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There are also additional Prostitutes Mbeya 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 Prostitutes Mlowo [44][45]. During this microbicide trial feasibility study Prostitutes Mlowo northern Tanzania, we were able to recruit and retain a large number of participants from a high-risk occupational cohort of women Prostitutes Mbeya to engage in transactional sex.

Of the potential Prostitutes Mlowo identified during community Prostitutes Mbeya, Among a sub-cohort of Prostitutes Mbeya negative non-pregnant women attending a first Prostitutes Mbeya who would have been considered broadly eligible to enroll in a microbicide trial, there were Prostitutes Mlowo early losses to follow-up.

Subsequent retention among a sub-cohort of eligible women who attended a second clinic visit was however more satisfactory. Comparable Prostitutes Mbeya rates have been reported in similar high-risk occupational groups and in female sex worker cohorts elsewhere in Africa Prostitutes Mbeya in Prostitutes Mbeya Asia [46][47][48][49][50]illustrating the considerable logistical difficulties that need to be addressed when working with such study populations.

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Key factors likely to have contributed to the early losses observed in Mwanza include single clinic attendance by women who wanted to receive STI treatment alone but who had no intention of remaining in the study; attendance by women curious to know more about the study having attended community mobilization Prostitutes Mlowo but who subsequently decided not to participate further; and difficulties tracing women in the community to remind them to re-attend clinic due to inaccuracies in baseline locator information and high cohort mobility [26][37].

Prostitutes Mlowo is difficult however, to define a suitable cut off level for HIV incidence above which prevention Prostitutes Prostitutes Mlowo are likely to be feasible because in any given at-risk Prostitutes Mlowo population, feasibility depends on additional interrelated factors, principally the total sample size likely to be achievable and the risk of significant losses to follow up.

Prior Prostitutes Mlowo the MDP trial in Mwanza, a second, more intensive, participatory community Prostitutes Mlowo survey was conducted in Maywhich identified a Prostitutes Mbeya of women working in facilities. In addition, there are considerable challenges in attempting to contact all potential participants in this setting Prostitutes Mlowo to a variety of external contextual factors e.

The total sample size considered achievable was hence estimated Prostitutes Mlowo around — subjects. This essentially makes single-centre HIV prevention trials unfeasible in this setting, particularly when current candidate Prostitutes Mbeya microbicides and HIV vaccines are expected to be only Prostitutes Mlowo Prostitutes Mbeya.

In addition, given the modest overall HIV incidence Prostitutes Mbeya in the Mwanza feasibility study cohort Prostitutes Mbeya the relatively high incidence seen among younger women working Prostitutes Mbeya modern bars and restaurants 4. In addition there were significant reductions in reported numbers of sexual partners and the prevalence of laboratory-confirmed STIs and vaginal infections observed and an increase in reported condom use with non-regular partners.

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An alternative explanation is that these findings are the result of effective clinical Prostitutes Mlowo for STI management and Prostitutes Mlowo reduction counselling, as reported in similar studies elsewhere [48][53]. Social desirability bias may also have played some role in modifying reported sexual behaviour over the period of follow-up.

Researchers in a variety of settings have conducted preparedness or feasibility studies in order to assess the suitability of potential study populations for future HIV prevention trials [5][6][7][8][10][11][12][13].

Pregnancy rates were Prostitutes Mlowo high during the feasibility study but lower than those observed in some Prostitutes Mbeya at-risk cohorts, for Prostitutes Mlowo, among female sex Prostitutes Mbeya in Madagascar, where an incidence of 53 pregnancies Prostitutes Mbeya PYs has been reported [43].

Low contraceptive prevalence and the lack of predictive value of stated intent to become pregnant are also cause for concern and represent a major risk to the successful conduct and completion of any future microbicide trial in this setting.

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In order Prostitutes Mlowo minimise this risk during the MDP trial, potential participants were advised in community meetings and during informed consent procedures that they should only consider enrolment if they were willing to forgo further pregnancies during the trial; that they should not enrol Prostitutes Mlowo they were considering pregnancy in the next 6—12 months; and that they should consider using highly effective family planning methods such as long-acting intramuscular progesterone, oral contraceptive pill Prostitutes Mbeya the intra-uterine Prostitutes Mlowo device IUCD.

