Search
Close this search box.

Point-of-care Tests for Vaginal Discharge in Nepal

Studies

Study First Submitted Date 2023-07-04
Study First Posted Date 2023-08-04
Last Update Posted Date 2023-08-04
Start Month Year February 1, 2024
Primary Completion Month Year December 31, 2024
Verification Month Year July 2023
Verification Date 2023-07-31
Last Update Posted Date 2023-08-04

Detailed Descriptions

Sequence: 20786687
Description 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 test 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: Can POCTs effectively reduce the use of antibiotics? A) The amount of antibiotics prescribed at the time of the appointment B) Additional antibiotics used, as reported by the patients, Barriers and facilitators for patients and health practitioners with a focus on psychosocial and educational elements For this purpose, a RCT with three arms was designed: (A) Treatment as usual, (B) Treatment according to POCT results, (C) Treatment according to POCT results and additional patient information on vaginal discharge and antibiotics and screening for and attention by the attending health care practitioner to psychosocial problems. The investigators plan to include 1500 women with the complaint of abnormal vaginal during a 10-12 month period at Dhulikhel hospital, a tertiary university hospital in central Nepal and selected outreach centers in 2024. Sample size calculation are based on RQ1 and RQ2, feasibility of recruitment and the precision of the estimates, a two-sided 95 % confidence intervals (CI). For RQ1, the use of any antibiotics will be assessed in both POCT arms combined versus the treatment as usual arm (n = 1500), whilst the effect of the educational material on the use of over-the-counter medications will be assessed in the POCTplus versus the POCT group (n = 1000). As many as 85% of women with AVD are overtreated with antibiotics in LLMICs, around 50 % receive antimicrobial resistance driving antibiotics and it is expected, that around 40 % women in the POCT group will subsequently seek over the counter antibiotics. With 1500 participants randomized 1:1:1, a 10 to 20 percentage point reduction in any of these measures will produce CIs with a width between 8 and 12 % and at least 90% power. When allowing for around 40 % loss to follow-up, when assessing the use of over-the-counter antibiotics, the expected width of the CI is still around 15 %. The investigators will collect self-sampled urine and vaginal swabs from all included women and a self-administered questionnaire with a color-coded audio-computer. The questionnaire contains demographic information and a validated tool to screen for anxiety, depression and domestic violence. Gold standard testing for the STIs and BV will be performed on all women. Participants will be randomized into three arms. In the standard treatment arm, the attending health practitioner will not be informed about POCT results. In the two POCT arms, the health care practitioner will be informed about CT and NG status and about the pH, inclusive a confirmatory whiff test. In the POCT-PLUS arm, patients will receive additional educational information about physiological and abnormal vaginal discharge and about potentially negative effects of antibiotic treatment. In this arm, health care practitioners will be informed if the woman screened positive for anxiety, depression or domestic violence. Participants will be followed up telephonically after 1 and 4 months.

Conditions

Sequence: 52337473 Sequence: 52337474
Name Vaginal Discharge Name Sexually Transmitted Diseases
Downcase Name vaginal discharge Downcase Name sexually transmitted diseases

Id Information

Sequence: 40277385
Id Source org_study_id
Id Value 335889

Design Groups

Sequence: 55778275 Sequence: 55778276 Sequence: 55778277
Group Type No Intervention Group Type Active Comparator Group Type Active Comparator
Title Standard treatment Title POCT based treatment Title POCT based treatment PLUS
Description 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. Description 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). Examination of the patient is performed according to the discretion of the health care practitioner. Description Same as in POCT based treatment PLUS: 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. All women complete a questionnaire prior to examination, including a screening tool for anxiety and depression and domestic violence. If they screen positive, the health care practitioner will be informed, in addition to the POCT result.

Interventions

Sequence: 52648066 Sequence: 52648067 Sequence: 52648068
Intervention Type Diagnostic Test Intervention Type Diagnostic Test Intervention Type Other
Name Health care practitioner is informed of POCT results for CT and NG Name Health care practitioner is informed about POCT result for TV and BV Name Health care practitioner is informed on result for anxiety, depression,domestic violence screening
Description Molecular, PCR based near-POCT performed by the research assistant on self -collected urine. The outcome is positive or negative Description The pH of vaginal secretion is measured from a self-collected swab by the research assistant, and if above 4.5 a dropp of KOH is added. If it smells fishy, the whiff test is positive. Description The research assistant will inform the health care practitioner if screening positive for anxiety, depression or domestic violence.

