31 results on '"Vita W. Jongen"'
Search Results
2. Impaired lung function in adolescents with pulmonary tuberculosis during treatment and following treatment completionResearch in context
- Author
-
Marieke M. van der Zalm, Vita W. Jongen, Ruan Swanepoel, Klassina Zimri, Brian Allwood, Megan Palmer, Rory Dunbar, Pierre Goussard, H Simon Schaaf, Anneke C. Hesseling, and James A. Seddon
- Subjects
Tuberculosis ,Adolescents ,Morbidity ,Lung health ,Post-tuberculosis ,Medicine (General) ,R5-920 - Abstract
Summary: Background: Little is known about post-tuberculosis lung disease in adolescents. We prospectively assessed lung function in adolescents with microbiologically confirmed pulmonary tuberculosis during treatment and after treatment completion. Methods: In a prospective study, we enrolled adolescents diagnosed with microbiologically confirmed tuberculosis and healthy tuberculosis-exposed household controls, between October 2020 and July 2021 in Cape Town, South Africa. Spirometry, plethysmography, diffusion capacity lung function tests and 6-min walking test (6MWT) were completed according to international guidelines 2 months into treatment and following treatment completion. Abnormal lung function was defined as abnormal spirometry (z-score 45%) and/or diffusion capacity (DLCO z-score
- Published
- 2024
- Full Text
- View/download PDF
3. Trajectories of PrEP use among men who have sex with men: a pooled analysis of two prospective, observational cohort studies
- Author
-
Vita W. Jongen, Thijs Reyniers, Maarten Schim van der Loeff, Tom Smekens, Elske Hoornenborg, Mark van den Elshout, Hanne Zimmermann, Liza Coyer, Chris Kenyon, Irith De Baetselier, Udi Davidovich, Henry J. C. de Vries, Maria Prins, Marie Laga, Bea Vuylsteke, and Anders Boyd
- Subjects
cohort studies ,Europe ,HIV prevention and control ,men who have sex with men ,pre‐exposure prophylaxis ,public health ,Immunologic diseases. Allergy ,RC581-607 - Abstract
Abstract Introduction Daily and event‐driven oral pre‐exposure prophylaxis (PrEP) reduce the risk of HIV acquisition. PrEP use can vary over time, yet little is known about the trajectories of PrEP use irrespective of the chosen PrEP regimens among men who have sex with men (MSM). Methods Using data from a mobile, web‐based diary application collected daily from 17 August 2015 until 6 May 2018, we analysed PrEP use and sexual behaviour in two large cohorts, AMPrEP (Amsterdam, the Netherlands) and Be‐PrEP‐ared (Antwerp, Belgium). In both cohorts, participants could choose between daily and event‐driven oral PrEP every 3 months. We used group‐based trajectory modelling to identify trajectories of PrEP use over time and their determinants. In addition, we estimated the incidence rate of chlamydia, gonorrhoea and syphilis within these trajectories. Results We included 516 MSM (n = 322 AMPrEP; n = 194 Be‐PrEP‐ared), of whom 24% chose event‐driven PrEP at PrEP initiation. Participants contributed 225,015 days of follow‐up (median = 508 days [IQR = 429−511]). Four distinct PrEP use trajectories were identified: ≤2 tablets per week (“low frequency,” 12% of the total population), 4 tablets per week (“variable,” 17%), “almost daily” (31%) and “always daily” (41%). Compared to participants with “low frequency” PrEP use, participants with “variable” (odds ratio [OR] = 2.18, 95% confidence interval [CI] = 1.04−4.60) and “almost daily” PrEP use were more often AMPrEP participants (OR = 2.64, 95% CI = 1.27−5.49). “Almost daily” PrEP users were more often employed (OR = 6.76, 95% CI = 2.10−21.75) and were younger compared to participants with “low frequency” PrEP use. In addition, the number of days on which anal sex occurred was lower among participants with “low frequency” PrEP use compared to the other groups (all p
- Published
- 2023
- Full Text
- View/download PDF
4. Human papillomavirus vaccination uptake: a longitudinal study showing ethnic differences in the influence of the intention-to-vaccinate among parent-daughter dyads
- Author
-
Vita W. Jongen, Maarten F. Schim van der Loeff, Anders Boyd, Mariska Petrignani, Maria Prins, Marcel van der Wal, Astrid Nielen, Hester de Melker, Theo G.W.M. Paulussen, and Catharina J. Alberts
- Subjects
human papillomavirus ,hpv ,vaccination ,vaccination uptake ,vaccination intention ,vaccination acceptability ,the netherlands ,parent-daughter dyads ,Immunologic diseases. Allergy ,RC581-607 ,Therapeutics. Pharmacology ,RM1-950 - Abstract
Introduction It is unclear what role daughters play in the decision-making process regarding HPV vaccination. Therefore, we explored the impact of HPV vaccination intention among parents and their 12–13 year-old daughters on HPV vaccination uptake. Methods In February 2014 parents/guardians and their 12–13 year-old daughters were invited to complete a questionnaire about socio-psychological determinants of the decision-making process regarding HPV vaccination. Vaccination status of the daughter was retrieved from the national vaccination database after the last possible vaccination date in 2014. The association between HPV vaccination uptake and intention, and determinants of intention, was jointly assessed using a generalized structural equation model, stratified by origin of parents (Dutch versus non-Dutch). Results In total, 273 Dutch parent-daughter dyads and 165 non-Dutch dyads were analyzed for this study. HPV vaccination uptake was 90% (246/273) and 84% (139/165) in the Dutch and non-Dutch group, respectively. In the Dutch group, high parental intention (β = 2.3, 95%CI 1.2–3.3) and high daughters’ intention (β = 1.5, 95%CI 0.41–2.6) were significantly associated with HPV vaccination uptake. In the non-Dutch group, high daughters’ intention (β = 1.2, 95%CI 0.16–2.2) was significantly associated with HPV vaccination, but high parental intention was not (β = 0.52, 95%CI −0.47–1.5). Attitude was the most prominent socio-psychological determinant associated with vaccination intention among all groups. Conclusion In the non-Dutch group, only daughters’ intention was significantly associated with HPV vaccination uptake, whereas in the Dutch group both the parents’ and the daughters’ intention were significantly associated with uptake. The role of the child in the decision-making process might need to be taken into account when developing new interventions focused on increasing HPV vaccination uptake, especially among individuals of non-Dutch origin.
- Published
- 2021
- Full Text
- View/download PDF
5. Hypertension in a rural community in South Africa: what they know, what they think they know and what they recommend
- Author
-
Vita W. Jongen, Samanta T. Lalla-Edward, Alinda G. Vos, Noortje G. Godijk, Hugo Tempelman, Diederick E. Grobbee, Walter Devillé, and Kerstin Klipstein-Grobusch
- Subjects
Hypertension ,Hypertension perception ,Hypertension knowledge ,Rural community ,Focus group discussions ,South Africa ,Public aspects of medicine ,RA1-1270 - Abstract
Abstract Background Hypertension is one of the most important risk factors for cardiovascular disease and has a high prevalence in South Africa and other low- and middle-income countries. However, awareness of hypertension has been reported to be low. Health programmes can increase awareness of hypertension and its causes, but hinge on the knowledge and perception of the targeted community. Therefore, this study investigated knowledge on and perceptions about hypertension of community members in a rural area in Limpopo, South Africa with the aim to increase awareness of hypertension and cardiovascular disease in the local population. Methods Using a mixed methods study approach, 451 participants of the Ndlovu Cohort Study, attending a follow-up visit between August 2017 and January 2018, completed a questionnaire on cardiovascular risk perception. A knowledge score was calculated for all participants. Sixty participants were invited to participate in six focus group discussions, of which 56 participated. Audio recordings were transcribed verbatim, transcripts coded, and thematic analysis of the data undertaken to obtain an understanding of knowledge and perception of hypertension in the community. Results Most members of the community seemed to have intermediate (74.3%) or good (14.0%) knowledge of hypertension based on the knowledge score, and only 11.8% of the population had poor knowledge. The risk factors of hypertension seemed to be well known in the community. Poverty was identified as a major vulnerability in this community limiting choices for healthy lifestyles such as nutritious foods, recreational physical activity and accessing health care timely. Participants proposed community-based activities as an effective way to reach out to community members for prevention and management of hypertension. Conclusion This study highlights the need for improved health promotion efforts to increase knowledge of hypertension in rural communities, and to address poverty as a major obstacle to healthy life-style choices.
