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

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ClinicalTrials.gov Identifier: NCT02257658
Recruitment Status : Completed
First Posted : October 6, 2014
Last Update Posted : October 6, 2014
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
Matthew Beymer, Los Angeles LGBT Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Syphilis Drug: Doxycycyline Behavioral: Incentive Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Doxycycline Prophylaxis or Incentive Payments to Reduce Incident Syphilis Among HIV- Infected Men Who Have Sex With Men Who Continue to Engage in High Risk Sex: A Randomized, Controlled Pilot Study
Study Start Date : September 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013


Arm Intervention/treatment
Experimental: Doxycycline
Subjects in the doxycycyline arm will receive Doxycycline, oral, 100 mg, once daily for 36 weeks.
Drug: Doxycycyline
Active Comparator: Incentive
Subjects in the incentive arm will receive escalating payments for remaining STI free at Weeks 12, 24 and 36.
Behavioral: Incentive



Primary Outcome Measures :
  1. Measure changes in the incidence of Syphilis, Gonorrhea and Chlamydia at 12 weeks, 24 weeks, 26 weeks and 48 weeks in the Doxycycline Arm and Contingency Management Arms [ Time Frame: 12 Weeks, 24 Weeks, 36 Weeks and 48 Weeks ]

Secondary Outcome Measures :
  1. Measure adherence to study visits in the Doxycycline and Contingency Management Arms at Weeks 12, 24, 36 and 48 [ Time Frame: 12 Weeks, 24 Weeks, 36 Weeks and 48 Weeks ]
  2. Measure adherence to daily Doxycycline Use using Blood Samples in the Doxycycline Arm at Weeks 12, 24 and 36 [ Time Frame: 12 Weeks, 24 Weeks and 36 Weeks ]
    At Weeks 12, 24 and 36, blood samples were drawn from participants in the Doxycycline arm and sent to a lab to measure doxycyline levels in each participant in the Doxycyline Arm. The purpose of this outcome is to determine if individuals in the Doxycycline Arm are consistently adhering to the daily regimen of the drug.

  3. Measure changes in self-report sexual risk behaviors (e.g., condom use, drug use and number of partners) in the Doxycycline and Contingency Management Arms at Weeks 12, 24 and 36 [ Time Frame: 12 Weeks, 24 Weeks and 36 Weeks ]
    Prior to having labs drawn, participants in both the Doxycycline and Contingency Management Arms were asked about their risk behaviors in the past three months including: meth use, condom use with casual partners, condom use with regular partners, condom use with a main partner, number of casual sexual partners and number of regular sexual partners.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02257658


Sponsors and Collaborators
Los Angeles LGBT Center
University of California, Los Angeles
Investigators
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Principal Investigator: Jeffrey D Klausner, MD University of California, Los Angeles
Publications:
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Responsible Party: Matthew Beymer, Epidemiologist, Health and Mental Health Services, Los Angeles LGBT Center
ClinicalTrials.gov Identifier: NCT02257658    
Other Study ID Numbers: PHS 398/2590
First Posted: October 6, 2014    Key Record Dates
Last Update Posted: October 6, 2014
Last Verified: October 2014
Keywords provided by Matthew Beymer, Los Angeles LGBT Center:
Men who have Sex with Men
HIV-positive
Syphilis
Contingency Management
Additional relevant MeSH terms:
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Syphilis
Treponemal Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Spirochaetales Infections
Sexually Transmitted Diseases
Infection