protocol_id stringclasses 263
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NCT02706847 | 8.1.4.1.2 | Key Secondary Efficacy Variables | 8.1.4.1.2 Key Secondary Efficacy Variables Key secondary endpoints (at Week 12): Key secondary endpoints (at Week 12) for US/FDA regulatory purposes are listed in Section [5.3.3.1.2](#page-80-1). Key secondary endpoints (at Week 12) for EU/EMA regulatory purposes are also listed in Section [5.3.3.1.2.](#page-80-1) For ... | [] |
NCT02706847 | 8.1.4.1.3 | Other Efficacy Variables | 8.1.4.1.3 Other Efficacy Variables Additional efficacy variables are listed in Section [5.3.3.1.3](#page-81-1) and will be summarized for all visits, including visits beyond Week 12. For binary endpoints, frequencies and percentages will be reported for each treatment group. For continuous endpoints, the change from ba... | [] |
NCT02706847 | 8.1.4.1.4 | Multiplicity Control for Primary and Ranked Secondary Endpoints | 8.1.4.1.4 Multiplicity Control for Primary and Ranked Secondary Endpoints The overall type I error rate of the primary and key secondary endpoints for the two doses will be strongly controlled using a graphical multiple testing procedure.[23](#page-134-2) Specifically, the testing will utilize the endpoint sequence of ... | [] |
NCT02706847 | 8.1.4.1.5 | Imputation Methods | 8.1.4.1.5 Imputation Methods The following methods will be used for missing data imputation: Observed Cases (OC): The OC analysis will not impute values for missing evaluations, and thus a subject who does not have an evaluation on a scheduled visit will be excluded from the OC analysis for that visit. Multiple Imputat... | [] |
NCT02706847 | 8.1.4.2 | Long-Term Efficacy Analysis for Period 1 and Period 2 Combined | 8.1.4.2 Long-Term Efficacy Analysis for Period 1 and Period 2 Combined The efficacy endpoints of long-term efficacy analysis are listed in Section [5.3.3.2](#page-82-0) and will be summarized for all visits. Long-term efficacy by time point will be summarized using descriptive statistics. For binary endpoints, frequenc... | [] |
NCT02706847 | 8.1.5 | Safety Analyses | 8.1.5 Safety Analyses | [] |
NCT02706847 | 8.1.5.1 | General Considerations | 8.1.5.1 General Considerations Safety analyses will be carried out using the Safety Analysis Set. Analyses will be conducted for Period 1 alone, as well as for Period 1 and Period 2 combined. Safety analyses are based on treatments actually received. Safety will be assessed by AEs, physical examination, laboratory asse... | [] |
NCT02706847 | 8.1.5.2 | Analysis of Adverse Events | 8.1.5.2 Analysis of Adverse Events Unless otherwise specified, the following conventions apply for both the Period 1 safety analysis and the combined safety analysis of Period 1 and Period 2.  | [] |
NCT02706847 | 8.1.5.2.1 | Treatment-Emergent Adverse Events (TEAE) | 8.1.5.2.1 Treatment-Emergent Adverse Events (TEAE) AEs will be coded using MedDRA. A TEAE is defined as AE that began or worsened in severity after initiation of study drug. AEs starting more than 30 days following the last dose of study drug will not be included in summaries of TEAEs. For subjects who continued into P... | [] |
NCT02706847 | 8.1.5.2.2 | Serious Adverse Events and Death | 8.1.5.2.2 Serious Adverse Events and Death All treatment-emergent SAEs and AEs leading to death will also be presented in listing format. In addition, SAEs will be summarized by SOC and MedDRA PT. | [] |
NCT02706847 | 8.1.5.3 | Analysis of Laboratory, Vital Sign, and ECG Data | 8.1.5.3 Analysis of Laboratory, Vital Sign, and ECG Data Changes from baseline by visit, and changes from baseline to minimum value, maximum value, and final values in continuous laboratory data, and vital signs will be summarized by treatment group. Baseline values are defined as the last non-missing measurements reco... | [] |
NCT02706847 | 8.1.6 | Pharmacokinetic and Exposure-Response Analyses | 8.1.6 Pharmacokinetic and Exposure-Response Analyses Individual upadacitinib plasma concentrations at each study visit will be tabulated and summarized with appropriate statistical methods.  Data from this study may be combined with data from other studies for the population PK and exposure-res... | [] |
