|
|||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
Completed research Safety and Feasibility of the Diaphragm used with ACIDFORM gel or K-Y Jelly® Feasibility and Acceptability of Cervical Barriers among Vulnerable Youth in Africa Acceptability among Sex Workers in the Dominican Republic Duet® for Menstrual Protection: a Feasibility Study in Zimbabwe Phase I Study of the Functional Performance, Safety, and Acceptability of the BufferGel Duet™ Acceptability of SILCS Diaphragm among Couples in South Africa and Thailand Post-Coital Testing and Safety Study of SILCS Diaphragm Prototype 6 Methods for Improving Reproductive Health in Africa (MIRA) Acceptability and Safety of the Diaphragm among Women in Mombasa, Kenya Safety Analysis of the Diaphragm in Combination with Vaginal Microbicide Gels A Randomized, Controlled Trial of the Efficacy, Safety, and Acceptability of BufferGel® A Safety Trial of the Diaphragm and Sodium Cellulose Sulfate in Zimbabwe Acceptability of Diaphragm Use in Zimbabwe Diaphragm Acceptability in Nairobi, Kenya Women’s Acceptability of the Vaginal Diaphragm
Safety and Feasibility of the Diaphragm used with ACIDFORM gel or K-Y Jelly® Phase II Location: South Africa 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: This trial was successfully completed and although no primary safety comparisons achieved statistical significance, there was a trend towards more events in the ACIDFORM group than in the K-Y Jelly group. A positive finding of this study was that women were willing and able to use a diaphragm with a gel over a relatively long period of time. Adding a microbicidal gel, when one becomes available, to a mechanical barrier could prove to be an important method of preventing both pregnancy and HIV/STI transmission. Related publication: This trial was conducted during 2004-2005 by researchers at CONRAD and Family Health International (FHI) using funds provided by USAID.
Feasibility and Acceptability of Cervical Barriers among Vulnerable Youth in Africa Location: Zimbabwe The objective of this study was to explore the feasibility and acceptability of cervical barriers for HIV prevention among female youth. Approximately 40 sexually-experienced female youth ages 16 to 21 were enrolled in the study in addition to approximately 20 female adult relatives (mothers or aunts) of female youth (who were not related to youth participants). This qualitative exploratory behavioral study assessed device preference, including focus group discussions and follow-up insertion/removal practice sessions. The study products tested were the Ortho All-Flex® diaphragm, the SILCS diaphragm, and the FemCap®. This study was initiated in 2006. Key Findings: All 45 young women were willing and able to insert their assigned device. The majority reported "easy" insertion and removal and 93% "liked" the device they tried. All showed interest in participating in future CB studies: when asked which device they would like to try in the future, over half (58%) chose SILCS, regardless of the device they had tried. The majority felt comfortable touching their genitals to insert/remove the CB and most participants favoured methods' attributes associated with female-control and non-interference with sex. Over half the participants said they would prefer to use a CB continuously compared to episodic use. Two-thirds of them expressed interest in CB for dual protection. Related Publications: van der Straten A, Sahin-Hodoglugil N, Clouse K, Mtetwa S, Chirenje MZ. Feasibility and potential acceptability of three cervical barriers among vulnerable young women in Zimbabwe. J Fam Plann Reprod Health Care. 36:1 (2010) 13-19. This study was conducted by the University of California, San Francisco (UCSF) Women’s Global Health Imperative and the University of Zimbabwe-UCSF Collaborative Research Programme. Acceptability among Sex Workers in the Dominican Republic Location: Santiago and Puerto Plata, Dominican Republic Started in 2006, the objective of this ongoing study was to test the acceptability of the Ortho All-Flex® diaphragm and the FC female condom as potential STI prevention methods among sex workers. A total of 250 women aged 18 to 35 were enrolled in this randomized control trial based on the introduction of methods. Participants were sex workers, not pregnant at enrollment, planned to live in the area for at least six months, and did not have untreated C. trachomatis or N. gonorrhea at enrollment. Participants were followed for 5.5 months. Key Findings: Seventy-six percent reported used of