- Published
- 2019
- Full Text
- View/download PDF
6. Heart Rate Variability, HIV and the Risk of Cardiovascular Diseases in Rural South Africa
- Author
-
Noortje G. Godijk, Alinda G. Vos, Vita W. Jongen, Robert Moraba, Hugo Tempelman, Diederick E. Grobbee, Roel A. Coutinho, Walter Devillé, and Kerstin Klipstein-Grobusch
- Subjects
heart rate variability ,hiv ,antiretroviral treatment ,sub-saharan africa ,cardiovascular disease ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 ,Public aspects of medicine ,RA1-1270 - Abstract
Background: Antiretroviral therapy (ART) transformed human immunodeficiency virus (HIV) infection into a chronic disease. Possible HIV-associated complications have emerged including cardiovascular diseases (CVD). Objectives: This study aims to determine the heart rate variability (HRV) distribution and association between HRV and HIV treated with ART in a rural African population. Methods: This cross-sectional study included 325 participants of the Ndlovu Cohort Study, South Africa. HRV was measured using a standardized five-minute resting ECG and assessed by the standard deviation of normal RR intervals (SDNN), root of mean squares of successive RR differences (RMSSD), percentage of RR intervals greater than 50 milliseconds different from its predecessor (pNN50), total-, low- and high-frequency power. CVD risk factors were assessed using measurements (blood pressure, anthropometry, cholesterol) and questionnaires (e.g. socio-demographics, alcohol, smoking, physical activity, age, diabetes). We used a Wilcoxon rank test to assess differences in medians between HIV-infected and HIV-uninfected participants and multivariable linear regression to investigate associations between HRV and HIV treated with ART. Conclusions: Of the participants, 196 (61.4%) were HIV-infected treated with ART and 123 (38.6%) were HIV-uninfected. HIV-infected consumed less alcohol, 52% versus 35%, smoked less, were less physically active, more often attained lower education, 26% versus 14%, and had lower systolic blood pressure, 134 mmHg versus 140 mmHg, compared to HIV-uninfected. Medians of all HRV parameters were lower for HIV-infected participants. The model fully adjusted for CVD risk factors showed a significant inverse association between HIV treated with ART and log RMSSD (–0.16) and log pnn50 (–0.61). Although HIV-infected participants treated with ART presented with less CVD risk factors they had a lower HRV indicating an increased risk of CVD. Highlights – African HIV-infected participants on ART had less conventional CVD risk factors than HIV-uninfected. – However, HIV-infected participants had lower HRV than HIV-uninfected participants. – Lower HRV of the HIV-infected participants indicates that they are at a higher risk for CVD.
- Published
- 2020
- Full Text
- View/download PDF
7. Estimating incidence rates of grouped HPV types: A systematic review and comparison of the impact of different epidemiological assumptions
- Author
-
Vita W. Jongen, Daniëla K. van Santen, Catharina J. Alberts, and Maarten F. Schim van der Loeff
- Subjects
Infectious and parasitic diseases ,RC109-216 - Abstract
Background: Some studies on human papillomavirus (HPV) provide not only type-specific incidence rates (IR), but also IRs of HPV groupings (e.g. the nonavalent grouping). We made an inventory of the different approaches used to calculate such IRs and assessed their impact on the estimated IRs of HPV groupings. Methods: We performed a systematic review assessing all approaches used in literature to estimate IRs. Subsequently we applied these approaches to data of a Dutch cohort study on HPV in men who have sex with men (H2M). IRs were estimated for six different HPV groupings. Results: The systematic review yielded six different approaches (A-F) for estimating the IRs, varying in exclusion criteria at baseline, and the definitions of an incident event and person-time. Applying these approaches to the H2M dataset (n = 749), we found differences in the number of participants at risk, number of incidents events, person-time, and IR. For example, for the nonavalent grouping, depending on the approach chosen, the IR varied between 3.09 and 6.54 per 100 person-months. Conclusion: In published studies different epidemiological assumptions are used to estimate IRs of grouped HPV types, leading to widely differing estimates of IRs. IRs between different studies may therefore not be comparable. Keywords: Human papillomavirus, HPV, Incidence rate, Epidemiology
- Published
- 2019
- Full Text
- View/download PDF
8. Can we screen less frequently for STI among PrEP users?
- Author
-
Vita W. Jongen, Hanne M.L. Zimmermann, Marit Goedhart, Johannes A. Bogaards, Udi Davidovich, Liza Coyer, Henry J.C. de Vries, Maria Prins, Elske Hoornenborg, Maarten F. Schim van der Loeff, Graduate School, AII - Infectious diseases, APH - Global Health, Dermatology, APH - Methodology, Infectious diseases, Medical Microbiology and Infection Prevention, Internal medicine, Section Applied Social Psychology, and RS: FPN WSP II
- Subjects
GAY MEN ,PREP ,DRUG-USE ,Dermatology ,Chlamydia Infections ,SYPHILIS ,Infectious Diseases ,SETTINGS ,Pre-Exposure Prophylaxis ,GONORRHEA ,SEXUALLY-TRANSMITTED INFECTIONS ,NEISSERIA GONORRHOEAE ,BEHAVIOR ,HIV PREEXPOSURE PROPHYLAXIS - Abstract
BackgroundIn many countries, HIV pre-exposure prophylaxis (PrEP) users are screened quarterly for STIs. We assessed the consequences of less frequent STI testing. We also assessed determinants of asymptomatic STI and potential for onward transmission.MethodsUsing data from the AMPrEP study, we assessed the proportion of syphilis, and genital, anal, and pharyngeal chlamydia and gonorrhoea diagnoses which would have been delayed with biannual versus quarterly screening. We assessed the potential for onward transmission by examining reported condomless anal sex (CAS) in periods after to-be-omitted visits when screening biannually. We assessed determinants of incident asymptomatic STIs using Poisson regression and calculated individual risk scores on the basis of the coefficients from this model.ResultsWe included 366 participants. Median follow-up was 47 months (IQR 43–50). 1,183STIs were diagnosed, of which 932(79%) asymptomatic. With biannual screening, 483 asymptomatic STIs (52%) diagnoses would have been delayed at 364 study visits. Of these visits, 129 (35%), 240 (66%) and 265 (73%) were followed by periods of CAS with steady, known casual or unknown casual partners, respectively. Older participants had a lower risk of asymptomatic STI (incidence rate ratio (IRR) 0.86/10-year increase, 95% CI 0.80 to 0.92), while CAS with known (IRR 1.36, 95% CI 1.10 to 1.68) and unknown (IRR 1.86, 95% CI 1.48 to 2.34) casual partners and chemsex (IRR 1.51, 95% CI 1.28 to 1.78) increased the risk. The individual risk scores had limited predictive value (sensitivity=0.70 (95% CI 0.66 to 0.74), specificity=0.50 (95% CI 0.48 to 0.51)).ConclusionReducing the STI screening frequency to biannually among PrEP users will likely result in delayed diagnoses, potentially driving onward transmission. Although determinants for asymptomatic STIs were identified, predictive power was low.
- Published
- 2023
- Full Text
- View/download PDF
9. Incidence and risk factors of C. trachomatis and N. gonorrhoeae among young women from the Western Cape, South Africa: The EVRI study.
- Author
-
Vita W Jongen, Maarten F Schim van der Loeff, Matthys H Botha, Staci L Sudenga, Martha E Abrahamsen, and Anna R Giuliano
- Subjects
Medicine ,Science - Abstract
ObjectiveYoung women in South Africa are highly affected by sexually transmitted infections (STI), like C. trachomatis (CT) and N. gonorrhoeae (NG). We aimed to estimate the incidence of CT and NG, and its determinants, among young women from the Western Cape, South Africa, participating in an HPV vaccine trial (the EVRI study).MethodsHIV-negative women aged 16-24 years were enrolled between October 2012 and July 2013. At enrolment and month 6 participants were screened for CT and NG (Anyplex CT/NG real-time detection method). A questionnaire on demographic and sexual history characteristics was completed at enrolment and month 7. Treatment for CT and/or NG was offered to infected participants. Incidence rates (IR) of CT and NG were estimated. Determinants of incident CT and NG infections were assessed using Poisson regression.Results365 women were tested for CT and/or NG at least twice. Prevalence of CT and NG at baseline was 33.7% and 10.4%, respectively. Prevalence of co-infection with CT and NG was 7.1%. During 113.3 person-years (py), 48 incident CT infections were diagnosed (IR = 42.4 per 100 py, 95% confidence interval (CI) 31.9-56.2). Twenty-nine incident NG were diagnosed during 139.3 py (IR = 20.8 per 100 py, 95%CI 14.5-29.9). Prevalent CT infection at baseline was associated with incident CT (adjusted incidence rate ratio (aIRR) 5.8, 95%CI 3.0-11.23. More than three lifetime sex partners increased the risk for incident NG (3-4 partners aIRR = 7.3, 95%CI 2.1-26.0; ≥5 partners aIRR = 4.3, 95%CI 1.1-17.5).ConclusionsThe IR of bacterial STIs among young women in the Western Cape is very high. Besides being previously infected and a higher lifetime number of sex partners, no other risk factors were found for CT and NG, suggesting that the majority of these women were at risk. This indicates the need for intensified prevention of STIs as well as screening and treatment programs to increase sexual health in this region.
- Published
- 2021
- Full Text
- View/download PDF
10. Approaches to Estimating Clearance Rates for Human Papillomavirus Groupings: A Systematic Review and Real Data Examples
- Author
-
Eline S, Wijstma, Vita W, Jongen, Catharina J, Alberts, Hester E, de Melker, Joske, Hoes, and Maarten F, Schim van der Loeff
- Subjects
Male ,Sexual and Gender Minorities ,Adolescent ,Incidence ,Papillomavirus Infections ,Humans ,Female ,Papillomavirus Vaccines ,Alphapapillomavirus ,Homosexuality, Male ,Papillomaviridae - Abstract
Approaches to estimating clearance rates, an important metric of human papillomavirus (HPV) clearance, for HPV groupings differ between studies. We aimed to identify the approaches used in the literature for estimating grouped HPV clearance rates. We investigated whether these approaches resulted in different estimations, using data from existing studies.In this systematic review, we included articles that reported clearance rates of HPV groupings. We identified approaches to data in the HAVANA cohort, comprising adolescent girls, and the H2M cohort, comprising men who have sex with men. We estimated clearance rates for six HPV groupings (bivalent-, quadrivalent- and nonavalent vaccine-related, and low-risk, high-risk, and any HPV).From 26 articles, we identified 54 theoretically possible approaches to estimating clearance rates. These approaches varied regarding definitions of clearance events and person-time, and prevalence or incidence of infections included in the analysis. Applying the nine most-used approaches to the HAVANA ( n = 1,394) and H2M ( n = 745) cohorts demonstrated strong variation in clearance rate estimates depending on the approach used. For example, for grouped high-risk HPV in the H2M cohort, clearance rates ranged from 52.4 to 120.0 clearances/1000 person-months. Clearance rates also varied in the HAVANA cohort, but differences were less pronounced, ranging from 24.1 to 57.7 clearances/1000 person-months.Varied approaches from the literature for estimating clearance rates of HPV groupings yielded different clearance rate estimates in our data examples. Estimates also varied between study populations. We advise clear reporting of methodology and urge caution in comparing clearance rates between studies.