NCT02706847 | 8.1.7 | Statistical Analysis of Biomarker Data | 8.1.7 Statistical Analysis of Biomarker Data Summary statistics for the in vivo pharmacodynamic biomarkers (including but not limited to NK, NKT, B cells, and T cells) at baseline and post-treatment time points (Weeks 8, 12, 16 and 24/PD in Period 1, and Weeks 36, 48 and every 24 weeks thereafter in Period 2), in addit... | [] |
NCT02706847 | 8.2 | Determination of Sample Size | 8.2 Determination of Sample Size The planned total sample size of 450 can provide approximately 90% power to detect a 20% difference in ACR20 rates (assuming a placebo ACR20 response rate of 27%), at two-sided α = 0.025 and accounting for 10% dropout rate. This sample size also provides approximately 90% power for a 17... | [] |
NCT02706847 | 8.3 | Randomization Methods | 8.3 Randomization Methods Subjects will be randomly assigned in a 2:2:1:1 ratio to one of the four treatment groups: - Group 1: upadacitinib 30 mg QD, N = 150 (Day 1 to Week 12) → upadacitinib 30 mg QD (Week 12 and thereafter) - Group 2: upadacitinib 15 mg QD, N = 150 (Day 1 to Week 12) → upadacitinib 15 mg QD (Week 12... | [] |
NCT02706847 | 9.0 | Ethics | 9.0 Ethics | [] |
NCT02706847 | 9.1 | Independent Ethics Committee (IEC) or Institutional Review Board (IRB) | 9.1 Independent Ethics Committee (IEC) or Institutional Review Board (IRB) Good Clinical Practice requires that the clinical protocol, any protocol amendments, the Investigator's Brochure, the informed consent, and all other forms of subject information related to the study (e.g., advertisements used to recruit subject... | [] |
NCT02706847 | 9.2 | Ethical Conduct of the Study | 9.2 Ethical Conduct of the Study The study will be conducted in accordance with the protocol, ICH guidelines, applicable regulations and guidelines governing clinical study conduct and the ethical principles that have their origin in the Declaration of Helsinki. Responsibilities of the clinical investigator are specifi... | [] |
NCT02706847 | 9.3 | Subject Information and Consent | 9.3 Subject Information and Consent The Investigator or his/her representative will explain the nature of the study to the subject, and answer all questions regarding this study. Prior to any study-related screening procedures being performed on the subject, the informed consent statement will be reviewed and signed an... | [] |
NCT02706847 | 10.0 | Source Documents and Case Report Form Completion | 10.0 Source Documents and Case Report Form Completion | [] |
NCT02706847 | 10.1 | Source Documents | 10.1 Source Documents Source documents are defined as original documents, data, and records. This may include joint evaluation form, hospital records, clinical and office charts, laboratory data/information, subjects' diaries or evaluation checklists, pharmacy dispensing and other records, recorded data from automated ... | [] |
NCT02706847 | 10.2 | Case Report Forms | 10.2 Case Report Forms Case report forms (CRFs) must be completed for each subject screened/enrolled in this study. These forms will be used to transmit information collected during the study to AbbVie and regulatory authorities, as applicable. The CRF data for this study are being collected with an EDC system called R... | [] |
NCT02706847 | 11.0 | Data Quality Assurance | 11.0 Data Quality Assurance Prior to the initiation of the study, a meeting will be held with AbbVie personnel, the investigators and appropriate site personnel. This meeting will include a detailed discussion of the protocol, performance of study procedures, CRF, subject dosing diary, and specimen collection methods. ... | [] |
NCT02706847 | 12.0 | Use of Information | 12.0 Use of Information Any research that may be done using optional exploratory research/validation samples from this study will be experimental in nature and the results will not be suitable for clinical decision making or patient management. Hence, the subject will not be informed of individual results, should analy... | [] |