female condom at least once during the final month of the study, compared with 50% that used the diaphragm with male condoms and 9% that used the diaphragm alone. The proportion of women reporting every sex act protected with some barrier method increased from 66% at first month to 77% at final month (p < 0.05). Participants reported higher acceptability and use of the female condom than the diaphragm. The introduction of female-controlled barrier methods resulted in the use of a wide range of prevention methods and a significant reduction in unprotected sex. Key Publications: Lara D, Grossman D, Muñoz J, This study was conducted by researchers at the Population Council and Ibis Reproductive Health and is funded by the Bill and Melinda Gates Foundation. Duet® for Menstrual Protection: a Feasibility Study in Zimbabwe Feasibility Study Location: University of Zimbabwe-University of California San Francisco Programme in Women’s Health, Epworth, Zimbabwe The purpose of this study was to explore Zimbabwean women’s interest and hypothetical acceptability of a new cervical barrier that can be used as a reusable menstrual collection device: the Duet. Four exploratory focus group discussions (FGDs) were conducted with 43 menstruating women. Two FGDs were conducted with women aged 18-24 (n=22) and 2 FGDs with women aged 25-45 (n=21) in 2008. Participants had ever had vaginal sex and spoke, read, and wrote in Shona or English. Women also completed a self-administered demographic form (prior to the FGD) and a Duet attitude questionnaire (after the FGD). Key Findings: All 43 women reported that if the Duet were available, they would “definitely” try it, and that it was “very important” that Duet is low cost and easy to clean; 86% reported that using it would make a difference in their lives. FGD findings highlighted unhygienic practices due to the lack of affordable options for menstrual management and a genuine interest in Duet, including its potential use for multiple purposes (contraception, disease prevention, and menstrual protection). In conclusion, accessing affordable and hygienic menstrual protection was a problem for these Zimbabwean women. Duet appeared acceptable and it would be feasible to conduct a user-acceptability study of Duet as a menstrual cup in Zimbabwe. Related Publications: Averbach S, Sahin-Hodoglugil N, Musara P, Chipato T, van der Straten A. Duet® for menstrual protection: a feasibility study in Zimbabwe. Contraception. 79 (2009) 463-468. This project was funded by a contract from Reprotect, Inc. Most of the work was done while Drs. van der Straten and Sahin-Hodoglugil were at the University of California, San Francisco, Department of Obstetrics, Gynecology & Reproductive Sciences. Phase I Study of the Functional Performance, Safety, and Acceptability of the BufferGel Duet™ Phase I Location: CONRAD Clinical Research Center, Eastern Virginia Medical School, Norfolk, Virginia; PROFAMILIA, Santo Domingo, Dominican Republic 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 phase I study of BufferGel Duet™ function, safety, effect on vaginal pH, and acceptability demonstrated that women were able to insert the device and use it with their partners during intercourse. The unaided ease of use raised the possibility of over-the-counter delivery. No significant safety issues were apparent though peeling of the epithelium was increased. A recommendation for careful monitoring of epithelial status is made for future studies with increased frequency and/or duration of product exposure. This trial was conducted by CONRAD during 2005 using funds provided by USAID. Related Publications: Ballagh SA, Brache V, Mauck C, Callahan MM, Cochon L, Wheeless A, Moench TR. A Phase I study of the functional performance, safety and acceptability of the BufferGel Duet. Contraception. 77:2 (2008) 130-137. Acceptability of SILCS Diaphragm Prototype 6 Compared to the Ortho All-Flex® Diaphragm During Couples’ Use Location: PROFAMILIA, Santo Domingo, Dominican Republic This study assessed the fit and acceptability of the SILCS diaphragm, a new single-size device to the Ortho All-Flex diaphragm (a fitted diaphragm) to validate the product design among primarily multiparous women in a low-resource setting. Data were collected from August 2004 to April 2005. Twenty sexually active couples not at risk of pregnancy and at low risk of sexually transmitted infection were recruited and randomly assigned to one of two groups in this cross-over study and provided feedback on performance indicators for both devices.
