Phase 2 Completed N=746 Randomized Double-blind Prevention

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

HIV · Sexually Transmitted Diseases

Source: ClinicalTrials.gov NCT00183456 ↗

Enrolled (actual)

746

Serious AEs

0.0%

Results posted

Oct 2012

Primary outcomePrimary: Sex Risk Behaviors: Number of Sex Partners (>=2 Sex Partners) — 17; 29; 50; 53 participants — p=<0.01

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).

Outcome Measures

Outcome	Result	p-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

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. Informational only — not medical advice.