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 evaluated 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 crossover study, 115 female participants were randomized to use the SILCS Diaphragm with placebo gel (delivered by applicator into SILCS cervical cup) for five sexual acts followed by use of vaginal applicators for five 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 interviewed to gather issues of partner acceptability of each method. These interviews were conducted after completion of their partner's last visit. A sub-sample of male and female participants were also 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 was launched in September 2014, and the clinical portion of the study was completed in January 2015. Results were shared at international conferences in 2016, and a manuscript has been submitted to share the study results more broadly.
This study was funded by USAID via the Program for Appropriate Technology in Health (PATH), and was implemented by MRU (MatCH Research Unit).
Beksinska M, Smit J, Maphumulo B, et al. SILCS Diaphragm as an MPT: new data from South Africa. 14th European Society for Contraception (ESC) Congress, May 2016. Basel, Switzerland.
Beksinska M, Smit J, Maphumulo B, et al. SILCS Diaphragm as a multipurpose prevention technology: An Acceptability study comparing SILCS Diaphragm and standard applicators to deliver vaginal gel in Durban, South Africa. 21st International AIDS Conference, July 18-22, 2016. Durban South Africa.
Postcoital barrier effectiveness study of the SILCS Diaphragm with Contragel
Phase I PCT study, multi-center, randomized crossover, nonsignificant risk
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. Since 2013, Contragel also has been marketed as Caya Gel for use with the Caya (SILCS) diaphragm in more than 25 countries. Contragel has not 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 then evaluated SILCS used with Contragel in a postcoital study of barrier effectiveness. This study compared effectiveness in preventing sperm from penetrating midcycle cervical mucus of each of the following scenarios: SILCS Diaphragm used with 3% N-9 gel; SILCS Diaphragm used with Contragel; and SILCS Diaphragm used with no gel.
The study was launched in late 2014 and completed in August 2016. Twenty-seven women were enrolled into the study and nine women completed all test cycles. Results suggest that SILCS with Contragel appeared to function as well as SILCS with the marketed product N-9 in preventing progressively motile sperm from reaching mid-cycle mucus.
A manuscript was submitted to a peer-reviewed journal in early 2017.
The study was implemented by CONRAD at Eastern Virginia Medical School and by Profamilia in the Dominican Republic. The study was 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 seven 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. Results from this health systems assessment were presented at the European Society for Contraception meeting in Lisbon in May 2014. In 2016, PATH created a Project Brief summarizing key findings.
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
PATH. Feasibility of SILCS introduction in India (Project Brief) September 2016: http://www.path.org/publications/detail.php?i=2648
MRU. Expanding Contraceptive Options for Women:the SILCS Diaphragm. Policy Brief. June 2016.
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 MatCH Research Unit (MRU) 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 guidelines 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 seven 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 a 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 was finalized in 2016, and a project brief is available online. 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. http://sites.path.org/rhtech/files/2014/06/FINAL_SILCS-desk-review_24March2014.pdf
MatCH Research Unit. Assessment of opportunities and challenges for potential introduction of the SILCS Diaphragm in South Africa. October 2016 (Full report and abridged report versions available). http://www.path.org/publications/detail.php?i=2660
PATH. Feasibility of SILCS introduction in South Africa (Project Brief). September 2016. http://www.path.org/publications/files/DT_silcs_hsa_sa_br.pdf