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The following is a list of cervical barrier trials that have recently been completed, are currently underway, or are in the planning stages. This list is up-to-date as of September 2006. If you have any questions about any of these trials, have comment or suggestions or would like your trial to be added to the list, please send an email to info(at)cervicalbarriers.org. Phase I Study of the Functional Performance, Safety and Acceptability of the BufferGel Duet™ Phase I The objective of this non-comparative safety study was to test the function, safety, effect on vaginal pH, and acceptability of the BufferGel Duet™, a pre-coated diaphragm-like device. Thirty sexually active, mutually monogamous couples aged 18 and above were enrolled in this non-comparative safety study. Study participants engaged in two acts of intercourse using the BufferGel Duet™ in one week and returned to the clinic for an exam after the second act. Key Findings: This trial was successfully completed and subsequent phase trials are being planned. This trial was conducted and funded by CONRAD. Acceptability of SILCS Diaphragm Prototype 6 Compared to the Ortho All-Flex® Diaphragm During Couples’ Use Comparative Acceptability Study Started in 2004, the goal of this study was to compare the acceptability of a new, single-size silicone contraceptive diaphragm and the Ortho All-Flex® diaphragm among couples after use. In addition, the objective also included gathering feedback about user instructions and counseling needs related to the SILCS device from women in a low-resource setting that has had little previous contraceptive diaphragm use experience. This was a non-blinded, non-randomized, non-significant risk study. The study participants were twenty sexually-active couples comprised of males and females 18 years of age and older who were using an effective, non-barrier method contraceptive method throughout the study. Key Findings: To be announced. The trial was conducted by Profamilia, Santo Domingo, Dominican Republic and PATH. Funding was provided by CONRAD and PATH. Acceptability and Safety of diaphragm among women in Mombassa, Kenya Phase IV Initiated in 2004, the purpose of this cohort study was to assess the acceptability and safety with six months of use of the latex diaphragm without lubricant using quantitative and qualitative outcomes. In addition, researchers examined the change in condom and other contraceptive use and users’ perspectives. A total of 185 women were enrolled, 95 of whom were sex workers. Women were 18 years or older, a resident in the study area and likely to remain in the study area for six months. Key Findings: To be announced. The study was conducted by the International Center for Reproductive Health Kenya and funding was provided by the Welcome Trust. Diaphragm Acceptability in Nairobi, Kenya Phase II Started in November 2004, the objective of this study was to determine the acceptability of the diaphragm and to describe the use patterns among women attending an STI clinic. A total of 140 women aged 18 to 57 were enrolled in this prospective cohort study. All participants must have completed a previous azythromicin trial and reported trading sex for money or gifts. Participants were involved in the trial for six months. The Milex Wide Seal® diaphragm and K-Y Jelly® were the products tested. Key Findings: Regular diaphragm inspection is recommended in this population. Age, education, and number of sex partners per month were not factors in the development of diaphragm problems. Given the number and variety of diaphragm problems encountered in this brief study, further evaluation of the silicone device design may be necessary. This trial was conducted by researchers from the University of Washington, University of Nairobi, the Centers for Disease Control and Prevention (CDC), and the Kenya Medical Research Institute (KEMRI). The study was funded by the CDC, CONRAD, and the United States Agency for International Development (USAID). Acceptability of SILCS Diaphragm among Couples in South Africa and Thailand Consumer Acceptability Study The objective of this study was to assess the acceptability of the SILCS diaphragm among couples after one use and after multiple uses. Researchers gathered feedback about user instructions and counseling needs from women in these low-resource settings. Twenty couples in Thailand and 21 couples in South Africa participated in the main study with another seven couples in South Africa participated in an additional sub-study of a modified SILCS diaphragm with a polymer spring. Participants were sexually-active couples comprised of males and females 18 years of age who were using an effective, non-barrier contraceptive method