Table 1.
Characteristics of included studies table
| Study Id | Study period | Design | Country | Sample size | Participants | Intervention | Comparator | Outcome assessment |
|---|---|---|---|---|---|---|---|---|
| FC1 + MC compared to MC | ||||||||
| Fontanet 1998 [29] | 1994–1995 | Community based cluster randomised trial (sex establishments) | Thailand | 548 | Women aged over 18 years, female sex workers, not be pregnant, not using a diaphragm, cervical cap, vaginal spermicides or intravenous drugs and should have no evidence of STI | 282 women were randomised to FC1 + MC. Participants received training on condom use at baseline |
266 women randomised to MC only. Participants received training on condom use at baseline |
Incidence of STI Chlamydia: Elisa Gonorrhea: culture Adverse effects Information from coital logs and questionnaires Failure modes Information from coital logs and questionnaires |
| Feldblum 2001 [30, 42, 43] | Not stated | Community based cluster randomised trial | Kenya | 1929 | Women aged 18 ± 50 years of age who are not pregnant or desiring pregnancy in the coming year, sexually active and permanent female plantation employees | 969 women were randomised to FC1 + MC. Participants received training on condom use at baseline | 960 women randomised to MC only. Participants received training on condom use at baseline |
Incidence of STI Gonorrhoea & chlamydia: ligase chain reaction on urine specimens Vaginal trichomoniasis: InPouchTM TV test system |
| Ray 2001 [41] | Not stated | Community based randomised trial | Zimbabwe | 149 | Women aged over 18 who are female sex workers with at least three different paying clients the previous month and residents of Harare | 99 women randomised to FC1 + MC | 50 women randomised to MC only |
Incidence of HIV Methods of outcome measurement not described Incidence of STIs gonorrhoea: culture Trichomonas: culture Chlamydia: enzyme immunoassay Syphyliis: RPR and TPHA Failure modes Information on condom breakage, and reports of invagination and misdirection during interviews Adverse events Information on problems, irritation and discomfort during structured interviews |
| French 2003 [40] | 1995–1996 | Clinic based randomised trial | USA | 1442 | Women clinically evaluated on at least one occasion at the main public STD clinic in Philadelphia during the study period. Age range not specified | 855 women randomised to FC1 and had access to MCs. They received counselling sessions on the FC | 587 women randomised to MC only. They received enhanced MC counselling sessions |
Incidence of STIs Gonorrhea: culture Chlamydia: Gen-Probe Pace 2C Early syphilis: RPR/MHA or FTA analysis Trichomoniasis: Wet mount microscopy |
| FC1 compared to MC | ||||||||
| Galvao 2005 [31, 44] | Not stated | Clinic based crossover randomised trial | Brazil | 400 | Women aged between 15 and 49 years old, sexually active, had not been using condoms as primary birth control method for 1 year or longer and willing to try both FCs and MCs. They had to be able to read the instruction sheet of the FC and MC packages and willing to comply with the study protocol | At different sequences, women were randomly assigned to use FC1 or MCs. Patients were randomly assigned to receive in-clinic educational instructions on condom use or the recommendation to read the condom package inserts. |
Failure modes Information collected using condom data forms and questionnaires and interviews Adverse events Information collected using condom data forms and questionnaires and interviews Semen exposure Prostate specific antigen |
|
| Macaluso 2007 [32, 44] | 2000–2001 | Clinic based crossover randomised trial | USA | 108 | Women aged over 19 years, in a mutually monogamous relationship, with no STIs during the past 6 months, who reported four or more acts of sexual intercourse in the past 30 days | At different sequences, women were randomly assigned to use FC1 or MCs, all within 4 months. They were given a motivational intervention and instructions on condom use and trained on vaginal fluid sample collection |
Failure modes Information collected using participant filled questionnaires and post-trial interviews Semen exposure Prostate specific antigen |
|
| FC1 compared to FC2 | ||||||||
| Beksinska 2006 [33] | 2004 | Clinic based crossover randomised trial | South Africa | 276 | Women at least 18 years of age who are sexually active, not pregnant or nursing, using a hormonal contraceptive method, IUD or sterilized and in good general and genital health. Participants included urban women from family planning, STI and student clinics, rural women attending family planning clinics and commercial sex workers from a sex worker lodge | At different sequences, women were randomly assigned to use FC2 or FC1 with each condom type to be used over a 2–3 months period |
