Trichomoniasis


Guideline Developer(s)

New York State Department of Health

Date Released

2012 Aug

Full Text Guideline

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The type of supporting evidence is identified and graded for selected recommendations (see the "Major Recommendations" field).

Implementation of the Guideline

Description of Implementation Strategy

The AIDS Institute's Office of the Medical Director directly oversees the development, publication, dissemination and implementation of clinical practice guidelines, in collaboration with The Johns Hopkins University, Division of Infectious Diseases. These guidelines address the medical management of adults, adolescents and children with human immunodeficiency virus (HIV) infection; primary and secondary prevention in medical settings; and include informational brochures for care providers and the public.

Guidelines Dissemination

Guidelines are disseminated to clinicians, support service providers, and consumers through mass mailings and numerous AIDS Institute-sponsored educational programs. Distribution methods include the HIV Clinical Resource website, the Clinical Education Initiative (CEI), the AIDS Educational Training Centers (AETC), and the HIV/AIDS Materials Initiative. Printed copies of clinical guidelines are available for order from the New York State Department of Health (NYSDOH) Distribution Center.

Guidelines Implementation

The HIV Clinical Guidelines Program works with other programs in the AIDS Institute to promote adoption of guidelines. Clinicians, for example, are targeted through the CEI and the AETC. The CEI provides tailored educational programming on site for health care providers on important topics in HIV care, including those addressed by the HIV Clinical Guidelines Program. The AETC provides conferences, grand rounds and other programs that cover topics contained in AIDS Institute guidelines.

Support service providers are targeted through the HIV Education and Training initiative which provides training on important HIV topics to non-physician health and human services providers. Education is carried out across the State as well as through video conferencing and audio conferencing.

The HIV Clinical Guidelines Program also works in a coordinated manner with the HIV Quality of Care Program to promote implementation of HIV guidelines in New York State. By developing quality indicators based on the guidelines, the AIDS Institute has created a mechanism for measurement of performance that allows providers and consumers to know to what extent specific guidelines have been implemented.

Finally, best practices booklets are developed through the HIV Clinical Guidelines Program. These contain practical solutions to common problems related to access, delivery or coordination of care, in an effort to ensure that HIV guidelines are implemented and that patients receive the highest level of HIV care possible.

Implementation Tools

Staff Training/Competency Material

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits
  • Appropriate diagnosis and management of trichomoniasis in human immunodeficiency virus (HIV)-infected patients
  • Reduction in risk of transmission of HIV and trichomoniasis to partners
Potential Harms
  • Metronidazole is associated with gastrointestinal (GI) intolerance, metallic taste, and headache.
  • Tinidazole causes occasional GI intolerance.

Rating Scheme for the Strength of the Recommendations

Strength of Recommendation

  1. Strong recommendation for the statement
  2. Moderate recommendation for the statement
  3. Optional recommendation

Qualifying Statements

Qualifying Statements

When formulating guidelines for a disease as complex and fluid as human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS), it is impossible to anticipate every scenario. It is expected that in specific situations, there will be valid exceptions to the approaches offered in these guidelines and sound reason to deviate from the recommendations provided within.

Methodology

Methods Used to Collect/Select the Evidence

Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases

Description of Methods Used to Collect/Select the Evidence

Medline was searched through July 2012 using appropriate key words on the topic. The Centers for Disease Control and Prevention guidelines on sexually transmitted diseases were also reviewed. The committee considered case reports and expert opinion on screening and treatment, including the experiences of local health departments.

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence

Expert Consensus (Committee)
Weighting According to a Rating Scheme (Scheme Given)

Rating Scheme for the Strength of the Evidence

Quality of Evidence for Recommendation

  1. One or more randomized trials with clinical outcomes and/or validated laboratory endpoints
  2. One or more well-designed, non-randomized trials or observational cohort studies with long-term clinical outcomes
  3. Expert opinion
Methods Used to Analyze the Evidence

Review

Description of the Methods Used to Analyze the Evidence

Not stated

Methods Used to Formulate the Recommendations

Expert Consensus

Description of Methods Used to Formulate the Recommendations

AIDS Institute clinical guidelines are developed by distinguished committees of clinicians and others with extensive experience providing care to people with HIV infection. Committees* meet regularly to assess current recommendations and to write and update guidelines in accordance with newly emerging clinical and research developments.

The Committees* rely on evidence to the extent possible in formulating recommendations. When data from randomized clinical trials are not available, Committees rely on developing guidelines based on consensus, balancing the use of new information with sound clinical judgment that results in recommendations that are in the best interest of patients.

