Ignite Creation Date:
2024-05-06 @ 7:20 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05977491
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2023-07-04
Brief Title:
Point-of-care Tests for Vaginal Discharge in Nepal
Sponsor:
Norwegian University of Science and Technology
Organization:
Norwegian University of Science and Technology
Study Overview
Official Title:
Randomized Controlled Trial in Nepal Introducing Point-of-care Tests and Identifying Barriers to Reduce Antibiotics for Vaginal Discharge
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POCT-BRA
Brief Summary:
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
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
Detailed 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 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
1 Can POCTs effectively reduce the use of antibiotics A The amount of antibiotics prescribed at the time of the appointment B the proportion of correcly pescribed antibiotics as defined by gold-standard tests C Additional antibiotics used as reported by the patients
2 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 and available counseling for 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 and 2025
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 over-treated 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 111 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
Addition 22092024 after the first 100 participants it was recognized that sensitivity of the combination pH and whiff test was unacceptably low for TV for women with a high pH and negative whiff test We will add another low cost immunological POCT for TV for women with a high pH and a negative whiff test after the first half of participants has been enrolled Based on our additional power calculation we will have sufficient power to seperately analyse the diagnostic accuracy for TV both before and after the addition of this 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 woman screening positive for positive for anxiety depression or domestic violence will be offered psychological counseling or referral to a crisis center Participants will be followed up telephonically after 1 and 4 months
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
1 Can POCTs effectively reduce the use of antibiotics A The amount of antibiotics prescribed at the time of the appointment B the proportion of correcly pescribed antibiotics as defined by gold-standard tests C Additional antibiotics used as reported by the patients
2 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 and available counseling for 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 and 2025
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 over-treated 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 111 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
Addition 22092024 after the first 100 participants it was recognized that sensitivity of the combination pH and whiff test was unacceptably low for TV for women with a high pH and negative whiff test We will add another low cost immunological POCT for TV for women with a high pH and a negative whiff test after the first half of participants has been enrolled Based on our additional power calculation we will have sufficient power to seperately analyse the diagnostic accuracy for TV both before and after the addition of this 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 woman screening positive for positive for anxiety depression or domestic violence will be offered psychological counseling or referral to a crisis center Participants will be followed up telephonically after 1 and 4 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None