NCT02706847 | 13.0 | Completion of the Study | 13.0 Completion of the Study The Investigator will conduct the study in compliance with the protocol and complete the study within the timeframe specified in the contract between the Investigator and AbbVie. Continuation of this study beyond this date must be mutually agreed upon in writing by both the Investigator and... | [] |
NCT02706847 | 14.0 | Investigator's Agreement | 14.0 Investigator's Agreement - 1. I have received and reviewed the Investigator's Brochure for upadacitinib. - 2. I have read this protocol and agree that the study is ethical. - 3. I agree to conduct the study as outlined and in accordance with all applicable regulations and guidelines. - 4. I agree to maintain the c... | [] |
NCT02706847 | 15.0 | Reference List | 15.0 Reference List - 1. Grigor C, Capell H, Stirling A, et al. Effect of treatment strategy of tight control for rheumatoid arthritis (the TICORA study): a single-blind randomised controlled trial. Lancet. 2004;364(9430):263-9. - 2. Vermeer M, Kuper HH, Bernelot Moens HJ, et al. Adherence to a treat-to-target strategy... | [
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"Canada",
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NCT02748694 | P | R O T O C O L A M E N D M E N T | P R O T O C O L A M E N D M E N T
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"1. 0 A D MI NI S T R A TI V E I N F O R M A TI O N",
"1. 1 C o nt acts",
"1. 2 A p pr o v al"
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NCT02748694 | R | E P R E S E N T A TI V E S O F T A K E D A | R E P R E S E N T A TI V E S O F T A K E D A T his st u d y will be c o n d ucte d wit h t he hi g hest res pect f or t he i n di vi d ual partici pa nts i n acc or da nce wi t h t he re q uire me nts of t his clini c al st u d y pr ot oc ol a n d als o i n acc or da nce with t he f o ll owi n g: Pr o p ert y of T a k ... | [
"I N V E S TI G A T O R A G R E E M E N T",
"1. 3 Pr ot oc ol A me n d me nt 0 5 S u m m ar y of C h a n ges"
] |
NCT02748694 | R | ati o n ale f or A me n d me nt 0 5 | R ati o n ale f or A me n d me nt 0 5 T his d oc u me nt descri bes t he c ha n ges i n refere nce t o t he pr ot oc ol i nc or p orati n g A me n d me nt N o. 0 5. T he pri mar y reas o ns f or t his a me n d me nt are t o m o dif y t he st u d y desi g n t o i ncl u de: de: ! Part 3 t o assess t he bi oa vaila bilit ... | [
"C h a n ges i n A me n d me nt:",
"2. 0 S T U D Y S U M M A R Y",
"St u d y Desi g n",
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"P art 1 C o h orts 1 t o 2: St u d y Sc he d ule f or E ac h Peri o d ( He alt h y S u bjects)",
"P art 1 C o h orts 3 t o 5: St u d y Sc he d ule ( He alt h y S u bjects)",
"P art 2: Sc he m atic of St u d ... |
NCT02748694 | T | a ble 8. c C o m p ositi o n of Pl ace b o t o T A K- 0 4 1 Or al S us pe nsi o n | T a ble 8. c C o m p ositi o n of Pl ace b o t o T A K- 0 4 1 Or al S us pe nsi o n | Component | Quantity per Dosing Bottle | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------... | [
"8. 1. 1. 1 S p o ns or- S u p plie d Dr u g",
"8. 1. 2 St or a ge",
"8. 1. 3 D ose a n d Re gi me n Re gi me ne gi m",
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"8. 3 R a n d o miz ati o n C o de Cre ati o n a n d St or a ge",
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NCT02748694 | W | o rse ni n g of P T Es or A Es: | W o rse ni n g of P T Es or A Es: - If the s u bject e x perie nces a w orse ni n g or c o m plicati o n o f a P T E after starti n g a d mi nistrati o n of t he st u d y me dicat i on, t he w orse ni n g o r c o mplicat i o n s h o ul d be rec or de d a p pr o priatel y as a n A E. I n vest i gat ors s h o ul d e ns u... | [
"C ha n ges i n se verit y of AEs / Seri o us P T Es:",
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NCT02753842 | 1 | INTRODUCTION | 1. INTRODUCTION Male condoms effectively prevent human immunodeficiency virus (HIV) and sexually transmitted infection (STI) transmission, but are underutilized in large part to due to reduced experiences of pleasure. Annually, in the United States, there are approximately 20 million incident cases of STIs,1 and over 5... | [] |
