Randomized Controlled Trial in Nepal: Introducing Point-of-care Tests and Identifying Barriers to Reduce Antibiotics for Vaginal Discharge
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Proportion of participants overtreated with antibiotics (excluding antifungals)
研究概览
简要总结
The goal of this clinical trial is to examine if and how the implementation of point-of care-tests (POCT) for sexually transmitted infections in the management of abnormal vaginal discharge reduces the overtreatment with antibiotics in a low income country. The setting is a university hospital in a semi-rural area in Nepal and several of its rural out-reach-centers. The plan is to include 1500 women attending the gynecological outpatients with a problem of vaginal discharge over approximately a one year period.
The main questions the clinical trial aims to answer are:
- Does POCT guided treatment result in reduced over-treatment of antibiotics, compared to the current approach in Nepal?
- What are the barriers and facilitators of the acceptability of POCTs and the resulting treatment from the perspective of both patients and health care practitioners?
Participants will be randomized in three groups:
- standard treatment according to current practice
- POCT result based treatment
- POCT result based treatment plus patient education and addressing of psycho social vulnerabilities
详细描述
Abnormal vaginal discharge (AVD) is a common problem women seek treatment for allover the world. In low and low- middle income countries (LLMICs) about one third of these women will have a sexually transmitted disease (STI) caused by Chlamydia trachomatis (CT), Neisseria gonorrhoea (NG) or Trichomonal vaginalis (TV). Approximately another third will have an imbalance in the vaginal microbiotic flora, bacterial vaginosis (BV). These women and their sexual partners in the case of sexually transmitted diseases will benefit from specific antibiotic treatment. The last third of women will not have any infection and there are indications that psychosocial problems may be expressed as somatic complaints, for example of abnormal vaginal discharge in some cultures.
In high income countries, with the help of laboratory-based tests, available after few days, treatment is usually with a narrow spectrum antibiotic for specific bacteria. This involves less risk for the development of antibiotic resistance. In low-income countries, laboratory testing is not feasible due to costs and logistics. Women are usually receiving antibiotic treatment with several types of antibiotics to cover STIs. More recently, point-of -care tests which are nearly as accurate as laboratory-based tests have been developed. Implementation studies for these tests in LLMICs are lacking. However, these molecular tests are still expensive.
In this study the investigators propose a combination of molecular tests for the two most serious infections (CT and NG) and a cheap and simple tests for TV and BV, which both are treated with the same type of antibiotic.
In addition, women attending an outpatient department in a LLMIC setting, expect (antibiotic) treatment, which they will not receive with a negative POCT. In LLMICs it is common practice to purchase over the counter medication, inclusive antibiotics. In particular for women with negative POCT results, there could be a lack of adherence to treatment recommendations.
We want to examine the following research questions (RQ) in the context of treatment for vaginal discharge:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The health care provider will know if informed about the POCT results (in groups 2,3) or not (group 1). He will not know if patient is in group 2 or 3.
The investigator will be present at various times during inclusion for quality control and therefore is not blinded.
The outcome assessor ( the PhD candidate and the statistician) will receive data files without specific group label.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women presenting with vaginal discharge to gynecological outpatients
排除标准
- •Minors below the age of 18 years.
- •Any bleeding from the vagina.
- •Suspicion of gynecological cancer.
- •Previous inclusion in the same study.
研究组 & 干预措施
Standard treatment
Patients are treated by the health care practitioner according to local protocol. This protocol corresponds to the syndromic approach without laboratory or microscopic testing. This may or may not include inspection and examination of the vulva, vagina, cervix and lower abdomen.
POCT based treatment
The health care practitioner is informed about the POCT results for CT and NG (positive or negative). In addition, if the pH is within the normal level (4.5 and below). If it is higher, he will receive the outcome of the whiff test (positive or negative). For the second half of enrolled participants: if pH is > 4.5 and whiff test is negative, the OSOM test for TV will be performed an self collected vaginal discharge. The Health care practitioner is informed if the TV test is positive or negative.
Examination of the patient is performed according to the discretion of the health care practitioner.
干预措施: Health care practitioner is informed of POCT results for CT and NG (Diagnostic Test)
POCT based treatment
The health care practitioner is informed about the POCT results for CT and NG (positive or negative). In addition, if the pH is within the normal level (4.5 and below). If it is higher, he will receive the outcome of the whiff test (positive or negative). For the second half of enrolled participants: if pH is > 4.5 and whiff test is negative, the OSOM test for TV will be performed an self collected vaginal discharge. The Health care practitioner is informed if the TV test is positive or negative.