- Published
- 2022
11. Adherence to event-driven HIV PrEP among men who have sex with men in Amsterdam, the Netherlands
- Author
-
Peter L. Anderson, Vita W Jongen, Henry Jc de Vries, Anders Boyd, Elske Hoornenborg, Maria Prins, Mark A M van den Elshout, Liza Coyer, Maarten F. Schim van der Loeff, Udi Davidovich, Hanne M L Zimmermann, RS: FPN WSP II, Section Applied Social Psychology, Sociale Psychologie (Psychologie, FMG), Psychology Other Research (FMG), APH - Methodology, APH - Global Health, Graduate School, Medical Microbiology and Infection Prevention, Infectious diseases, AII - Infectious diseases, and Dermatology
- Subjects
Male ,Casual ,Human immunodeficiency virus (HIV) ,men who have sex with men ,HIV Infections ,medicine.disease_cause ,Men who have sex with men ,COST-EFFECTIVENESS ,Pre-exposure prophylaxis ,Sexual and Gender Minorities ,0302 clinical medicine ,Interquartile range ,Surveys and Questionnaires ,Emtricitabine ,030212 general & internal medicine ,Research Articles ,Netherlands ,Emtricitabine/therapeutic use ,Homosexuality ,On‐demand PrEP ,Diphosphates ,Infectious Diseases ,0305 other medical science ,Anal sex ,Research Article ,medicine.drug ,Diphosphates/therapeutic use ,Tenofovir ,Anti-HIV Agents ,Sexual Behavior ,HIV Infections/drug therapy ,DRUG-USE ,Transgender Persons ,Medication Adherence ,03 medical and health sciences ,medicine ,Humans ,Homosexuality, Male ,Pre‐exposure prophylaxis ,030505 public health ,business.industry ,Public Health, Environmental and Occupational Health ,HIV ,On-demand PrEP ,Anti-HIV Agents/therapeutic use ,HIV prevention and control ,business ,Demography ,PREEXPOSURE PROPHYLAXIS - Abstract
IntroductionEvent-driven pre-exposure prophylaxis (edPrEP) with oral tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) is highly effective for preventing HIV acquisition in men who have sex with men (MSM) and is preferred over daily PrEP by some MSM. However, it is largely unknown how well MSM adhere to edPrEP. We then aimed to assess PrEP protection during CAS among MSM using edPrEP and participating in the Amsterdam PrEP demonstration project (AMPrEP).MethodsWe analysed data from participants enrolled in AMPrEP who were taking edPrEP. We measured adherence through (1) a mobile application in which sexual behaviour and PrEP-use were recorded daily, (2) three-monthly self-completed questionnaires and (3) dried blood spot (DBS) samples collected around six, twelve and twenty-four months after PrEP initiation. We assessed the proportion of days with condomless anal sex (CAS) acts that were protected by PrEP, per partner type (i.e. steady partners, known casual partners, unknown casual partners), and the proportion of three-month periods during which PrEP was correctly used. Intracellular TFV-diphosphate (TFV-DP) concentrations were determined from DBS. Good adherence was defined as at least one tablet before and one tablet within 48 hours after a CAS act.ResultsBetween 11 September 2015 and 6 October 2019, 182 of 376 MSM (48.4%) used edPrEP for at least one three-month period. Of the 8224 CAS days that were reported in the app during edPrEP-use, we observed good protection for most CAS days involving steady partners (n = 1625/2455, 66.9%), known casual partners (n = 3216/3472, 92.6%) and unknown casual partners (n = 2074/2297, 90.3%). Men reported consistently correct PrEP-use in 851 (81.4%) of the 1046 three-month periods of edPrEP-use. The median TFV-DP concentration was 591 fmol/sample (interquartile range = 270 to 896).ConclusionsAdherence to edPrEP was high as determined from the online app and questionnaire. DBS measurements were consistent with two to three tablets per week on average.
- Published
- 2021
- Full Text
- View/download PDF
12. Efficacy of ertapenem, gentamicin, fosfomycin, and ceftriaxone for the treatment of anogenital gonorrhoea (NABOGO):a randomised, non-inferiority trial
- Author
-
Henry J C de Vries, Myrthe de Laat, Vita W Jongen, Titia Heijman, Carolien M Wind, Anders Boyd, Jolinda de Korne-Elenbaas, Alje P van Dam, Maarten F Schim van der Loeff, Sylvia Bruisten, Elske Hoornenborg, Mirjam Knol, Ron A.A. Mathôt, Jan M. Prins, Dermatology, AII - Infectious diseases, APH - Methodology, Graduate School, APH - Global Health, Infectious diseases, Medical Microbiology and Infection Prevention, Pharmacy, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, General practice, Other Research, and Internal medicine
- Subjects
Adult ,Ertapenem ,Gonorrhea ,Infectious Diseases ,Treatment Outcome ,Fosfomycin ,Ceftriaxone ,Humans ,Gentamicins ,Neisseria gonorrhoeae ,Anti-Bacterial Agents - Abstract
Background: Neisseria gonorrhoeae causes gonorrhoea, a common sexually transmitted infection. Emerging strains resistant to first-line ceftriaxone threaten N gonorrhoeae management. Hence, alternative treatments are needed. We aimed to evaluate the efficacy of ertapenem, gentamicin, and fosfomycin as alternative treatments for anogenital N gonorrhoeae. Methods: In a randomised, controlled, double-blind, non-inferiority trial (three experimental groups and one control group) at the Centre for Sexual Health in Amsterdam, Netherlands, we included adults aged 18 years or older, with anorectal or urogenital gonorrhoea. With random permuted blocks, participants were randomly assigned (1:1:1:1) to receive intramuscular 500 mg ceftriaxone (control group), intramuscular 1000 mg ertapenem, intramuscular 5 mg/kg gentamicin (maximum 400 mg), or oral 6 g fosfomycin. The primary outcome was the proportion of participants with a negative nucleic acid amplification test of the predefined primary infected site, 7−14 days after treatment. The primary analysis was per protocol (ie, excluding those lost to follow-up). The modified intention-to-treat analysis included all randomly assigned patients with anogenital gonorrhoea considering those lost-to-follow-up as treatment failure. Non-inferiority was established if the lower Hochberg-corrected 95% CI for difference between the experimental and control groups was greater than −10%. For the analysis of adverse events, we included all participants who received medication. The trial was registered at ClinicalTrials.gov (NCT03294395) and is complete. Findings: Between Sept 18, 2017, and June 5, 2020, from 2160 patients invited to participate, we assigned 346 (16%) participants to receive either ceftriaxone (n=103), ertapenem (n=103), gentamicin (n=102), or fosfomycin (n=38). The fosfomycin group was terminated early after interim analysis revealed less than 60% efficacy. In the primary per-protocol analysis, 93 (100%) of 93 patients in the ceftriaxone group, 86 (99%) of 87 patients in the ertapenem group, 79 (93%) of 85 patients in the gentamicin group, and four (12%) of 33 patients in the fosfomycin group cleared N gonorrhoeae (risk difference vs ceftriaxone −0·01 [95% CI −0·08 to 0·05] for ertapenem and −0·07 [−0·16 to −0·01] for gentamicin). Thus, ertapenem proved non-inferior to ceftriaxone. In mITT analysis, risk differences versus ceftriaxone were −0·08 (−0·17 to 0·003) for ertapenem and −0·11 (−0·21 to −0·04) for gentamicin. We observed a higher proportion of patients with at least one adverse event in the ertapenem group (58 [56%] of 103) and fosfomycin group (36 [95%] of 38) versus the ceftriaxone group (24 [23%] of 103). Interpretation: Single-dose 1000 mg ertapenem is non-inferior to single-dose 500 mg ceftriaxone in gonorrhoea treatment. Yet, 5 mg/kg gentamicin (maximum 400 mg) is not non-inferior to ceftriaxone. Ertapenem is a potential effective alternative for anogenital N gonorrhoeae infections and merits evaluation for ceftriaxone-resistant infections. Funding: ZonMw and GGD-Amsterdam. Translation: For the Dutch translation of the abstract see Supplementary Materials section.
