Efficacy of Doxycycline Prophylaxis to Reduce Syphilis in High-Risk, HIV-Positive MSM (DPMSM)
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|ClinicalTrials.gov Identifier: NCT02257658|
Recruitment Status : Completed
First Posted : October 6, 2014
Last Update Posted : October 6, 2014
|Condition or disease||Intervention/treatment||Phase|
|Syphilis||Drug: Doxycycyline Behavioral: Incentive||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||September 2011|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
Subjects in the doxycycyline arm will receive Doxycycline, oral, 100 mg, once daily for 36 weeks.
Active Comparator: Incentive
Subjects in the incentive arm will receive escalating payments for remaining STI free at Weeks 12, 24 and 36.
- 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 ]
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02257658
|Principal Investigator:||Jeffrey D Klausner, MD||University of California, Los Angeles|