Infections

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Neoplasms

Symptoms and General Pathology

Chlamydia Infections

Gonorrhea

Virus Diseases

Papilloma

Vaginosis, Bacterial

Vaginal Diseases

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Communicable Diseases

Bacterial Infections

Mycoses

Bacterial Infections and Mycoses

Vaginitis

Gram-Negative Bacterial Infections

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Bacterial

Neisseriaceae Infections

Participants will take the self-swab sample, followed by the DDT sample at home. They will then have the clinician swab taken in the clinic.

Participants will take the DDT sample, followed by the self-swab sample at home. They will then have the clinician swab taken in the clinic.

The DAYE Diagnostic Tampon is a class A in vitro diagnostic device. It has CE certification (self-certified via a declaration of conformity, following the IVDR (EU) 2017/746). The DDT is constructed entirely from woven cotton and consists of an absorbent core wrapped in a protective sleeve. The DDT is loaded in an applicator to aid with insertion.

DAYE Diagnostic Tampon

A vaginal self-swab typically consists of a long, slender, and flexible stick or handle, often made of plastic or a similar material. At one end, there's a soft, absorbent tip made of cotton or synthetic material. This tip is designed to collect a sample from the vaginal walls or cervix.

Vaginal self-swab

A clinician vaginal swab is a medical tool used by healthcare professionals to collect samples from the vaginal canal for diagnostic purposes. It's typically a long, thin, and flexible instrument. At one end, there's a cotton, rayon, or synthetic tip designed to collect cells, discharge, or other materials from the vaginal walls, cervix, or other areas within the vaginal canal.

Clinician vaginal swab

Luke Twelves

Diagnostic trial comparing the diagnostic accuracy of the DAYE Diagnostic Tampon (DDT) with a vaginal swab (self-collected and clinician taken).

A diagnostic trial comparing the diagnostic accuracy, usability and acceptability of the DAYE Diagnostic Tampon (DDT) compared to standard vaginal self-swabs and clinician administration of a vaginal swabs. Diagnostic accuracy will be compared for detection of Chlamydia, Gonorrhoea, BV \& HPV.

A total of 350 eligible participants will be enrolled into the trial in the UK and Italy. To adequately assess DDT performance on specificity and sensitivity, participants will be recruited from one of two groups:

* Group 1: 50 participants with a recent confirmed HPV diagnosis (UK and Italy)
* Group 2: 300 participants from the general population (UK only)

All participants will be randomised according to sample order for the DDT and self-swab using block randomisation:

* Group A: Approximately half the participants will perform the self-swab followed by the DDT.
* Group B: Approximately half the participants will perform the DDT followed by the self-swab

All eligible participants will be provided with a trial kit containing the DDT and self-swab and attend at least 1 clinic visit as part of their participation in the trial. Participants will also provide answers to questionnaires at baseline and after all sampling is complete.

Participation in the trial is expected to last approximately 2-3 weeks (dependent on timing of clinic appointment(s)). All samples collected during the trial will be sent to a central laboratory for analysis, either in the UK or Italy i.e., samples will be analysed in the country they were collected.

All participants will have 3 samples taken: DAYE Diagnostic Tampon (DDT), self-swab and clinician administered swab. Participants will be randomised into 2 groups for sampling order between the DDT and self-swab.

Screening With Tampons: Evaluating Diagnostic Accuracy and HPV and Assessing Participant Views

Screening With Tampons: Evaluating Diagnostic Accuracy for STIs, BV and HPV and Assessing Participant Views

Duration of DDT wear and diagnostic accuracy

Accuracy of the STI, BV and HPV detection using menstrual tampons compared to other specimen collection methods (clinician taken and self-swab) via assays

After scenario questionnaire scores - higher scores = more usable

Quantitative and qualitative feedback from pre- and post-sampling questionnaires

Comparison between the detection accuracy of infections between sample order (Group A and Group B) using assays