- Published
- 2022
- Full Text
- View/download PDF
13. Does Previous Syphilis Alter the Course of Subsequent Episodes of Syphilis?
- Author
-
Vita W Jongen, Maarten F. Schim van der Loeff, Sylvia M. Bruisten, Helene Zondag, Infectious diseases, AII - Infectious diseases, APH - Global Health, and APH - Methodology
- Subjects
Microbiology (medical) ,Pediatrics ,medicine.medical_specialty ,Infectious Diseases ,business.industry ,Correspondence ,Humans ,Medicine ,HIV Infections ,Syphilis ,business ,medicine.disease - Published
- 2022
14. Decision-making regarding condom use among daily and event-driven users of preexposure prophylaxis in the Netherlands
- Author
-
Elske Hoornenborg, Vita W Jongen, Anders Boyd, Henry J. C. de Vries, Udi Davidovich, Hanne M L Zimmermann, Maria Prins, Maarten F. Schim van der Loeff, Sociale Psychologie (Psychologie, FMG), Psychology Other Research (FMG), AII - Infectious diseases, APH - Global Health, AII - Inflammatory diseases, Graduate School, APH - Methodology, Infectious diseases, Medical Microbiology and Infection Prevention, and Dermatology
- Subjects
0301 basic medicine ,Male ,medicine.medical_specialty ,Casual ,Sexual Behavior ,Immunology ,Perceived vulnerability ,Decision Making ,Human immunodeficiency virus (HIV) ,Human sexuality ,HIV Infections ,medicine.disease_cause ,Hiv risk ,Men who have sex with men ,law.invention ,Condoms ,03 medical and health sciences ,0302 clinical medicine ,Condom ,law ,medicine ,Immunology and Allergy ,Humans ,030212 general & internal medicine ,Homosexuality, Male ,Netherlands ,virus diseases ,030104 developmental biology ,Infectious Diseases ,Sexual Partners ,Family medicine ,Pre-Exposure Prophylaxis ,Psychology ,Anal sex - Abstract
Objective: To explore the frequency of and reasons for using condoms among men who have sex with men (MSM) on preexposure prophylaxis (PrEP).Design: We analyzed quantitative app-based diary data on daily sexual practices (August 2015–February 2019) and qualitative in-depth interviews among MSM using daily PrEP and event-driven PrEP (edPrEP) in the Amsterdam PrEP demonstration project.Methods: Participants could report daily about sex acts, PrEP use and condom use per partner type (steady and casual partners). We examined four strategies of PrEP and condom use: PrEP only, PrEP and condoms, condoms only, and neither strategy. We compared the proportions of sex acts per strategy between PrEP regimens. In 43 in-depth interviews, we explored motives for implementing each strategy.Results: Three hundred and fifty-two participants reported 48 949 anal sex acts. PrEP only was the most common strategy employed with any partner type (81%, n = 39 650/48 949) and was motivated by anticipating more pleasurable sex, sexually transmitted infection's perceived curability, and habituation to condomless sex. Combining PrEP and condoms was more often chosen for sex acts with casual partners (18%, n = 6829/37 317) than with steady partners (5%, n = 614/11 632) and was linked to, for example, higher perceived vulnerability for sexually transmitted infections or HIV and avoidance of PrEP disclosure. Condoms only was uncommon but occurred particularly among edPrEP users (4%, n = 379/8695). Applying neither strategy was common among edPrEP users with steady partners (25%, n = 538/2122) and was motivated by low perceived HIV risk.Conclusion: Condoms remain a viable option for PrEP users in certain settings. Condoms were applied in higher risk settings, to avoid PrEP disclosure, or as substitute for PrEP, especially among edPrEP users.
- Published
- 2020
15. Evaluation of the Hepatitis C Testing Strategy for Human Immunodeficiency Virus–Positive Men Who Have Sex With Men at the Sexually Transmitted Infections Outpatient Clinic of Amsterdam, the Netherlands
- Author
-
Vita W Jongen, Guido E.L. van den Berk, Maria Prins, Marc van der Valk, Louise de Vos Klootwijk, Elske Hoornenborg, Martijn S. van Rooijen, Astrid M. Newsum, Titia Heijman, Arjan Hogewoning, Maarten F. Schim van der Loeff, APH - Methodology, APH - Global Health, Graduate School, AII - Infectious diseases, Medical Microbiology and Infection Prevention, Dermatology, Infectious diseases, APH - Digital Health, and APH - Personalized Medicine
- Subjects
Male ,Microbiology (medical) ,medicine.medical_specialty ,Hepatitis C virus ,Sexually Transmitted Diseases ,HIV Infections ,Dermatology ,medicine.disease_cause ,Ambulatory Care Facilities ,Men who have sex with men ,Sexual and Gender Minorities ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,Humans ,Medicine ,Outpatient clinic ,030212 general & internal medicine ,Homosexuality, Male ,Netherlands ,030505 public health ,Framingham Risk Score ,business.industry ,Incidence (epidemiology) ,Public Health, Environmental and Occupational Health ,HIV ,virus diseases ,Hepatitis C ,medicine.disease ,digestive system diseases ,Confidence interval ,Infectious Diseases ,Female ,Observational study ,0305 other medical science ,business - Abstract
INTRODUCTION: As the incidence of hepatitis C virus (HCV) infections remains high among human immunodeficiency virus (HIV)-positive men who have sex with men (MSM) an HCV testing strategy was introduced at the sexually transmitted infections (STI) clinic in Amsterdam in 2017. We aimed to evaluate this HCV testing strategy. METHODS: The HIV-positive MSM and transgender women (TGW) were eligible for HCV testing (anti-HCV and HCV ribonucleic acid) at the STI clinic if they did not visit their HIV clinician in the 3 months before the consultation and had not been tested for HCV at the STI clinic in the previous 6 months. All eligible individuals were administered the 6 questions on risk behavior of the HCV-MSM observational study of acute infection with hepatitis C (MOSAIC) risk score; a risk score of 2 or greater made a person eligible for testing. RESULTS: From February 2017 through June 2018, 1015 HIV-positive MSM and TGW were eligible for HCV testing in 1295 consultations. Eleven active HCV infections (HCV ribonucleic acid positive) were newly diagnosed (positivity rate, 0.9%; 95% confidence interval [CI], 0.4-1.5%). Sensitivity and specificity of the HCV-MOSAIC score for newly diagnosed active HCV infections were 80.0% (95% CI, 49.0-94.3%) and 53.7% (95% CI, 50.8-56.5%), respectively. If an HCV-MOSAIC score of 2 or greater were used to determine whom to test, 46.6% of individuals currently tested for HCV would be eligible for testing. CONCLUSIONS: Using the new HCV testing strategy, HCV testing was done in 1295 consultations with HIV-positive MSM and TGW in 17 months. We newly diagnosed 11 active HCV infections. The HCV-MOSAIC risk score could reduce the number of tests needed, but some active HCV infections will be missed.
- Published
- 2020
- Full Text
- View/download PDF
16. Choosing event‐driven and daily HIV pre‐exposure prophylaxis – data from two European PrEP demonstration projects among men who have sex with men
- Author
-
Udi Davidovich, Hanne M L Zimmermann, Mark A M van den Elshout, Bea Vuylsteke, Vita W Jongen, Elske Hoornenborg, Henry J. C. de Vries, Liza Coyer, Maarten F. Schim van der Loeff, Tom Smekens, Kristien Wouters, Maria Prins, Thijs Reyniers, Marie Laga, Zorah M. H. Ypma, APH - Methodology, APH - Global Health, Graduate School, AII - Infectious diseases, Dermatology, Infectious diseases, Medical Microbiology and Infection Prevention, Sociale Psychologie (Psychologie, FMG), and Psychology Other Research (FMG)
- Subjects
Male ,Sexual Behavior ,Short Report ,syphilis ,men who have sex with men ,HIV Infections ,Rate ratio ,Men who have sex with men ,Sexual and Gender Minorities ,Pre-exposure prophylaxis ,Humans ,Medicine ,Prospective Studies ,Homosexuality, Male ,pre-exposure prophylaxis ,sexually transmitted infections ,pre‐exposure prophylaxis ,Chlamydia ,business.industry ,Incidence (epidemiology) ,event‐driven PrEP ,Public Health, Environmental and Occupational Health ,Odds ratio ,medicine.disease ,event-driven PrEP ,Regimen ,Infectious Diseases ,Syphilis ,HIV prevention & control ,business ,Demography - Abstract
IntroductionDaily and event-driven PrEP are both efficacious in reducing the risk for HIV infection. However, the practice of event-driven PrEP (edPrEP) is less well studied, in particular when provided as an alternative to daily PrEP. We studied regimen preferences and switches, and sexually transmitted infection (STI) incidence.MethodsWe analysed pooled data from two prospective cohort studies among MSM: Be-PrEP-ared, Belgium and AMPrEP, the Netherlands. In both projects, participants could choose between daily and edPrEP at three-monthly study visits, when they were also screened for sexually transmitted infections including hepatitis C (HCV). We assessed the proportion choosing each regimen, and the determinants of choosing edPrEP at baseline. Additionally, we compared the incidence rates (IRs) of HCV, syphilis and chlamydia or gonorrhoea between regimens using Poisson regression. The study period was from 3 August 2015 until 24 September 2018.Results and discussionWe included 571 MSM, of whom 148 (25.9%) chose edPrEP at baseline. 31.7% of participants switched regimen at least once. After 28 months, 23.5% used edPrEP. Older participants (adjusted odds ratio (aOR) = 1.38 per 10 years, 95% confidence interval (CI) = 1.15 to 1.64) and those unemployed (aOR = 1.68, 95% CI = 1.03 to 1.75) were more likely to initially choose edPrEP. IR of HCV and syphilis did not differ between regimens, but the IR of chlamydia/gonorrhoea was higher among daily users (adjusted incidence rate ratio = 1.61, 95% CI = 1.35 to 1.94).ConclusionsA quarter of participants chose edPrEP at baseline and at 28 months this proportion was similar. Although the IR of HCV and syphilis were similar in the two regimens, the lower incidence of chlamydia and gonorrhoea among edPrEP users may suggest that less frequent STI testing of this group could be considered.
