perception (AOR: 2.95, 95% CI 1.40 to 6.23).ConclusionsGay app use was significantly associated with increased HIV testing among MSM hard to reach by traditional outreach. Therefore, it is imperative to expand HIV testing among non-app-using MSM. Continued efforts, innovative strategies and increased resource are highly needed to realise the first ‘90’ target.

Relationship between the use of gay mobile phone applications and HIV infection among men who have sex with men in Ningbo, China: a cross-sectional study

2017 ◽  
Vol 29 (5) ◽  
pp. 491-497 ◽  
Author(s):  
Hang Hong ◽  
Jie Xu ◽  
Jennifer McGoogan ◽  
Hongjun Dong ◽  
Guozhang Xu ◽  
...  
Keyword(s):  
Hiv Infection ◽  
Mobile Phone ◽  
Cross Sectional Study ◽  
Unprotected Sex ◽  
Categorical Variables ◽  
Sectional Study ◽  
Cross Sectional ◽  
The Past ◽  
Mobile Phone Applications ◽  
Sex With Men

In recent years, there has been a significant increase in the use of gay mobile phone applications (gay apps) and HIV prevalence among men who have sex with men (MSM) in China. The aim of this study was to investigate whether there was a relationship between the use of gay apps and HIV infection and provide a targeted intervention to MSM. A cross-sectional study was conducted. Chinese MSM who were over 18 years old and had self-reported homosexual intercourse in the past six months were interviewed in 2016. Proportions were used for categorical variables and determinants of HIV infection were assessed using univariate and multivariate regression. Of the 403 participants, nearly 66.0% reported having used gay apps to seek sexual partners in the past six months. A higher proportion of the gay app users were younger than 19 years old, single, had high school education, were earning less than 115 GBP income per month, and identified themselves as homosexual. Compared to app non-users, a greater proportion of app users reported a higher frequency of male–male sexual contact (≥1 time/week: 57.5% versus 39.4%, p < 0.01), multiple male sex partners (34.2% versus 11.7%, p < 0.001), and unprotected sex with men (51.5% versus 36.5%, p < 0.01) in the past six months. The prevalence of HIV among app users was 7.9%. HIV infection was significantly associated with being an app user (adjusted odds ratio = 5.2, 95% CI = 1.1–24.3). It is suggested that the use of gay apps, especially Blued, is popular among Chinese MSM and is associated with high-risk sexual behaviors and HIV infection. Therefore, there is an urgent need to promote HIV testing and HIV prevention through gay apps to decrease the risk of HIV infection among Chinese MSM.

scholarly journals Trends and differences in sexual practices and sexually transmitted infections in men who have sex with men only (MSMO) and men who have sex with men and women (MSMW): a repeated cross-sectional study in Melbourne, Australia

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e037608
Author(s):  
Mario Martín-Sánchez ◽  
Richard Case ◽  
Christopher Fairley ◽  
Jane S Hocking ◽  
Catriona Bradshaw ◽  
...  
Keyword(s):  
Health Centre ◽  
Cross Sectional Study ◽  
Sexual Practices ◽  
Sectional Study ◽  
Anal Sex ◽  
Cross Sectional ◽  
Men And Women ◽  
Sexually Transmitted ◽  
Receptive Anal Sex ◽  
Sex With Men

ObjectivesIn the 2010s, there has been an increase in sexually transmitted infections (STI) in men who have sex with men (MSM) in Australia, and since 2015 also in urban heterosexuals. Men who have sex with both men and women (MSMW) have characteristics that may differ from both men who have sex with men only (MSMO) and heterosexual men. We aimed to compare the sexual practices and the trends in HIV/STI positivity between MSMO and MSMW.DesignRepeated cross-sectional study.SettingA sexual health centre in Melbourne, Australia.ParticipantsMSM aged 18 years and above who attended the Melbourne Sexual Health Centre for the first time between 2011 and 2018. This includes 12 795 MSMO and 1979 MSMW.Primary outcome measuresDemographic characterics, sexual practices and HIV/STI positivity.ResultsCompared with MSMW, MSMO were more likely to practice anal sex and to have condomless receptive anal sex with casual male partners, and less likely to have a current regular relationship. Over the 8-year period, there was an increase in condomless receptive anal sex with casual male partners for both groups (MSMO: from 46.2% to 63.3%, ptrend <0.001; MSMW: from 41.3% to 57.9%, ptrend=0.011). Syphilis positivity increased in MSMO (from 5.5% to 7.9%, ptrend=0.012) and MSMW (from 0.9% to 6.4%, ptrend=0.004) and HIV remained stable. Gonorrhoea increased among MSMO from 2011 to 2014 (from 6.7% to 9.6%, ptrend=0.002), and remained stable from 2015 to 2018. MSMO had higher odds of testing positive for gonorrhoea (adjusted OR (aOR) 1.36, 95% CI 1.13 to 1.64), chlamydia (aOR 1.39, 95% CI 1.16 to 1.67), syphilis (aOR 1.74, 95% CI 1.37 to 2.22) and HIV (aOR 4.60, 95% CI 2.43 to 8.70) than MSMW.ConclusionsMSMW have overall lower condomless sex and lower HIV/STI positivity. In the last years, changes in sexual practices in MSM have affected both MSMW and MSMO leading to an increased STI risk.