Keywords

Sequence: 80098044 Sequence: 80098045 Sequence: 80098046 Sequence: 80098047 Sequence: 80098048 Sequence: 80098049 Sequence: 80098050 Sequence: 80098051 Sequence: 80098052 Sequence: 80098053
Name antibiotic overtreatment Name psychosomatic Name domestic violence Name anxiety and depression Name chlamydia trachomatis Name neisseria gonorrhoea Name trichomonas vaginalis Name bacterial vaginosis Name process evaluation Name point-of-care-test
Downcase Name antibiotic overtreatment Downcase Name psychosomatic Downcase Name domestic violence Downcase Name anxiety and depression Downcase Name chlamydia trachomatis Downcase Name neisseria gonorrhoea Downcase Name trichomonas vaginalis Downcase Name bacterial vaginosis Downcase Name process evaluation Downcase Name point-of-care-test

Design Outcomes

Sequence: 177991755 Sequence: 177991756 Sequence: 177991757 Sequence: 177991758 Sequence: 177991759 Sequence: 177991760 Sequence: 177991761 Sequence: 177991762 Sequence: 177991763
Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Amount of prescribed antibiotics (excluding antifungals) Measure Antimicrobial resistance driving antibiotics prescribed Measure Adherence to treatment recommendations Measure Adherence to treatment recommendations Measure Correct antibiotic treatment Measure Effect of educational measures on over the counter acquisition of medication Measure Effect of screening for anxiety and depression on over the counter acquisition of medication Measure Effect of addressing domestic violence on over the counter acquisition of medication Measure Patient satisfaction
Time Frame At the primary appointment for the individual included patient. During inclusion (10-12 months), for the trial. Time Frame At the primary appointment for the individual included patient. During inclusion (10-12 months), for the trial. Time Frame At telephonic follow up after 1 month. Time Frame At telephonic follow up after 4 months Time Frame At the primary appointment for the individual included patient. During inclusion (10-12 months), for the trial. Time Frame At follow up 1 and 4 months after initial consultation Time Frame At follow up 1 and 4 months after initial consultation Time Frame At follow up 1 and 4 months after initial consultation Time Frame At follow up after 4 months
Description Comparing the proportion of women prescribed antibiotics for treatment in total and in subgroups, depending if the health care practitioner was informed about the POCT results. Self reported by the health care practitioner. Subgroups: Doxycycline, Tetracycline, Ciprofloxacin, Azithromycin or Trimethoprim(sulfa), Metronidazole, Cephalosporin, other antibiotics. Description Comparing the proportion of women prescribed antimicrobial resistance driving antibiotics, in total and in subgroups (Cephalosporins, Azithromycin, Ciprofloxacin), depending if the health care practitioner was informed about the POCT results. Reported by health care practitioner. Description Comparing the proportion of women reporting acquisition of self reported over the counter medication in total and subgroups (antibiotics, painkillers, others, unknown type) for the three different RCT arms. Description Comparing the proportion of women reporting acquisition of over the counter medication in total and subgroups (antibiotics, painkillers, others, unknown type) for the three different RCT arms. Description Comparing the proportion of women receiving correct antibiotic treatment for a Chlamydia trachomatis, Neisseria gonorrhoea, Trichomonas vaginalis infection or for bacterial vaginosis, depending if the health practitioner received POCT results. Description Comparing the proportion of patients buying over the counter medication in total and subgroups, depending if they received education on vaginal discharge and antibiotics. Subgroups: Antibiotics, painkillers, others, unknown type. Description Comparing the proportion of patients buying over the counter medication in total and subgroups, depending if the health practitioner was informed about a positive anxiety or depression screen. Subgroups: Antibiotics, painkillers, others, unknown type. Description Comparing the proportion of patients buying over the counter medication in total and subgroups, depending if the health practitioner was informed about a history of domestic violence. Subgroups: Antibiotics, painkillers, others, unknown type. Description Satisfaction with consultation and treatment on a scale from 1-10

