Dataset Information

Efficacy of antiviral drug AV2 in the treatment of human papillomavirus-associated precancerous lesions of the uterine cervix: A randomized placebo-controlled clinical trial in Kinshasa, DR Congo. (KINVAV study).

ABSTRACT: Background:Cervical Cancer (CC) is a major public health problem in DR Congo; the high incidence of CC is due to the inexistence of effective screening programs based on cytology and/or HPV detection followed by appropriate treatments. This situation highlights the need to implement efficacious and inexpensive treatment methods. This study aims at evaluating the efficacy of a topical antiviral drug named AV2® as a treatment for HPV-associated lesions of the cervix. Methods:Women will undergo cytology sampling, HPV testing and Visual inspection of the cervix after application of 5% acetic acid (VIA). VIA-positive women will be randomized to one of two groups to receive treatment by either AV2®or placebo. They will undergo control examinations after two months and after six months. In case of persistent lesions on VIA, treatment by cryotherapy will be done. The primary outcomes will be the change of lesions, the clearance of HPV DNA, and the correlation of the two 2 months after treatment with AV2®. Conclusion:This study is the first large-scale study in Africa to evaluate systematically the efficacy and safety of a topical antiviral drug for the treatment of HPV- associated lesions of the cervix. Its findings will direct the planning of suitable algorithms for CC screening and treatment. Clinical trial registration:ClinicalTrials.gov - Unique identifier: NCT02346227, registered on November 8, 2014.

SUBMITTER: Mutombo AB

PROVIDER: S-EPMC5898533 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Efficacy of antiviral drug AV2 in the treatment of human papillomavirus-associated precancerous lesions of the uterine cervix: A randomized placebo-controlled clinical trial in Kinshasa, DR Congo. (KINVAV study).

Mutombo Alex Baleka AB Tozin Rahma R Simoens Cindy C Lisbeth Ramokone R Bogers Johannes J Van Geertruyden Jean-Pierre JP Jacquemyn Yves Y

Contemporary clinical trials communications 20170928

<h4>Background</h4>Cervical Cancer (CC) is a major public health problem in DR Congo; the high incidence of CC is due to the inexistence of effective screening programs based on cytology and/or HPV detection followed by appropriate treatments. This situation highlights the need to implement efficacious and inexpensive treatment methods. This study aims at evaluating the efficacy of a topical antiviral drug named AV2<sup>®</sup> as a treatment for HPV-associated lesions of the cervix.<h4>Methods< ...[more]

PMID: 29696202

Similar Datasets

Project description:BackgroundCervical cancer is the most frequent cancer of women in the Democratic Republic of Congo (DRC). Nevertheless, the level of women's awareness about cervical cancer is unknown. Knowledge, attitude and practice (KAP) are important elements for designing and monitoring screening programs. The study purpose was to estimate KAP on cervical cancer and to identify associated factors.MethodsA cross-sectional study was conducted in Kinshasa, DRC, including 524 women aged 16-78 years (median age 28; interquartile range 22-35). The women were interviewed at home by trained field workers using a standardized questionnaire. The women's score on knowledge, attitude and practice were dichotomized as sufficient or insufficient. We used binary and multiple logistic regression to assess associations between obtaining sufficient scores and a series of socio-demographic factors: age, residence, marital status, education, occupation, religion, and parity.ResultsThe women's score on knowledge was not significantly correlated with their score on practice (Spearman's rho = 0.08; P > 0.05). Obtaining a sufficient score on knowledge was positively associated with higher education (adjusted odds ratio (OR) 7.65; 95% confidence interval (95% CI) 3.31-17.66) and formal employment (adjusted OR 3.35; 95% CI 1.85-6.09); it was negatively associated with being single (adjusted OR 0.44; 95% CI 0.24-0.81) and living in the eastern, western and northern zone of Kinshasa compared to the city centre. The attitude score was associated with place of residence (adjusted OR for east Kinshasa: 0.49; 95% CI 0.27-0.86 and for south Kinshasa: 0.48; 95% CI 0.27-0.85) and with religion (adjusted OR 0.55; 95% CI 0.35-0.86 for women with a religion other than Catholicism or Protestantism compared to Catholics). Regarding practice, there were negative associations between a sufficient score on practice and being single (adjusted OR 0.24; 95% CI 0.13-0.41) and living in the eastern zone of the city (adjusted OR 0.39; 95% CI 0.22-0.70). Although 84% of women had heard about cervical cancer, only 9% had ever had a Papanicolaou (Pap) smear test.ConclusionsThis study shows a low level of knowledge, attitude and practice on cervical cancer among women in Kinshasa. Increasing women's awareness would be a first step in the long chain of conditions to attain a lower incidence and mortality.