NCT02753842 | 2 | AIMS | 2. AIMS The study will enroll 252 MSM and 252 men who sex with women (MSW) into a double-blind, three-way randomized crossover trial with conditions of fitted, thin, and standard condoms. For the MSM arm of the trial we will assess outcomes based on anal sex, and for the MSW we will assess outcomes based on vaginal sex... | [] |
NCT02753842 | 3 | STUDY OVERVIEW | 3. STUDY OVERVIEW | [] |
NCT02753842 | 3.0 | Study Design | 3.0 Study Design This study is a randomized crossover trial of 252 HIV-negative MSM and 252 HIV-negative MSW. Every participant in the trial will receive a batch of five fitted condoms, a batch of five thin condoms, and a batch of five standard condoms over a series of study visits. We will randomize the order in which... | [] |
NCT02753842 | 3.1 | Study Timeline | 3.1 Study Timeline We estimate the study will start enrolling participants in March 2016, although it may start at an earlier time point. Recruitment will last until 252 eligible MSM and 252 eligible MSW are recruited, approximately 6-12 months. As eligible participants are recruited, they will be scheduled for a basel... | [] |
NCT02753842 | 3.2 | Study Locations | 3.2 Study Locations In order to allow a diverse group of participants to take part and remain in this study, we will select study sites in central areas of Atlanta that are easily accessible both by public transit and by private car with ample parking. Possible sites at which participants will be seen include: - Rollin... | [] |
NCT02753842 | 4 | STUDY POPULATION | 4. STUDY POPULATION | [] |
NCT02753842 | 4.0 | Sample | 4.0 Sample Eligible participants will be HIV-negative, aged 18-54 years, live in the Atlanta metro area, and be currently sexually active. We will enroll 252 HIV-negative MSM and 252 HIVnegative MSW. All 504 enrolled participants will be eligible to attend at least four, and up to seven study visits. For purposes of st... | [] |
NCT02753842 | 4.1 | Participant Inclusion and Exclusion Criteria | 4.1 Participant Inclusion and Exclusion Criteria | [] |
NCT02753842 | 4.1.1 | Inclusion criteria | 4.1.1 Inclusion criteria Participants must meet all of the inclusion criteria to enter into the study. The entry inclusion criteria are: - 1. Age 18-54 - 2. Lives in or near Atlanta metropolitan statistical area (MSA) - 3. Plans to be in Atlanta for the majority of the 12 weeks of enrollment - 4. Able to independently ... | [] |
NCT02753842 | 4.1.2 | Exclusion criteria | 4.1.2 Exclusion criteria Potential participants meeting any of the exclusion criteria at baseline will be excluded from participating in the study. The exclusion criteria for the study are: - 1. 54 years of age - 2. Does not live in or near Atlanta MSA - 3. Does not plan to be in Atlanta for the majority of the 12 week... | [] |
NCT02753842 | 4.2 | Recruitment Procedures | 4.2 Recruitment Procedures | [] |
NCT02753842 | 4.2.1 | Primary recruitment method | 4.2.1 Primary recruitment method The primary method of recruitment for both MSM and MSW will be venue-based, face-to-face recruitment that will take place in a variety of public and private venues in Atlanta where men congregate. These will include bars, dance clubs, retail stores, street corners, restaurants, churches... | [] |
NCT02753842 | 4.2.1.1 | Primary recruitment procedures | 4.2.1.1 Primary recruitment procedures All recruiters will be trained in the Collaborative Institutional Training Initiative (CITI)'s ethical conduct of research. At the recruitment event, trained recruiters will approach potential participants, obtain permission to screen, and administer a brief recruitment script and... | [] |
NCT02753842 | 4.2.1.2 | Description of recruitment contacts | 4.2.1.2 Description of recruitment contacts The recruiter will walk up to potential participants and introduce the project according to a recruitment script. We will then perform the first stage of eligibility assessment. MSM and MSW who are not eligible for reasons other than insertive partner status will be thanked f... | [] |
NCT02753842 | 4.2.2 | Secondary recruitment methods | 4.2.2 Secondary recruitment methods If primary recruitment methods do not identify a sufficient number of either MSM or MSW, we will incorporate secondary recruitment methods, which may include (1) flyers and paid advertisements, (2) recruitment from previous studies, (3) recruitment through female partners or receptiv... | [] |
