The following ongoing studies on cervical barriers and female condoms are listed in reverse chronological order based on the start date of the study.
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A randomized crossover study evaluating the use and acceptability of SILCS diaphragm compared to vaginal applicators for placebo gel delivery
Randomized crossover study
Location: Durban, South Africa
This study evaluates the use and acceptability of the SILCS Diaphragm compared to standard vaginal applicators for delivery of a placebo vaginal gel. This is a foundational step before evaluating additional questions such as feasibility and acceptability of service delivery scenarios for the SILCS Diaphragm as either a microbicide delivery system or a contraceptive diaphragm. In this randomized crossover study 115 female participants were randomized to use the SILCS Diaphragm with placebo gel (delivered by applicator into SILCS cervical cup) for 5 sexual acts followed by use of vaginal applicators for 5 sexual acts to deliver placebo gel directly into the vagina, or vice-versa. The vaginal applicators in both study arms were of the same design. The use and acceptability of both methods of gel delivery were assessed at four follow-up visits in total (two visits per method, after first use and fifth use). Women completed a coital log at home that gathered data on experience after use of each method. A sub-sample of male partners (n=20) were recruited to gather issues of partner acceptability of each method, at one interview on completion of their partner's last visit. A sub-sample of participants (women (n=24-40) and men (n=12-20) also were asked to participate in focus group discussions on completion of the crossover study. Participants were recruited from the Commercial City Reproductive Health/Primary Health Care (PHC) Clinic in Durban, South Africa.
This study received final approval in August 2014, and was launched in September 2014. The clinical portion of the study was completed in January 2015. A peer-reviewed publication and report are being prepared.
This study is funded by USAID via the Program for Appropriate Technology in Health (PATH), and is being implemented by MRU (MatCH Research Unit).
Postcoital barrier effectiveness study of the SILCS diaphragm with Contragel
Phase I PCT study
Location: United States and Dominican Republic
Clinical guidelines recommend that diaphragms be used with a contraceptive gel to increase effectiveness. Most commercially available contraceptive gel products contain nonoxynol-9 (N-9), and are only available in developed countries. Products with N-9 are no longer recommended for use in countries where women are at risk of HIV (see the WHO guidance or RHTP fact sheet on N-9). Alternative contraceptive gel products that do not contain N-9 are needed for use with diaphragms, especially for women in countries where N-9 products are no longer available, or for women who cannot or do not want to use N-9 gel.
Contragel is a lactic acid based contraceptive gel product approved in Europe for use with cervical barrier products such as diaphragms and cervical caps. It has CE Mark certification and has been marketed for nearly 20 years primarily in Europe, where it has a good safety and acceptability profile. It has never been submitted to the US FDA for market approval.
In 2012, CONRAD evaluated Contragel safety in animal studies. No safety concerns were found. This laid the groundwork for a clinical study in humans. CONRAD will evaluate SILCS used with Contragel in a postcoital study of barrier effectiveness.
Ethics approvals by relevant IRBs were obtained in 2014. The study was launched in both sites in late 2014. Enrollment and implementation is underway at both sites. This study is scheduled to be completed by July/August 2016.
The study is being conducted by CONRAD at Eastern Virginia Medical School and by Profamilia in the Dominican Republic. The study is funded by USAID.
Health systems and market opportunities for SILCS as a barrier contraceptive in India
Health systems assessment
Location: Delhi, Mysore (Karnataka), and Rajasthan, India
This assessment explored opportunities and challenges for future introduction of the SILCS diaphragm in India. The study team interviewed 22 national stakeholders in Delhi and 7 state-level stakeholders in the state of Karnataka, including family planning/sexual and reproductive health providers and members of NGOs. They also conducted focus group discussions (FGDs) with potential SILCS users. Additionally, this assessment explored perceptions among potential end users. A total of nine FGDs were conducted in Karnataka and Rajasthan. FGD participants included urban and rural women who were either married or in a relationship; female sex workers; and male partners and clients. Using a systems perspective, this assessment characterized issues and attitudes that will need to be considered when planning for future introduction of this non-hormonal barrier contraceptive in this context. This assessment outlined the regulatory pathway, potential service delivery scenarios, target audiences, and communications and training materials needed to support future introduction in India. Market research has been implemented in India separately to supplement findings from this health systems assessment about potential target markets and to inform potential introduction strategies.
