Efficacy of Doxycycline Prophylaxis to Reduce Syphilis in High-Risk, HIV-Positive MSM

NCT ID: NCT02257658

Last Updated: 2014-10-06

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

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-01-31

Brief Summary

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This pilot study will investigate the feasibility of conducting a large, randomized trial comparing a structural intervention to contingency management to reduce incident syphilis infections in an especially high risk group: HIV+ men who have sex with men (MSM) who have had syphilis twice or more since their HIV diagnosis. Subjects will be randomized to receive either QD doxycycline as syphilis prophylaxis or a financial incentive to remain STI free. The investigators will : 1) measure adherence to study visits in both arms; 2) measure adherence to the prophylaxis regimen; 3) measure any changes in risk behaviors among study participants and 4) to the extent possible in a small pilot study of short duration, compare effectiveness of doxycycline with that of a monetary incentive for remaining STI free.

Detailed Description

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Conditions

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Syphilis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Doxycycline

Subjects in the doxycycyline arm will receive Doxycycline, oral, 100 mg, once daily for 36 weeks.

Group Type EXPERIMENTAL

Doxycycyline

Intervention Type DRUG

Incentive

Subjects in the incentive arm will receive escalating payments for remaining STI free at Weeks 12, 24 and 36.

Group Type ACTIVE_COMPARATOR

Incentive

Intervention Type BEHAVIORAL

Interventions

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Doxycycyline

Intervention Type DRUG

Incentive

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* HIV-infected MSM or transgender women who have sex with men
* At least two documented and adequately treated episodes of syphilis since HIV diagnosis

Exclusion Criteria

* Had a known allergy or intolerance to doxycycline
* Abused alcohol or other substances which in the opinion of the investigators would jeopardize adherence to study procedures
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role collaborator

Los Angeles LGBT Center

OTHER

Sponsor Role lead

Responsible Party

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Matthew Beymer

Epidemiologist, Health and Mental Health Services

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeffrey D Klausner, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

References

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Celum CL. Sexually transmitted infections and HIV: epidemiology and interventions. Top HIV Med. 2010 Oct-Nov;18(4):138-42.

Reference Type BACKGROUND
PMID: 21107013 (View on PubMed)

Goh BT. Syphilis in adults. Sex Transm Infect. 2005 Dec;81(6):448-52. doi: 10.1136/sti.2005.015875.

Reference Type BACKGROUND
PMID: 16326843 (View on PubMed)

Lynn WA, Lightman S. Syphilis and HIV: a dangerous combination. Lancet Infect Dis. 2004 Jul;4(7):456-66. doi: 10.1016/S1473-3099(04)01061-8.

Reference Type BACKGROUND
PMID: 15219556 (View on PubMed)

Centers for Disease Control and Prevention (CDC). Outbreak of syphilis among men who have sex with men--Southern California, 2000. MMWR Morb Mortal Wkly Rep. 2001 Feb 23;50(7):117-20.

Reference Type BACKGROUND
PMID: 11393490 (View on PubMed)

Horberg MA, Ranatunga DK, Quesenberry CP, Klein DB, Silverberg MJ. Syphilis epidemiology and clinical outcomes in HIV-infected and HIV-uninfected patients in Kaiser Permanente Northern California. Sex Transm Dis. 2010 Jan;37(1):53-8. doi: 10.1097/OLQ.0b013e3181b6f0cc.

Reference Type BACKGROUND
PMID: 19734820 (View on PubMed)

Marcus JL, Katz KA, Bernstein KT, Nieri G, Philip SS. Syphilis testing behavior following diagnosis with early syphilis among men who have sex with men--San Francisco, 2005-2008. Sex Transm Dis. 2011 Jan;38(1):24-9. doi: 10.1097/OLQ.0b013e3181ea170b.

Reference Type BACKGROUND
PMID: 20679965 (View on PubMed)

Fleming DT, Wasserheit JN. From epidemiological synergy to public health policy and practice: the contribution of other sexually transmitted diseases to sexual transmission of HIV infection. Sex Transm Infect. 1999 Feb;75(1):3-17. doi: 10.1136/sti.75.1.3.

Reference Type BACKGROUND
PMID: 10448335 (View on PubMed)

Other Identifiers

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PHS 398/2590

Identifier Type: -

Identifier Source: org_study_id

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