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

October 3, 2014 updated by: Matthew Beymer, Los Angeles LGBT Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 Weeks, 24 Weeks, 36 Weeks and 48 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
12 Weeks, 24 Weeks and 36 Weeks
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.
12 Weeks, 24 Weeks and 36 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Los Angeles LGBT Center

Collaborators

University of California, Los Angeles

Investigators

  • Principal Investigator: Jeffrey D Klausner, MD, University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

October 1, 2014

First Submitted That Met QC Criteria

October 3, 2014

First Posted (Estimate)

October 6, 2014

Study Record Updates

Last Update Posted (Estimate)

October 6, 2014

Last Update Submitted That Met QC Criteria

October 3, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHS 398/2590 (Other Identifier: Massachusetts General Hospital Cancer Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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