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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Los Angeles LGBT Center

Collaborator
University of California, Los Angeles

Information provided by (Responsible Party)
Matthew Beymer, Los Angeles LGBT Center

ClinicalTrials.gov Identifier
NCT02257658

First received: October 1, 2014
Last updated: October 3, 2014
Last Verified: October 2014
History of Changes
Purpose

Purpose

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 Intervention
Syphilis

Drug : Doxycycyline
Behavioral : Incentive

Study Type: Interventional
Study Design: 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

Further study details as provided by Matthew Beymer, Los Angeles LGBT Center:

Primary Outcome Measures

  • 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:
  • 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 ]
  • 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.
  • 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.

Enrollment: 30
Study Start Date: September 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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
Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02257658

Sponsors and Collaborators

Los Angeles LGBT Center
University of California, Los Angeles

Investigators

Principal Investigator: Jeffrey D Klausner, MD University of California, Los Angeles
More Information

More Information


Responsible Party: Matthew Beymer, Epidemiologist, Health and Mental Health Services, Los Angeles LGBT Center  
ClinicalTrials.gov Identifier: NCT02257658   History of Changes  
Other Study ID Numbers: PHS 398/2590  
Study First Received: October 1, 2014  
Last Updated: October 3, 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:
Syphilis
Doxycycline

ClinicalTrials.gov processed this data on October 20, 2017
This information is provided by ClinicalTrials.gov.