Browse Conditions

Sequence: 194119448 Sequence: 194119449 Sequence: 194119450 Sequence: 194119451 Sequence: 194119452 Sequence: 194119453 Sequence: 194119454 Sequence: 194119455 Sequence: 194119456 Sequence: 194119457 Sequence: 194119458 Sequence: 194119459
Mesh Term Sexually Transmitted Diseases Mesh Term Vaginal Discharge Mesh Term Communicable Diseases Mesh Term Infections Mesh Term Genital Diseases Mesh Term Urogenital Diseases Mesh Term Disease Attributes Mesh Term Pathologic Processes Mesh Term Vaginal Diseases Mesh Term Genital Diseases, Female Mesh Term Female Urogenital Diseases Mesh Term Female Urogenital Diseases and Pregnancy Complications
Downcase Mesh Term sexually transmitted diseases Downcase Mesh Term vaginal discharge Downcase Mesh Term communicable diseases Downcase Mesh Term infections Downcase Mesh Term genital diseases Downcase Mesh Term urogenital diseases Downcase Mesh Term disease attributes Downcase Mesh Term pathologic processes Downcase Mesh Term vaginal diseases Downcase Mesh Term genital diseases, female Downcase Mesh Term female urogenital diseases Downcase Mesh Term female urogenital diseases and pregnancy complications
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48474931 Sequence: 48474932 Sequence: 48474933 Sequence: 48474934
Agency Class OTHER Agency Class OTHER Agency Class OTHER Agency Class OTHER
Lead Or Collaborator lead Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator
Name Norwegian University of Science and Technology Name Kathmandu University School of Medical Sciences Name University of Oslo Name Universiteit Antwerpen

Overall Officials

Sequence: 29373672
Role Principal Investigator
Name Risa AM Lonnee-Hoffmann, PhD
Affiliation Norwegian University for Science and Technology

Central Contacts

Sequence: 12050538 Sequence: 12050539
Contact Type primary Contact Type backup
Name Risa AM Lonnee-Hoffmann, PhD Name Sunila Shakya, PhD
Phone 004741482354 Phone 009779803972599
Email risa.lonnee-hoffmann@ntnu.no Email sunilashakya@kusms.edu.np
Role Contact Role Contact

Design Group Interventions

Sequence: 68374221 Sequence: 68374222 Sequence: 68374223 Sequence: 68374224 Sequence: 68374225
Design Group Id 55778276 Design Group Id 55778277 Design Group Id 55778276 Design Group Id 55778277 Design Group Id 55778277
Intervention Id 52648066 Intervention Id 52648066 Intervention Id 52648067 Intervention Id 52648067 Intervention Id 52648068

Eligibilities

Sequence: 30861687
Gender Female
Minimum Age 18 Years
Maximum Age 60 Years
Healthy Volunteers Accepts Healthy Volunteers
Criteria Inclusion Criteria: Women presenting with vaginal discharge to gynecological outpatients Exclusion Criteria: Minors below the age of 18 years. Any bleeding from the vagina. Suspicion of gynecological cancer. Previous inclusion in the same study.
Gender Description Vaginal discharge under investigation is restricted to genetic females.
Gender Based True
Adult True
Child False
Older Adult False

Calculated Values

Sequence: 253916064
Registered In Calendar Year 2023
Were Results Reported False
Has Single Facility False
Minimum Age Num 18
Maximum Age Num 60
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 5
Number Of Secondary Outcomes To Measure 4

Designs

Sequence: 30607513
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Other
Time Perspective
Masking Double
Masking Description 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.
Intervention Model Description Three armed RCT. Standard treatment POCT result based treatment POCT result based treatment plus patient education and addressing of anxiety, depression and domestic violence
Subject Masked True
Outcomes Assessor Masked True

Intervention Other Names

Sequence: 26751580 Sequence: 26751581
Intervention Id 52648066 Intervention Id 52648067
Name GeneXpert test from Cepheid for CT andNG Name Narrow range pH and confirmatory whiff test with potassium hydroxide (KHO), Amsel criteria

Responsible Parties

Sequence: 28974047
Responsible Party Type Sponsor

Ipd Information Types

Sequence: 3347342
Name Study Protocol