Point-of-care Tests for Vaginal Discharge in Nepal

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-22

Study Completion Date

2026-01-25

Brief Summary

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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

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Detailed Description

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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 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.

Addition (22.09.2024): 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.

Conditions

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Vaginal Discharge Sexually Transmitted Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Three armed RCT.

1. Standard treatment
2. POCT result based treatment
3. POCT result based treatment plus patient education and addressing of anxiety, depression and domestic violence

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

Health care practitioner is informed of POCT results for CT and NG

Intervention Type DIAGNOSTIC_TEST

Molecular, PCR based near-POCT performed by the research assistant on self -collected urine. The outcome is positive or negative

Health care practitioner is informed about POCT result for TV and BV

Intervention Type DIAGNOSTIC_TEST

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.

POCT based treatment PLUS

Same as in POCT based treatment PLUS in addition:

1. 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.
2. 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.

Group Type ACTIVE_COMPARATOR

Health care practitioner is informed of POCT results for CT and NG

Intervention Type DIAGNOSTIC_TEST

Molecular, PCR based near-POCT performed by the research assistant on self -collected urine. The outcome is positive or negative

Health care practitioner is informed about POCT result for TV and BV

Intervention Type DIAGNOSTIC_TEST

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.

addressing psycholsocial problems

Intervention Type OTHER

1. Participants screening positive for anxiety, depression or domestic violence will be offered psychological counseling or referral to a crisis management center in the POCT-PLUS arm
2. All participants of the POCT-PLUS arm receive audio- visual and written education on vaginal discharge and antibiotics

Interventions

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Health care practitioner is informed of POCT results for CT and NG

Molecular, PCR based near-POCT performed by the research assistant on self -collected urine. The outcome is positive or negative

Intervention Type DIAGNOSTIC_TEST

Health care practitioner is informed about POCT result for TV and BV

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.

Intervention Type DIAGNOSTIC_TEST

addressing psycholsocial problems

1. Participants screening positive for anxiety, depression or domestic violence will be offered psychological counseling or referral to a crisis management center in the POCT-PLUS arm
2. All participants of the POCT-PLUS arm receive audio- visual and written education on vaginal discharge and antibiotics

Intervention Type OTHER

Other Intervention Names

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GeneXpert test from Cepheid for CT andNG Narrow range pH and confirmatory whiff test with potassium hydroxide (KHO), Amsel criteria for second half of participants to be included: if pH > 4.5 and whiff test is negative, the OSOM test will be performed for TV providing basic information on vaginal discharge and antibiotics