Couples provided data on a total of 160 product uses (80 for each device). Women also provided feedback about user instructions and counseling needs related to the SILCS device and acceptability of washing and storing diaphragms. This was a non-blinded, non-significant risk study. Study results were published in 2008. Key Findings: The SILCS diaphragm fits women representing a range of baseline diaphragm sizes, parity, and body mass. Women with no previous diaphragm experience were able to use both types of diaphragms comfortably at home and found both devices were acceptable during use. The SILCS diaphragm was preferred over the Ortho device by 19 of 20 female and 15 of 20 male participants. Results from this study point toward the likely acceptance of diaphragms in general, and the SILCS in particular, among couples willing to use a barrier method. This study was a collaborative project of the PATH; CONRAD; and PROFAMILIA, using funds provided by USAID. Related Publications: Coffey PS, Kilbourne-Brook M, Brache V, Cochón L. Comparative acceptability of the SILCS and Ortho ALL-FLEX® diaphragms among couples in the Dominican Republic. Contraception. 2008;78(5):418-423. Acceptability of SILCS Diaphragm among Couples in South Africa and Thailand Location: Durban, South Africa, and Khon Kaen, Thailand The objective of this study was to assess the acceptability of the SILCS diaphragm among couples after one use and after multiple uses among couples with no previous diaphragm experience in two regionally diverse low-resource settings. Data from this study also confirmed fit of the SILCS—a single size diaphragm—among women of varying body size, parity, and differing regional geography. 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 (evaluating the SILCS metal spring device). 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, 18+ years of age, who were protected from pregnancy during the study by use of another method. Results from this study were presented at the Microbicides 2006 conference in Durban South Africa. Study findings were published in 2008. Key Findings: The SILCS diaphragm – a new, single-size cervical barrier – fits women representing a range of standard diaphragm sizes, parity, and body mass. Women and men in low-resource settings, including women with no previous experience with diaphragms, reported that the SILCS diaphragm was acceptable and easy to use. Female and male partners reported that sexual intercourse while using the SILCS was satisfactory. This study was conducted by the Reproductive Health Research Unit, South Africa; Khon Kaen University, School of Nursing and Medicine, Khon Kaen, Thailand; and the Program for Appropriate Technology in Health (PATH). Funding was provided by CONRAD and the Bill and Melinda Gates Foundation and PATH sponsored the study. Related Publications: Coffey PS, Kilbourne-Brook M, Beksinska M, Thongkrajai E. Short term acceptability of a single-size diaphragm among couples in South Africa and Thailand. Journal of Family Planning and Reproductive Health Care. 2008;34(4):233-236.
Post-Coital Testing and Safety Study of SILCS Diaphragm Prototype 6 Locations: CONRAD Clinical Research Center, Eastern Virginia Medical School, Norfolk, VA; University of Pittsburgh/Magee Women’s Research Institute, Pittsburgh, PA, USA This study compared 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. This was a cross-over postcoital test (PCT) study among healthy, sexually active women, not at risk for pregnancy. Data from this multi-center, randomized, single-blinded study were collected from October 2003-July 2004. A sub-study also evaluated the fit, effectiveness, and acceptability of the SILCS (polymer spring) with nonoxynol-9 (N-9). Fifteen couples completed a baseline cycle and were randomized to order of gel for this study. Key Findings: Twelve couples completed the study with data from two test cycles. Eight couples also completed the cycle with the SILCS polymer spring device. Results indicate that the SILCS diaphragm 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 using funds provided by USAID. Related Publications: Schwartz JL, Ballagh SA, Creinin MD, Rountree RW, Kilbourne-Brook M, Mauck CK, Callahan MM. SILCS diaphragm: postcoital testing of a new single-size contraceptive device. Contraception. 2008;78(3):237-244. Consistent Use of a Combination Product versus a Single Product in a Safety Trial of the Diaphragm and Microbicide in Harare, Zimbabwe Location: Harare, Zimbabwe This analysis examined the use and acceptability of a combination product (diaphragm and gel) compared to a single product (gel) during the safety trial in Zimbabwe. Women were randomized to the use of a diaphragm with gel or the use of gel alone, in addition to male condoms. Ever use and use of study product on the last act of sexual intercourse were assessed monthly by Audio Computer-Assisted Self-Interviewing. Acceptability, correct use, and consistent use (use at every sexual act during the previous three months) were measured on the last visit by face-to face interview. Predictors of consistent use were examined using multivariate logistic regression analyses. Key Findings: In this sample of 117 sexually active, monogamous, contracepting women, rates of consistent use were similar in both groups (59.7% for combination method vs. 56.4% for gel