Willingness to pay for the DDT via questions in post-sampling questionnaire

Comparison of time taken for DDT vs clinician swab

Qualitative feedback from stakeholder questionnaires

Lindus Health

Careggi Hospital

Anne's Day Ltd

Skin and Connective Tissue Diseases

Immune System Diseases

Rare Diseases

Syphilis

Herpes Simplex

Acquired Immunodeficiency Syndrome

HIV Infections

Immunologic Deficiency Syndromes

Trichomonas Infections

Disease Attributes

Cervical Intraepithelial Neoplasia

Leandro A Mena, MD, MPH

The purpose of this study is to determine the rates of sexually transmitted infections (STI) among a group of African American women who have sex with women (AA WSW). The first study hypothesis is that AA WSW are at risk for acquiring and transmitting STI, including the human immunodeficiency virus (HIV). The second study hypothesis is that AA WSW participate in multiple high-risk sexual activities that may facilitate transmission of STIs, including HIV.

Historically, women who have sex with women (WSW) have been thought to be at low risk for acquiring sexually transmitted infections (STI), presumably due to the absence of genital mucosal contact present during vaginal-penile sex or due to the assumption that the vaginal mucosa experiences a lesser degree of trauma during female sex than during heterosexual sex. This assumption has been challenged and debated over the past two decades. In addition, the sexual health risks of WSW are only beginning to be understood.

To date the majority of research regarding STI in women has occurred in heterosexuals. National and local surveillance data that estimate the risk for STI transmission between WSW are limited, especially among African Americans. This is a group of women that may exhibit distinctive behavioral characteristics that may put them at higher risk for sexually transmitted infections STI and HIV than their Caucasian counterparts. This group of women has traditionally been reluctant to discuss their sexual orientation with physicians for fear of being stigmatized. The burden of STIs, including HIV, experienced by this group of women is largely unknown.

Endocervical and vaginal secretion specimens are being retained for future research studies in this field of sexually transmitted diseases.

Sexually Transmitted Infections Among African American Women Who Have Sex With Women

Prevalence Rates of Sexually Transmitted Infections and Sexual Risk Behaviors Among African American Women Who Have Sex With Women

Data will only be shared with investigators

Mississippi State Department of Health

University of Alabama at Birmingham

University of Mississippi Medical Center

Associate Professor of Medicine

Papillomavirus Infections

Herpes Genitalis

Sexually Transmitted Diseases, Viral

Treponemal Infections

DNA Virus Infections

Tumor Virus Infections

Herpesviridae Infections

Genital Diseases, Male

Male Urogenital Diseases

Treponema Infection

Men receive circumcision after randomization; procedure is generally provided within two weeks. A man randomized to the intervention arm who then declines circumcision for 6 or more months is considered a cross over.

Men wait for two years of follow up before being offered male circumcision

Male circumcision

David Serwadda, MBChB,MPH

Godfrey Kigozi, MBChB, MPH

This randomized controlled trial conducted in Rakai District, Uganda, has enrolled 997 HIV positive men and 500 men who declined to learn HIV results (regardless of HIV status). The hypotheses are that male circumcision will be acceptable to and safe in both groups and will reduce the rates of STD acquisition in both groups and of HIV acquisition in HIV-negative men.

Enrollment was ended on Dec 12, 2006, following an interim Data Monitoring and Safety Board (DSMB) review of a closed report. At that time the DSMB determined that futility with respect to the female HIV outcome. There was an non-significantly higher rate of HIV acquisition in women partners of HIV+ men in couples who had resumed sex prior to certified post-surgical wound healing. The data indicated significant reductions (\~50%) in GUD symptoms among circumcised HIV+ men. The DSMB recommended: 1) that men and women should continue to be followed in complete two year follow up on all, 2) that circumcision for remaining HIV+ intervention arm men and for control arm men who had completed their 2 year follow should continue, contingent on a) revision of the study protocol to add additional post-surgical visits to assess wound healing, b) protocol revision to further strengthen education for both male and female partners on the need to postpone sex until certified wound healing, and c) approval of the revised protocol by the IRBs in both the US and Uganda. 3) An additional follow up visit for women be instituted at 18 months after enrollment. Protocol revision and IRB approvals have been finalized in June, 2007.

The study has also enrolled and is following 3,700 women sexual partners of men enrolled in this study and in a complementary National Institutes of Health (NIH) funded study (U1 AI51171 which is separately registered). The hypotheses are that male circumcision will be acceptable to and safe in women partners, and will reduce the women's acquisition of HIV and STDs such as herpes simplex virus-2 (HSV-2) and human papillomavirus (HPV).