The health systems assessment was conducted in November 2012-March 2013. A final report of the findings and recommendations has been drafted and is being finalized. Results from this health systems assessment were presented at the European Society for Contraception meeting in Lisbon in May 2014.
This assessment was conducted by Ashodaya Samithi of Mysore in Karnataka state, India, and Katharine Shapiro, a reproductive health consultant, in collaboration with PATH. This assessment was funded by USAID.
Shapiro K , Roy A , Reza-Paul S , Gupta N, Kilbourne-Brook M , Coffey PS. Is SILCS Diaphragm an appropriate method for women in India? The European Journal of Contraception and Reproductive Health Care. 2014;19(1):S117–S118. Available at: http://informahealthcare.com/doi/pdf/10.3109/13625187.2014.894779.11
Health systems assessment of SILCS diaphragm in South Africa as a multipurpose prevention technology
Health systems assessment
Location: South Africa
This assessment explored opportunities and challenges and country readiness for future introduction of the SILCS diaphragm in South Africa, both as a barrier contraceptive and as a multipurpose prevention technology when used in combination with a microbicide gel. The assessment, implemented by MRU (MatCH Research Unit)of Durban, South Africa, began with a desk review of policies that would need to be considered for SILCS introduction. The policy assessment determined that the current policy environment is enabling for SILCS introduction; the newly revised contraception policy and guildelines promote choice; and dual protection is encouraged in several policies.
The health systems assessment was comprised of stakeholder interviews, facility assessments, and focus group discussions (FGDs) with potential users. MRU conducted 31 interviews with stakeholders such as policymakers, program managers, regulatory authorities, service providers, pharmacists, training managers, health center staff, NGO staff, and advocacy groups. They conducted seven facility assessments across public sector clinics, NGO service delivery sites, and tertiary education health center to explore feasibility of integrating SILCS distribution into current programs. MRU then conducted 24 focus FGDs (17 with women and 7 with men). Using a systems perspective, this assessment characterized issues and attitudes that will need to be considered when planning for future introduction of the SILCS diaphragm in South Africa. MRU presented findings from this health systems assessment at a meeting with key stakeholders in the HIV and sexual and reproductive health fields in November 2013 and developed recommendations for next steps. Market research also was implemented to supplement findings from this health systems assessment about potential target markets and to inform potential introduction strategies.
The policy landscape review was finalized and distributed in March 2014. MRU presented preliminary results from the assessment regarding SILCS as an multipurpose prevention technology at the International Family Planning Conference in Ethiopia in November 2013. Results from the FGDs also were presented at the R4P (Research for Prevention) in October 2014. The report from this assessment is being finalized and will be available in 2016. This assessment was funded by USAID.
Related presentations and publications:
SILCS in South Africa: Opportunities for introduction as a barrier contraceptive and as an MPT. International Conference on Family Planning, Addis Ababa, Ethiopia, November 12-15, 2013.
Introduction of the SILCS Diaphragm as a multipurpose technology in South Africa: Potential users, perceived benefits, and barriers to use. R4P Conference, October 2014.
Desktop review of the policy, research, and regulatory environment in South Africa relating to future introduction of the SILCS diaphragm as a nonhormonal barrier contraceptive and reusable delivery system for microbicide gel for HIV prevention. PATH Report. March 2014.
Providers' HIV/STI and pregnancy prevention practices in Southern Africa and the United States
In-depth interview and nationally representative survey study
Location: United States, South Africa, and Zimbabwe
Started in 2004, the objective of this study is to evaluate providers’ counseling practices for HIV and pregnancy prevention and their willingness to integrate new approaches and methods (including new and existing HIV prevention strategies with a range of hypothetical effectiveness) into client-specific prevention messages, counseling, and method provision. Approximately 1,400 physicians and nurses from Southern Africa and 1,200 from the United States were enrolled in this study.
