GHENT UNIVERSITY Karoline FONCK - International Centre for ...
GHENT UNIVERSITY Karoline FONCK - International Centre for ... GHENT UNIVERSITY Karoline FONCK - International Centre for ...
In some parts of Africa, FSWs and their clients are considered to be the group at highest risk of HW infection and hence constitute an important population for targeted interventions. Studies among sex workers in Nairobi have shown a HIV prevalence rate of 67% and an annual HIV incidence of 47% (Plummer 1991). There is considerable evidence that both ulcerative and non-ulcerative STIs enhance HIV-1 transmission and acquisition (Wasserheit 1992, Sewankambo 1997, Kreiss 1994, Moss 1995, Laga 1993). STI control may therefore offer a means of reducing the spread of the AIDS epidemic. A randomized community trial in Mwanza, Tanzania demonstrated that improved management of symptomatic STIs resulted in a 40% reduction in HIV-1 incidence in the intervention arm (Grosskurth 1995). However, a randomized community trial of antibiotic prophylaxis every 10 months in Rakai, Uganda, failed to demonstrate any reduction in HIV-1 incidence, despite a significant reduction in the incidence of T. vaginalis and T. pallidum infection (Wawer 1999). It has been suggested that this discrepancy may be due to the maturity of the HIV-1 epidemic in Rakai at the time of the trial, which meant that most HIV-1 transmission was no longer driven by STIs (Hitchcock 1999). However, rates of N. gonorrhoeae, C. trachomatis and Haemophilus ducreyi were not significantly reduced by antibiotic prophylaxis, possibly due to their low frequency in the target population. In addition, the administration of antibiotic prophylaxis every 10 months may be inadequate, since it may have little effect on the natural history of STIs such as gonorrhea, which frequently resolve within weeks, even if untreated and which may quickly be re-acquired after treatment (Handsfield 1995, Costa 1985). A more feasible and logical approach in the face of a mature HIV-1 epidemic may be to target frequent antibiotic prophylaxis towards high-risk 'core' transmitter groups, such as sex workers, who are at high risk of acquiring both STIs and HIV-1 infection instead of targeting unselected populations. Hence we decided to set up a randomized trial of monthly azithromycin prophylaxis to prevent STIs and HIV-1 infection in a cohort of Kenyan sex workers from the Kibera district of Nairobi. Azithromycin, a macrolide antibiotic with a favorable side effect profile and a long tissue half-life, has demonstrated efficacy against the STI pathogens N. gonorrhoeae, C. trachomatis and H. ducreyi (Ridgway 1996). The objectives of this study were: (1) to evaluate the impact of regular routine azithromycin chemoprophylaxis on STI and HIV-1 incidence in this population; (2) to examine potential adverse effects of monthly azithromycin administration, including effects on antibiotic PREVENTION OF SEXUALLY TRANSMITTED INFECTIONS INCLUDING HIV 81
esistance patterns in bystander flora. This paper describes the study design, and the baseline characteristics of the first 318 sex workers screened in the study. Methods The study design was an open, randomized placebo-controlled clinical trial. Half of those enrolled received monthly azithromycin prophylaxis during 2 years. Only HIV-seronegative women were enrolled but all women were provided with the appropriate medical and counseling services and health education. From previous experience in Kenya, the cumulative risk of HIV-1 seroconversion among the FSWs was estimated to be approximately 30% over 2 years (Plummer 1991) and it was assumed that monthly prophylaxis with azithromycin would reduce the incidence to about 15%. With a β error of 0.2 (power of 80%) and a 2-sided I error of 0.05, the required sample size was approximately 120 in each group. A loss to follow-up of about 30% was expected resulting in a required sample size of about 170 in each group. The HIV seroprevalence in these women was estimated to be approximately 50% so about 680 women would have to be screened to identify 340 seronegative women. The FSWs were recruited through a network of peer-leaders. FSWs who were interested in joining the study presented themselves at the study clinic. At the initial visit, after informed consent and HIV pre-test counseling, a structured questionnaire on sexual behavior, reproductive and medical histories was administered. A full physical examination including speculum examination and laboratory STI and HIV testing was performed. At the subsequent visit, HIV-1 seronegative women were invited for enrolment into the trial. More counseling on the nature of the trial, and emphasis on the need for reduction in risk behavior, was given. An information form was provided to the women who were asked to return to the clinic if they should decide to join the study. Block randomization to either azithromycin one gram monthly or placebo took place. The study medication was given monthly in the clinic under direct observation. At each visit a urine specimen was obtained for later analysis for asymptomatic STIs (gonorrhea and chlamydia) using polymerase chain reaction (PCR). Any symptomatic STIs were treated according to the Kenyan National AIDS/STD Control Program guidelines. At each visit, all women were extensively counseled about the need for risk reduction. PREVENTION OF SEXUALLY TRANSMITTED INFECTIONS INCLUDING HIV 82
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esistance patterns in bystander flora. This paper describes the study design, and the<br />
baseline characteristics of the first 318 sex workers screened in the study.<br />
Methods<br />
The study design was an open, randomized placebo-controlled clinical trial. Half of those<br />
enrolled received monthly azithromycin prophylaxis during 2 years. Only HIV-seronegative<br />
women were enrolled but all women were provided with the appropriate medical and<br />
counseling services and health education. From previous experience in Kenya, the<br />
cumulative risk of HIV-1 seroconversion among the FSWs was estimated to be<br />
approximately 30% over 2 years (Plummer 1991) and it was assumed that monthly<br />
prophylaxis with azithromycin would reduce the incidence to about 15%. With a β error of<br />
0.2 (power of 80%) and a 2-sided I error of 0.05, the required sample size was approximately<br />
120 in each group. A loss to follow-up of about 30% was expected resulting in a required<br />
sample size of about 170 in each group.<br />
The HIV seroprevalence in these women was estimated to be approximately 50% so about<br />
680 women would have to be screened to identify 340 seronegative women.<br />
The FSWs were recruited through a network of peer-leaders. FSWs who were interested in<br />
joining the study presented themselves at the study clinic. At the initial visit, after in<strong>for</strong>med<br />
consent and HIV pre-test counseling, a structured questionnaire on sexual behavior,<br />
reproductive and medical histories was administered. A full physical examination including<br />
speculum examination and laboratory STI and HIV testing was per<strong>for</strong>med.<br />
At the subsequent visit, HIV-1 seronegative women were invited <strong>for</strong> enrolment into the trial.<br />
More counseling on the nature of the trial, and emphasis on the need <strong>for</strong> reduction in risk<br />
behavior, was given. An in<strong>for</strong>mation <strong>for</strong>m was provided to the women who were asked to<br />
return to the clinic if they should decide to join the study.<br />
Block randomization to either azithromycin one gram monthly or placebo took place. The<br />
study medication was given monthly in the clinic under direct observation. At each visit a<br />
urine specimen was obtained <strong>for</strong> later analysis <strong>for</strong> asymptomatic STIs (gonorrhea and<br />
chlamydia) using polymerase chain reaction (PCR). Any symptomatic STIs were treated<br />
according to the Kenyan National AIDS/STD Control Program guidelines. At each visit, all<br />
women were extensively counseled about the need <strong>for</strong> risk reduction.<br />
PREVENTION OF SEXUALLY TRANSMITTED INFECTIONS INCLUDING HIV 82
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