Examination of the patient is performed according to the discretion of the health care practitioner.
干预措施: Health care practitioner is informed about POCT result for TV and BV (Diagnostic Test)
POCT based treatment PLUS
Same as in POCT based treatment PLUS in addition:
- All women complete a questionnaire prior to examination, including a screening tool for anxiety and depression and domestic violence. If they screen positive, they are offered psychological counseling. All women are informed about referral possibilities to a crisis management center.
- Patients are given a short educational leaflet and 10 min audio-recording about physiological and abnormal vaginal discharge and about problems associated with unnecessary use of antibiotics.
干预措施: Health care practitioner is informed of POCT results for CT and NG (Diagnostic Test)
POCT based treatment PLUS
Same as in POCT based treatment PLUS in addition:
- All women complete a questionnaire prior to examination, including a screening tool for anxiety and depression and domestic violence. If they screen positive, they are offered psychological counseling. All women are informed about referral possibilities to a crisis management center.
- Patients are given a short educational leaflet and 10 min audio-recording about physiological and abnormal vaginal discharge and about problems associated with unnecessary use of antibiotics.
干预措施: Health care practitioner is informed about POCT result for TV and BV (Diagnostic Test)
POCT based treatment PLUS
Same as in POCT based treatment PLUS in addition:
- All women complete a questionnaire prior to examination, including a screening tool for anxiety and depression and domestic violence. If they screen positive, they are offered psychological counseling. All women are informed about referral possibilities to a crisis management center.
- Patients are given a short educational leaflet and 10 min audio-recording about physiological and abnormal vaginal discharge and about problems associated with unnecessary use of antibiotics.
干预措施: addressing psycholsocial problems (Other)
结局指标
主要结局
Proportion of participants overtreated with antibiotics (excluding antifungals)
时间窗: At inclusion
Comparing the proportion of women overtreated with antibiotics for treatment depending if the health care practitioner was informed about the POCT results (arm 2+3) or not (arm1). Reported by the health care practitioner. Overtreatment is defined as receiving a cephalosporin when NG is negative; a tetracycline when CT is negative; a macrolide when NT and CT are neagtive; a nitroimidazole when the gold standard test for TV or BV is negative. These subgroups are anlayzed: (a) before addition of an additional POCT for women with a pH above 4.5 and a negative whiff test, this is the first half of participants; (b) after addition of this extra test, for the second half of included participants; (c) suburban- and (d) rural clinics. We compare arm 1 with the combined arms 2+3.
Proportion of participant prescribed antimicrobial resistance driving antibiotics
时间窗: At inclusion.
Comparing the proportion of women in arm 1( comparison arm) compared to arm 2 and 3 (intervention arms), receiving AMR driving antibiotics (Cephalosporins, Azithromycin, Ciprofloxacillin), depending if the health practitioner received POCT results. These subgroup analysis are planned: (a) suburban vs urban clinics. We compare arm 1 with the combined arms 2+3.
Proportion of participants adhering to treatment recommendations
时间窗: At telephonic follow up after 1 month.
Among participants, where the health practitioner had received POCT results, we compare the proportion of women adhering to treatment recommendations, depending on if they received psycho social intervention (arm 3) or not (arm2), in the arm Adherence is defined as follows: (1) participants report they took the prescribed medication, (2) no additional purchase of antibiotics; (3) no purchase of other medication for VD. Subgroup analysis for (a) suburban and (b) rural areas. (c) participants screening positive for domestic violence or (d) anxiety or depression, offered counseling or not. We compare all arms (arm1, 2 and 3)
次要结局
- Comparing mean patient satisfaction with consultation and treatment between all RCT arms(At follow up after 4 months)
- Proportion of participants prescribed antibiotics(At inclusion)
- Undertreatment with antibiotics for CT, NG, TV and BV with or without POCT guided treatment(At inclusion)
- Proportion of women adhering to treatment recommendationss(At telephonic follow up 4 months after initial consultation)
- Does educational and psychosocial measures affect change in VD symptoms?(At telephonic follow up after 4 weeks and 4 months.)
- Comparing prevalence of screening positive for anxiety and depression before and 4 months after consultation for VD(At telephonic follow up, 4 months after initial consultation)
- Comparing mean patient satisfaction with consultation and treatment between all RCT arms(At follow up after 4 months)