Please select the eligibility criteria that correspond to the clinical trial below.
Title: Periodical Presumptive Treatment of Gonorrhoea in Female Sex Workers: Impact on Prevalence of the Disease in Sex Workers and Their Clients
Brief Summary: In the early years of the HIV epidemic in Africa, female sex workers (FSWs) were identified as a high-prevalence, high-incidence, core group among whom the extraordinary prevalence of other sexually transmitted infections (STIs) facilitated transmission of the virus to their clients, who then infected low-risk women not involved in the sex trade. In resource-poor settings, control of Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) among FSWs is difficult. The purpose of this study is to determine whether periodical antibiotic treatment (PAT) is effective in controlling these infections among West African FSWs.

The study is designed as a cluster-randomized double-blind placebo-controlled trial conducted in West Africa. The study population consists of "seaters" FSWs who work from their homes in well-defined areas. Clusters will be paired according to their size and demographic characteristics of FSWs and clients. Within each pair, one cluster will be randomly allocated to the intervention and the other to the placebo group.

At enrollment, participants will be interviewed, a pelvic examination performed, cervical swabs obtained for NG and CT polymerase chain reaction (PCR), and current cervicitis or vaginitis managed syndromically. Blood specimens will be obtained for HIV testing. All participants will be given free condoms and counseled on risk reduction.

Monthly follow-up will be conducted within FSW communities, alternating with clinic visits where cervical samples will be collected. Study drugs (azithromycin 1 g and ciprofloxacin 500 mg, and their identical placebos) will be distributed every month according to a predefined schedule: directly-observed intake of azithromycin at months 1, 4 and 7, and ciprofloxacin at months 2, 3, 5, 6, 8 and 9.

Data will be analyzed with SAS. The investigators will assess the time trends in NG and CT prevalence separately in both study groups using χ2-for-trend.


Options:
A: Inclusion Criteria:

* Age 18 to 49 years old
* Sexually active (coital frequency at least four times per month on average)
* HIV negative based on testing within two weeks prior to enrollment
* Chlamydia trachomatis and Neisseria gonorrhoeae negative based on testing within 30 days prior to enrollment or if positive, completes treatment before enrollment
* Have a healthy cervix, as assessed by naked-eye speculum exam at enrollment
* Planning to live in the study area for the next 24 months
* Willing to be randomly assigned either to use or not use a latex diaphragm with lubricant gel during participation in the study, and to follow the protocol, including being tested for HIV and STIs
* Willing and able to give informed consent

Exclusion Criteria:

* Known sensitivity or allergy to latex
* History of TSS (as suggested by current labeling for diaphragm use)
* Currently pregnant, or desiring to become pregnant in the next two years
* No cervix (total hysterectomy)
* Refuses treatment for diagnosed or suspected current STI and/or reproductive tract infection requiring treatment at enrollment
* Within six weeks of any pelvic surgery or last pregnancy outcome at the time of screening and enrollment
* Presence of clinically apparent lesion(s) with epithelial disruption at enrollment (may enroll after lesion(s) has healed, if otherwise eligible)
* Injected illicit drugs in the 12 months prior to screening and enrollment
* Blood transfusion or received blood products in 3 months prior to screening and enrollment
* Unable or unwilling to insert the diaphragm correctly
* Participation in any other clinical trial (including those of a vaginal product or barrier contraceptive). Verification by comparing participant lists to other concurrently running research studies may be conducted if necessary.
* Unable to speak English, Zulu, Shona, or Sotho
* Other conditions that, in the opinion of the investigator, would constitute contraindications to participation in the study or would compromise ability to comply with the study protocol, such as a major psychiatric disorder
B: Inclusion Criteria:

* Female sex worker (seater) from one of the selected clusters

Exclusion Criteria:

* Allergy to study drugs
* Pregnancy
* Intention to leave the city within the next 3 months
C: Inclusion Criteria:

* Cohort I (Intervention community) : Joining the IMAGE programme
* Cohort I (Comparison community) : Female, Eligible to receive microfinance loan and residing in an IMAGE Comparison community, matched on community pair and age group (18-25, 26-35, 36-45, 46-55, 56+) to the index IMAGE participant.
* Cohort II (Intervention community) : 14-35 years old at time of interview. Current residence in the household of a woman who joins the IMAGE programme.
* Cohort II (Comparison community) : 14-35 years old at time of interview. Current residence in the household of the non-IMAGE participant selected for inclusion in Cohort I.
* Cohort III (Intervention community) : 14-35 years old at time of interview, Household member in a community where IMAGE is operating.
* Cohort III (Comparison community) : 14-35 years old at time of interview. Household member in an IMAGE study community where IMAGE is not operating.

Exclusion Criteria:

* Lack of informed consent
D: Inclusion Criteria for HIV Infected Partner:

* Positive HIV test within 60 days of study entry
* CD4 count between 350 and 550 cells/mm3 within 30 days of study entry
* If pregnant or breastfeeding, willing to be randomized to either arm of the study

Inclusion Criteria for HIV Uninfected Partner:

* Negative HIV test within 14 days of study entry

Inclusion Criteria for Both Partners:

* Plans to maintain sexual relationship with partner
* Reports having sex (vaginal or anal) with partner at least three times in the last 3 months
* Willing to disclose HIV test results to partner
* Plans to stay in the area and does not have a job or other obligations that may require long absences during the duration of the study

Exclusion Criteria for HIV Infected Partner:

* Current or previous use of any ART. Participants who previously took a short-term course of ART for prevention of mother-to-child transmission of HIV are not excluded.
* Documented or suspected acute hepatitis within 30 days of study entry, if the infected partner's starting regimen in the study contains nevirapine or atazanavir
* Current or previous AIDS-defining illness or opportunistic infection
* Documented or suspected acute hepatitis within 30 days prior to study entry
* Acute therapy of serious medical illnesses within 14 days prior to study entry
* Radiation therapy or systemic chemotherapy within 45 days prior to study entry
* Immunomodulatory or investigational therapy within 30 days prior to study entry
* Active drug or alcohol dependence that, in the opinion of the investigator, would interfere with the study
* Vomiting or inability to swallow medications
* Require certain medications
* Allergy or sensitivity to any of the study drugs

Exclusion Criteria for Both Partners:

* History of injection drug use within 5 years of study entry
* Previous and/or current participation in an HIV vaccine study
* Currently detained in jail or for treatment of a psychiatric or physical illness
* Any condition that, in the opinion of the study staff, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
* Certain abnormal laboratory values

Answer: B