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Phase 2 N=746 Randomized Double-blind Prevention

A Peer-Oriented HIV Prevention Outreach Program for Individuals at High Risk for HIV and Other STIs

HIV Infections · Sexually Transmitted Diseases

Enrolled (actual)
746
Serious AEs
0.0%
Results posted
Oct 2012
Primary outcome: Primary: Sex Risk Behaviors: Number of Sex Partners (>=2 Sex Partners) — 17; 29; 50; 53 participants — p=<0.01

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Peer-oriented intervention (Behavioral); Group cognitive behavioral therapy (CBT) (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Johns Hopkins Bloomberg School of Public Health
Primary completion
Jul 2007

Outcome Measures

OutcomeResultp-value
PRIMARY
Sex Risk Behaviors: Number of Sex Partners (>=2 Sex Partners)
17; 29; 50; 53 <0.01 sig
PRIMARY
Sex Risk Behaviors: Unprotected Sex With Non-main Partner (Past 90 Days)
10; 22; 47; 58 0.05
PRIMARY
Sex Risk Behaviors: Unprotected Anal Sex (Past 90 Days)
5; 18; 43; 35 0.01 sig
PRIMARY
Sex Risk Behaviors: Unprotected Vaginal Sex (Past 90 Days)
32; 49; 123; 119 0.05
PRIMARY
Sex Risk Behaviors: Unprotected Sex With Main Partner (Past 90 Days)
30; 50; 127; 113 0.01 sig
PRIMARY
Sex Risk Behaviors: Unprotected Sex With a Non-main Partner (Past 90 Days)
8; 21; 47; 51 0.05
PRIMARY
Sex Risk Behaviors: Any High Risk Sexual Behavior (Past 90 Days)
51; 69; 172; 151 0.01 sig
SECONDARY
HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)
56; 42; 141; 113 0.01 sig
SECONDARY
HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)
56; 42; 141; 113 0.01 sig
SECONDARY
HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)
56; 42; 141; 113 0.01 sig

Summary

This study will determine the effectiveness of a peer outreach intervention in preventing HIV infection in adults at high risk for contracting HIV and other sexually transmitted diseases (STDs).

Eligibility Criteria

Inclusion Criteria for CBT or Peer Intervention Participants:

  • Female
  • Age 18-55
  • Did not inject drugs in the past 6 months
  • Self-reported sex with at least 1 male partner in the past 6 months
  • Had at least 1 of the following sexual risk factors:
  • More than 2 sex partners in the past 6 months
  • STI diagnosis in the past 6 months
  • Had a high risk sex partner in the past 90 days (i.e. a sex partner that injected drugs, smoked crack, was HIV+, or MSM)

Inclusion Criteria for Peer Network Participants:

  • 18 years old or older
  • One of the following:
  • Injected drugs
  • Sex partner of index
  • Social network member that the index felt comfortable talking to about HIV/STIs

Exclusion Criteria for All Participants:

  • Currently enrolled in another HIV prevention intervention
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00183456). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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