alone). Product acceptability was high, but was not independently associated with consistent use. Independent predictors of consistent use included age [adjusted odds ratio (AOR)=1.08; 95% confidence interval (95% CI)=1.01–1.16], consistent condom use (AOR=3.85; 95% CI=1.54–9.63), and having a partner who approves of product use (AOR=2.66; 95% CI=1.10–6.39). Despite high reported acceptability and few problems with the products, the participants reported only moderate product adherence levels. Consistent use of condoms and consistent use of products were strongly associated. If observed in other studies, this may bias the estimation of product effectiveness in future trials of female-controlled methods. Related Publications: van der Straten A, Moore J, Napierala S, Clouse K, Mauck C, Hammond N, Padian N. Consistent use of a combination product versus a single product in a safety trial of the diaphragm and microbicide in Harare, Zimbabwe. Contraception. 77:6 (2008) 435-443. Methods for Improving Reproductive Health in Africa (MIRA) Phase III Location: South Africa and Zimbabwe Started in 2003, the objective of this study was to measure the effectiveness of the Ortho All-Flex® diaphragm with Replens® lubricant gel for the prevention of heterosexual acquisition of HIV among at-risk women. Additionally, sub-studies included: effectiveness of diaphragm and gel in preventing Chlamydia, gonorrhea, and trichomoniasis; long-term acceptability of the diaphragm; diaphragm safety; and feasibility of diaphragm and gel as a sustainable HIV prevention method. A total of 5,042 women over the age of 18 were enrolled in this multi-site randomized controlled trial. Participants were sexually active, tested negative for HIV, chlamydia, and gonorrhea, and were willing to be randomly assigned either to use or not use the latex diaphragm with lubricant gel during the study. Participants were enrolled for up to 24 months. Key Findings: The trial found no statistical difference in the rate of new HIV infections between women who received the diaphragm plus lubricant along with male condoms for their partners and those in the control arm who only received male condoms. Therefore, the results do not support the addition of the diaphragm to current HIV prevention strategies. To date, condoms remain the only proven barrier method for HIV prevention. This means there is still an urgent need for continued investment and research into current and new HIV prevention methods that give women and girls the power to protect their health. Read more This trial was conducted by researchers at the University of California, San Francisco (UCSF), Women’s Global Health Imperative; Ibis Reproductive Health; the Medical Research Council of South Africa; the Perinatal HIV Research Unit of South Africa; and the University of Zimbabwe-UCSF. The study was funded by the Bill and Melinda Gates Foundation. Related Publications: Padian NS, van der Straten A, Ramjee G, Chipato T, de Bruyn G, Blanchard K, Shiboski S, Montgomery ET, Fancher H, Cheng H, Rosenblum M, van der Laan M, Jewell N, McIntyre J, the MIRA Team. Diaphragm and lubricant gel for prevention of HIV acquisition in southern African women: a randomised controlled trial.
The Lancet. 370:9583 (2007) 251-261. [More information regarding MIRA Social Science Study] Acceptability and Safety of the Diaphragm among Women in Mombasa, Kenya Phase IV Location: Chaani district, Mombassa, Kenya 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: After six months, 55% of sexually-active women reported having used the diaphragm each sex act during the preceding month. The large majority (95%) of women liked using the diaphragm and 96% reported willingness to continue using it. Colposcopy did not reveal significantly more vaginal or cervical lesions. Use of the diaphragm was not associated with an increase in bacterial vaginosis or urinary tract infections (UTIs). A pregnancy rate of 12 per 100 women/years was observed. The study was conducted by the International Centre for Reproductive Health Kenya and funding was provided by the Wellcome Trust. Related Publications: Luchters S, Chersich MF, Jao I, Schroth A, Chidagaya S, Mandaliya K, Temmerman M. Acceptability of the diaphragm in Mombasa Kenya: a 6-month prospective study. European Journal of Contraception and Reproductive Health Care. 12:4 (2007) 345-353. Okal J, Stadler J, Ombidi W, Jao I, Luchters S, Temmerman M, Chersich MF. Secrecy, disclosure and accidental discovery: Perspectives of diaphragm users in Mombasa, Kenya. Culture, Health and Sexuality. 