- Published
- 2021
- Full Text
- View/download PDF
17. P096 Incidence and risk factors of C. trachomatis and N. gonorrhoeae among young women from the Western Cape, South Africa
- Author
-
M.F. Schim van der Loeff, Vita W Jongen, M H Botha, Anna R. Giuliano, Martha Abrahamsen, and Staci L. Sudenga
- Subjects
business.industry ,Incidence (epidemiology) ,Western cape ,Medicine ,business ,Demography ,N gonorrhoeae - Published
- 2021
- Full Text
- View/download PDF
18. O13.5 Comparing MSM using event-driven PrEP to those using daily PrEP – data from two European PrEP demonstration projects
- Author
-
Maria Prins, Udi Davidovich, Hanne M L Zimmermann, H J C de Vries, M.F. Schim van der Loeff, Tom Smekens, Thijs Reyniers, Elske Hoornenborg, Liza Coyer, Vita W Jongen, Kristien Wouters, M van den Elshout, Marie Laga, Z Ypma, and Bea Vuylsteke
- Subjects
medicine.medical_specialty ,Chlamydia ,business.industry ,Incidence (epidemiology) ,Odds ratio ,medicine.disease ,Rate ratio ,Confidence interval ,Men who have sex with men ,Regimen ,Internal medicine ,medicine ,Syphilis ,business - Abstract
Background Daily and event-driven PrEP are both efficacious in preventing HIV infection. However, event-driven PrEP (edPrEP) is less well understood, in particular when provided as an alternative to daily PrEP. We studied regimen preferences and switches, and sexually transmitted infection (STI) incidence. Methods We pooled data from the Dutch (AMPrEP) and the Belgian (Be-PrEP-ared) PrEP demonstration projects. In both projects, participants could choose between daily and event-driven PrEP (edPrEP) at 3-monthly study visits, when they were also screened for STIs including hepatitis C virus (HCV) infection. We assessed the proportion choosing each regimen, and the determinants of choosing edPrEP at baseline. Additionally, we compared the incidence rates (IRs) of HCV, syphilis, and chlamydia or gonorrhoea between regimens using Poisson regression. Results The pooled dataset consisted of data of 571 men who have sex with men (n=374 AMPrEP; n=197 Be-PrEP-ared), of whom 148 (25.9%) chose edPrEP at baseline. Older participants (adjusted odds ratio (aOR)=1.38 per 10 year increase, 95% confidence interval (CI)=1.15–1.64) and those unemployed (aOR=1.68, 95%CI=1.03–1.75) were more likely to choose edPrEP at baseline. Median follow up was 26 months [interquartile range 21–27]. 381 participants (68.3%) never switched between PrEP regimens, 96 (17.2%) switched once, and 81 (14.5%) more than once. After 28 months, 23.5% used edPrEP. IR of HCV and syphilis did not differ between regimens, but the IR of chlamydia/gonorrhoea was higher among daily users (adjusted incidence rate ratio=1.61, 95%CI=1.35–1.94). Conclusion A quarter of participants chose edPrEP at baseline and at 28 months this proportion was similar. The frequent switching suggests that participants adapt their PrEP regimen to their changing needs. Although the IR of HCV and syphilis were similar in both regimens, the lower incidence of chlamydia and gonorrhoea among edPrEP users may suggest that less frequent STI testing of this group could be considered.
- Published
- 2021
- Full Text
- View/download PDF
19. HPV vaccination to prevent recurrence of anal intraepithelial neoplasia in HIV+ MSM
- Author
-
Marcel G. W. Dijkgraaf, Jan M. Prins, Ramon P. van der Zee, Irina Cairo, Henry J. C. de Vries, Arne van Eeden, Wim Quint, Matthijs L. Siegenbeek van Heukelom, Carel J. M. van Noesel, Hella Pasmans, Karien C. M. Gosens, and Vita W Jongen
- Subjects
Male ,medicine.medical_specialty ,medicine.medical_treatment ,Immunology ,Human immunodeficiency virus (HIV) ,HIV Infections ,medicine.disease_cause ,Placebo ,Sexual and Gender Minorities ,Internal medicine ,medicine ,Immunology and Allergy ,Outpatient clinic ,Anal cancer ,Humans ,Homosexuality, Male ,medicine.diagnostic_test ,business.industry ,Papillomavirus Infections ,Vaccination ,Absolute risk reduction ,Anoscopy ,medicine.disease ,Anus Neoplasms ,Infectious Diseases ,Neoplasm Recurrence, Local ,business ,Adjuvant - Abstract
Objective Anal cancer precursor lesions high-grade anal intraepithelial neoplasia (HGAIN) are highly prevalent among HIV+ men-who-have-sex-with-men (MSM). Treatment of HGAIN is frustrated by high recurrence rates. We investigated the efficacy of the quadrivalent human papillomavirus (qHPV) vaccine as post-treatment adjuvant in preventing HGAIN recurrence in HIV+MSM. Design Randomised, double-blind, placebo-controlled, multicentre trial. Setting Three HIV outpatient clinics in Amsterdam, the Netherlands. Subjects HIV+MSM with CD4 count >350 cells/μl, biopsy-proven intra-anal HGAIN successfully treated in the past year, and lesions still in remission at enrolment, as assessed by high-resolution anoscopy (HRA). Intervention Participants were randomised to three doses of qHPV (Gardasil-4®, MSD) or placebo with vaccinations at 0, 2, and 6 months. HRA was repeated at 6, 12 and 18 months. Main outcome measure The primary outcome was cumulative, biopsy-proven HGAIN recurrence rate at 18 months, evaluated in an intention-to-treat (received all vaccinations) and per-protocol analysis (all vaccinations and complete follow-up). Results We randomised 126 participants of which 64 (50.8%) received qHPV and 62 (49.2%) placebo. All participants received three vaccinations and in both groups for two participants follow-up was incomplete. We found no difference (p = 0·38) in cumulative HGAIN recurrence rates between the qHPV (44/64, 68.8%) and placebo group (38/62, 61.3%) in the intention-to-treat analysis (absolute risk reduction -7.5 (95%CI -24.1-9.2)). This was similar in the per-protocol analysis. Conclusions Despite adequate serological responses to qHPV vaccination, short-term recurrence of HGAIN was not prevented. These findings do not support qHPV vaccination as a treatment adjuvant to prevent HGAIN recurrence in HIV+MSM.
- Published
- 2021
20. Incidence and risk factors of C. trachomatis and N. gonorrhoeae among young women from the Western Cape, South Africa: The EVRI study
- Author
-
Maarten F. Schim van der Loeff, Staci L. Sudenga, M H Botha, Vita W Jongen, Martha Abrahamsen, Anna R. Giuliano, APH - Methodology, APH - Global Health, Graduate School, Infectious diseases, and AII - Infectious diseases
- Subjects
RNA viruses ,Questionnaires ,Epidemiology ,Chlamydia trachomatis ,HIV Infections ,030312 virology ,Pathology and Laboratory Medicine ,Rate ratio ,Geographical locations ,Chlamydia Infection ,Gonorrhea ,South Africa ,Medical Conditions ,0302 clinical medicine ,Immunodeficiency Viruses ,Risk Factors ,Prevalence ,Medicine and Health Sciences ,Mass Screening ,Medicine ,030212 general & internal medicine ,Chlamydia ,Reproductive health ,0303 health sciences ,Multidisciplinary ,Coinfection ,Obstetrics ,Incidence ,Incidence (epidemiology) ,Bacterial Pathogens ,Sexual Partners ,Infectious Diseases ,Medical Microbiology ,Research Design ,Viral Pathogens ,Viruses ,symbols ,Female ,Pathogens ,Research Article ,Adult ,medicine.medical_specialty ,Adolescent ,Science ,Sexual Behavior ,Sexually Transmitted Diseases ,Research and Analysis Methods ,Microbiology ,Young Adult ,03 medical and health sciences ,symbols.namesake ,Retroviruses ,Humans ,Poisson regression ,Microbial Pathogens ,Survey Research ,Bacteria ,business.industry ,Lentivirus ,Organisms ,Vaccine trial ,Biology and Life Sciences ,HIV ,Chlamydia Infections ,medicine.disease ,Neisseria gonorrhoeae ,Confidence interval ,Medical Risk Factors ,Africa ,Western cape ,People and places ,business - Abstract
Objective Young women in South Africa are highly affected by sexually transmitted infections (STI), like C. trachomatis (CT) and N. gonorrhoeae (NG). We aimed to estimate the incidence of CT and NG, and its determinants, among young women from the Western Cape, South Africa, participating in an HPV vaccine trial (the EVRI study). Methods HIV-negative women aged 16–24 years were enrolled between October 2012 and July 2013. At enrolment and month 6 participants were screened for CT and NG (Anyplex CT/NG real-time detection method). A questionnaire on demographic and sexual history characteristics was completed at enrolment and month 7. Treatment for CT and/or NG was offered to infected participants. Incidence rates (IR) of CT and NG were estimated. Determinants of incident CT and NG infections were assessed using Poisson regression. Results 365 women were tested for CT and/or NG at least twice. Prevalence of CT and NG at baseline was 33.7% and 10.4%, respectively. Prevalence of co-infection with CT and NG was 7.1%. During 113.3 person-years (py), 48 incident CT infections were diagnosed (IR = 42.4 per 100 py, 95% confidence interval (CI) 31.9–56.2). Twenty-nine incident NG were diagnosed during 139.3 py (IR = 20.8 per 100 py, 95%CI 14.5–29.9). Prevalent CT infection at baseline was associated with incident CT (adjusted incidence rate ratio (aIRR) 5.8, 95%CI 3.0–11.23. More than three lifetime sex partners increased the risk for incident NG (3–4 partners aIRR = 7.3, 95%CI 2.1–26.0; ≥5 partners aIRR = 4.3, 95%CI 1.1–17.5). Conclusions The IR of bacterial STIs among young women in the Western Cape is very high. Besides being previously infected and a higher lifetime number of sex partners, no other risk factors were found for CT and NG, suggesting that the majority of these women were at risk. This indicates the need for intensified prevention of STIs as well as screening and treatment programs to increase sexual health in this region.
