NCT02257658: DPMSM

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

Completed NA Last updated 3 October 2014

What this trial tests

NA trial testing Doxycycyline in Syphilis in 30 participants. Completed in 1 January 2013.

Timeline

1 September 2011

Primary endpoint
1 January 2013

1 January 2013

Quick facts

Lead sponsor	Los Angeles LGBT Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	30
Start date	1 September 2011
Primary completion	1 January 2013
Estimated completion	1 January 2013

Drugs / interventions tested

• Doxycycyline — full drug profile →
• Incentive

Conditions studied

• Syphilis — all drugs for Syphilis →

Sponsor

Los Angeles LGBT Center — full company profile →

Who can join

18 and older, male only, with Syphilis. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Doxycycline prophylaxis 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.
   Bolan RK, Beymer MR, Weiss RE, Flynn RP, et al · · 2015 · cited 169× · PMID 25585069 · DOI 10.1097/olq.0000000000000216