NCT02753842 | 4.2.2.1 | Flyers and paid advertisements | 4.2.2.1 Flyers and paid advertisements Based on recruitment progress, and counts of MSM and MSW recruited, we may supplement primary recruitment using flyers and paid advertisements targeting the study population of interest. We may post flyers advertising the study in venues that men frequent, such as community and cl... | [] |
NCT02753842 | 4.2.2.2 | Recruitment from previous studies | 4.2.2.2 Recruitment from previous studies We may recruit participants, who have consented to be contacted, from previous research projects conducted by our team in Atlanta (NIH study number: R01MH085600, R43HD078154, R01HD067111). | [] |
NCT02753842 | 4.2.2.3 | Recruitment through partners | 4.2.2.3 Recruitment through partners We may also perform venue-based or online recruitment through female partners of MSW and through receptive partners of MSM. MSM who are ineligible because they are receptive will be asked if they have a partner. If they do have a partner, they will be given a study contact card in c... | [] |
NCT02753842 | 4.2.2.4 | Recruitment through referrals | 4.2.2.4 Recruitment through referrals Participants may be asked to provide a referral code to up to three peers. Peers who receive the code and visit the link will be given the opportunity to take an online eligibility screener and consent to be screened on the phone. Study staff will contact eligible and electronicall... | [] |
NCT02753842 | 4.3 | Participant Retention | 4.3 Participant Retention Once a participant enrolls in the study, study staff will seek to retain the participant throughout the follow-up period in order to minimize possible bias associated with loss-tofollow-up. Study staff will be responsible for developing and implementing standard operating procedures to target ... | [] |
NCT02753842 | 4.4 | Participant Withdrawal | 4.4 Participant Withdrawal Participants may voluntarily withdraw from the study for any reason at any time. The study investigators also may withdraw participants from the study in order to protect participant or staff safety. Study staff will record the reasons for all withdrawals or holds from the study on a Study St... | [] |
NCT02753842 | 5 | STUDY PRODUCT | 5. STUDY PRODUCT | [] |
NCT02753842 | 5.0 | TheyFit Condom | 5.0 TheyFit Condom TheyFit, LLC manufactures 56 condom sizes based on combinations of length (approximately 10 mm increments) and circumference (approximately 2 mm increments). To determine appropriate condom size, TheyFit, LLC developed a trademarked fitting tool. This tool is a paper template graduated with non-seque... | [] |
NCT02753842 | 5.1 | Thin Condom | 5.1 Thin Condom Thin condoms, as defined in section 1.1, were selected as an additional study condom because they are widely sold condoms in the United States and because of the general perception that are more pleasurable to use than standard condoms. Thin condoms will be manufactured by Karex. | [] |
NCT02753842 | 5.2 | Standard Condom | 5.2 Standard Condom Standard condoms, as defined in section 1.1, were selected as the control because they are the most widely used condoms internationally due to their use by programs distributing condoms, such as USAID (Steven Hamel, BS, email communication, June 23, 2015). Standard condoms will be manufactured by Ka... | [] |
NCT02753842 | 5.3 | Lubricant | 5.3 Lubricant Study staff will provide participants with two packets per condom of 10ml commercially available condom-compatible water-based lubricants. Participants will be instructed not to use any other lubricants when using study condoms. MSM will be instructed to use lubricant with all anal sex acts. Coital log en... | [] |
NCT02753842 | 6 | TRIAL DESIGN | 6. TRIAL DESIGN | [] |
NCT02753842 | 6.0 | Study Arms | 6.0 Study Arms The study will have two arms: 252 eligible MSM and 252 eligible MSW. Within each study population, we will randomly assign the sequence in which study condoms (fitted, thin, and standard) are received. MSM n=252 MSM Combination 1 Sequence: Fitted, Thin, Standard MSM Combination 2 Sequence: Fitted, MSM Co... | [] |