- Published
- 2021
21. Reply to Fang and Buchwald
- Author
-
Vita W Jongen, Renske D.M. Steenbergen, Maarten F. Schim van der Loeff, APH - Methodology, APH - Global Health, Graduate School, Infectious diseases, AII - Infectious diseases, and Pathology
- Subjects
Infectious Diseases ,Fang ,business.industry ,Immunology and Allergy ,Medicine ,business ,Classics - Published
- 2021
- Full Text
- View/download PDF
22. Transient Changes in Preexposure Prophylaxis Use and Daily Sexual Behavior After the Implementation of COVID-19 Restrictions Among Men Who Have Sex With Men
- Author
-
Mark A M van den Elshout, Anders Boyd, Vita W Jongen, Elske Hoornenborg, Maarten F Schim van der Loeff, Henry J C de Vries, Udi Davidovich, Hanne M L Zimmermann, Liza Coyer, Yvonne T. H. P. van Duijnhoven, Maria Prins, Sociale Psychologie (Psychologie, FMG), Psychology Other Research (FMG), RS: FPN WSP II, Section Applied Social Psychology, APH - Methodology, APH - Global Health, Graduate School, AII - Infectious diseases, Infectious diseases, Medical Microbiology and Infection Prevention, and Dermatology
- Subjects
Adult ,Male ,Safe Sex ,PREP ,Casual ,Epidemiology ,media_common.quotation_subject ,Sexual Behavior ,COVID-19/prevention & control ,preexposure prophylaxis ,Sexually Transmitted Diseases ,men who have sex with men ,Men who have sex with men ,law.invention ,Condoms ,Sexually Transmitted Diseases/drug therapy ,Pre-exposure prophylaxis ,Sexual and Gender Minorities ,Condom ,law ,Medicine ,Humans ,Pharmacology (medical) ,prevention and control ,Homosexuality ,Homosexuality, Male ,Reproductive health ,media_common ,RISK ,business.industry ,SARS-CoV-2 ,COVID-19 ,HIV ,Odds ratio ,Middle Aged ,Confidence interval ,Infectious Diseases ,ComputingMethodologies_DOCUMENTANDTEXTPROCESSING ,Pre-Exposure Prophylaxis ,business ,Demography - Abstract
Supplemental Digital Content is Available in the Text., Background: We assessed how the Dutch restrictions imposed on March 15, 2020, affected sexual behavior, preexposure prophylaxis (PrEP), and condom use among PrEP users in Amsterdam. Methods: We used data on (1) PrEP use, (2) anal sex acts, and (3) condom use, per partner type [steady partners (SPs), known casual partners (KCPs), and unknown casual partners (UCPs)], collected daily through a mobile application used between December 1, 2019, and June 30, 2020. We compared the period before versus after March 15, 2020, regarding average proportion of days per week at which each end point was reported and average proportion of anal sex acts covered by PrEP and/or condoms. Results: We included data from 136 men who have sex with men. After March 15, 2020, the proportion of days with anal sex increased with SPs [odds ratio (OR) = 1.26; 95% confidence interval (CI) = 1.10 to 1.44) and decreased with KCPs (OR = 0.73; 95% CI = 0.64 to 0.82) and UCPs (OR = 0.54; 95% CI = 0.48 to 0.61). Shifts in partner types were most profound immediately after March 15, 2020, whereas returning to prerestriction levels mid-May 2020. The proportion of days with PrEP use decreased from 74% before to 58% after March 15, 2020 (P < 0.001). After March 15, 2020, PrEP use during sex decreased with UCPs (β = −0.36; 95% CI = −0.72 to 0.00) but not with SPs and KCPs. Condom use during sex decreased with KCPs (β = −0.36; 95% CI = −0.67 to 0.04) and UCPs (β = −0.24; 95% CI = −0.46 to 0.03) but not with SPs. Conclusions: MSM decreased sex with casual partners and increased sex with SP, but changes were transient. Decreases in sex acts with casual partners paralleled decreases in PrEP use. However, condom use during sex with casual partners decreased, indicating the importance of continued sexual health services, including sexually transmitted infections screening and PrEP care, during COVID-19 restrictions.
- Published
- 2021
23. Ertapenem is Non-Inferior to Ceftriaxone for the Treatment of Anogenital Gonorrhea in a Single Intramuscular Dose: The NABOGO Randomized Double Blind Non-Inferiority Trial
- Author
-
Henry John de Vries, Myrthe de Laat, Vita W. Jongen, Titia Heijman, Carolien M. Wind, Anders Boyd, Jolinda de Korne-Elenbaas, Alje P. van Dam, Maarten F. Schim van der Loeff, and NABOGO Steering Group
- Subjects
medicine.medical_specialty ,business.industry ,Gonorrhea ,Fosfomycin ,medicine.disease ,Interim analysis ,medicine.disease_cause ,Clinical trial ,chemistry.chemical_compound ,chemistry ,Internal medicine ,medicine ,Neisseria gonorrhoeae ,Ceftriaxone ,Gentamicin ,business ,Ertapenem ,medicine.drug - Abstract
Background: Neisseria gonorrhoeae (Ng) is a common sexually transmitted infection (STI). Emerging strains resistant to first-line ceftriaxone threaten Ng management. Hence, alternative treatments are needed. We evaluated the efficacy of ertapenem, gentamicin and fosfomycin as alternatives for Ng. Methods: We included adults 18 years or older, with anorectal or urogenital gonorrhea in a randomized controlled, double-blind, non-inferiority trial (three experimental- and one control-arm). Participants were randomized (1:1:1:1) to receive: intramuscular (IM) 500mg ceftriaxone, IM 1000mg ertapenem, IM 5mg/kg gentamicin (maximum 400mg), or 6g fosfomycin orally. The primary outcome was the proportion of participants with a negative nucleic acid amplification test of the primary infected site, 7-14 days after treatment. Non-inferiority was established if the lower Hochberg-corrected 95% confidence interval for difference between experimental and control arms was greater than -10%. Findings: Between 18 September 2017 and 5 June 2020, we assigned 346 participants to ceftriaxone (n=103), ertapenem (n=103), gentamicin (n=102), and fosfomycin (n=38). The fosfomycin arm was terminated early after interim analysis revealed
- Published
- 2021
- Full Text
- View/download PDF
24. Human papillomavirus vaccination uptake: a longitudinal study showing ethnic differences in the influence of the intention-to-vaccinate among parent-daughter dyads
- Author
-
Catharina J Alberts, Anders Boyd, Marcel F. van der Wal, Astrid Nielen, Hester E. de Melker, Maarten F. Schim van der Loeff, Theo G. W. M. Paulussen, Maria Prins, Mariska Petrignani, Vita W Jongen, APH - Methodology, APH - Global Health, Graduate School, Infectious diseases, and AII - Infectious diseases
- Subjects
Parents ,Health Knowledge, Attitudes, Practice ,Longitudinal study ,HPV ,Human papillomavirus ,parent-daughter dyads ,Adolescent ,media_common.quotation_subject ,030231 tropical medicine ,Immunology ,Ethnic group ,Psychological intervention ,Intention ,Alphapapillomavirus ,Nuclear Family ,vaccination uptake ,03 medical and health sciences ,0302 clinical medicine ,vaccination acceptability ,Vaccination status ,Surveys and Questionnaires ,vaccination intention ,Humans ,Immunology and Allergy ,Medicine ,Longitudinal Studies ,Papillomavirus Vaccines ,030212 general & internal medicine ,Child ,media_common ,Pharmacology ,Daughter ,business.industry ,Papillomavirus Infections ,Hpv vaccination ,The Netherlands ,vaccination ,Human papillomavirus vaccination ,Vaccination ,Female ,business ,Research Paper ,Demography - Abstract
INTRODUCTION: It is unclear what role daughters play in the decision-making process regarding HPV vaccination. Therefore, we explored the impact of HPV vaccination intention among parents and their 12–13 year-old daughters on HPV vaccination uptake. METHODS: In February 2014 parents/guardians and their 12–13 year-old daughters were invited to complete a questionnaire about socio-psychological determinants of the decision-making process regarding HPV vaccination. Vaccination status of the daughter was retrieved from the national vaccination database after the last possible vaccination date in 2014. The association between HPV vaccination uptake and intention, and determinants of intention, was jointly assessed using a generalized structural equation model, stratified by origin of parents (Dutch versus non-Dutch). RESULTS: In total, 273 Dutch parent-daughter dyads and 165 non-Dutch dyads were analyzed for this study. HPV vaccination uptake was 90% (246/273) and 84% (139/165) in the Dutch and non-Dutch group, respectively. In the Dutch group, high parental intention (β = 2.3, 95%CI 1.2–3.3) and high daughters’ intention (β = 1.5, 95%CI 0.41–2.6) were significantly associated with HPV vaccination uptake. In the non-Dutch group, high daughters’ intention (β = 1.2, 95%CI 0.16–2.2) was significantly associated with HPV vaccination, but high parental intention was not (β = 0.52, 95%CI −0.47–1.5). Attitude was the most prominent socio-psychological determinant associated with vaccination intention among all groups. CONCLUSION: In the non-Dutch group, only daughters’ intention was significantly associated with HPV vaccination uptake, whereas in the Dutch group both the parents’ and the daughters’ intention were significantly associated with uptake. The role of the child in the decision-making process might need to be taken into account when developing new interventions focused on increasing HPV vaccination uptake, especially among individuals of non-Dutch origin.