STUDY DESCRIPTION:

The study is being carried out by the Rakai Health Sciences Program, a research collaboration between the Uganda Virus Research Institute/Uganda Ministry of Health, Johns Hopkins Bloomberg School of Public Health and researchers from Makerere University, Kampala, Uganda.

* The study, being conducted in Rakai District, Uganda, has enrolled 997 HIV+ and following a detailed informed consent process, randomizing them to receive either immediate (within several days or weeks) or delayed (two years) circumcision. The goals are to assess the safety and acceptability of male circumcision among HIV+ men, and to assess potential effects of male circumcision on the acquisition of STDs such as HSV-2. Hypotheses are that male circumcision will be acceptable to and safe in HIV+ men, will reduce the rate of acquisition of STDs, and will reduce the frequency of STD symptoms, such as genital ulceration.
* The study has also enrolled 500 men who, regardless of their HIV status, decline to receive their HIV results, despite encouragement to do so. Hypotheses are that circumcision will be acceptable and safe in men who decline their HIV results, and will reduce the rate of acquisition of HIV and STDs, and the frequency of STD symptoms such as genital ulcers.
* The study has enrolled 3,700 female partners of the men in groups 1 and 2 above, as well as of 5,000 HIV-negative men enrolled in a complementary NIH-funded study of male circumcision for HIV prevention (U1 AI51171 which is being separately registered). Following informed consent, the women partners are being followed annually to assess the acceptability and safety of male circumcision in female partners, and potential effects of male circumcision on HIV and STD acquisition. The hypotheses are that male circumcision will be acceptable to and safe in women partners, and will reduce the acquisition of HIV and STDs such as HSV-2 and HPV (human papilloma virus which causes cervical cancer.)
* Finally, the study is also following \~3,000 men and women in the \~50 communities where the circumcision trials are taking place, in order to assess community attitudes towards and knowledge of male circumcision, and to assess whether other preventive behaviors (abstinence, monogamy, numbers of partners, condom use, etc...) change in the community once circumcision becomes available. The hypothesis is that male circumcision will be acceptable in the community and will not result in behavioral disinhibition (increased rates of high risk behaviors).

The Gates-funded study being registered here is complementary to a separate NIH-funded trial of male circumcision in HIV-negative men who accept their HIV results, being carried out by the Rakai Health Sciences Program study team. The latter study, which is enrolling 5000 HIV-negative men, is designed to answer whether male circumcision is acceptable and safe in HIV-neg men, and whether the procedure reduces the acquisition of HIV and STDs.

The complementary Gates-funded trial is designed to answer the following additional questions:

* Is male circumcision acceptable to and safe in HIV-infected men, and will it reduce the rates of acquisition of STDs in these men?

These questions are of great importance for future circumcision programs:

* Will such programs need to screen out HIV+ men (if circumcision is shown to be unsafe in such men, potentially as a result of delayed healing) or should future programs include HIV+ men, if the procedure is safe in them, and has potential benefits such as reduced STD acquisition, improved genital hygiene and reduced rates of STD symptomatology?
* Is male circumcision acceptable and safe in men who decline their HIV results, and will it reduce rates of acquisition of HIV and STDS in these men?

From prior Rakai Program data, the researchers know that men who decline their HIV results tend to have higher risk behaviors. Determining potential circumcision risks in these men (such as, potentially delayed healing because of their higher risk behaviors) or benefits (such as potentially, reduced rates of HIV and STD acquisition) is thus very important for the design of any future large scale circumcision programs. From the public health viewpoint, it will be important to know whether such programs should include or exclude men who decline HIV results. (Please note: the Rakai Program strongly recommends and encourages the receipt of HIV results, and provides the results confidentially and free of charge. The great majority of Rakai Program research participants (85-90%) accept their HIV results, but a minority continue to decline, although the latter group is getting smaller every year. In addition, please also note that even if participants decline their HIV results, the Rakai Program still provides them with detailed HIV prevention education and counseling.) Enrollment of men who decline their HIV results is also congruent with Ugandan Ministry of Health Policy, which encourages but does not force individuals and study participants to receive their HIV results.

