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

HIV Prevention for STD Clinic Patients

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00183573
Enrollment
1554
Registered
2005-09-16
Start date
2004-03-31
Completion date
2007-07-31
Last updated
2013-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Sexually Transmitted Diseases

Keywords

STDs, Sexual Behavior, Health Behavior, HIV Seronegativity

Brief summary

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).

Detailed 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.

Interventions

15-20 minute, motivational one-on-one counseling

BEHAVIORALBrief Informational Intervention

15 minute informational DVD on safer sex

BEHAVIORALIntensive Informational Intervention

4-hour, information-only intensive group workshop

BEHAVIORALIntensive Info-Motivation-Behavioral Skills Intervention

4-hour, intensive group workshop with emphasis on motivation and skills

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of Rochester
CollaboratorOTHER
Syracuse University
CollaboratorOTHER
The Miriam Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Sexual behavior12 months

Secondary

MeasureTime frame
STD incidence12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026