NCT02753842 | 6.1 | Randomization | 6.1 Randomization Eligible and consented study participants who complete their fitted condom selfmeasurement will be randomized to one of six crossover condition orders that balance the allocation of conditions (Table 1). The randomization sequence lists will be developed as follows. Within each study stratum (MSM or M... | [] |
NCT02753842 | 6.2 | Blinding Procedures | 6.2 Blinding Procedures In this closed label, double-blind trial, study condoms will be manufactured in plain foil packaging, with identifying two-digit random codes printed on each foil. Thin condoms will have a two-digit code, standard condoms will have a two-digit code, and each fitted condom size will have a random... | [] |
NCT02753842 | 6.3 | Crossover Procedures | 6.3 Crossover Procedures There will be three crossover conditions during this study. Each participant will be given five of each study condom set and will have up to four weeks to use all five condoms. If five coital log events are recorded by the end of the two-week follow-up visit for any crossover condition, partici... | [] |
NCT02753842 | 7 | STUDY PROCEDURES | 7. STUDY PROCEDURES | [] |
NCT02753842 | 7.0 | Visit Structure | 7.0 Visit Structure Visual depictions of the baseline and follow-up visit structures are provided below. Figure 3. Baseline visit structure  Figure 4. Follow-up visit structure | [] |
NCT02753842 | 7.1 | Visit Procedures | 7.1 Visit Procedures | [] |
NCT02753842 | 7.1.1 | Scheduling | 7.1.1 Scheduling Using contact information gathered from primary or secondary recruitment methods, study staff will contact potential participants via phone or email. During the screening call, study staff will assess additional eligibility criteria. Eligible and interested participants will be scheduled for an enrollm... | [] |
NCT02753842 | 7.1.2 | Enrollment/Baseline Visit | 7.1.2 Enrollment/Baseline Visit | [] |
NCT02753842 | 7.1.2.1 | Consent for Study Participation | 7.1.2.1 Consent for Study Participation § Upon arrival at the baseline visit, participants will be provided with the ICF for study participation. Each participant will be given a chance to review the consent document with and have any questions answered by study staff. Consenting participants and the witnessing study s... | [] |
NCT02753842 | 7.1.2.2 | Eligibility Assessment | 7.1.2.2 Eligibility Assessment - § All consenting participants will be screened for eligibility. - § Study staff will complete an electronic Case Report Form (eCRF) to assess eligibility of participants. - § As part of the eligibility assessment, participants will be screened with an eCRF for symptoms of STIs and acute... | [] |
NCT02753842 | 7.1.2.3 | HIV Testing | 7.1.2.3 HIV Testing - § Eligible participants will receive HIV counseling, rapid testing, and results. Ineligible participants will be encouraged to receive HIV counseling and testing, but these services will not be required. - Participants will receive pre- and post-test counseling per CDC guidelines. 23 - HIV rapid t... | [] |
NCT02753842 | 7.1.2.4 | Baseline Questionnaire | 7.1.2.4 Baseline Questionnaire - § Participants will complete a self-administered behavioral survey (uploaded to eIRB) on an electronic tablet or study computer including questions in the domains of: - Sexual history - Condom history - Sexual dysfunction - Condom slippage and breakage - Lubricant use - Therapeutic meth... | [] |
NCT02753842 | 7.1.2.5 | Participant Training | 7.1.2.5 Participant Training Study staff will train all eligible participants regarding correct condom use and completion of coital logs. Participant training materials are uploaded to eIRB. - § Study staff will train participants in correct condom use based on a training module that comes from a CDC-determined Effecti... | [] |
NCT02753842 | 7.1.2.6 | Distribution of Study Materials | 7.1.2.6 Distribution of Study Materials - § Study condoms will be provided to participants in batches of five. Each time a participant enters into a crossover condom condition, they will be given the batch of those five condoms, other batches will not be provided until the appropriate crossover time. - If we are out of... | [] |