* Current committees include:

  • Medical Care Criteria Committee
  • Committee for the Care of Children and Adolescents with HIV Infection
  • Dental Standards of Care Committee
  • Mental Health Guidelines Committee
  • Committee for the Care of Women with HIV Infection
  • Committee for the Care of Substance Users with HIV Infection
  • Physicians' Prevention Advisory Committee
  • Pharmacy Advisory Committee
Cost Analysis

A formal cost analysis was not performed and published cost analyses were not reviewed.

Method of Guideline Validation

External Peer Review

Description of Method of Guideline Validation

All guidelines developed by the Committee are externally peer reviewed by at least two experts in that particular area of patient care, which ensures depth and quality of the guidelines.

Identifying Information and Availability

Bibliographic Source(s)

New York State Department of Health. Trichomoniasis. New York (NY): New York State Department of Health; 2012 Aug. 7 p. [27 references]

Adaptation

Not applicable: The guideline was not adapted from another source.

Source(s) of Funding

New York State Department of Health

Guideline Committee

Committee for the Care of Women with HIV Infection

Composition of Group That Authored the Guideline

Chair: Mary Jo Fink, MD, Columbia University College of Physicians and Surgeons, New York, New York

Vice-Chair: Barbara C Zeller, MD, HELP/Project Samaritan AIDS Services, Inc., Bronx, New York

Members: Machelle Allen, MD, Bellevue Hospital Center, New York, New York; Kathryn Anastos, MD, Montefiore Medical Center, Bronx, New York; Jeffrey M Birnbaum, MD, MPH, SUNY Downstate Medical Center, Brooklyn, New York; Susan E Cohn, MD, MPH, Northwestern University Feinberg School of Medicine, Chicago, Illinois; Vanessa E Cullins, MD, MPH, MBA, Planned Parenthood Federation of America, New York, New York; Katherine D LaGuardia, MD, MPH, FACOG, Ortho-McNeil Janssen Scientific Affairs, Raritan, New Jersey; Howard Minkoff, MD, Maimonides Medical Center, Brooklyn, New York; Renee Samelson, MD, MPH, Albany Medical College, Albany, New York; Diane J Tufaro, NP, Westchester Medical Center, Valhalla, New York; Janice R Verley, MD, Nassau University Medical Center, East Meadow, New York; Mary Vogler, MD, Weill College of Medicine, New York, New York; Barbara L Warren, BSN, MPH, PNP, New York State Department of Health AIDS Institute, Albany, New York; Rodney L Wright, MD, Montefiore Medical Center and Albert Einstein College of Medicine, Bronx, New York

AIDS Institute Staff Liaison: Gina M Brown, MD, National Institutes of Health, Bethesda, Maryland

Financial Disclosures/Conflicts of Interest

Not stated

Guideline Status

This is the current release of the guideline.

Guideline Availability
Availability of Companion Documents

The following is available:

Patient Resources

None available

NGC Status

This NGC summary was completed by ECRI Institute on February 25, 2013.

Copyright Statement

This NGC summary is based on the original guideline, which is copyrighted by the guideline developer. See the New York State Department of Health AIDS Institute Web site for terms of use.

Scope

Disease/Condition(s)
  • Human immunodeficiency virus (HIV) infection
  • Trichomoniasis
Guideline Category

Counseling
Diagnosis
Management
Prevention
Screening
Treatment

Clinical Specialty

Allergy and Immunology
Family Practice
Infectious Diseases
Internal Medicine
Obstetrics and Gynecology
Preventive Medicine

Intended Users

Advanced Practice Nurses
Health Care Providers
Nurses
Physician Assistants
Physicians
Public Health Departments

Guideline Objective(s)

To develop guidelines for diagnosis and treatment of trichomoniasis in human immunodeficiency virus (HIV)-infected patients and to assist these patients in protecting their partners

Target Population

Human immunodeficiency virus (HIV)-infected women with trichomoniasis and their partners

Interventions and Practices Considered

Screening/Diagnosis

  1. Screening all sexually active human immunodeficiency virus (HIV)-infected women for trichomoniasis at baseline and at least annually
  2. Confirming the clinical diagnosis of trichomoniasis with laboratory testing
    • Wet mount
    • Trichomonas culture
    • Nucleic acid tests (NATs)
    • Point-of-care tests, such as rapid antigen test or nucleic acid probe test
  3. Confirming diagnosis of trichomoniasis when it is detected with the conventional Papanicolaou (Pap) smear
  4. Screening for other sexually transmitted infections (STIs) when a patient presents with trichomoniasis

Treatment/Management

  1. Metronidazole or tinidazole treatment (oral)
  2. Rescreening sexually active HIV-infected women 3 months after completion of therapy
  3. Avoiding metronidazole gel and other topical regimens
  4. Management of both HIV and STI exposures in partners
  5. Reporting confirmed cases of HIV infection according to New York State Public Health Law
  6. Patient education
Major Outcomes Considered
  • Sensitivity and specificity of diagnostic tests
  • Cure rates of metronidazole and tinidazole
  • Reinfection by untreated sex partners

Recommendations

Major Recommendations

The quality of evidence (I-III) and strength of recommendation (A-C) are defined at the end of the "Major Recommendations" field.

