Aim, design and setting
We conducted a cross-sectional study between June 2014 and July 2015 to investigate VIA positivity among FSWs in the early detection of pre-cancerous and cancerous cervical lesions at the Good Health for Women Project (GHWP) clinic in Kampala, Uganda. The clinic was established in 2008 to study HIV and STIs epidemiology and to implement HIV/STIs prevention among FSWs. The clinic, a stand-alone clinic located in a peri-urban suburb in Southern Kampala, the capital city of Uganda reported a high HIV/STIs prevalence combined with high-risk behaviour in 2011 (8). The clinic offers HIV care and preventative services, sexual and reproductive health (SRH) services such as syndromic management of STIs, family planning, antenatal care, promotion and distribution of free condoms, and risk reduction counselling to both HIV positive and negative FSWs.
The participants were asymptomatic, healthy and previously unscreened FSWs who were receiving targeted HIV prevention, care, and treatment services at a dedicated GHWP clinic. FSWs were defined as women having sex with men in exchange for money, favours or other goods either regularly or casually at least once in the past 12 months.
The eligibility criteria for participation in the study included: 1) being a FSW aged > 14 years old; 2) a resident of the catchment area; 3) no previous history of total hysterectomy; 4) not using any intra-vaginal medication at the time of the study visit; 5) ability to provide informed consent; 6) had not been previously diagnosed with cervical cancer.
We excluded those; 1) who were very ill requiring emergency care; 2) women with evidence of acute STIs; 3) women less than 12 weeks after delivery; 4) pregnant women; 5) currently menstruating; and 6) women with known allergy to acetic acid. For women who were menstruating, the screening procedure was deferred until menstruation was over.
VIA program and procedures
a) VIA training and quality assurance
Before implementation of the VIA program, the nurses and clinicians were given a 5-days training using the WHO guidelines (20). The training included a mixture of interactive and practical sessions and discussions. The facilitators included a senior gynaecologist and midwife from St Francis hospital Nsambya, a tertiary referral hospital. Following hands-on experience under supervision for two consecutive weeks, the trained staff were allowed to screen the women independently. Periodic reorientation sessions and routine quality checks were conducted to improve quality assurance. The VIA screening protocol was distributed in the clinic to use during the screening of the women. Awareness campaigns among the FSWs were performed by the trained staff during the health education activities at the GHWP clinic. Information, education and communication (IEC) materials were used to assist in this process.
b) Recruitment and VIA screening procedure
The women were recruited during their three-monthly routine clinic visits. Those who were interested and eligible for screening were offered the screening test after obtaining informed consent. VIA was performed according to the Uganda MoH guidelines (17). The women underwent a routine vaginal examination using a sterile bivalve self-retaining vaginal speculum. The squamo-columnar junction (SCJ) was identified and any secretions or exudate were cleaned off before applying a cotton swab soaked in a 3-5% freshly prepared acetic acid solution to the cervix. The results were recorded after 1- 3 minutes using a bright halogen lamp. The VIA result was classified as negative, positive or inconclusive. Pre-cancerous and cancerous lesions were recorded positive when a well-defined, dense aceto-white area with regular margins appeared attached to the SCJ or if the whole cervix or cervical growth turned white. The test was reported negative if no change was observed or suspicious for invasive cancer, i.e, if no growth or ulcerative lesion was observed (21). If there was any uncertainty about the lesion observed, such women were recalled for rescreening. All VIA positive women were immediately informed and offered accompanied referral to the senior gynaecologist at St Francis hospital Nsambya for colposcopy, and further management. The participants had a pregnancy test followed by a general physical and gynaecological exam. The entire screening procedure and procedures done at referral facility were paid for by project to ensure that all women who tested positive receive treatment.
c) Clinical management procedure
The women with a positive VIA result were referred to a collaborating tertiary hospital on the same day for further evaluation in accordance with the “screen and treat” program (17). At the referral facility, colposcopy was done to grade the lesions and biopsies taken from areas which looked to be suspicious or abnormal. Colposcopic findings were reported as normal, inflammation, probable low- or high-grade precancerous lesions, or suspected invasive cancer. The colposcopic findings and procedure were explained to the woman. Immediate treatment with cryotherapy was offered in the same session, if the lesion involved <75% of the transformational zone, did not involve the endocervix or if there was no evidence of invasive cancer. Women with lesions involving >75% of the transformation zone, endocervical involvement or suspicious of invasive cancer were offered loop electrosurgical excision procedure (LEEP) to remove abnormal cervical tissues (22). Similarly, those who were found to have invasive cervical cancer were managed as per the national guidelines (17). All the women who were treated were given a course of antibiotics for a week. Cervical biopsy specimens were analyzed and the results were reported using the CIN system (23) and explained to the participant during the follow-up clinic visit 1–4 weeks later.
