The purpose of this project is to research, refine and test three prototypes of the ORIGAMI RAI CONDOM, an RAI (receptive anal intercourse) condom made of a biocompatible, viral-impermeable silicone, which may provide better sensation and less breakage than latex products and provide maximum protection against viral transmission. Three prototypes will be injection-molded and pre-clinically tested for biocompatibility and structural integrity. The ORIGAMI RAI CONDOM is intended to: 1. Facilitate a pleasurable and safe RAI sexual experience for both partners, 2. Increase the acceptability of condoms among those who practice anal intercourse and are at risk of HIV / STIs, 3. Encourage and increase consistent and correct use for those who practice anal intercourse and 4.Provide a receptive-partner-controlled strategy for HIV prevention. Upon completion of pre-clinical testing and identification of safe and biocompatible prototypes, we propose to conduct Two human volunteer studies will be conducted: 1. A User Preference Study, to identify a preferred prototype, comparing measures of user preference of the three prototypes among 30 volunteers, in a non-coital context and 2. a Couples Acceptability & Performance Study (CAP) to investigate the acceptability and performance of the preferred prototype during anal intercourse among 24 couples.
Public Health Relevance: To introduce an urgently needed, effective HIV prevention strategy for RAI (receptive anal intercourse), the primary objective of this Study is to research the feasibility and acceptability of the ORIGAMI RAI CONDOM: a new biocompatible, viral-impermeable, silicone, anorectally inserted condom, intended to provide an alternative to male latex condoms and increase acceptability and compliance for consumers at risk of HIV/STIs. Its user-friendly design is intended to introduce a pleasurable, more acceptable, receptive- partner-controlled barrier and to encourage its use.
Public Health Relevance Statement: PROJECT NARRATIVE To introduce an urgently needed, effective HIV prevention strategy for RAI (receptive anal intercourse), the primary objective of this Study is to research the feasibility and acceptability of the ORIGAMI RAI CONDOM¿: a new biocompatible, viral-impermeable, silicone, anorectally inserted condom, intended to provide an alternative to male latex condoms and increase acceptability and compliance for consumers at risk of HIV/STIs. Its user-friendly design is intended to introduce a pleasurable, more acceptable, receptive- partner-controlled barrierandtoencourageits use.
Project Terms: AIDS Virus; AIDS prevention; AIDS/HIV prevention; Abscission; Acquired Immune Deficiency Syndrome Virus; Acquired Immunodeficiency Syndrome Virus; Actinic Rays; Address; Advertisements; Age; Allergic Reaction; American; Anal; Analysis, Data; Anus; Bacteriophage phi X 174; Barrier Contraception; Barrier Methods; Barrier Methods, Contraceptive; Biocompatible; Biocompatible Materials; Biomaterials; Bone structure of rib; Breast; Budgets; Calendar; Cardiac Valves; Cervical Caps; Chemicals; Clinical Research; Clinical Study; Clinical Trials, Phase I; Coitus; Coliphage phi X 174; Collection; Communication; Condom; Condoms, Female; Condoms, Male; Condoms, Unspecified; Consent Documents; Consent Forms; Contraception, Barrier; Contraceptive Devices; Contractor; Cosmetics; Couples; Data Analyses; Data Collection; Devices; Diaphragm; Diaphragm (Anatomy); EJC; Early-Stage Clinical Trials; Effectiveness; Ejaculation; Elastomers; Ensure; Enterobacteria phage phi X 174; Esthesia; Ethics Committees, Research; Evaluation; Excision; Extirpation; Extravasation; FDA approved; FLR; Failure (biologic function); Female Condoms; Figs; Figs - dietary; Fungi, Filamentous; General Population; General Public; Genital; Genital System, Female, Vagina; Genital System, Male, Penis; Genital system; Government; Guidelines; HIV; HIV Infections; HIV Prevention; HIV/AIDS prevention; HTLV-III; HTLV-III Infections; HTLV-III-LAV Infections; Health Care Providers; Health Personnel; Healthcare Providers; Healthcare worker; Heart Valves; Heating; Hour; Human Figure; Human Immunodeficiency Viruses; Human Sexual Intercourse; Human T-Cell Leukemia Virus Type III; Human T-Cell Lymphotropic Virus Type III; Human T-Lymphotropic Virus Type III; Human Volunteers; Human body; IRBs; Individual; Informed Consent Documents; Informed Consent Forms; Injection of therapeutic agent; Injections; Institutional Review Boards; International; Internet; Interview; LAV-HTLV-III; Label; Laboratories; Latex; Latex Hypersensitivity; Latex allergy; Leakage; Left; Legal patent; Life; Liquid substance; Lubrication; Lymphadenopathy-Associated Virus; Mails; Male Condoms; Materials Testing; Measures; Medical; Medical Device; Membrane; Memory; Modification; Molds; Natural Rubber Latex Allergy; Oils; On-Line Systems; Online Systems; Ostamer; Patents; Pellethane; Penetration; Penile Implant; Penile Prosthesis; Penis Prosthesis; Penis, Artificial; Performance; Permeability; Persons; Phage phi X174; Phase 1 Clinical Trials; Phase I Clinical Trials; Phase I Study; Phone; Polyisocyanates; Polymers; Polyurethanes; Population; Preclinical Testing; Prevention strategy; Preventive strategy; Principal Investigator; Procedures; Property; Property, LOINC Axis 2; Protocol; Protocols documentation; Pump; Questionnaire Designs; Questionnaires; Reaction; Rectum; Removal; Reporting; Research; Research Ethics Committees; Resistance; Respiratory Diaphragm; Ribs; Risk; Rubber Allergy; Rubber Latex Allergy; SCHED; Safety; Sampling; Schedule; Semen; Seminal fluid; Sensation; Sexual Intercourse; Shapes; Silicone Elastomers; Silicone Rubber; Silicones; Simulate; Societies; Spillage; Standardization; Sun/Ultra-Violet Rays; Surface; Surgical Removal; System; System, LOINC Axis 4; T-Lymphotropic Virus Type III Infections, Human; Telephone; Temperature; Tensile Strength; Test Result; Testing; Thick; Thickness; Time; TimeLine; Tissue Expanders; Toxicity Testing; Toxicity Tests; Transmission; UV radiation; Ultraviolet Rays; Vagina; Vaginal; Videoconference; Videoconferences; Videoconferencing; Videoconferencings; Viral; Virus; Virus-HIV; Viruses, General; Volunteers, Human; WWW; Woman; Writing; bacteriophage phi X174; biocompatibility; biomaterial compatibility; condoms; conference; cosmetic product; data exchange; design; designing; experience; experiment; experimental research; experimental study; failure; fluid; health care personnel; health care worker; health provider; healthcare personnel; high risk; human tissue; innovate; innovation; innovative; instrument; irritation; liquid; male; medical personnel; meetings; member; membrane structure; men; men's; nondrug contraceptive; online computer; pathogen; penis; phase 1 study; phase 1 trial; phase I trial; phi X 174 Phage; pleasure; pre-clinical; preclinical; preference; prevent; preventing; protocol, phase I; prototype; public health relevance; rectal; research study; resection; resistant; rib bone structure; sex; symposium; technological innovation; transmission process; treatment provider; ultraviolet light; ultraviolet radiation; urogenital system (genital part); user-friendly; volunteer; web; web based; web site; world wide web
