Evaluation of 2 Synthetic Nitrile Male Condoms Compared to a Standard Latex Male Condom

Study Overview
=================
Brief Summary
-----------------
This is a multi-site, randomised 3-period cross-over trial evaluating the functional performance of two synthetic nitrile male condoms against a control latex male condom.

Detailed Description
-----------------
A sequential randomised 3-period cross-over trial comparing five uses of two synthetic nitrile male condoms of different sizes with a control latex male condom. Each couple will be asked to use five synthetic nitrile condoms (53 mm width), five synthetic nitrile condoms (56 mm width) and five latex male condoms (53 mm width) in a randomised order. Couples will complete a Condom Use Report after each condom use. Function, safety, and acceptability will be assessed at each of three follow-up visits conducted after using each set of five condoms. The trial will enrol 300 couples, anticipating that at least 255 couples will complete the study. Half of the couples (150) will be enrolled in Durban, South Africa and half (150) enrolled in California USA.

Official Title
-----------------
A Functional Performance and Acceptability Evaluation of 2 Synthetic Nitrile Male Condoms Compared to a Standard Latex Male Condom

Conditions
-----------------
Sexually Transmitted Diseases

Intervention / Treatment
-----------------
* Device: Synthetic Nitrile Condoms (53mm)
* Device: Synthetic Nitrile Condoms (56mm)
* Device: Control Latex Condom


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be between the ages of 18 and 45 years (inclusive); Be literate (able to read a newspaper or letter easily); Have been in an exclusive (monogamous) sexual relationship with partner for at least 3 months; and intend to continue to be an exclusive (monogamous) sexual relationship with their spouse or partner while participating in this research study; Be sexually active (defined as having at least one vaginal coital act per week); Willing to give informed consent; Willing to complete the male condom coital use reports; Willing to use the study condoms as directed; Agree to use only the study lubricant provided; Agree to only use the study condoms sequentially during time of participation Willing to adhere to the follow-up schedule and all study procedures; Willing to provide research study staff with an address, phone number or other locator information while participating in the study; Willing to participate in the study for the duration of 15 condom uses (approximately 3-5 months); Willing to provide photo identification and/or have fingerprint scan to exclude co-enrolment in other research projects; Female partner using hormonal or other non-barrier contraception (e.g. OCs, injectable, implant, IUD, or have had a tubal sterilization) or male partner vasectomised; Agree to return any unopened condoms; Male partner willing to ejaculate during vaginal intercourse; Male partner willing to hold on to the condom ring when withdrawing the erect penis after sexual intercourse; Agree to not bring study condoms in contact with genital or oral piercing jewelry EAH: Both partners have valid personal email and operable mobile phones; Exclusion Criteria: Female partner is pregnant or desires to become pregnant during the time of the research study; Either partner is known to be HIV positive (based on self report [EAH] or documented HIV-negative test result within past two months [MRU]); Self-reported history of recurrent sexually transmitted infection (e.g. gonorrhea, syphilis, Chlamydia); Male partner has known erectile or ejaculatory dysfunction; Either partner has genital piercing jewelry, uses genital beading or uses sex toys, drugs, medications or non-study devices that can affect sexual performance; Either partner has known sensitivities or allergies to latex, synthetic nitrile, vaginal/sexual lubricants or lubricants used on condoms; Either partner reports symptoms of STI (EAH) or has observable evidence of STI as determined through syndromic diagnosis and vaginal/penile examination (MRU); Either partner is currently participating in another condom study; Either partner is a past or current employee of Essential Access Health, University of the Witwatersrand, or Karex; Either partner is a sex worker.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: A sequential randomised 3-period cross-over trial comparing the functional performance of two synthetic male condoms against a control latex male condom.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Synthetic Nitrile Condoms (53mm)<br>53mm width synthetic nitrile condoms | Device: Synthetic Nitrile Condoms (53mm)<br>* 53mm width synthetic nitrile condoms<br>|
| Experimental: Synthetic Nitrile Condoms (56mm)<br>56mm width synthetic nitrile condoms | Device: Synthetic Nitrile Condoms (56mm)<br>* 56mm width synthetic nitrile condoms<br>|
| Active Comparator: Control Latex Condom<br>Commercial natural rubber latex condom | Device: Control Latex Condom<br>* Commercial natural rubber latex condom<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical breakage | Clinical breakage is defined as breakage or tearing during sexual intercourse or during withdrawal of the male condom from the vagina. Clinical breakage is breakage with potential adverse clinical consequences. The clinical breakage rate is calculated by dividing the number of male condoms reported to have broken or torn during sexual intercourse or during withdrawal by the number of male condoms used during vaginal intercourse. | 3 - 5 months | 
| Clinical slippage | Clinical slippage is defined as a condom slipping completely off the penis during sexual intercourse or during withdrawal from the vagina. The clinical slippage rate is calculated by dividing the number of male condoms that slipped by the number of male condoms used during vaginal intercourse. | 3 - 5 months | 
| Clinical failure | A Clinical failure is defined as a clinical breakage or a clinical slippage. The clinical failure rate is calculated by dividing the number of male condoms with a clinical failure by the number of male condoms used during vaginal intercourse. | 3 - 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genital discomfort | Rates of genital discomfort reported to have occurred during or immediately after condom use. Genital adverse events will be classified by relatedness, expectedness and severity. | 3 - 5 months | 
| Acceptability | Frequency of key acceptability outcome measures will be calculated and include: comfort in use; ease of insertion and removal; like or dislike of product attributes; adequacy and feel of lubrication and sensitivity and stimulation. | 3 - 5 months | 
| Non-Clinical breakage | Defined as breakage noticed before sexual intercourse or occurring after withdrawal of the male condom from the vagina. Non-clinical breakage is breakage with no potential adverse clinical consequences. The non-clinical breakage rate is calculated by dividing the number of male condoms reported to have broken before sexual intercourse or after withdrawal by the number of male condom packages opened. | 3 - 5 months | 
| Non-Clinical slippage | Defined as slippage along the shaft of the penis during sexual intercourse (but not completely off the penis). Non-clinical slippage is slippage with no potential adverse clinical consequences. The non-clinical slippage rate is calculated by dividing the number of male condoms reported to have partially slipped during sexual intercourse by the number of male condoms used during vaginal intercourse. | 3 - 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Synthetic Male Condom, Slippage-Breakage Study