HIV, Sexually Transmitted Infections (STI)
Conditions
Keywords
HIV/STI, Prevention, Microbicides, Topical
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
The Miriam Hospital
Boston University
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Women who: * are between the ages of 18 and 45 at prescreening * report vaginal sex with a man in the past 12 months at prescreening * report negative pregnancy status and no intention to become pregnant during the course of the study * report negative or unknown HIV status, and * are willing and able to provide informed consent.
Exclusion criteria
Women who: * self-report being pregnant, or intention to become pregnant during the course of the study * self-report being HIV-positive * self-report an allergy or sensitivity to vaginal contraceptive film (VCF), nonoxynol-9 (N9), or product(s) containing N9 * are unable or unwilling to give informed consent, or * have any condition that, in the opinion of the project leader or principle investigator, would compromise the participant's ability to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Use | 1 year | 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) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKathleen M Morrow, PhD
The Miriam Hospital
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Focus Groups Focus Groups | 24 |
| Cognitive Interviews Cognitive Interviews | 12 |
| Total | 36 |
Baseline characteristics
| Characteristic | Focus Groups |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants |
| Current Marital Status Divorced | 0 Participants |
| Current Marital Status Married | 9 Participants |
| Current Marital Status Never Been Married | 16 Participants |
| Current Marital Status Other: Engaged | 1 Participants |
| Current Marital Status Separated | 1 Participants |
| Current Marital Status Widowed | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Highest Education Level Bachelor's Degree | 10 Participants |
| Highest Education Level Graduate or Professional Degree | 1 Participants |
| Highest Education Level High School Diploma or GED | 7 Participants |
| Highest Education Level Some College | 9 Participants |
| Highest Education Level Some High School | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Region of Enrollment United States | 29 Participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 0 Participants |
| Yearly Income $15,000 to $36,000 | 13 Participants |
| Yearly Income Less than $15,000 | 11 Participants |
| Yearly Income More Than $36,000 | 4 Participants |
| Yearly Income Refused To Answer | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 29 |
| other Total, other adverse events | 0 / 29 |
| serious Total, serious adverse events | 0 / 29 |
Outcome results
Primary
Number of Participants: Comprehension of Study Product
Focus groups captured participant understandings (in narrative form) of plant-produced monoclonal antibodies, how they come about, how they are manufactured, how they differ from other anti-HIV actives, etc. Participant-derived language informed development of study materials, including study product instruction sheets and informed consent materials and documents. Cognitive Interview assessed Participant comprehension of language used in insertion instruction materials, and monoclonal antibody education and informed consent materials.
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Number of Participants: Focus Group | Number of Participants: Comprehension of Study Product | 24 Participants |
| Number of Participants: Cognitive Interviews | Number of Participants: Comprehension of Study Product | 12 Participants |
Other Pre-specified
Number of Participants: Drug Delivery Systems Evaluations
Members of focus groups evaluated various drug delivery system designs, to determine final design to move forward with in development
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Number of Participants: Focus Group | Number of Participants: Drug Delivery Systems Evaluations | 24 Participants |
| Number of Participants: Cognitive Interviews | Number of Participants: Drug Delivery Systems Evaluations | 12 Participants |