scholarly journals 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

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Olusegun A. Adeyemi ◽  
Andrew Mitchell ◽  
Ashley Shutt ◽  
Trevor A. Crowell ◽  
Nicaise Ndembi ◽  
...  
Keyword(s):  
Hepatitis B Virus ◽  
Hepatitis B ◽  
Cross Sectional Study ◽  
Sectional Study ◽  
Cross Sectional ◽  
Condomless Sex ◽  
B Virus ◽  
Hbv Prevalence ◽  
Sex With Men ◽  
Living With Hiv

Abstract 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.

scholarly journals Sexual health norms and communication patterns within the close social networks of men who have sex with men and transgender women in Lima, Peru: a 2017 cross-sectional study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Amrita Ayer ◽  
Eddy R. Segura ◽  
Amaya Perez-Brumer ◽  
Susan Chavez-Gomez ◽  
Rosario Fernandez ◽  
...  
Keyword(s):  
Social Networks ◽  
Social Network ◽  
Sexual Health ◽  
Cross Sectional Study ◽  
Sectional Study ◽  
Cross Sectional ◽  
Sti Prevention ◽  
Sti Testing ◽  
Trans Women ◽  
Sex With Men

Abstract Background Social networks, norms, and discussions about sexual health may inform sexual practices, influencing risk of human immunodeficiency virus (HIV) or sexually transmitted infection (STI) acquisition. To better understand social networks of Peruvian men who have sex with men (MSM) and transgender women (trans women), we examined key social network members (SNMs), participant perceptions of these network members’ opinions toward sexual health behaviors, and associations between network member characteristics and condomless anal intercourse (CAI). Methods In a 2017 cross-sectional study, a convenience sample of 565 MSM and trans women with HIV-negative or unknown serostatus was asked to identify three close SNMs; describe discussions about HIV and STI prevention with each; and report perceived opinions of condom use, HIV/STI testing, and partner notification of STIs. Generalized estimating equations evaluated relationships between SNM characteristics, opinions, and discussions and participant-reported CAI. Results Among participants who identified as MSM, 42.3% of key SNMs were perceived to identify as gay. MSM “never” discussed HIV and STI prevention concerns with 42.4% of heterosexual SNMs, but discussed them “at least once weekly” with 16.9 and 16.6% of gay- and bisexual- identifying SNMs, respectively. Among participants who identified as trans women, 28.2% of key SNMs were perceived as heterosexual; 25.9%, as bisexual; 24.7%, as transgender; and 21.2%, as gay. Trans women discussed HIV/STI prevention least with cis-gender heterosexual network members (40.2% “never”) and most with transgender network members (27.1% “at least once weekly”). Participants perceived most of their close social network to be completely in favor of condom use (71.2% MSM SNMs, 61.5% trans women SNMs) and HIV/STI testing (73.1% MSM SNMs, 75.6% trans women SNMs), but described less support for partner STI notification (33.4% MSM SNMs, 37.4% trans women SNMs). Most participants reported CAI with at least one of their past three sexual partners (77.5% MSM, 62.8% trans women). SNM characteristics were not significantly associated with participant-reported frequency of CAI. Conclusions Findings compare social support, perceived social norms, and discussion patterns of Peruvian MSM and trans women, offering insight into social contexts and sexual behaviors. Trial registration The parent study from which this analysis was derived was registered at ClinicalTrials.gov (Identifier: NCT03010020) on January 4, 2017.

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