Condom failure modes Information collected using coital logs and interviews Adverse events Information collected using coital logs and interviews |
|
| FC1 compared to new female condoms | ||||||||
| Schwartz 2008 [39] | 2004–2005 | Clinic based Crossover randomised trial | USA | 75 | Couples ≥18 yrs. with low risk for HIV or STIs without any known sensitivities or allergies to study products or prior experience with FCs. Those at risk for pregnancy used a steroidal contraceptive | At different sequences, women were randomly assigned to use Woman’s condom or FC1 with each condom type to be used over a 2–4-week period. 3-mL package of lubricant and instructions for use was distributed alongside the Woman’s condom |
Condom failure modes Self-reported information collected using dairies and questionnaires Adverse events Self-reported information collected using dairies and questionnaires |
|
| FC2 compared to new female condoms | ||||||||
| Hou 2010 [37] | 2007 | Community based crossover randomised trial | China | 291 | Women who are female sex workers. Women with an STI, allergies or known sensitivities to polyurethane silicone lubricants, or vaginal lubricants and prior experience with FCs were excluded | At different sequences, women were randomly assigned to use Pheonurse condoms or FC2. An insertion tool, a water-based lubricant, sanitary towels, and disposal bags were provided in the Phoenurse packaging |
Condom failure modes Information collected using daily recording forms given to participants as well as questionnaires |
|
| Joanis 2011 [38] | 2007–2008 | Clinic based crossover randomised trial | South Africa | 170 | Women aged over 18 years, with no known allergies to the study products, using a reliable, non-barrier method of contraception, free of STIs, sexually active and monogamous. They should not be practicing sex workers and should not be pregnant or breastfeeding | At different sequences, women were randomly assigned to use Woman’s condom, V-amour condoms or FC2 with each condom type to be used over a 3 week period. During the Woman’s condom use period, participants were also provided with five packages of water-based lubricant |
Condom failure modes Information collected using coital logs and interviews Adverse events Information collected using coital logs and interviews |
|
| Beksinska 2013 [34] | 2011–2012 | Clinic based non-inferiority crossover randomised trial | China and South Africa | 600 | Women aged 18 to 45 years, with no known allergies to the study products, using a reliable, non-barrier method of contraception, free of STIs, sexually active and monogamous. They should not be practicing sex workers and should not be pregnant | At different sequences, women were randomly assigned to use Woman’s condom, Condom Feminine, Cupid or FC2. Woman’s condom was supplied with a water-based lubricant |
Condom failure modes Information collected using coital logs and interviews Adverse events Information collected using coital logs and interviews |
|
| Beksinska 2015 [35] | 2013–2014 | Clinic based non- inferiority crossover randomised trial | South Africa | 300 | Women aged 18–45 years, no known allergies to study products, using a reliable non barrier method of contraception, free of STIs, sexually active and monogamous. They should not be practicing sex workers and should not be pregnant | At different sequences, women were randomly assigned to use Velvet, Cupid 2 or FC2 |
Condom failure modes Information collected using coital logs and interviews Adverse events Information collected using coital logs and interviews |
|
| Beksinskaa 2018 [36] | 2017 | Crossover randomised trial | South Africa | 55 | Women with mean age of 28 years, with ≥10 years of schooling | At different sequences, women were randomly assigned to use Wondaleaf condom or FC2 |
Condom failure modes Methods of outcome measurement not described |
|
| Beksinska 2019 [45] | 2015–2016 | Clinic based non-inferiority crossover randomised trial | South Africa | 278 | Sexually active monogamous women, 18 to 45 years, with no known allergies to the study products, using a reliable, nonbarrier method of contraception, and free of STIs. Pregnant women were excluded. | At different sequences, women were randomly assigned to use modified Woman’s condom (WC2) or FC2 |
Condom failure modes Information collected using coital logs and interviews Adverse events Information collected using coital logs and interviews |
|
| Cheng 2019 [46]a | Not stated | Randomised trial | Not stated | 300 | Not stated | Women were randomly assigned to use either China made FC (FCc) or USA made FC (FC2) |
Condom failure modes Method of data collection not described |
|
a Conference Poster/Abstract
FC1 Polyurethane female condom; FC2 Synthetic latex prototype female condom; FTA Fluorescent treponemal antibody absorption; FC Female condom
MHA Microhemagglutination assay; MC Male condom; TPHA Treponema Pallidium Hemagglutination; RPR Rapid Plasma Reagin