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The following ongoing studies on cervical barriers and female condoms are listed in reverse chronological order based on the start date of the study.

Help us keep the list complete and up to date!

If you have updated information for a study below or know of research that is not included, please email us:
info@cervicalbarriers.org.

Cervical Barriers

Female Condoms

 


Cervical Barriers

Phase I safety study of the SILCS diaphragm used with Contragel

Randomized, parallel double-blind Phase I study

The purpose of this study was to evaluate the safety of ContraGel versus the HEC Universal Placebo gel when used with the Caya diaphragm during two 7-day periods of daily use.   During the first 7-day period, the participant abstained from intercourse and during the second 7-day period, she engaged in two acts of intercourse.

Safety was assessed by adverse events (AEs), colposcopy, vaginal pH, microflora, anti-microbial activity and soluble markers of inflammation in the cervicovaginal fluid (CVF); and epithelial integrity, and immune cell phenotype and activation status in genital tissue.


This study aimed to enroll up to 24 healthy premenopausal women protected from pregnancy by female sterilization. Participants were randomized in a 1:1 ratio to insert the SILCS diaphragm used with either Contragel or the HEC Universal Placebo gel every day for two 7-day periods in two separate menstrual cycles. 

After ethics approvals were received, the study began in July 2015, and closed in July 2016. CONRAD is finalizing the data analyses and reporting, and will draft a manuscript to submit to a peer-reviewed journal to share the study results.


This study was implemented by CONRAD at the Eastern Virginia Medical School, and funded by USAID.


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Female Condoms

Interpersonal Communication to encourage use of female condoms in Zambia

Randomized Evaluation

Location: 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.

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Evaluation of the national South African female condom program: Investigating factors associated with uptake and sustained use
Mixed-methods study

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.

Related publications and presentations:

 

Beksinska ME, Nkosi P, Kubeka M, Smit JA, Mabude Z, Mantell JE, Greener R, Phungula L,

Marumo E, Chidarikire T, Rodríguez H. Who has heard of or ever used the female condom in South Africa? The National Female Condom Evaluation in South Africa. Poster presented at 21st International Aids Conference;  2016 July 18-22; Durban, South Africa.

Mabude Z, Beksinska M, Mantell JE, Nkosi P, Mnguni N, Greener R, Smit J, Jacobson L. “Will he let me use a female condom? Will sex be the same?” Attitudes and experiences of female condom users attending selected public-sector health facilities in KwaZulu-Natal, South Africa. Poster presented at 21st International Aids Conference;  2016 July 18-22; Durban, South Africa.

Beksinska M, Nkosi P, Mabude Z, Smit J, Zulu B, Phungula L, Greener R, Kubeka M, Milford C, Lazarus N, Jali Z, Mantell JE.  Twenty years of the female condom programme in South Africa:  past, present and future. South African Health Review, 2017.  Chapter 14. In: Padarath A, Barron P, editors. South African Health Review 2017. Durban: Health Systems Trust; 2017.

 

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A pilot functional performance study of the Wondaleaf Condom
Randomized controlled study

Location: South Africa

The purpose of this study was to evaluate the functional performance of the Wondaleaf female condom.  Primary endpoints will be total clinical failure and total device failure. Secondary objectives were to assess acceptability and safety data (as determined by the number of adverse events) on each female condom type.

This study aimed to enroll up to 55 healthy women protected from pregnancy by an effective method of contraception. Recruitment was from the Commercial City MatCH Research Unit site in Durban, South Africa. Participants were randomized to condom use order. Each woman was asked to use five Wondaleaf female condoms and five FC2 female condoms.   Function, safety, and acceptability was assessed at two follow-up visits approximately one month after enrollment.

After ethics approvals were received, the study began in July 2017, and closed in November 2017. MRU is finalizing the data analyses and reporting, and will draft a manuscript to submit to a peer-reviewed journal to share the study results.

This study was implemented by MRU, and funded by Twin Catalyst, Malaysia.

 

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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.

 

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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.

Related publications:

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.


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Ibis Reproductive Health

CBAS is coordinated by Ibis Reproductive Health