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

L

Los Angeles LGBT Center

Status

Completed

Conditions

Syphilis

Treatments

Behavioral: Incentive
Drug: Doxycycyline

Study type

Interventional

Funder types

Other

Identifiers

NCT02257658
PHS 398/2590

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

Male

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Doxycycline
Experimental group
Description:
Subjects in the doxycycyline arm will receive Doxycycline, oral, 100 mg, once daily for 36 weeks.
Treatment:
Drug: Doxycycyline
Incentive
Active Comparator group
Description:
Subjects in the incentive arm will receive escalating payments for remaining STI free at Weeks 12, 24 and 36.
Treatment:
Behavioral: Incentive

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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