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Completed

NCT Number: NCT02257658

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

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.

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Key information

Conditions

Syphilis Bacterial Infections Bacterial Infections and Mycoses Behavior Blood-Borne Infections Communicable Diseases Genital Diseases Gram-Negative Bacterial Infections HIV Infections HIV Seropositivity Homosexuality Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexual Behavior Sexuality Sexually Transmitted Diseases Sexually Transmitted Diseases, Bacterial Sexually Transmitted Diseases, Viral Spirochaetales Infections Treponemal Infections Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Doxycycyline

Drug

Incentive

Behavioral

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Los Angeles LGBT Center

Other

Collaborators

  • University of California, Los Angeles

Registry information

Official study 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

Acronym: DPMSM

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Oct 6, 2014
Registry last updated
Oct 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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