- Published
- 2021
25. Anal squamous intraepithelial lesions (SILs) in human immunodeficiency virus-positive men who have sex with men: Incidence and risk factors of SIL and of progression and clearance of low-grade SILs
- Author
-
M.F. Schim van der Loeff, A van Eeden, Jan M. Prins, E Marra, M L Siegenbeek van Heukelom, Irina Cairo, Olivier Richel, H J C de Vries, Vita W Jongen, APH - Methodology, APH - Global Health, Graduate School, AII - Infectious diseases, Dermatology, and Infectious diseases
- Subjects
medicine.medical_specialty ,Anal intraepithelial neoplasia ,Gastroenterology ,Men who have sex with men ,immune system diseases ,Internal medicine ,medicine ,Immunology and Allergy ,Cumulative incidence ,AIN ,MSM ,Squamous intraepithelial lesions ,medicine.diagnostic_test ,business.industry ,Incidence (epidemiology) ,Anal Squamous Cell Carcinoma ,Anoscopy ,virus diseases ,HIV ,Odds ratio ,Anus ,medicine.disease ,lnfectious Diseases and Global Health Radboud Institute for Health Sciences [Radboudumc 4] ,Infectious Diseases ,medicine.anatomical_structure ,Dysplasia ,Anal neoplasms ,business - Abstract
BackgroundHuman immunodeficiency virus (HIV)–positive men who have sex with men (MSM) are at risk of anal squamous cell carcinoma. Data are limited on the natural history of the precursor to this carcinoma, anal squamous intraepithelial lesions (SILs).MethodsHIV-positive MSM were screened for histopathological SILs by means of high-resolution anoscopy (HRA). For participants without SILs at baseline, we estimated the cumulative incidence and risk factors for SILs. For those with low-grade SILs (LSILs) at baseline, the risk of progression to high-grade SILs (HSILs) and the clearance rate were estimated at the lesion level.ResultsOf 807 men without SILs at baseline, 107 underwent follow-up HRA between 1 to 4.5 years later. At the second visit 18 men (16.8%) showed LSIL, and 25 (23.4%) HSIL. Age was associated with incident LSILs (adjusted odds ratio [aOR], 2.10 per 10-year increase in age; P = .01). Of 393 men with LSILs at baseline, 114 underwent follow-up HRA 0.5 to 2.5 years later. Of the 177 LSILs found at baseline, 87 (49.2%) had cleared at the second visit, and 29 (16.4%) had progressed to HSILs.ConclusionIncident LSILs and HSILs were common during follow-up among HIV-positive MSM without dysplasia at baseline. Among men with LSILs at baseline, nearly half of these lesions cleared, and a small portion progressed.
- Published
- 2020
26. Heart Rate Variability, HIV and the Risk of Cardiovascular Diseases in Rural South Africa
- Author
-
Diederick E. Grobbee, Kerstin Klipstein-Grobusch, Robert Moraba, Vita W Jongen, Walter Devillé, Alinda G. Vos, Noortje G. Godijk, Roel A. Coutinho, Hugo A. Tempelman, and AISSR Other Research (FMG)
- Subjects
antiretroviral treatment ,sub-Saharan Africa ,Male ,Rural Population ,lcsh:Diseases of the circulatory (Cardiovascular) system ,Epidemiology ,Human immunodeficiency virus (HIV) ,HIV Infections ,030204 cardiovascular system & hematology ,medicine.disease_cause ,South Africa ,0302 clinical medicine ,cardiovascular disease ,Heart Rate ,Risk Factors ,Heart rate variability ,030212 general & internal medicine ,Original Research ,lcsh:Public aspects of medicine ,Incidence ,heart rate variability ,virus diseases ,Prognosis ,Cardiovascular Diseases ,Female ,Cardiology and Cardiovascular Medicine ,HIV ,Cohort study ,Adult ,medicine.medical_specialty ,Cardiology ,Risk Assessment ,03 medical and health sciences ,Internal medicine ,Diabetes mellitus ,medicine ,Humans ,Community and Home Care ,business.industry ,lcsh:RA1-1270 ,Anthropometry ,medicine.disease ,Cross-Sectional Studies ,Blood pressure ,Increased risk ,African population ,lcsh:RC666-701 ,Morbidity ,business - Abstract
Background: Antiretroviral therapy (ART) transformed human immunodeficiency virus (HIV) infection into a chronic disease. Possible HIV-associated complications have emerged including cardiovascular diseases (CVD). Objectives: This study aims to determine the heart rate variability (HRV) distribution and association between HRV and HIV treated with ART in a rural African population. Methods: This cross-sectional study included 325 participants of the Ndlovu Cohort Study, South Africa. HRV was measured using a standardized five-minute resting ECG and assessed by the standard deviation of normal RR intervals (SDNN), root of mean squares of successive RR differences (RMSSD), percentage of RR intervals greater than 50 milliseconds different from its predecessor (pNN50), total-, low- and high-frequency power. CVD risk factors were assessed using measurements (blood pressure, anthropometry, cholesterol) and questionnaires (e.g. socio-demographics, alcohol, smoking, physical activity, age, diabetes). We used a Wilcoxon rank test to assess differences in medians between HIV-infected and HIV-uninfected participants and multivariable linear regression to investigate associations between HRV and HIV treated with ART. Conclusions: Of the participants, 196 (61.4%) were HIV-infected treated with ART and 123 (38.6%) were HIV-uninfected. HIV-infected consumed less alcohol, 52% versus 35%, smoked less, were less physically active, more often attained lower education, 26% versus 14%, and had lower systolic blood pressure, 134 mmHg versus 140 mmHg, compared to HIV-uninfected. Medians of all HRV parameters were lower for HIV-infected participants. The model fully adjusted for CVD risk factors showed a significant inverse association between HIV treated with ART and log RMSSD (–0.16) and log pnn50 (–0.61). Although HIV-infected participants treated with ART presented with less CVD risk factors they had a lower HRV indicating an increased risk of CVD. Highlights – African HIV-infected participants on ART had less conventional CVD risk factors than HIV-uninfected. – However, HIV-infected participants had lower HRV than HIV-uninfected participants. – Lower HRV of the HIV-infected participants indicates that they are at a higher risk for CVD.
- Published
- 2020
27. Transient Changes in Pre-Exposure Prophylaxis Use and Daily Sexual Behaviour after the Implementation of COVID-19 Restrictions Among Men Who Have Sex with Men
- Author
-
Vita W. Jongen, Hanne M. L. Zimmermann, Anders Boyd, Elske Hoornenborg, Mark A. M. van den Elshout, Udi Davidovich, Yvonne T. H. P. van Duijnhoven, Henry J. C. de Vries, Maria Prins, Maarten F. Schim van der Loeff, Liza Coyer, and Amsterdam PrEP team in the HIV Tran Group
- Subjects
Study drug ,Coronavirus disease 2019 (COVID-19) ,Casual ,business.industry ,law.invention ,Men who have sex with men ,Pre-exposure prophylaxis ,Condom ,law ,Medicine ,University medical ,business ,Demography ,Reproductive health - Abstract
Introduction: We assessed how the Dutch restrictions of 15-March-2020 affected sexual behaviour, pre-exposure prophylaxis (PrEP) and condom use among PrEP-users from the Amsterdam PrEP demonstration project. Methods: We used data on (1) PrEP use, (2) anal sex acts and (3) condom use, per partner type (steady [SP], known casual [KCP], unknown casual [UCP]), collected daily through a mobile application used between 1-December-2019 and 30-June-2020. We compared the period before versus after 15-March-2020 with respect to average proportion of days per week at which each endpoint was reported (multilevel logistic regression) and average proportion of anal sex acts covered by PrEP and/or condoms (bivariate probit regression). We evaluated whether the difference in sex acts were also observed before versus after the same date in the previous year. Findings: We included data from 136 MSM. After 15-March-2020, the proportion of days with anal sex increased with SP (OR=1·26;95%CI=1·10-1·44) and decreased with KCP (OR=0·73;95%CI=0·64-0·82) and UCP (OR=0·54;95%C=0·48-0·61), while these changes were not seen (SP/KCP) or less apparent (UCP) during the previous year. Shifts in partner types were most profound immediately after 15-March-2020, while returning to pre-restriction levels mid-May-2020. The proportion of days with PrEP use decreased from 74% before to 58% after 15-March-2020 (p
- Published
- 2020
- Full Text
- View/download PDF
28. Estimating incidence rates of grouped HPV types: A systematic review and comparison of the impact of different epidemiological assumptions
- Author
-
Daniela K van Santen, Maarten F. Schim van der Loeff, Catharina J Alberts, and Vita W Jongen
- Subjects
Male ,medicine.medical_specialty ,Human papillomavirus ,HPV ,Genotype ,Epidemiology ,HPV, human papillomavirus ,Incidence rate ,Article ,Men who have sex with men ,lcsh:Infectious and parasitic diseases ,03 medical and health sciences ,MSM, men who have sex with men ,0302 clinical medicine ,Virology ,medicine ,Humans ,Public Health Surveillance ,lcsh:RC109-216 ,030212 general & internal medicine ,Homosexuality, Male ,Papillomaviridae ,Hpv types ,business.industry ,Incidence ,Papillomavirus Infections ,IR, incidence rate ,CI, confidence interval ,Infectious Diseases ,030220 oncology & carcinogenesis ,STI, sexually transmitted infections ,Female ,business ,Cohort study ,Demography - Abstract
Background: Some studies on human papillomavirus (HPV) provide not only type-specific incidence rates (IR), but also IRs of HPV groupings (e.g. the nonavalent grouping). We made an inventory of the different approaches used to calculate such IRs and assessed their impact on the estimated IRs of HPV groupings. Methods: We performed a systematic review assessing all approaches used in literature to estimate IRs. Subsequently we applied these approaches to data of a Dutch cohort study on HPV in men who have sex with men (H2M). IRs were estimated for six different HPV groupings. Results: The systematic review yielded six different approaches (A-F) for estimating the IRs, varying in exclusion criteria at baseline, and the definitions of an incident event and person-time. Applying these approaches to the H2M dataset (n = 749), we found differences in the number of participants at risk, number of incidents events, person-time, and IR. For example, for the nonavalent grouping, depending on the approach chosen, the IR varied between 3.09 and 6.54 per 100 person-months. Conclusion: In published studies different epidemiological assumptions are used to estimate IRs of grouped HPV types, leading to widely differing estimates of IRs. IRs between different studies may therefore not be comparable. Keywords: Human papillomavirus, HPV, Incidence rate, Epidemiology