NCT02753842 | 7.1.2.7 | Enrollment and Randomization | 7.1.2.7 Enrollment and Randomization - § Eligible participants who have completed initial study procedures will be enrolled in the study. - § Participants will be randomized to a study arm, based on methodology specified in section 6.1, once they complete their fitted condom sizing. - Participants who choose to complet... | [] |
NCT02753842 | 7.1.3 | Follow-up Visits (Week 2, 4, 6, and if applicable, weeks 8, 10, and 12) | 7.1.3 Follow-up Visits (Week 2, 4, 6, and if applicable, weeks 8, 10, and 12) At the end of the participant's baseline visit, enrolled participants will be scheduled for follow-up visits at weeks two, four, and six. If the participant is unable to schedule all three visits at this time, or as conflicts arise, visits ca... | [] |
NCT02753842 | 7.1.3.1 | Follow-up Preparation | 7.1.3.1 Follow-up Preparation Prior to each visit, study staff will review electronic reports of the following for each scheduled participant: - § The number of condoms were recorded as used in the coital log in the last period - § The study visit number - § The cross-over schedule | [] |
NCT02753842 | 7.1.3.2 | eCRF Completion and Coital Log Review | 7.1.3.2 eCRF Completion and Coital Log Review - § During each follow-up visit, study staff will perform a manual count of returned condoms and record this on an eCRF. The number of returned unused condoms will be compared to the number of study condom uses reported in the coital logs, and the number of returned broken ... | [] |
NCT02753842 | 7.1.3.3 | Visit Behavioral Survey | 7.1.3.3 Visit Behavioral Survey - § Participants will complete a self-administered behavioral survey (uploaded to eIRB) in the domains of: - Condom fit of the last study condom used - Perceived crossover condition - New sexual partners - § Prior to beginning the third crossover condition, participants will be asked the... | [] |
NCT02753842 | 7.1.3.4 | Visit Adverse Event Screening | 7.1.3.4 Visit Adverse Event Screening - § Study staff will screen participants for symptoms of a STI or acute HIV infection using procedures from the baseline visit. - If the participant self-reports symptoms of any STI at follow-up, they will be referred to AID Atlanta for testing and treatment as needed. Participants... | [] |
NCT02753842 | 7.1.4 | Last Study Visit | 7.1.4 Last Study Visit § At their last study visit, participants will complete questions addressing overall condom preference (the study outcome for Aim 2). These pairwise comparison questions will assess preference for (1) fitted or standard condoms, (2) thin or standard condoms, and (3) fitted or thin condoms. Questi... | [] |
NCT02753842 | 7.1.5 | Reminders | 7.1.5 Reminders - § Participants will be instructed to complete a daily mobile-optimized, webbased home coital logs, and to complete a coital log entry as soon as possible after each study condom use. - § To assist participants in timely completion, participants will receive a daily email or text reminder with a link t... | [] |
NCT02753842 | 7.1.6 | Coital Log | 7.1.6 Coital Log - § Participants will be instructed to complete mobile-optimized, web-based home coital logs as soon as possible following any vaginal or anal sex acts. Participants can complete a coital log entry on a smartphone, tablet, or personal computer. For participants without access to web browsers at home, w... | [] |
NCT02753842 | 7.2 | Referral Procedures | 7.2 Referral Procedures | [] |
NCT02753842 | 7.2.1 | Laboratory Referrals | 7.2.1 Laboratory Referrals All participants who have a preliminary positive HIV rapid test result, two invalid results, or are unable to provide enough blood for the rapid test at the enrollment visit will be scheduled to receive confirmatory testing at a private location of Emory's choosing. Confirmatory testing will ... | [] |
NCT02753842 | 7.2.2 | HIV Referrals | 7.2.2 HIV Referrals Once confirmatory results are received, study staff will contact the participant by phone. If the result is negative, the participant will be informed during the phone call. If the result is positive, the participant will be requested to come in for an additional visit, with the goal of having parti... | [] |