throughout the study. Couples reported on acceptability after each of four different product uses. Study recruitment began in 2004 and lasted six months. Key Findings: To be announced. This study was conducted by the Reproductive Health Research Unit, South Africa; Khon Kaen University, School of Nursing and Medicine, Khon Kaen, Thailand; and PATH. Funding was provided by CONRAD and the Bill and Melinda Gates Foundation and PATH sponsored the study. Safety and Feasibility of the Diaphragm used with ACIDFORM gel or K-Y Jelly® Phase II The objective of this study was to assess the safety and feasibility of the Ortho All-Flex® diaphragm used with ACIDFORM gel (a candidate microbicide) or K-Y Jelly® when applied prior to sexual intercourse for six months in HIV-negative, sexually-active women. A total of 120 women aged 18 to 48 were enrolled in this randomized placebo-controlled trial. All participants were HIV-negative, sexually active, and in mutually monogamous relationships. Participants were involved in the trial for six months. Key Findings: To be announced. This trial was conducted by researchers at CONRAD and Family Health International (FHI) and was funded by CONRAD and USAID. Safety Analysis of the Diaphragm in Combination with Vaginal Microbicide Gels Phase I The objective of this study was to determine the safety of ACIDFORM or BufferGel®, both candidate microbicides, as compared to K-Y Jelly® when used in conjunction with a Milex Wide Seal® diaphragm. Eighty-one women aged 18 to 41 were enrolled in this study in which they were randomly assigned to one of three arms (ACIDFORM, BufferGel®, or K-Y Jelly®). Participants were sexually active, were willing to abstain from intercourse during the trial, had regular menstrual cycles, were willing to undergo colposcopy, and had an ASCUS-negative Pap. Participants were involved in the trial for 14 nights. Key Findings: This trial was successfully completed and subsequent phase trials are being planned. This trial was conducted by researchers at Magee Women’s Hospital, Eastern Virginia Medical School, and the University of Pennsylvania and was funded by CONRAD and the CDC. A Randomized, Controlled Trial of the Efficacy, Safety and Acceptability of BufferGel® Phase III Started in 2001, the objective of this study was to compare the safety and contraceptive efficacy of ReProtect's BufferGel® with Gynol II when the products are used with an Ortho All-Flex® diaphragm. It will also determine the effectiveness of BufferGel® in preventing urinary tract infections, bacterial vaginosis and symptomatic yeast vaginitis. A total of 1055 women aged 18 to 45 participated in this randomized, double-masked, non-inferiority study. Participants were sexually active, desiring contraception, in a mutually monogamous relationship and at low risk for HIV and STIs. Participants also were willing to engage in an average of one to two acts of heterosexual vaginal intercourse per week for six months. Key Findings: The results of this study have not yet been released. This trial was conducted by researchers at the California Family Health Council, Columbia University, Eastern Virginia Medical College, Magee Women’s Hospital, Robert Wood Johnson School of Medicine, the University of Colorado, and the University of Cincinnati and was funded by the National Institutes for Childhood Health and Human Development (NICHD). Post-coital Testing and Safety Study of SILCS Diaphragm Prototype 6 Phase I The objective of the study was to compare the effectiveness of a new, single-size silicone contraceptive diaphragm used with either spermicide (2% nonoxynol-9) or K-Y Jelly® to prevent sperm from penetrating mid-cycle cervical mucus. A sub-study also evaluated the fit, effectiveness and acceptability of the SILCS (polymer spring) with nonoxynol-9. Up to forty healthy sexually-active women ages 18-45 years of age were enrolled. Women were not at risk of pregnancy, in a stable relationship with only one sex partner and willing to adhere to the study protocol. This multi-center, randomized, single-blinded Phase I study was initiated in 2003 and lasted approximately 14 months. Key Findings: Results from this most recent post-coital trial indicate that the current SILCS diaphragm design with polymer spring and used with N-9 performed well and is acceptable for contraceptive effectiveness testing. The next step is a contraceptive effectiveness study to demonstrate equivalence of the SILCS diaphragm to traditional diaphragms in order to obtain clearance by the US Food and Drug Administration. This study was conducted by the CONRAD clinical research site at Eastern Virginia Medical School, Norfolk, Virginia and Magee Women’s Hospital, University of Pittsburgh, Pittsburgh, Pennsylvania. Funding was provided by CONRAD. Women’s Acceptability of the Vaginal Diaphragm Acceptability Study Started in 2001, the objective of this study was to examine the acceptability of the diaphragm with the aim of facilitating the development of female-controlled HIV prevention methods. 