- Published
- 2019
29. Hypertension in a rural community in South Africa: what they know, what they think they know and what they recommend
- Author
-
Hugo A. Tempelman, Diederick E. Grobbee, Kerstin Klipstein-Grobusch, Walter Devillé, Vita W Jongen, Alinda G. Vos, Samanta T. Lalla-Edward, Noortje G. Godijk, and AISSR Other Research (FMG)
- Subjects
Adult ,Male ,Rural Population ,medicine.medical_specialty ,Health Knowledge, Attitudes, Practice ,Adolescent ,Population ,030209 endocrinology & metabolism ,Cohort Studies ,03 medical and health sciences ,South Africa ,Young Adult ,0302 clinical medicine ,Risk Factors ,Surveys and Questionnaires ,Health care ,Rural community ,Medicine ,Humans ,030212 general & internal medicine ,education ,education.field_of_study ,business.industry ,lcsh:Public aspects of medicine ,Public health ,1. No poverty ,Public Health, Environmental and Occupational Health ,lcsh:RA1-1270 ,Focus Groups ,Middle Aged ,Focus group ,3. Good health ,Hypertension knowledge ,Risk perception ,Health promotion ,Focus group discussions ,Family medicine ,Hypertension ,Female ,Hypertension perception ,Rural area ,business ,Cohort study ,Research Article - Abstract
Background Hypertension is one of the most important risk factors for cardiovascular disease and has a high prevalence in South Africa and other low- and middle-income countries. However, awareness of hypertension has been reported to be low. Health programmes can increase awareness of hypertension and its causes, but hinge on the knowledge and perception of the targeted community. Therefore, this study investigated knowledge on and perceptions about hypertension of community members in a rural area in Limpopo, South Africa with the aim to increase awareness of hypertension and cardiovascular disease in the local population. Methods Using a mixed methods study approach, 451 participants of the Ndlovu Cohort Study, attending a follow-up visit between August 2017 and January 2018, completed a questionnaire on cardiovascular risk perception. A knowledge score was calculated for all participants. Sixty participants were invited to participate in six focus group discussions, of which 56 participated. Audio recordings were transcribed verbatim, transcripts coded, and thematic analysis of the data undertaken to obtain an understanding of knowledge and perception of hypertension in the community. Results Most members of the community seemed to have intermediate (74.3%) or good (14.0%) knowledge of hypertension based on the knowledge score, and only 11.8% of the population had poor knowledge. The risk factors of hypertension seemed to be well known in the community. Poverty was identified as a major vulnerability in this community limiting choices for healthy lifestyles such as nutritious foods, recreational physical activity and accessing health care timely. Participants proposed community-based activities as an effective way to reach out to community members for prevention and management of hypertension. Conclusion This study highlights the need for improved health promotion efforts to increase knowledge of hypertension in rural communities, and to address poverty as a major obstacle to healthy life-style choices. Electronic supplementary material The online version of this article (10.1186/s12889-019-6642-3) contains supplementary material, which is available to authorized users.
- Published
- 2019
30. Sexual behaviour and incidence of sexually transmitted infections among men who have sex with men (MSM) using daily and event-driven pre-exposure prophylaxis (PrEP): Four-year follow-up of the Amsterdam PrEP (AMPrEP) demonstration project cohort.
- Author
-
Mark A M van den Elshout, Eline S Wijstma, Anders Boyd, Vita W Jongen, Liza Coyer, Peter L Anderson, Udi Davidovich, Henry J C de Vries, Maria Prins, Maarten F Schim van der Loeff, Elske Hoornenborg, and Amsterdam PrEP Project team in the HIV Transmission Elimination AMsterdam Initiative (H-TEAM)
- Subjects
Medicine - Abstract
BackgroundAn increasing number of countries are currently implementing or scaling-up HIV pre-exposure prophylaxis (PrEP) care. With the introduction of PrEP, there was apprehension that condom use would decline and sexually transmitted infections (STIs) would increase. To inform sexual health counselling and STI screening programmes, we aimed to study sexual behaviour and STI incidence among men who have sex with men (MSM) and transgender women who use long-term daily or event-driven PrEP.Methods and findingsThe Amsterdam PrEP demonstration project (AMPrEP) was a prospective, closed cohort study, providing oral daily PrEP and event-driven PrEP to MSM and transgender women from 2015 to 2020. Participants could choose their PrEP regimen and could switch at each three-monthly visit. STI testing occurred at and, upon request, in-between 3-monthly study visits. We assessed changes in numbers of sex partners and condomless anal sex (CAS) acts with casual partners over time using negative binomial regression, adjusted for age. We assessed HIV incidence and changes in incidence rates (IRs) of any STI (i.e., chlamydia, gonorrhoea, or infectious syphilis) and individual STIs over time using Poisson regression, adjusted for age and testing frequency. A total of 367 participants (365 MSM) commenced PrEP and were followed for a median 3.9 years (interquartile range [IQR] = 3.4-4.0). Median age was 40 years (IQR = 32-48), 315 participants (85.8%) self-declared ethnicity as white and 280 (76.3%) had a university or university of applied sciences degree. Overall median number of sex partners (past 3 months) was 13 (IQR = 6-26) and decreased per additional year on PrEP (adjusted rate ratio [aRR] = 0.86/year, 95% confidence interval [CI] = 0.83-0.88). Overall median number of CAS acts with casual partners (past 3 months) was 10 (IQR = 3-20.5) and also decreased (aRR = 0.92/year, 95% CI = 0.88-0.97). We diagnosed any STI in 1,092 consultations during 1,258 person years, resulting in an IR of 87/100 person years (95% CI = 82-92). IRs of any STI did not increase over time for daily PrEP or event-driven PrEP users. Two daily PrEP users, and no event-driven PrEP users, were diagnosed with HIV during their first year on PrEP. Study limitations include censoring follow-up due to COVID-19 measures and an underrepresentation of younger, non-white, practically educated, and transgender individuals.ConclusionsIn this prospective cohort with a comparatively long follow-up period of 4 years, we observed very low HIV incidence and decreases in the numbers of casual sex partners and CAS acts over time. Although the STI incidence was high, it did not increase over time.Trial registrationThe study was registered at the Netherlands Trial Register (NL5413) https://www.onderzoekmetmensen.nl/en/trial/22706.
- Published
- 2024
- Full Text
- View/download PDF
31. Online-Mediated HIV Pre-exposure Prophylaxis Care and Reduced Monitoring Frequency for Men Who Have Sex With Men: Protocol for a Randomized Controlled Noninferiority Trial (EZI-PrEP Study)
- Author
-
Marije L Groot Bruinderink, Anders Boyd, Liza Coyer, Sophie Boers, Laura Blitz, Jean-Marie Brand, Hannelore M Götz, Martijn Stip, Joey Woudstra, Kenneth Yap, Koenraad Vermey, Amy Matser, Allard R Feddes, Vita W Jongen, Maria Prins, Elske Hoornenborg, Frenk van Harreveld, Maarten F Schim van der Loeff, and Udi Davidovich
- Subjects
Medicine ,Computer applications to medicine. Medical informatics ,R858-859.7 - Abstract
BackgroundDaily and event-driven HIV pre-exposure prophylaxis (PrEP) with oral tenofovir-emtricitabine is highly effective to prevent HIV in men who have sex with men (MSM). PrEP care generally consists of in-clinic monitoring every 3 months that includes PrEP dispensing, counseling, and screening for HIV and sexually transmitted infections (STIs). However, the optimal frequency for monitoring remains undetermined. Attending a clinic every 3 months for monitoring may be a barrier for PrEP. Online-mediated PrEP care and reduced frequency of monitoring may lower this barrier. ObjectiveThe primary objective of this study is to establish the noninferiority of online PrEP care (vs in-clinic care) and monitoring every 6 months (vs every 3 months). The secondary objectives are to (1) examine differences between PrEP care modalities regarding incidences of STIs, HIV infection, and hepatitis C virus infection; retention in PrEP care; intracellular tenofovir-diphosphate concentration; and satisfaction, usability, and acceptability of PrEP care modalities; and (2) evaluate associations of these study outcomes with sociodemographic, behavioral, and psychological characteristics. MethodsThis study is a 2×2 factorial, 4-arm, open-label, multi-center, randomized, controlled, noninferiority trial. The 4 arms are (1) in-clinic monitoring every 3 months, (2) in-clinic monitoring every 6 months, (3) online monitoring every 3 months, and (4) online monitoring every 6 months. The primary outcome is a condomless anal sex act with a casual partner not covered or insufficiently covered by PrEP (ie, “unprotected act”) as a proxy for HIV infection risk. Eligible individuals are MSM, and transgender and gender diverse people aged ≥18 years who are eligible for PrEP care at 1 of 4 participating sexual health centers in the Netherlands. The required sample size is 442 participants, and the planned observation time is 24 months. All study participants will receive access to a smartphone app, which contains a diary. Participants are requested to complete the diary on a daily basis during the first 18 months of participation. Participants will complete questionnaires at baseline and 6, 12, 18, and 24 months. Dried blood spots will be collected at 6 and 12 months for assessment of intracellular tenofovir-diphosphate concentration. Incidence rates of unprotected acts will be compared between the online and in-clinic arms, and between the 6-month and 3-month arms. Noninferiority will be concluded if the upper limit of the 2-sided 97.5% CI of the incidence rate ratio is
- Published
- 2023
- Full Text
- View/download PDF
Catalog
Discovery Service for Jio Institute Digital Library
For full access to our library's resources, please sign in.