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HIV Prevention Program for Patients Receiving Care at a Sexually Transmitted Diseases Clinic

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Status and phase

Completed
Phase 3
Phase 2

Conditions

Sexually Transmitted Diseases
HIV Infections

Treatments

Behavioral: Intensive Informational Intervention
Behavioral: Brief Informational Intervention
Behavioral: Intensive Info-Motivation-Behavioral Skills Intervention
Behavioral: Brief Motivational Intervention

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00183573
R01MH068171 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study will determine the effectiveness of a two-step HIV prevention program in reducing risky sexual practices and decreasing the incidence of sexually transmitted diseases (STDs).

Full description

Numerous factors influence one's sexual choices, including social support and pressure, internal feelings and beliefs, and knowledge about the subject. Data indicate that people who are well-informed about the risks associated with certain sexual behaviors are more likely to protect themselves than those who are less informed. This study will determine whether an intervention comprising information, motivation, and behavioral skills components is more effective than an information-only workshop in changing sexual behavior for HIV prevention.

At study entry, participants will undergo a physical exam, various STD tests, and a rapid HIV test, which can provide test results within several hours. While waiting for their test results at the study clinic, participants will complete a computerized questionnaire assessing their thoughts, feelings, and behaviors regarding sexual activities. Participants will also be exposed to one of two brief health promotion interventions: a motivational, one-on-one counseling session or a DVD on safer sex. After receiving their test results, participants will be asked to complete a brief postassessment questionnaire about their attitudes toward their test results and the intervention.

Two-thirds of the participants will then be invited to attend an intensive, 4-hour safer sex workshop. These participants will be randomly assigned to one of two workshops: an information-only workshop or a workshop that includes information, motivation, and behavioral skills components. Participants who choose not to participate in the workshop will complete the study after receiving their STD and HIV test results. Participants who participate in the workshop will return to the clinic at 3, 6, and 12 months after the workshop to complete another questionnaire about sexual behaviors and give a urine sample for STD testing.

Enrollment

1,554 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Diagnosis or symptoms of an STD within 3 months prior to study entry OR have had unprotected vaginal or anal intercourse with one or more of the following: two or more sexual partners, a partner with two or more partners, an anonymous partner, an injection drug-using partner, or a partner with an STD
  • Able to understand English

Exclusion criteria

  • Psychosis or impaired mental status that would prevent participant from providing informed consent
  • Have been tested for HIV within 3 months prior to study entry
  • HIV infected

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,554 participants in 6 patient groups

1
Experimental group
Description:
Brief Motivational Intervention only
Treatment:
Behavioral: Brief Motivational Intervention
2
Experimental group
Description:
Brief Informational Intervention only
Treatment:
Behavioral: Brief Informational Intervention
3
Experimental group
Description:
Brief Motivational Intervention + Intensive Informational Intervention
Treatment:
Behavioral: Intensive Informational Intervention
Behavioral: Brief Motivational Intervention
4
Experimental group
Description:
Brief Motivational Intervention + Intensive Information-Motivation-Behavioral Skills Intervention
Treatment:
Behavioral: Brief Motivational Intervention
Behavioral: Intensive Info-Motivation-Behavioral Skills Intervention
5
Experimental group
Description:
Brief Informational Intervention + Intensive Informational Intervention
Treatment:
Behavioral: Intensive Informational Intervention
Behavioral: Brief Informational Intervention
6
Experimental group
Description:
Brief Informational Intervention + Intensive Information-Motivation-Behavioral Skills Intervention
Treatment:
Behavioral: Brief Informational Intervention
Behavioral: Intensive Info-Motivation-Behavioral Skills Intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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