NCT02753842 | 7.2.3 | STI Referrals | 7.2.3 STI Referrals All participants who are symptomatic for STIs at their enrollment or follow-up visits will be referred to either AID Atlanta or Pride Medical. AID Atlanta offers free STI screening and treatment, and we have successfully referred more than 190 men for STI treatment in previous studies (NIH study num... | [] |
NCT02753842 | 7.2.4 | Acute HIV Referrals | 7.2.4 Acute HIV Referrals Once results are received, study staff will contact the participant by phone. Those with detectable viral load will be brought in for a visit, targeting within 24 hours of receiving a positive results. Participants at the visit will receive counseling regarding the infectiousness of the acute ... | [] |
NCT02753842 | 7.2.5 | Reactions/Side Effects to Condoms | 7.2.5 Reactions/Side Effects to Condoms Study staff will consult with an independent physician regarding the severity of any reactions or side effects to the study condoms. As appropriate, participants will be referred to AID Atlanta and study stopped. | [] |
NCT02753842 | 7.2.6 | Pregnancy | 7.2.6 Pregnancy All participants who report that their current partner is pregnant or may be pregnant will be referred to the Grady Family Planning Wellness Clinic. | [] |
NCT02753842 | 7.2.7 | Condom Failure Referrals | 7.2.7 Condom Failure Referrals Participants who report condom slippage or breakage in electronic coital log entries will receive an email with resources for HIV and STI testing, plan B, and nonoccupational post-exposure prophylaxis. An example email script is uploaded to eIRB. | [] |
NCT02753842 | 7.3 | Measures | 7.3 Measures | [] |
NCT02753842 | 7.3.1 | Visit Case Report Forms | 7.3.1 Visit Case Report Forms Study staff will collect key data points using eCRFs at study visits. For the baseline visit, information to be collected on eCRF includes eligibility criteria, basic demographic information, and acute HIV and STI symptoms. For follow-up visits, eCRFs will include information regarding doc... | [] |
NCT02753842 | 7.3.2 | Baseline Survey | 7.3.2 Baseline Survey The baseline questionnaire will collect self-reported demographic information, information on prior HIV testing, information on history of condom use problems, information on substance use, and information on past sexual partners. Anticipated completion time is 30-45 minutes. | [] |
NCT02753842 | 7.3.3 | Coital Log | 7.3.3 Coital Log Participants will be instructed to complete a mobile-optimized, web-based home coital log that can be securely loaded on personal devices (e.g. smart phones, tablets, personal computers). The coital log will first ask whether the participant has had sex since their last coital log entry. If the partici... | [] |
NCT02753842 | 7.3.4 | Outcome Measures | 7.3.4 Outcome Measures § Pleasure, an outcome measure for Aim 1, will be measured at the event level through the coital log. Based on a literature search and consultation with experts, there is no extant event-level scale to assess pleasure. We therefore - developed and validated a measure, based on a process that incl... | [] |
NCT02753842 | 7.4 | Training | 7.4 Training All study recruiters will complete a two-hour training on recruitment procedures and use of study screening instruments. All study staff, including recruiters, counselors, phlebotomists, and others involved with research events will complete CITI training regarding biomedical and social/behavioral ethics i... | [] |
NCT02753842 | 8 | SAFETY MONITORING AND ADVERSE EVENT REPORTING | 8. SAFETY MONITORING AND ADVERSE EVENT REPORTING | [] |
NCT02753842 | 8.0 | Safety Monitoring | 8.0 Safety Monitoring To minimize risks and ensure the safety of subjects, at study visits study staff will refer to participants by their initials, not their names and keep all participant materials locked in a secure location. All electronic data will be stored in a secure environment hosted by Dacima, and copies of ... | [] |
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