Project description:Background:Non-surgical topical therapies have been assessed in the treatment of precancerous lesions of the cervix. Their use can offer logistical and feasibility advantages in low-resource settings. Antiviral AV2® is a mixture of natural essential oils (eugenol, carvone, nerolidol, geraniol) in olive oil, and has a broad spectrum anti-viral activity. In a phase II randomized controlled trial (RCT), AV2® proved effective in reducing the size of cervical lesions associated with human papillomavirus (HPV). The purpose of the present study was to further evaluate the efficacy of AV2 over placebo in the topical treatment of HPV-associated cervical lesions. Methods:Women aged 25 years and older were included in this phase 3 RCT. Cytology screening, HPV testing and visual inspection of the cervix with 5% acetic acid (VIA) were performed on all participants. VIA-positive women were randomized to one of two groups to receive treatment by either AV2® or placebo. The treatment consisted of 2 puffs of spray of the investigational drug directed to the cervix. Participants were subjected to repeat examinations two months and six months later for assessment of outcomes. The primary outcome was the change of lesions on VIA at 2 months after application of the investigational drug. Secondary outcomes were: HPV clearance and cytologic regression at 2 months and 6 months, and number of participants with AEs. Results:A total 327 VIA positive women were randomized in two groups (168 in AV2 group and 159 in placebo group). Women in the 2 groups were similar with respect to baseline demographics and clinical characteristics. At 2 months, regression of lesions on VIA was observed in 127 (89.4%) out of 142 women in AV2 group compared to 120 (91.6%) out of 131 women in placebo group (P?=?0.7). On cytology, regression of lesions occurred in 14 (56%) out of 25 women in the AV2 arm and in 13 (48.1) out of 27 women in the placebo arm (p?=?0.7), and HPV clearance rates were 34.1% and 35% in AV2 group and placebo group respectively (p?=?0.8). At 6 months cytologic regression was observed in 64.7% of women in AV2 group and 45.8% in placebo group (p?=?0.2), while HPV clearance occurred in 11 (51.9%) out of 17 women in AV2 arm versus 11 (34.4%) in placebo arm (p?=?0.3).Some local side effects (burning, itching, irritation) were similarly noted in the 2 groups (p-values?=?0.169, 0.623 and 0.172 respectively) but they were mild and transitory. Conclusion:A topical application of AV2 onto the cervix can induce the regression of cervical precancerous lesions, but its efficacy does not significantly differ with that of placebo. The discrepancy between the expected and the recorded sample size as well as the huge number of lost to follow-up probably impeded the power of analyses, which could be one of the reasons for the lack of difference seen between AV2 and placebo. Further evaluation of the effects of AV2 with different diagnostic methods and treatment regimen and arms is warranted. Clinical trial registration:NCT02346227 registered on November 8, 2014.

Project description:IntroductionPrecancerous lesions of the cervix are changes in cervical cells that make them more likely to develop into cancer. Understanding the prevalence and determinants of the precancerous lesions of the cervix among women helps to take an action like vaccination programs, improving screening coverage, and close management and follow-up which could decrease the morbidity and mortality caused by cervical cancer.Materials and methodsThe international databases, PubMed/MEDLINE, Web of Science, EMBASE, CINAHL, Google Scholar, Science Direct and Cochrane Library and unpublished reports were systematically searched. Two authors independently extracted all necessary data using a standardized data extraction format. STATA 14 statistical software was employed to analyse the data. The Cochrane Q test statistics and I2 tests were used to assess the heterogeneity between the studies. A random-effect model was computed to estimate the pooled prevalence of precancerous lesions of the cervix in Ethiopia. Determinants of the precancerous lesion of cervix (early initiation of sexual intercourse, multiple sexual partners, and history of sexually transmitted infection) were analysed.ResultsThirteen studies fulfilled the inclusion criteria and included in the meta-analysis. The I2 test result showed high heterogeneity (I2, 93.2%, p = <0.001). Using the random effect analysis, the pooled prevalence of precancerous lesions of the cervix among women in Ethiopia was 14.21% (95% CI (10.49, 17.94). After adjusting of publication bias using trim-and-fill method, the pooled prevalence was 9.43% (95% CI (5.23, 13.62). Women who had multiple sexual partners in their lifetime (OR:2.67 CI: 1.49,4.79) and had a history of sexually transmitted infections (OR:6.22 CI: 2.99,12.92) were more likely to have a precancerous lesion of the cervix.ConclusionThe pooled prevalence of the precancerous lesions of the cervix among Ethiopian women was 9.43%. It was associated with having multiple sexual partners and a history of sexually transmitted infections.

Project description:IntroductionPrehospital care in many low- and middle-income countries is underdeveloped and needs strengthening for improved outcomes. Where formal prehospital care systems are under development, integration of a layperson first responder programme may help improve access for those in need. The World Health Organization recently developed the Community First Aid Responder (CFAR) learning program in support of this system, providing that it may require adaptation to be contextually suitable and sustainably implemented at country level. This study assesses a pilot WHO CFAR course in Kinshasa, Democratic Republic of Congo, to inform future rollouts and related research.MethodsWe conducted a 3-day in-person pilot CFAR training with 42 purposively selected community health workers. Data collection involved quantitative and qualitative phases. The first consisted of structured pre- and post-training surveys, and a course evaluation by participants. The second consisted of two focus group discussions involving purposively selected community health workers in one group, and a convenience sample of course instructors and organisers in the other. Perceptions regarding course content, perceived knowledge acquisition and self-confidence gain were analysed using descriptive statistics for the quantitative data and content analysis for qualitative data.ResultsCourse participants were predominantly male (76.3 %) with a median age of 42 years and most (80.5 %) had no prior first aid training. Most were satisfied that the learning objectives were reached, the logistics were adequate, and that the content and teaching language were appropriately tailored to local context. The majority (94.7 %) found the 3-day duration insufficient. There was a significant self-confidence gain regarding first aid skills (average 17.9 % in pre- to 95.3 % in post-training, p < 0.001). Favourable opinions on the course structure, content, logistics and teaching methods were noted.ConclusionA CFAR course pilot was successfully conducted in Kinshasa. The course is appropriate for context and well received by participants. It can form a key component of developing prehospital care systems in resource-constrained settings.

Dataset Information

Efficacy of antiviral drug AV2 in the treatment of human papillomavirus-associated precancerous lesions of the uterine cervix: A randomized placebo-controlled clinical trial in Kinshasa, DR Congo. (KINVAV study).

Publications

Efficacy of antiviral drug AV2 in the treatment of human papillomavirus-associated precancerous lesions of the uterine cervix: A randomized placebo-controlled clinical trial in Kinshasa, DR Congo. (KINVAV study).

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets