A randomized controlled safety and acceptability trial of dextrin sulphate vaginal microbicide gel in sexually active women in Uganda

Bakobaki, Julie; Lacey, Charles; Bukenya, Michael I.; Nunn, Andrew; McCormack, Sheena; Byaruhanga, Romano; Okong, Pius; Namukwaya, Stella; Grosskurth, Heiner; Whitworth, James

doi:10.1097/01.aids.0000194129.05264.55

Cited by 13 publications

(4 citation statements)

References 8 publications

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“…MIA001 [15]: A randomised trial to assess the safety of a vaginal microbicide gel versus vehicle placebo in Uganda http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=136 A researcher from the trial team felt that there had been a direct impact of involving consumers in terms of the team "being more confident that we were appropriately targeting and responding to consumer needs"…”

Section: Resultsmentioning

confidence: 99%

Involvement of consumers in studies run by the Medical Research Council Clinical Trials Unit: Results of a survey

Vale

Thompson

Murphy

et al. 2012

Trials

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BackgroundWe aimed to establish levels of consumer involvement in randomised controlled trials (RCTs), meta-analyses and other studies carried out by the UK Medical Research Council (MRC) Clinical Trials Unit across the range of research programs, predominantly in cancer and HIV.MethodsStaff responsible for studies that were included in a Unit Progress Report (MRC CTU, April 2009) were asked to complete a semi-structured questionnaire survey regarding consumer involvement. This was defined as active involvement of consumers as partners in the research process and not as subjects of that research. The electronic questionnaires combined open and closed questions, intended to capture quantitative and qualitative information on whether studies had involved consumers; types of activities undertaken; recruitment and support; advantages and disadvantages of involvement and its perceived impact on aspects of the research.ResultsBetween October 2009 and April 2010, 138 completed questionnaires (86%) were returned. Studies had been conducted over a 20 year period from 1989, and around half were in cancer; 30% in HIV and 20% were in other disease areas including arthritis, tuberculosis and blood transfusion medicine. Forty-three studies (31%) had some consumer involvement, most commonly as members of trial management groups (TMG) [88%]. A number of positive impacts on both the research and the researcher were identified. Researchers generally felt involvement was worthwhile and some felt that consumer involvement had improved the credibility of the research. Benefits in design and quality, trial recruitment, dissemination and decision making were also perceived. Researchers felt they learned from consumer involvement, albeit that there were some barriers.ConclusionsWhilst most researchers identified benefits of involving consumers, most of studies included in the survey had no involvement. Information from this survey will inform the development of a unit policy on consumer involvement, to guide future research conducted within the MRC Clinical Trials Unit and beyond.

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Section: Resultsmentioning

confidence: 99%

Involvement of consumers in studies run by the Medical Research Council Clinical Trials Unit: Results of a survey

Vale

Thompson

Murphy

et al. 2012

Trials

View full text Add to dashboard Cite

show abstract

“…HIV incidence rates need to be sufficiently high to support large scale clinical trials; cost-effective strategies for recruiting and retaining sufficient numbers of subjects need to be available or developed; the impact of effective risk reduction counseling and syndromic STI management on HIV and STI rates during follow up need to be taken into account; the ability to collect reliable, valid sexual behaviour data assessed; and key risks to future clinical trials, such as high pregnancy rates and differential losses to follow-up of those most at risk of HIV seroconversion, appraised and corrective strategies developed. There are also additional issues specific to vaginal microbicide trials that need to be taken into account such as product acceptability (among participants and their sexual partners)[39], [40], [41], [42], [43] and intravaginal practices[44], [45].…”

Section: Discussionmentioning

confidence: 99%

Are Women Who Work in Bars, Guesthouses and Similar Facilities a Suitable Study Population for Vaginal Microbicide Trials in Africa?

et al. 2010

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BackgroundA feasibility study was conducted to investigate whether an occupational at-risk cohort of women in Mwanza, Tanzania are a suitable study population for future phase III vaginal microbicide trials.Methodology/Principal Findings1573 women aged 16–54 y working in traditional and modern bars, restaurants, hotels, guesthouses or as local food-handlers were enrolled at community-based reproductive health clinics, provided specimens for HIV/STI and pregnancy testing, and asked to attend three-monthly clinical follow-up visits for 12-months. HIV positive and negative women were eligible to enter the feasibility study and to receive free reproductive health services at any time. HIV prevalence at baseline was 26.5% (417/1573). HIV incidence among 1156 sero-negative women attending at baseline was 2.9/100PYs. Among 1020 HIV sero-negative, non-pregnant women, HIV incidence was 2.0/100PYs, HSV-2 incidence 12.7/100PYs and pregnancy rate 17.8/100PYs. Retention at three-months was 76.3% (778/1020). Among 771 HIV sero-negative, non-pregnant women attending at three-months, subsequent follow-up at 6, 9 and 12-months was 83.7%, 79.6%, and 72.1% respectively. Older women, those who had not moved home or changed their place of work in the last year, and women working in traditional bars or as local food handlers had the highest re-attendance.Conclusions/SignificanceWomen working in food outlets and recreational facilities in Tanzania and other parts of Africa may be a suitable study population for microbicide and other HIV prevention trials. Effective locally-appropriate strategies to address high pregnancy rates and early losses to follow-up are essential to minimise risk to clinical trials in these settings.

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“…; Bakobaki et al . ; D'Cruz and Uckun ) for example. Their charged structure apparently restricts cellular adhesion and subsequently cell entry of viruses (e.g.…”

Section: Prebioticsmentioning

confidence: 99%

Biotherapeutic agents and vaginal health

Al‐Ghazzewi¹,

Tester²

2016

J Appl Microbiol

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Summary Treatment of vaginal infection requires different drugs although the recurrence rate post treatment remains high due to adverse effects on the beneficial microbiota. Thus, there are clear clinical advantages for the use of biotherapeutic agents (prebiotics and/or probiotics) for treating these infections. Pre‐ and probiotic beneficial effects can be delivered topically or systemically. In general, both approaches have the potential to optimize, maintain and restore the ecology of the vaginal ecosystem. Specific carbohydrates provide a therapeutic approach for controlling infections by stimulating the growth of the indigenous lactobacilli but inhibiting the growth and adhesion of pathogens to the vaginal epithelial cells. Overall, little evidence exists to promote the prevention or treatment of vaginal disease with prebiotic carbohydrates in formulations such as pessaries, creams or douches. However, recent reports have promoted prebiotic applications in ecosystems other than the gut and include the mouth, skin and vagina. This review focuses on the utilization of pre‐ and probiotics for vaginal health.

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A randomized controlled safety and acceptability trial of dextrin sulphate vaginal microbicide gel in sexually active women in Uganda

Abstract: Results show a satisfactory safety and acceptability profile of dextrin sulphate gel.

Cited by 13 publications

References 8 publications

Involvement of consumers in studies run by the Medical Research Council Clinical Trials Unit: Results of a survey

Involvement of consumers in studies run by the Medical Research Council Clinical Trials Unit: Results of a survey

Are Women Who Work in Bars, Guesthouses and Similar Facilities a Suitable Study Population for Vaginal Microbicide Trials in Africa?

Biotherapeutic agents and vaginal health

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