Screening for Trichomoniasis

Clinicians should screen all sexually active human immunodeficiency virus (HIV)-infected women for trichomoniasis at baseline and at least annually. (AIII)

Diagnosis

Clinicians should confirm the clinical diagnosis of trichomoniasis with laboratory testing. (AI) Confirmatory testing may include the following:

  • Wet mount
  • Trichomonas culture
  • Nucleic acid tests (NATs)
  • Point-of-care tests, such as rapid antigen test or nucleic acid probe test

Clinicians should confirm the diagnosis of trichomoniasis when it is detected with the conventional Papanicolaou (Pap) smear. (AI)

Clinicians should screen for other sexually transmitted infections (STIs) when a patient presents with trichomoniasis. (AII)

Treatment

Clinicians should treat HIV-infected patients with trichomoniasis with either metronidazole 2 g by mouth (PO) in a single dose or tinidazole 2 g PO in a single dose (see table below). (AI)

Clinicians should not use topical antimicrobials (metronidazole gel) to treat trichomoniasis. (AI)

Clinicians should consider rescreening sexually active HIV-infected women 3 months after completion of therapy. (BIII)

Table: Recommended Regimens for Treatment of Trichomoniasis in HIV-Infected Patients

Metronidazolea 2 g orally (PO) in a single doseb

or

Tinidazolea 2 g PO in a single doseb

Alternative Regimen

Metronidazolea 500 mg PO twice daily for 7 days

Post-Treatment Failure Regimen

Metronidazolea 2 g PO for 5 days

or

Tinidazolea 2 g PO for 5 days

Common Side Effects

  • Metronidazole: gastrointestinal (GI) intolerance, metallic taste, headache
  • Tinidazole: generally well tolerated with occasional GI intolerance

a Patients should be advised not to consume alcohol during treatment with metronidazole or tinidazole. Abstinence from alcohol should continue for 24 hours after completion of metronidazole or 72 hours after completion of tinidazole.

b Preferably observed in the clinic/office setting. The advantage of single-dose therapy is that it can be taken under observation in the clinic/office setting and excludes non-adherence as a factor for treatment failure.

 

Key Point:

Metronidazole gel and other topical regimens have been shown to have unacceptably low cure rates (<50% for metronidazole) and are not recommended for treatment of Trichomonas vaginalis.

Management of Partners

Clinicians should consider both HIV and STI exposures to partners when HIV-infected patients present with a new STI. Clinicians should also assess for the presence of other STIs (see Management of STIs in HIV-Infected Patients). (AIII)

Management of HIV Exposure in Partners

When HIV-infected patients present with a new STI, clinicians should offer assistance with notifying partners of both the potential HIV and STI exposures or should refer patients to other sources for partner notification assistance (Partner Services in New York State or Contact Notification Assistance program [CNAP] in New York City). Partners without confirmed HIV infection should undergo HIV testing at baseline, 1, 3, and 6 months. Confirmatory testing according to New York State regulations must be performed to confirm HIV diagnoses.

Clinicians must report confirmed cases of HIV according to New York State Public Health Law (for more information about required reporting, see www.health.ny.gov/diseases/aids/regulations/index.htm).

Clinicians should educate patients with non-HIV-infected partners or partners of unknown HIV status to be vigilant for any post-exposure acute HIV symptoms in their partners, such as febrile illness accompanied by rash, lymphadenopathy, myalgias, and/or sore throat (see the New York State Department of Health [NYSDOH] guideline Diagnosis and Management of Acute HIV Infection). (AIII)

Partners who present within 36 hours of an HIV exposure should be evaluated as soon as possible for initiation of post-exposure prophylaxis therapy (see the NGC summary of the NYSDOH guideline HIV Prophylaxis for Victims of Sexual Assault). (AII)

Management of T. vaginalis Exposure in Sex Partners

All recent and current sex partners of patients with acute, persistent, or recurrent trichomoniasis should be treated or referred for treatment regardless of symptoms. (AII)

Definitions:

Quality of Evidence for Recommendation

  1. One or more randomized trials with clinical outcomes and/or validated laboratory endpoints
  2. One or more well-designed, non-randomized trials or observational cohort studies with long-term clinical outcomes
  3. Expert opinion

Strength of Recommendation

  1. Strong recommendation for the statement
  2. Moderate recommendation for the statement
  3. Optional recommendation
Clinical Algorithm(s)

None provided

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need

Getting Better
Living with Illness
Staying Healthy

IOM Domain

Effectiveness
Patient-centeredness

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