Enrollment of female partners is designed to answer important questions regarding potential effects of male circumcision on women. Should male circumcision reduce HIV and STD acquisition in women, this would represent an additional important public health benefit of the procedure and would add to the cost effectiveness of male circumcision programs. However, if the procedure is associated with increased HIV transmission (for example, due to increased transmission before a circumcision surgical would is fully healed), it is crucial that such a potential risk be identified rapidly within a trial, in order to prevent the risk within trials and in any potential future circumcision programs.

Following enrollment, men in the circumcision arm are followed post-operatively at weekly intervals until wound healing is fully certified, , at 4-6 weeks, 6 months, 12 months and 24 months. Men in the control arm are followed at 4-6 weeks and 6, 12 and 24 months. At baseline and follow up, men respond to a detailed sociodemographic, behavioral and health questionnaire, and provide biological samples (venous blood, urine, sub-preputial swabs \[prior to circumcision\] and for circumcised men, foreskins are collected at time of surgery.) Samples will allow assessment of multiple infections, including HIV, HSV-2, gonorrhea, chlamydia and syphilis.

Women partners are followed annually, through the Rakai Community Cohort Study. Following written informed consent, women are administered a detailed sociodemographic, behavioral and health status questionnaire, and provide venous blood and self-administered vaginal swabs at baseline and study follow up visits. The samples will allow assessment of multiple infections and conditions, including HIV, syphilis, gonorrhea, chlamydia, trichomonas, bacterial vaginosis, HSV-2 and HPV. Women partners of HIV+ men receive additional visita at 6 and 18 months post enrollment.

Community members (men not in the trials, and women who are not partners of men in the trials) are followed annually through the Rakai Community Cohort Study.

Services offered by the Rakai Program to all study participants include HIV and STD prevention education (information on behavioral risk factors and on abstinence, monogamy, being faithful and condom use), free condoms, free HIV counseling and testing for individuals and couples, free STD treatment, access to Rakai Program clinics for general health care, access to Rakai clinics for free HIV antiretroviral (ARV) drug screening and services, prophylaxis for opportunistic infections and nevirapine services for the prevention of mother-to-child HIV transmission. Please note: residents in the 50 villages where the circumcision trials are being conducted have access to Rakai clinics and ARV services whether or not they consent to be in Rakai studies, in order to avoid undue pressure to participate.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Screening With Tampons: Evaluating Diagnostic Accuracy and HPV and Assessing Participant Views	NCT06154239	Chlamydia Gonorrhea Bacterial Vagin... Human Papilloma...	DAYE Diagnostic... Vaginal self-sw... Clinician vagin...	25 Years - 65 Years	Anne's Day Ltd
Sexually Transmitted Infections Among African American Women Who Have Sex With Women	NCT01043081	Sexually Transm... HIV Infections		18 Years -	University of Mississippi Medical Center
Sexually Transmitted Infections Among African American Women Who Have Sex With Women	NCT01043081	Sexually Transm... HIV Infections		18 Years -	University of Mississippi Medical Center
Sexually Transmitted Infections Among African American Women Who Have Sex With Women	NCT01043081	Sexually Transm... HIV Infections		18 Years -	University of Mississippi Medical Center
Sexually Transmitted Infections Among African American Women Who Have Sex With Women	NCT01043081	Sexually Transm... HIV Infections		18 Years -	University of Mississippi Medical Center
Screening With Tampons: Evaluating Diagnostic Accuracy and HPV and Assessing Participant Views	NCT06154239	Chlamydia Gonorrhea Bacterial Vagin... Human Papilloma...	DAYE Diagnostic... Vaginal self-sw... Clinician vagin...	25 Years - 65 Years	Anne's Day Ltd
Trial of Male Circumcision: HIV, Sexually Transmitted Disease (STD) and Behavioral Effects in Men, Women and the Community	NCT00124878	HIV Infections Sexually Transm... Papillomavirus ... Genital Herpes Gonorrhea Chlamydia Infec... Syphilis Bacterial Vagin...	Male circumcisi...	15 Years - 49 Years	Wawer, Maria J., M.D.

Spots Global Cancer Trial Database for bacterial vaginosis