Efficacy of Doxycycline Prophylaxis to Reduce Syphilis in High-Risk, HIV-Positive MSM (DPMSM)
Primary Purpose
Syphilis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Doxycycyline
Incentive
Sponsored by
About this trial
This is an interventional prevention trial for Syphilis focused on measuring Men who have Sex with Men, HIV-positive, Syphilis, Contingency Management
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Doxycycline
Incentive
Arm Description
Subjects in the doxycycyline arm will receive Doxycycline, oral, 100 mg, once daily for 36 weeks.
Subjects in the incentive arm will receive escalating payments for remaining STI free at Weeks 12, 24 and 36.
Outcomes
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
Secondary Outcome Measures
Measure adherence to study visits in the Doxycycline and Contingency Management Arms at Weeks 12, 24, 36 and 48
Measure adherence to daily Doxycycline Use using Blood Samples in the Doxycycline Arm at Weeks 12, 24 and 36
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
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.
Full Information
NCT ID
NCT02257658
First Posted
October 1, 2014
Last Updated
October 3, 2014
Sponsor
Los Angeles LGBT Center
Collaborators
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT02257658
Brief Title
Efficacy of Doxycycline Prophylaxis to Reduce Syphilis in High-Risk, HIV-Positive MSM
Acronym
DPMSM
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 Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Los Angeles LGBT Center
Collaborators
University of California, Los Angeles
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Syphilis
Keywords
Men who have Sex with Men, HIV-positive, Syphilis, Contingency Management
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Doxycycline
Arm Type
Experimental
Arm Description
Subjects in the doxycycyline arm will receive Doxycycline, oral, 100 mg, once daily for 36 weeks.
Arm Title
Incentive
Arm Type
Active Comparator
Arm Description
Subjects in the incentive arm will receive escalating payments for remaining STI free at Weeks 12, 24 and 36.
Intervention Type
Drug
Intervention Name(s)
Doxycycyline
Intervention Type
Behavioral
Intervention Name(s)
Incentive
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
Measure adherence to daily Doxycycline Use using Blood Samples in the Doxycycline Arm at Weeks 12, 24 and 36
Description
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.
Time Frame
12 Weeks, 24 Weeks and 36 Weeks
Title
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
Description
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.
Time Frame
12 Weeks, 24 Weeks and 36 Weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey D Klausner, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
21107013
Citation
Celum CL. Sexually transmitted infections and HIV: epidemiology and interventions. Top HIV Med. 2010 Oct-Nov;18(4):138-42.
Results Reference
background
PubMed Identifier
16326843
Citation
Goh BT. Syphilis in adults. Sex Transm Infect. 2005 Dec;81(6):448-52. doi: 10.1136/sti.2005.015875.
Results Reference
background
PubMed Identifier
15219556
Citation
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.
Results Reference
background
PubMed Identifier
11393490
Citation
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.
Results Reference
background
PubMed Identifier
19734820
Citation
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.
Results Reference
background
PubMed Identifier
20679965
Citation
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.
Results Reference
background
PubMed Identifier
10448335
Citation
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.
Results Reference
background
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Efficacy of Doxycycline Prophylaxis to Reduce Syphilis in High-Risk, HIV-Positive MSM
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