Orange farm trial


















Thank you, Nicole, for helping us put together such a wonderful itinerary for the day. A real highlight of our stay. Ange Flannery. Nicole Farrell is the founder of Country Food Trails and has been an Orange local for most of her life. With years of experience taking small groups on textile safaris of India and Morocco, Nicole knows how to plan a tour that's fun, flexible and filled with exciting hands-on experiences.

If you're looking for a down-to-earth food and wine tour of Orange, join Nicole on one of our signature tours , or let her design a fully customised private tour. We use cloth napkins and reusable containers, cups and cutlery. We also contribute to Greenfleet to offset our carbon emissions.

To help reduce waste, please:. Got a question or want to enquire about last-minute availability? Call Nicole Facebook Instagram. The Farm Trail. Their bodies were found a few hundred metres away from each other. Residents marching of Orange farm, south of Johannesburg marching after the discovery of bodies of six-year-old Simphiwe Mncina and eight-year-old Mpho Makondo in Extension 4.

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Zuma asks ConCourt to hear his case fairly as he files new court Bodies of two missing children found in Orange Farm. Boy's body found in Orange Farm tavern fridge. The earliest documentary evidence for circumcision is from Egypt. Tomb artwork from the Sixth Dynasty — B. Genesis places the origin of the rite among the Jews in the age of Abraham, who lived around B. Presently, MC practices in Africa are varied. Whereas men in Muslim countries are circumcised, as in North Africa or a large part of West Africa, in other societies the prevalence of MC depends on other cultural factors, such as changes that occurred under colonization.

In countries such as Cameroon and the Democratic Republic of Congo, which are predominately non-Muslim, most men are circumcised [ 1 — 3 ]. In Kenya, where only a minority of men are Muslims, men in all tribes except the Luo practice MC [ 4 ]. The first paper suggesting a protective effect of MC against HIV infection was published in [ 5 ]. Since then, many observational studies have been published, some of which have observed that most men living in East and southern Africa, the regions with the highest prevalence of HIV, are not circumcised [ 1 — 3 ].

A majority of these observational studies are cross-sectional, and a minority are prospective [ 6 — 11 ]. A systematic review and meta-analysis found that in sub-Saharan Africa MC is associated with a significantly reduced risk of HIV infection among men, with an adjusted relative risk of 0.

All of these studies were based on observational data, and, in the absence of experimental studies, a causal relationship between MC and protection against HIV infection could not be determined [ 13 ]. Direct experimental evidence is needed to establish this relationship and, should a protective effect of MC be proven, to convince public health policy makers of the role of MC in reducing the spread of HIV [ 7 , 13 , 14 ].

The primary objective of this study was to determine the impact of MC on the acquisition of HIV by young men through a randomized, controlled, blindly evaluated intervention trial. The secondary objective was to assess the role of behavioural factors known to be associated with HIV serostatus in explaining the possible impact.

This study was conducted in the Gauteng province of South Africa, where HIV prevalence among pregnant women was estimated to be A randomized, controlled, blindly evaluated intervention trial was carried out in Orange Farm and surrounding areas, a semi-urban region close to the city of Johannesburg. The recruitment of participants took place in the general population from July to February Information about the trial was disseminated in the community through meetings during the recruitment period.

Precise oral and written information was delivered at the investigation centre to potential participants during a pre-screen visit. A minimum of 3 d after the pre-screen visit, potential participants were screened for eligibility. Potential participants with genital ulcerations were temporarily excluded until successful treatment. The inclusion and exclusion criteria are listed in Table 1. The protocol, the consent form, and the participant information sheet are provided as Text S1 — S3.

At the end of the screen visit, following screening and written consent, participants were divided into two groups, using sealed envelopes. Participants requested to participate actively in the random assignment. Consequently, each participant was invited by the manager of the centre to choose an envelope containing the group name from a basket of ten envelopes.

After each randomization, a new envelope was added to the basket. Participants of the intervention group were offered to be circumcised within a week.

Participants of the control group were asked to wait until the end of the trial before being offered to be circumcised. After the screen visit, which took place at month 1 M1 , the three follow-up visits took place at the end of M3, M12, and M The M3 visit was designed to study the possible impact of surgery on HIV acquisition as a result of sexual activity during the healing phase following circumcision or contamination during surgery.

These three follow-up visits defined three sequential periods, M1—M3, M4—M12, and M13—M21, with expected durations of 3, 9, and 9 mo, respectively. The duration of these periods was measured in days from the dates of the visits, the day after the end of a period being the beginning of the next period. A participant lost to follow-up was defined as a participant who had not completed a planned visit in the 2 mo following the planned date of this visit and who did not complete any further visit.

A missing visit was defined as a visit not completed prior to a completed visit. At each of the four visits, each participant was invited to answer a face-to-face questionnaire, to provide a blood sample, and to have a genital examination and an individual counselling session.