These strategies were partly successful: in the first months of the main phase Prostitutes Mlowo trial Prostitutes Mbeya Mwanza, the incidence of pregnancy was In addition to the epidemiological considerations above there are a range of other factors that contribute to feasibility, principally ethical considerations; a Prostitutes Mbeya discussion of which is beyond the scope of this paper but which are described in detail elsewhere [26].

The prevalence and nature of intravaginal practices are also important since internal cleansing and the use of vaginal inserts such as herb poultices could have a significant impact on the apparent efficacy of a future trial product, particularly if these are carried out immediately before or after sex when they may inactivate Prostitutes Mbeya remove the candidate microbicide under Prostitutes Mbeya. In Mwanza, detailed quantitative and qualitative research was conducted Prostitutes Mlowo the feasibility study in order to better understand the nature, timing and different types of intravaginal practices prevalent in this setting Allen C et al, Prostitutes Mlowo, October The Mwanza Prostitutes Prostitutes Mlowo study data suggest that women working in food and recreational facilities in Tanzania and other parts of sub-Saharan Prostitutes Mlowo are likely to be suitable study populations for microbicide and Prostitutes Mlowo HIV prevention trials.

We thank the staff of the National Institute for Medical Research, Tanzania and the African Medical and Research Foundation, Tanzania for their support and assistance in carrying out this study.

Our special thanks go to Prostitutes Mlowo women of Mwanza who participated in the study.

Competing Interests: The authors Prostitutes Mlowo declared that no competing Prostitutes Mbeya exist. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. National Center for Biotechnology InformationU.

Prostitutes Mlowo One. Ian R. Suzanna C. Richard J. Landon Myer, Editor. Author information Article notes Copyright and License information Disclaimer.

This is an open-access article distributed under Prostitutes Mbeya terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in Prostitutes Mlowo medium, provided the original author and source are Prostitutes Mbeya credited.

This article has been Prostitutes Mlowo by other articles in PMC. Abstract Background Prostitutes Mlowo feasibility study was conducted to investigate whether an occupational at-risk cohort of women in Mwanza, Tanzania are a suitable study population for Prostitutes Mbeya phase III vaginal microbicide trials.

Prostitutes Mbeya Introduction In many developed and developing countries, HIV prevention trials are usually undertaken among vulnerable, disadvantaged communities at high-risk of HIV Prostitutes Mbeya STIs, where HIV incidence rates make randomised controlled clinical trials feasible [1][2] but where poverty and social exclusion Prostitutes Mbeya ethical considerations are paramount [3][4].

Methods Prostitutes Mbeya Prostitutes Mlowo The design of the study, study population Prostitutes Mlowo laboratory methods have been described previously [37].

Study procedures and investigations Free reproductive health services, including syndromic management of STIs, family planning, health education, and voluntary HIV counselling and testing VCT were provided. Statistical Methods Data were Prostitutes Mlowo and verified.

Prostitutes Mlowo Mbeya Results General characteristics of the study population Participatory community mapping conducted in March showed that there Prostitutes Mbeya around women working in food and recreational facilities in ten administrative wards in Mwanza City [37].

Table 1 Prostitutes Mlowo among women eligible to enrol in a Prostitutes Mbeya microbicide trial.

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Attendance Visit Full cohort Eligible and Prostitutes Mlowo at baseline 1 Eligible and attending at 3 mo. Of these Participants were tested Prostitutes Mlowo each incident endpoint at baseline, and at three-monthly intervals during follow-up.

Incidence was calculated as the Prostitutes Mbeya of new cases divided by the total time in years that participants remained in the study without the incident endpoint of interest.

Following standard Prostitutes Mlowo, participants were considered censored at their last recorded study visit. By definition, HIV prevalence was therefore zero among eligible women at baseline.

Table 4 Prevalence of Prostitutes Mlowo, pregnancy, contraception and reported Prostitutes Mbeya behaviour at baseline Prostitutes Mbeya scheduled follow-up visits among potential trial participants.

For each variable, we modelled the change in prevalence between visits using a random-effects logistic regression model adjusting for Prostitutes Mlowo as a continuous Prostitutes Mlowo and including a random intercept.

This modelling approach adjusted for the expected additional correlation between multiple responses by the same participant.

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