Data collection is complete and several publications from this study are listed below. Analyses focused on contraceptive counseling and provision for HIV-positive women, and knowledge, attitudes, and provision of intrauterine devices and other long-acting reversible contraceptive methods in Southern Africa is underway.
This study is being conducted by researchers at the University of California, San Francisco and Ibis Reproductive Health and is funded by NICHD.
Harper C, Holt K, Nhemachena T, Chipato T, Ramjee G, Stratton L, et al. Willingness of clinicians to integrate microbicides into HIV prevention practices in Southern Africa. AIDS and Behavior. 2012: 1-9.
Henderson JT, Sawaya GF, Blum M, Stratton L, Harper CC. Pelvic examinations and access to oral hormonal contraception. Obstetrics & Gynecology. 2010; 116(6): 1257-64.
Holt K, Blanchard K, Chipato T, Nhemachena T, Blum M, Stratton L, et al. A nationally representative survey of healthcare provider counselling and provision of the female condom in South Africa and Zimbabwe. BMJ Open. 2013; 3(3).
Morse J, Chipato T, Blanchard K, Nhemachena T, Ramjee G, McCulloch C, Blum M, Saleeby E, Harper CC. Provision of long-acting reversible contraception in HIV-prevalent countries: results from nationally representative surveys in southern Africa. BJOG. October 2013; 1386-94
Sheldon WR, Nhemachena T, Blanchard K, Chipato T, Ramjee G, Trussell J, et al. Male circumcision for HIV prevention: Clinical practices and attitudes among healthcare providers in South Africa and Zimbabwe. Sexually Transmitted Diseases. 2012; 39(7): 567-75.
Interpersonal Communication to encourage use of female condoms in Zambia
Under the Expanding Effective Contraceptive Options (EECO) project, Population Services International (PSI) and its Zambian subsidiary, the Society for Family Health (SFH), registered and launched the new Maximum Diva brand Woman’s Condom (MDWC) in Zambia in February 2016. Researchers are using a randomized evaluation to measure the impact of an interpersonal communication (IPC) program—which are person-to-person or small group interactions aimed at increasing the sharing of information, feelings and experience—on self-reported knowledge, acceptability, and use of condoms in the context of the mass distribution and mass marketing campaign of the MDWC.
A baseline survey was conducted prior to the MDWC distribution and launch of the supporting marketing campaign. Researchers will randomly assign 40 wards in Lusaka to either receive an IPC program or serve as the comparison group (20 wards each). Local young people recruited and trained in IPC interventions will set up information booths in central market areas in each intervention ward, and go door to door, in order to organize groups of young people to participate in the IPC sessions. These IPC sessions will occur over a 6 month period.
Researchers will measure the impact of the IPC intervention by comparing outcomes in wards that receive the program to wards in the comparison group that do not receive the program. To measure the impact of this intervention, researchers will compare overall condom use, use of the female condom, and willingness to use a female condom between comparison and IPC wards. They will also non-randomized methods to measure the effect of the distribution and mass media campaign on contraception knowledge, attitudes and practices.
Data collection is underway with results expected in Spring 2017.
This project is being funded by a two year grant from USAID.
Evaluation of the national South African female condom program: Investigating factors associated with uptake and sustained use
Location: South Africa
The evaluation uses a mixed-methods approach and has three complementary components. First, a national evaluation sample including all 265 STI Sentinel surveillance sites in the public sector and a sample of non-public sector sites (NGOs, social marketing, tertiary education, and private) are participating in a telephone survey and review of distribution statistics. A sub-sample of these sites will participate in a more intensive phase involving site visits, client and provider interviews, and collection of basic costing data.
The second component includes a cohort of 500 new female condom acceptors and 60 of their male partners for a longitudinal assessment of key outcomes related to female condom and male condom use, HIV-related behaviors, and relationship characteristics.
The third component consists of key informant interviews with policymakers and program managers.
Data collection is underway and scheduled to conclude in mid-2016 with results expected in late 2016.
This 3-year grant from USAID is awarded to MRU (MatCH Research Unit), Department of Obstetrics and Gynaecology, University of the Witwatersrand, under the second round of the “Implementation Science Research to Support Programs under PEPFAR.” The HIV Centre, University of Columbia, is a collaborating partner.
