Hiv Clinical Trial
Official title:
A 3-month Pilot Crossover Study in 24 US Couples to Compare Adherence, Preference and Acceptability of 3 Non-medicated Silicone Intravaginal Rings (IVRs) of Different External Diameters, Each Used for 30 Days
NCT number | NCT05128136 |
Other study ID # | 957 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 20, 2022 |
Est. completion date | January 31, 2023 |
Verified date | February 2023 |
Source | Population Council |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The overall aim of this study is to assess different external diameters of intravaginal rings (IVRs) for adherence, preference, and acceptability. To assess these domains, women in male-partnered relationships will use three different size IVRs.
Status | Completed |
Enrollment | 48 |
Est. completion date | January 31, 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: Females: - Aged 18-40 years old, inclusive, at Screening based on self-report - Sexually active, defined as having had penile-vaginal sex with a male partner at least four times per month (e.g. once a week), on average, in the three months before Screening - In a mutually monogamous relationship with the same male partner for at least 6 months prior to Screening, based on self-report - Male partner is eligible and consents to participation - Healthy based on medical history and physical exam at Screening - Currently using effective non-vaginal contraception for at least 3 months prior to screening, including injectable, oral contraception, contraceptive patch or sterilization (male or female) based on self-report - HIV-negative per test at Screening - Not pregnant per urine pregnancy test at Screening and Enrollment - Negative for chlamydia, gonorrhea, trichomoniasis or urinary tract infection (UTI) at screening - Symptomatic vulvovaginal candidiasis or bacterial vaginosis (BV) at Screening. (Participants who test positive at initial screening may be treated and rescreened after completing treatment). - Competent to provide written informed consent based on Investigator's assessment - Owns or has access to Smart phone per self-report - Agrees to not participate in any other clinical research for the duration of this trial Males: - Aged at least 18 years old at Screening based on self-report - Sexually active, defined as having had penile-vaginal sex with a female partner at least four times per month (e.g. once a week), on average, in the three months before Screening - In a mutually monogamous relationship with the same female partner for at least 6 months prior to Screening, based on self-report - Female partner is eligible and consents to participation - Healthy based on medical history and physical exam, including visual inspection of genitalia at Screening - HIV-negative per test at Screening - Negative for chlamydia, gonorrhea, trichomoniasis per tests at Screening (per local standard of care) at Screening - Competent to provide written informed consent based on investigator's assessment - Owns or has access to a Smart phone, per self-report - Agrees to not participate in any other clinical research for the duration of this trial Exclusion Criteria: Females: - Known or suspected allergy to silicone, as reported by participant - Positive pregnancy test at Screening or Enrollment based on urine hCG test - Positive for HIV per test at Screening - Presence of any clinically significant genital epithelial findings (e.g. abrasions, ulcerations, lacerations, or vesicles) suspicious of STIs at Screening or Enrollment - Positive chlamydia, gonorrhea, or trichomoniasis test at Screening (or Enrollment) - Current urinary complaints or diagnosed UTI at Screening (or Enrollment) - Presence of genital abnormalities via visual exam with speculum that would contraindicate IVR use at Screening or Enrollment - Significant uterine or vaginal prolapse, or urethral obstruction - Recurrent vaginitis (three or more episodes within the prior year) - Unexplained vaginal bleeding per self-report within the 3 months before Screening - Currently breastfeeding per self-report - Partial or complete hysterectomy per self-report - Gynecological surgery in the 6 months prior to Screening per self-report - Within 6 weeks post abortion or 6 months postpartum, per Self-report. - Using vaginal contraception (diaphragm, female condom, spermicide, IVR) - Abnormal finding on examination or a social or medical condition which, in the opinion of the investigator, would make participation in the study unsafe or would complicate interpretation of data. - Any other condition the clinician feels would jeopardize the health and wellbeing of the participant after assessing the participant's potential eligibility for the study - Unable to comply with study requirements, including but not limited to, attending all study visits and using the IVRs as directed. - Currently participating in any other clinical research trial involving investigational or marketed products Males: - Known or suspected allergy to silicone, as reported by - Positive test for HIV at Screening |
Country | Name | City | State |
---|---|---|---|
United States | Emory University | Atlanta | Georgia |
United States | Albert Einstein College of Medicine, | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Population Council | Albert Einstein College of Medicine, Emory University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adherence | To determine which of 3 non-medicated IVRs each used continuously for 30 days yields the highest adherence as measured by the proportion of women who are adherent to instructions for IVR use for each for ~30 days continuously, based on daily text messages | Up to 90 days | |
Primary | Preference | To assess which of 3 non-medicated IVRs each used continuously for 30 days is preferred by women and their male partners based on self reported preference by completing a questionnaire during and by the end of the study. Women and male partners will be asked to state their preference for one of the 3 IVRs at the end of the study. | Up to 90 days | |
Secondary | Acceptability | Participants will be asked to respond to a questionnaire measuring domains of acceptability at the end of using each of the 3 IVRs. Acceptability will be measured by the IVR acceptability measurement tool (IAMT). We will also explore the association between demographics, previous contraceptive use, parity, sexual/vaginal practices, and menses on acceptability. We will compare preferences between women and their male partners and we will compare actual preference at the end of the study with assumed preferences at baseline. | Up to 90 days | |
Secondary | Collection of Adverse Events | To evaluate and compare the safety of 3 nonmedicated silicone IVRs each used and continuously for 30 days as measured by the number and percent of participants with AEs and serious AEs. AEs will be summarized overall by severity and by relation to product use. AEs that are potentially related could be abrasion or erythema due to the device. | Up to 90 days | |
Secondary | Patterns of adherence | To explore patterns of adherence based on frequency of removals and expulsions per IVR and overall; duration of removals and expulsions per IVR and overall; reasons for removals for each IVR and overall; activities associated with expulsions per IVR and overall; and association between demographics and other background characteristics, sexual activity, and menstruation on adherence to each IVR and overall. | 90 days |
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