If any STIs were diagnosed, the women were offered free treatment using a syndromic approach at the GHWP clinic. The women who tested HIV positive were enrolled into care. Pregnant women were provided with iron and folate supplements according to Uganda national clinical guidelines (24). The women were also encouraged to invite their male regular partners (MRPs) to the clinic for free HIV/STIs screening and treatment as well as counselling on safe medical male circumcision and condom use. The details of all the medical procedures remained totally confidential.
As part of routine clinical care, blood samples were collected by an experienced and trained health worker for assessing HIV sero-positivity at the GHWP clinic laboratory. Participants received confidential HIV pre-test and post-test counselling on the study visit. HIV status was determined by performing a rapid HIV test (Determine, Statpak, Unigold) on a serum sample according to the Uganda National algorithms (25) for HIV testing HIV status was recorded as negative or positive. The HIV test results were linked to participants by their unique study identification number. Samples of urine were taken off for routine testing for the presence of Human Chorionic Gonadotropic (hCG) at the GHWP clinic laboratory. The biopsy cervical specimens were analysed at the referral hospital laboratory. The 3-5% acetic acid was freshly prepared at the GHWP clinic laboratory by carefully adding 5 mL of glacial acetic acid into 95 mL of distilled water and mixing thoroughly. Unused acetic acid was discarded at the end of the day.
Data collection and study measures
After obtaining written informed consent, eligible FSWs were consecutively enrolled and face-to-face semi-structured interviews conducted. Counsellors collected data on socio-demographic characteristics, sexual behaviour and clinical characteristics. The primary outcome of this study was VIA positivity which was categorised as negative or positive. Socio-demographic measures included age, marital status, education level, alcohol use, and illicit drug use. Alcohol use was assessed by using a standardized WHO Alcohol Use Disorders Identification Test (AUDIT) (26). Alcohol use was classified into three categories i.e. harmless or low-risk drinkers: score 1-7, harmful or high-risk drinkers: score 8-19 and alcohol dependent: score 20+. The sexual behaviour characteristics included: the total number of lifetime partners, condom use at last sexual intercourse, and age at first sexual intercourse. Sexual and reproductive health characteristics included: age at first pregnancy, parity, family planning use in the last 12 months, and family planning method. Participants’ clinical characteristics included; the presence of STI symptoms in the last 12 months, HIV status, receiving ART, VIA result, and Biopsy result. Presence of STI symptoms was determined if a FSW self-reported having had any symptoms suggesting STIs in the last 12 months including vaginal discharge, genital ulcer, and pain. HIV status was categorised as negative or positive. The histopathological findings were categorized into five categories: normal, inflammation, CIN 1 (low-grade cervical lesions), CIN 2/3 (high-grade cervical lesions), and invasive cervical cancer.
Data were double entered in Microsoft Access, cleaned, and exported to STATA 14.0 (StataCorp, College Station, TX, USA) for analysis. We resolved discrepancies by checking the source documents for clarification. Categorical demographic and clinical characteristics were summarized by counts and percentages. Continuous variables were summarized by means and standard deviations or medians and interquartile ranges. The proportion of those who were VIA positive was analysed by the different demographic, sexual behavioural and clinical characteristics. Factors for which the association attained statistical significance on log likelihood ratio test (LRT) of p<0.20 were selected for the multivariable logistic regression model. Logistic regression models were fitted to identify factors associated with VIA positivity at unadjusted analysis. Factors were retained in the final multivariable logistics regression model if their inclusion did not make the fit of the model significantly worse at the 5% level on a likelihood ratio test (LRT).