Potential distribution channels for the Woman's Condom in China
Location: Multiple sites across nine provinces in China
Female condoms are a new product in China. They are not currently included in the national family planning program or HIV prevention programs, and few women or men have seen or heard of female condoms. Female condoms have been evaluated primarily in studies focused on sex workers. To explore public and commercial sector opportunities for the Woman’s Condom in China, research partners have implemented five market tests to assess uptake and acceptability of the Woman’s Condom across different market segments in nine provinces in China. These included: 1) unmarried youth/factory workers at MSI clinics in 3 cities, with MSI; 2) married couples/general population at family planning centers in Beijing (urban) and 10 villages in Guangdong (rural), with the China Population and Development Research Center and China Contraceptive Supplies Administration; 3) married couples/general population at family planning centers in 3 cities, with the Shanghai Institute of Planned Parenthood Research; 4) female sex workers in 3 cities, with the Beijing Union Medical College; and 5) HIV discordant couples in Sichuan and Hunan provinces, with the National AIDS Control Center (NCAIDS).
The methodology for each market assessment was developed by the local research partner in consultation with PATH. In all studies participants were asked to report on use over several months.
The Woman’s Condom was well accepted by women/couples across all target groups, with 58%-89% of the participants across the market tests expressing willingness to continue use, and 10% reporting liking it very much. The MSI market study generated particular interest by the family planning stakeholders, since the MSI clinic reaches target groups not well covered by government clinics. The NCAIDS study showed that including the Woman’s Condom into outreach services for sero-discordant couples helped increase levels of protected sex and reduced the reported levels of forced sex. Health providers and family planning managerial staff at various levels were positive about introducing this new contraceptive method. Results from the market tests were shared with family planning and HIV stakeholders and provincial and district levels decision makers at two stakeholder meetings in late 2014.
A pilot study evaluating the functionality of the Panty Condom
Pilot functionality evaluation
Location: South Africa
There are no published data on the performance of the Panty Condom (PC). We conducted a pilot study among experienced female condom users in Durban, South Africa to assess the functional performance of the PC. Nineteen participants were recruited and returned for a follow-up survey after five uses of the PC. Results of the trial have been submitted for publication.
The study was conducted by MRU (MatCH Research Unit) and is funded by the Universal Access to Female Condoms (UAFC) Joint Programme and I+Solutions.
Performance and failure mode study comparing the Woman’s Condom and the FC2 female condom, and using prostate-specific antigen as a biomarker of semen exposure
Randomized crossover study
Location: United States
This study is a randomized crossover study comparing self-reported clinical failure rates among 330 couples using the Woman’s Condom and the FC2 female condom. The secondary objects are: to compare the ability of the Woman’s Condom and the FC2 to prevent vaginal exposure to semen, as indicated by detection of PSA within the vagina; to calculate the sensitivity and specificity of reported failures for the presence of semen, using PSA as the indicator of the presence of semen; and to compare acceptability of the Woman's Condom and FC2.
The clinical portion of this study was completed in 2011. The statistical report has been submitted to the FDA.
A manuscript presenting study results is in process.
This study was implemented by California Family Health Council; CONRAD is the regulatory sponsor.
Mauck et.al. Critical next steps for female condom research – report from a workshop. Contraception. 2009 May;79(5):339-44.
Woman’s Condom safety and contraceptive efficacy study
Contraceptive effectiveness study
Location: 10 research sites in the United States
Begun in 2011, this is a multi-center, open-label, non-comparative study testing the safety and efficacy of the Woman’s Condom among 450 women recruited from 10 research centers in the United States. Participants agreed to use the Woman’s Condom as their primary contraceptive method for 6 months. A subset of women participated in a sub-study using prostate specific antigen (PSA) as a biomarker of semen exposure. These PSA data will be compared to PSA data collected as part of the CONRAD comparative performance and failure mode study (see previous entry), to build evidence of the sensitivity and specificity of PSA to measure female condom failures.
The clinical portion of this study was completed in late 2012, and data analyses are underway. The clinical study report is being drafted for FDA review.
This study was implemented by NICHD; CONRAD is the regulatory sponsor.