Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U19AI096398 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Boston University | OTHER |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
Not provided
Not provided
Not provided
Not provided
The purpose of this project is to explore women's thoughts, opinions, and ideas about vaginal products. Women who enroll in the project will complete a brief demographics and sexual behavior questionnaire.
The purpose of this project is to explore women's thoughts, opinions, and ideas about vaginal products. The investigators will ask women to help design the best strategy for applying a vaginal product using a specific kind of applicator. The investigators want to identify designs that women think would be easy to prepare and insert. Women's thoughts and opinions will help researchers develop new products called microbicides that may protect against HIV and other sexually transmitted diseases, that are easy to use, and that will be acceptable to women who use them. If researchers can make products that are easy to use and that women like to use, the products will be used more often, and more infections will be prevented.
Women who enroll in the project will complete a brief demographics and sexual behavior questionnaire.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Female Participants | Participants who completed demographics and sexual behavior questionnaire. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Use | Frequency of product use during specified sex in the past 12 months. Response options: 0= None of the time; 1 = Some of the time, 2 = Half of the time, 3 = Most of the time; 4 = All of the time; 5 = Not applicable (did not have specified sex) | 1 year |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| EVER Engaged in Behavior | Number of participants who ever engaged in specified behavior. | 1 year |
| Product Use CURRENT | Number of participants currently using specified product. |
Inclusion Criteria:
Women who:
Exclusion Criteria:
Women who:
Not provided
Not provided
Females who are 18-45 years old, HIV negative or unknown (self report), non-pregnant and not intending to get pregnant (self report), and report vaginal sex with a man in the past 12 months.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kathleen M Morrow, PhD | The Miriam Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Miriam Hospital - ReproHealth Team | Providence | Rhode Island | 02903 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Recruited May-Aug 2013 (RI, MA USA) via call-lists, flyers, ads, internet/social media, clinics, CBOs, word-of-mouth. Volunteers complete prescreen survey. If eligible, each was invited to participate in research questionnaire assessing previous product use and sexual and reproductive history.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Female Participants | Participants exploring thoughts, opinions, and ideas about vaginal products. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Female Participants | Female research study participants who completed a demographics and sexual behavior questionnaire. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Frequency of Use | Frequency of product use during specified sex in the past 12 months. Response options: 0= None of the time; 1 = Some of the time, 2 = Half of the time, 3 = Most of the time; 4 = All of the time; 5 = Not applicable (did not have specified sex) | Numbers analyzed for each scale may differ from overall sample as some items may not have been answered by a given participant. | Posted | Mean | Standard Deviation | units on a scale | 1 year |
|
|
4 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Female Participants | Participants who completed demographics and sexual behavior questionnaire. |
Not provided
Not provided
These data are demographic and sexual behavior data associated with participants providing information to inform study product development.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | The Miriam Hospital | 401-793-4775 or 401-793-8180 | scu-uvin@lifespan.org; kate.guthrie@lifespan.org |
Not provided
| ID | Term |
|---|---|
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 1 year |
| Count (Number of Times) of Sexual Behavior | Number of times participant engaged in specified sex in the past 12 months. | 1 year |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Current Marital Status | Count of Participants | Participants |
|
| Yearly Income | Count of Participants | Participants |
|
| Highest Education Level | Count of Participants | Participants |
|
| Participants |
|
|
| Other Pre-specified | EVER Engaged in Behavior | Number of participants who ever engaged in specified behavior. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Other Pre-specified | Product Use CURRENT | Number of participants currently using specified product. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Other Pre-specified | Count (Number of Times) of Sexual Behavior | Number of times participant engaged in specified sex in the past 12 months. | Numbers analyzed for each item may differ from overall sample as some items may not have been answered by a given participant. | Posted | Mean | Standard Deviation | Number of times | 1 year |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
Not provided
Not provided
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
| How many times ANAL sex in past 12 MONTHS? |
|
|
| How many times Gave ORAL sex in past 12 MONTHS? |
|
|