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Risk Reduction for Sexually Transmitted Infections

N/A
Waitlist Available
Led By Gail E Wyatt, PhD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 3 months of completion of the intervention
Awards & highlights

Summary

This study focuses on the implementation of an evidence-based HIV risk reduction intervention for HIV-serodiscordant, heterosexual African American couples ("Eban II") in two geographic areas (Northern and Southern California - roughly, Alameda and Los Angeles Counties) that have a high prevalence of HIV infection and risk conditions among African Americans. The Specific Aims are as follows: 1. To evaluate implementation of Eban for HIV serodiscordant African American couples in 10 CBOs in California. To do this, we will document the implementation process and identify barriers and facilitators to Eban's adoption and use by the CBOs. We will interview 200 staff at CBOs to obtain this information. 2. To evaluate the effect of Eban on behavioral and biological outcomes among 180 couples, specifically incidents of protected sex, proportion of condom use, and incident sexually transmitted infections. Eban will be assessed using a randomized delayed enrollment (waitlist) control design to evaluate the impact of treatment on outcomes at posttest and 3-month follow-up (i.e., at these 10 CBOs, Eban will be conducted and offered to couples and evaluated for effectiveness - that is, how well it works in the real world.) 3. To determine the cost-effectiveness of implementation of Eban, based on implementation costs and potential cost savings.

Eligible Conditions
  • Sexually Transmitted Infections
  • Infectious Disease Transmission
  • Safe Sex
  • HIV/AIDS

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 3 months of completion of the intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 3 months of completion of the intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safe Sex

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Risk ReductionExperimental Treatment1 Intervention
The Risk Reduction group will receive the Eban II Intervention upon enrollment. This group will do the following: * Provide HIV and STI test results * First Interview * Attend 8 sessions - 1 session per week * Second interview occurs immediately following the 8th session with HIV and STI tests * Third interview occurs 3 months after the 8th session with HIV and STI tests
Group II: WaitlistActive Control1 Intervention
The Waitlist group will receive the same intervention after waiting for the Risk Reduction group to complete the entire intervention. * Provide HIV and STI test results * First Interview * No sessions for 8 weeks * Second interview and proof of HIV and STI status occurs after the 8 weeks from when you were enrolled * Third interview occurs 3 months after the 8th session with HIV and STI tests The Waitlist Group will then be invited to participate in the Risk Reduction group activities. * Attend 8 sessions - 1 session per week * Fourth interview occurs immediately after the 8th session with HIV and STI tests * Fifth interview occurs 3 months after the 8th session with HIV and STI tests
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Risk Reduction
2022
N/A
~40680

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,554 Previous Clinical Trials
10,263,714 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,869 Previous Clinical Trials
2,777,136 Total Patients Enrolled
Hector Myers, PhDStudy DirectorUniversity of California, Los Angeles
~30 spots leftby Sep 2025