Clinical trial NCT02257658: Efficacy of Doxycycline Prophylaxis to Reduce Syphilis in High-Risk, HIV-Positive MSM
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
Overall status: COMPLETED
Phase: NA
Conditions: Syphilis
Keywords: Men who have Sex with Men
HIV-positive
Syphilis
Contingency Management
Lead sponsor: Los Angeles LGBT Center
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
First posted: 2014-10-06
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: 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
timeFrame: 12 Weeks, 24 Weeks, 36 Weeks and 48 Weeks
Secondary outcomes:
measure: Measure adherence to study visits in the Doxycycline and Contingency Management Arms at Weeks 12, 24, 36 and 48
timeFrame: 12 Weeks, 24 Weeks, 36 Weeks and 48 Weeks
measure: Measure adherence to daily Doxycycline Use using Blood Samples in the Doxycycline Arm at Weeks 12, 24 and 36
timeFrame: 12 Weeks, 24 Weeks and 36 Weeks
measure: 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
timeFrame: 12 Weeks, 24 Weeks and 36 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of California, Los Angeles
name: Jeffrey D Klausner, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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.
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.
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.