10:1 (2008) 13-26. Safety Analysis of the Diaphragm in Combination with Vaginal Microbicide Gels Location: CONRAD Clinical Research Center, Eastern Virginia Medical School, Norfolk, Virginia; University of Pennsylvania, Philadelphia, Pennsylvania; University of Pittsburgh/Magee Woman’s Research Institute, Pittsburgh, Pennsylvania The objective of this study was to determine the safety of ACIDFORM and 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 used the diaphragm and gel each night for two weeks. Key Findings: This Phase I study found the safety profiles of ACIDFORM™ and BufferGel® used with a diaphragm to be as safe as K-Y® Jelly used with the diaphragm and sufficient to warrant further investigation. This trial was conducted in 2004 with funds provided by the CDC and USAID through CONRAD. Related Publications: Williams DL, Newman DR, Ballagh SA, Creinin MD, Barnhart K, Weiner DH, Bell AJ, Jamieson DJ. Phase I safety trial of two vaginal microbicide gels (Acidform or BufferGel) used with a diaphragm compared to KY jelly used with a diaphragm. Sex Transm Dis. 34:12 (2007) 977-984. A Randomized, Controlled Trial of the Efficacy, Safety, and Acceptability of BufferGel® Phase III Location: Virginia, California, New York, Pennsylvania, New Jersey, Colorado, and Ohio, United States 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 also determined 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 six-month pregnancy rates were comparable in acid buffering gel and nonoxynol-9 spermicide users and pregnancy probabilities were similar between groups participating in the 12-month study extension. Adverse events and acceptability were also similar between the two groups. In conclusion, an acid buffering gel used with a diaphragm is a safe, acceptable contraceptive with efficacy comparable to that of a common commercial spermicide with diaphragm. 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). Related Publications: Barnhart KT, Rosenberg MJ, MacKay HT, Blithe DL, Higgins J, Walsh T, Wan L, Thomas M, Creinin MD, Westhoff C, Schlaff W, Archer DF, Ayers C, Kaunitz A, Das S, Moench TR. Contraceptive efficacy of a novel spermicidal microbicide used with a diaphragm: a randomized controlled trial. Obstetrics & Gynecology. 110:3 (2007) 577-586. A Safety Trial of the Diaphragm and Sodium Cellulose Sulfate in Zimbabwe Location: Zimbabwe This was a single center, partially blinded, three-arm randomized trial conducted in 2004-2005 to assess the safety of using the diaphragm with sodium cellulose sulfate gel (CS), the diaphragm with K-Y® Jelly, or CS alone, when used prior to intercourse for six months in sexually active HIV-positive and HIV-negative women. Key Findings: One hundred nineteen women were enrolled and 105 completed the study. No urinary tract infections were diagnosed during the study; 81.4% of the women had symptoms and/or signs of genital irritation considered at least possibly related to the gel or device; and 41.5% had changes in vaginal flora. There were no statistically significant differences between treatment groups in safety endpoints. All six women with deep epithelial disruptions were diaphragm users and all such findings were on the external genitalia. Of those, four had herpetic ulcers which were unrelated to product use. This study was conducted by researchers from the University of California, San Francisco and the University Zimbabwe-University of California, San Francisco Collaborative Research Program (UZ-UCSF) and funded by CONRAD with USAID funds. Related Publications: van der Straten A, Napierala S, Cheng H, Mauck C, Depineres T, Dhlakama P, Thompson M, Chipato T, Hammond N, Padian N. A randomized controlled safety trial of the diaphragm and cellulose sulfate microbicide gel in sexually active women in Zimbabwe. Contraception. 76:5 (2007) 389-399. See here for more details on this study. Acceptability of Diaphragm Use in Zimbabwe Acceptability Study Location: Zimbabwe 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 SF, et al. Introducing Diaphragms into the Mix: What Happens to Male Condom Use Patterns? AIDS and Behavior. 9:4 (2005) 443-449. Buck J, et al. Barrier Method Preferences and Perceptions Among Zimbabwean Women and their Partners. AIDS and Behavior. 9:4 (2005) 415-422. Diaphragm Acceptability in Nairobi, Kenya Location: Nairobi, Kenya 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 azithromycin 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 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); CONRAD; and the Kenya Medical Research Institute (KEMRI) using funds provided by the CDC and USAID. A Formative Study for a Randomized Clinical Trial of the Diaphragm with a Candidate Microbicide to Prevent Sexually Transmitted Infections Location: Madagascar This study was conducted in 2005 at four public clinics in Madagascar to investigate the acceptability of a latex diaphragm used with a candidate vaginal microbicide gel (ACIDFORM) among 192 women at high risk for sexually transmitted infections and to assess the feasibility of the proposed study products and procedures for an upcoming randomized controlled trial. Key Findings: A trial of a microbicide with and without the diaphragm for STI prevention appears acceptable and feasible in this population. Gel + diaphragm users had better adherence than gel-only users, and predictors of adherence differed by arm type. Related Publications: Norris Turner A, et al. Predictors of Adherent Use of Diaphragms and Microbicide Gel in a Four-Arm, Randomized Pilot Study Among Female Sex Workers in Madagascar. Sexually transmitted diseases. 36:4 (2009) 249-257. This study was conducted by researchers at the University of North Carolina, Chapel Hill; the Centers for Disease Control and Prevention (CDC); and CONRAD and funded by the CDC and USAID. Women’s Acceptability of the Vaginal Diaphragm Acceptability Study Location: Oregon, United States 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. Seven hundred and sixty five 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, 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. Link to: |
|
|||||||||