765 women aged 18 to 50 enrolled in this acceptability-focused survey study. Participants were Kaiser Permanente Northwest members who were either current or former diaphragm users. Participants were interviewed in a 30-minute telephone call. Key Findings: The likelihood of being a current diaphragm user (vs. former) increased with age, greater confidence in being able to use the diaphragm, greater perceived risk of pregnancy and more positive perceptions of the diaphragm. Women who valued attributes of hormonal contraceptives were less likely to be current users. Former diaphragm users reported that the following reasons were moderately to extremely important in their decision to stop using the diaphragm: difficulty inserting or removing the diaphragm (50.8%), dislike of leaving the diaphragm inside the vagina (46.8%), and wanting a more effective method for preventing pregnancy (44.2%). This study was conducted by researchers at Center for the Study of Women in Society, University of Oregon, Oregon Department of Public Health, Oregon State University, Kaiser Permanente Center for Health Research, and Program Design and Evaluation Services, Multnomah County Health Department, Oregon Department of Human Services and Alliant International University. It was funded by the NICHD. Related Publications: Bird ST, Harvey SM, Maher JE, Beckman LJ. Acceptability of an existing, female-controlled contraceptive method that could potentially protect against HIV: a comparison of diaphragm users and other method users. Women’s Health Issues. 14:3 (2004) 85-93. Harvey SM, Bird ST, Maher JE, Beckman LJ. Who continues to use the diaphragm and who doesn't: implications for the acceptability of female-controlled HIV prevention methods. Women's Health Issues. 13:5 (2003) 185-193. Harvey SM, Bird ST, Branch MR. A new look at an old method: the diaphragm. Perspectives on Sexual and Reproductive Health 35:6 (2003) 270-273. Acceptability of Diaphragm Use in Zimbabwe Acceptability Study Started in December 2000, the objective of this study was to evaluate the acceptability of the diaphragm among women at risk for pregnancy and STIs/HIV. A total of 189 sexually-active HIV-positive and HIV-negative women ages 16 to 48 were enrolled in this prospective cohort study. All participants were recruited from family planning clinics in Harare, Zimbabwe. Participants were involved in the trial for six months. The products used were the Milex Wide Seal® diaphragm and K-Y Jelly®. Key Findings: Diaphragms were well accepted among women at risk for sexually transmitted diseases/HIV. This study was conducted by researchers at the University of California San Francisco (UCSF) Women’s Global Health Imperative and the University of Zimbabwe-UCSF Collaborative Research Programme. It was funded by CONRAD and the CDC. Related Publications: van der Straten A., et al. “Predictors of Diaphragm Use as a potential sexually transmitted disease/HIV prevention method in Zimbabwe” Sexually Transmitted Diseases. 32:1 (2005) 64-71. Posner, Samuel F., et al. "Introducing Diaphragms into the Mix: What Happens to Male Condom Use Patterns?" AIDS and Behavior. 9:4 (2005) 443-449. Buck, Jessica, et al. "Barrier Method Preferences and Perceptions Among Zimbabwean Women and their Partners." AIDS and Behavior. 9:4 (2005) 415-422. A Safety Trial of the Diaphragm and Sodium Cellulose Sulfate in Zimbabwe Extended Phase I Started in 2004, the objective of this study was to examine the safety of 6-month use of the Ortho All-Flex® diaphragm and sodium cellulose sulfate gel, a candidate microbicide, during sex compared to the diaphragm with K-Y Jelly® or cellulose sulfate gel alone. A total of 119 women ages 18 to 49 participated in this partially blinded placebo-controlled trial. Participants were HIV-positive and HIV-negative women living in Harare, Zimbabwe. They were sexually active with no STIs or reproductive tract infections, had a healthy cervix and were using a long-term contraceptive method. Participants were enrolled for 6 months and used their assigned study product before every act of intercourse. Key Findings: There is a 30% difference detectable between the control and intervention groups, in favor of the intervention. This trial was conducted by the University of California San Francisco (UCSF) Women’s Global Health Imperative and the University of Zimbabwe-UCSF Collaborative Research Programme. The study was funded by CONRAD and USAID. Link to: |
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