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

Syphilis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02257658
• Other study ID #: PHS 398/2590
• Status: Completed
• Phase: N/A
• First received: October 1, 2014
• Last updated: October 3, 2014
• Start date: September 2011
• Est. completion date: January 2013

Study information

• Verified date: October 2014
• Source: Los Angeles LGBT Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Syphilis

Intervention

Drug:
• Doxycycyline

Behavioral:
• Incentive

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Los Angeles LGBT Center	University of California, Los Angeles

References & Publications (7)

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

Goh BT. Syphilis in adults. Sex Transm Infect. 2005 Dec;81(6):448-52. Review. — View 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. — View Citation

Lynn WA, Lightman S. Syphilis and HIV: a dangerous combination. Lancet Infect Dis. 2004 Jul;4(7):456-66. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		12 Weeks, 24 Weeks, 36 Weeks and 48 Weeks	No
Secondary	Measure adherence to study visits in the Doxycycline and Contingency Management Arms at Weeks 12, 24, 36 and 48		12 Weeks, 24 Weeks, 36 Weeks and 48 Weeks	No
Secondary	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.	12 Weeks, 24 Weeks and 36 Weeks	No
Secondary	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.	12 Weeks, 24 Weeks and 36 Weeks	No