The questionnaire allowed for collection of data on background characteristics and reported sexual behaviour. The last section of the questionnaire allowed for the description of all sexual partnerships over the previous 3 mo for the M3 visit and over the previous 12 mo for all other visits. This section allowed each participant to describe the number of sexual contacts, the date of first and last sexual contact, the frequency of condom use never, sometimes, always , and the type of partnership spousal or non-spousal , a spousal partner being defined as a sexual partner with whom the respondent is married or living as married.

Characteristics of sexual behaviour during the 9-mo periods M4—M12 and M13—M21 were determined from this section, using the dates of first and last sexual contact of each sexual partner. The genital examination was performed by a trained nurse who recorded the circumcision status and took a blood sample from each participant. Blood samples were tested for syphilis and HIV The counselling session 15—20 min was delivered by a certified counsellor and focused on information about STIs in general and HIV in particular and on how to prevent the risk of infection.

During this session, participants were encouraged to attend voluntary counselling and testing in a public clinic located m away from the investigation centre or in a voluntary counselling and testing VCT centre funded by the project and located in the same building as the investigation centre. Condoms were provided in the waiting room of the investigation centre and were also provided by the counsellor.

Participants who had symptoms of STIs, as assessed by the nurse during the genital examination, or who tested positive for syphilis were treated at the local clinic or by doctors working for the project.

A specific programme for prevention of opportunistic infections and delivery of antiretroviral treatment, if required, was put in place at the VCT centre to assist participants who attended VCT and who tested positive for HIV. The arrangement will remain in place until the public sector programme becomes operational in the area. The standard of care in South Africa at the beginning of the trial in July included VCT but not access to antiretroviral therapy.

With the formal introduction of access to antiretroviral therapy in , there were increased efforts to encourage participants to attend VCT and referrals to appropriate facilities were instituted. In this context, it was decided to include participants independent of VCT attendance.

Consideration for making HIV testing compulsory for participation in the trial or recruiting only those who tested HIV-negative would certainly lead to stigmatization, and the investigators considered that the whole concept of VCT was that it should be voluntary. They considered it unethical to inform participants of their HIV status without their permission, even if they thought that participants should be aware of their HIV status. They also considered it unethical to deter from participating in the study potentially at-risk men who did not want to know their HIV status.

Indeed, HIV-positive participants would benefit from the trial: a by receiving counselling at each visit, b by undergoing clinical examination and syphilis testing, and c by having a medicalized circumcision that could possibly protect them or their sexual partners against other STIs or even against re-infection by HIV.

The circumcisions were performed by three local general practitioners in their surgical offices. The general practitioners were experienced in MC practices. The cost of each circumcision was South African Rand and was paid for by the project. The procedure was standardized and used the forceps-guided method, as is widely practiced in South Africa, and was reviewed by the Department of Urology, University of the Witwatersrand Medical School, South Africa.

To ensure confidentiality, participants' files were kept in a locked room at the centre and each participant received a number that was used to identify all documents related to that person. To ensure blinding of study personnel, the randomization group information was not available to the personnel in charge of counselling or collecting information in the centre during the participants' visits.

Questionnaires were checked at the end of each interview. Participants failing to turn up for any follow-up visit were visited at home by trial staff, who encouraged them to come for the follow-up visits or ascertained the reasons for dropping out. Laboratory results were stored in a database that was independent of the one used to store the information related to each participant. During the study, no HIV results were available to the investigation centre or to the investigators, apart from the statistician in charge of the interim analysis.

Laboratory results and data collected from questionnaires were entered twice in a database Microsoft Access, Redmond, Washington, United States by different people. The two entries were compared, and discrepancies were corrected. The data were then re-checked for inconsistencies using the source documents. Following the interview, a trained nurse collected whole blood samples in the investigation centre.

The research protocol was reviewed and approved by the University of Witwatersrand Human Research Ethics Committee Medical on 22 February protocol study no. A Data and Safety Monitoring Board was responsible for analyzing adverse events and for deciding on the results of the interim analysis.

Adverse events AEs were documented and analyzed for all participants, including those who were HIV-positive at randomization. These AEs related to surgery, and that occurred in the first month post-surgery, were reported by the practitioners using a specific form.

In addition, at each visit to the centre the nurse completed a questionnaire after the genital examination to record adverse events. During home visits for missing participants, any deaths were recorded. An interim analysis was planned for when all the M12 visits had been completed, and this was conducted blind with the database obtained on 29 November Bertran Auvert presented a late-breaker describing the results of this programme.

Orange Farm is a township of about , adults about 45kms from Johannesburg. Since January , free voluntary medical male circumcision to all boys and men older than 15 has been offered by the ANRS-sponsored project.

The intervention includes community mobilisation and outreach, counselling, condom distribution, STI treatment, HIV voluntary counselling and testing and ART if eligible. A baseline cross-sectional survey was done in This was a random sample of just under 1, males aged 15 to 49 years.

Male circumcision status was determined by genital examination. A second cross-sectional survey was done in This survey included a background and sexual behaviour questionaire.

Again male circumcision status was determined by genital examination. Male circumcision prevalence changed from



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