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CompletedNCT00183456Updated Jun 28, 2013Results posted

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

A Phase 2 interventional study of Peer-oriented intervention and Group cognitive behavioral therapy (CBT) in HIV Infections and Sexually Transmitted Diseases, sponsored by Johns Hopkins Bloomberg School of Public Health. Completed at 1 site in United States. Open to participants aged 18 Years to 74 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-06-28.

Sponsored by Johns Hopkins Bloomberg School of Public Health · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
746
Allocation
Randomized
Ages
18 Years to 74 Years
Sex
All
01

Study 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).

Read the detailed description

The persistence of HIV and STD epidemics indicates that more effective, sustainable preventive interventions are needed, particularly for low-income, inner-city populations. This study will determine the effectiveness of a theoretically based peer outreach program in preventing HIV and STD transmission among adults in the Baltimore, Maryland area.

Participants will be randomly assigned to receive either a network-oriented peer program emphasizing one's social identity and the goals of protecting one's family and community or group cognitive behavioral therapy (CBT). The peer program will also train participants to provide HIV/STD education to their peers. Participants will be assessed at study entry and during several subsequent follow-up visits. At these study visits, participants will complete questionnaires about their sexual health knowledge and sexual behaviors. Participants and members of their peer network will have follow-up visits at Months 6, 12, and 18.

02

Conditions studied

  • HIV Infections
  • Sexually Transmitted Diseases

Keywords

  • Sex Education
  • Peer Group
  • Social Identity Theory
  • HIV Seronegativity
  • Intervention
  • women
  • Social Networks
  • Peer Education
03

In context

Sexually Transmitted Diseases

424 studies on the registry are indexed under Sexually Transmitted Diseases; 71 are open to participants now.

This study's enrollment of 746 is above the median of 470 across 346 interventional studies indexed under Sexually Transmitted Diseases.

Browse Sexually Transmitted Diseases studies →

Lead sponsor

Johns Hopkins Bloomberg School of Public Health is the lead sponsor of 364 studies on the registry; 41 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion Criteria for CBT or Peer Intervention Participants:

  1. Female
  2. Age 18-55
  3. Did not inject drugs in the past 6 months
  4. Self-reported sex with at least 1 male partner in the past 6 months

  5. Had at least 1 of the following sexual risk factors:

    1. More than 2 sex partners in the past 6 months
    2. STI diagnosis in the past 6 months
    3. 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

Inclusion Criteria for Peer Network Participants:

  1. 18 years old or older

  2. One of the following:

    1. Injected drugs
    2. Sex partner of index
    3. Social network member that the index felt comfortable talking to about HIV/STIs

Exclusion criteria

Exclusion Criteria for All Participants:

  • Currently enrolled in another HIV prevention intervention
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
746 participants (actual)

Study arms

  • Experimental
    Intervention Condition: CHAT

    Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.

    Behavioral: Peer-oriented intervention

  • Active comparator
    Comparison Condition: Standard of Care

    The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.

    Behavioral: Group cognitive behavioral therapy (CBT)

  • No intervention
    Network Participants

    Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.

  • No intervention
    Non-randomized Baseline index participants

    This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.

Interventions

  • BehavioralPeer-oriented intervention

    The peer-oriented intervention program emphasized social identity and the goals of protecting family and community. The peer program also trained participants to provide HIV/STD education to their peers.

  • BehavioralGroup cognitive behavioral therapy (CBT)

    Group CBT will focus on teaching ways to modify thoughts and behaviors associated with risky sexual behaviors.

06

What researchers measure

Primary outcomes

  1. Sex Risk Behaviors: Number of Sex Partners (>=2 Sex Partners)

    Number of participants that had 2 or more sex partners in the past 90 days.

    Time frame: 6 months

  2. Sex Risk Behaviors: Unprotected Sex With Non-main Partner (Past 90 Days)

    Time frame: 12 months

  3. Sex Risk Behaviors: Unprotected Anal Sex (Past 90 Days)

    Time frame: 18 month

  4. Sex Risk Behaviors: Unprotected Vaginal Sex (Past 90 Days)

    Time frame: 18 months

  5. Sex Risk Behaviors: Unprotected Sex With Main Partner (Past 90 Days)

    Time frame: 18 months

  6. Sex Risk Behaviors: Unprotected Sex With a Non-main Partner (Past 90 Days)

    Time frame: 18 months

  7. Sex Risk Behaviors: Any High Risk Sexual Behavior (Past 90 Days)

    Time frame: 18 months

Secondary outcomes

  1. HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)

    Time frame: 6 months

  2. HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)

    Time frame: 12 months

  3. HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)

    Time frame: 18 months

07

Results

Posted Oct 18, 2012

Participant flow

The sample consisted of women and their social network members. Index participants were recruited through street outreach as well as at health clinics, and other local community agencies. Social network members were recruited by index participants after completion of the index's baseline visit. Recruitment took place from September 2005-July 2007

Participant flow — Overall Study
MilestoneIntervention Condition: CHATComparison Condition: Standard of CareNetwork ParticipantsNon-randomized Baseline Index Participants
Started8584329248
6 month follow-up7477278175
12 month follow-up7674267186
18 month follow-up8081303207
Completed8283313220
Not completed311628

Outcome measures

PrimarySex Risk Behaviors: Number of Sex Partners (>=2 Sex Partners)

Number of participants that had 2 or more sex partners in the past 90 days.

Time frame:
6 months
Reported as:
Number · participants
Sex Risk Behaviors: Number of Sex Partners (>=2 Sex Partners)
participantsIntervention Condition: CHATComparison Condition: Standard of CareNetwork ParticipantsNon-randomized Baseline Index Participants
Sex Risk Behaviors: Number of Sex Partners (>=2 Sex Partners)17295053
Statistical analysis
  • Intervention Condition: CHAT vs Comparison Condition: Standard of Care · Generalized Estimating Equations · p = <0.01 · Odds ratio (or): 0.28 · 95% CI 0.13 to 0.63
SecondaryHIV Communication: Talk to Family About HIV or STIs (Past 6 Months)
Time frame:
6 months
Reported as:
Number · participants
HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)
participantsIntervention Condition: CHATComparison Condition: Standard of CareNetwork ParticipantsNon-randomized Baseline Index Participants
HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)6152155117
Statistical analysis
  • Intervention Condition: CHAT vs Comparison Condition: Standard of Care · Generalized Estimating Equations · p = 0.05 · Odds ratio (or): 2.68 · 95% CI 1.22 to 5.89
PrimarySex Risk Behaviors: Unprotected Sex With Non-main Partner (Past 90 Days)
Time frame:
12 months
Reported as:
Number · participants
Sex Risk Behaviors: Unprotected Sex With Non-main Partner (Past 90 Days)
participantsIntervention Condition: CHATComparison Condition: Standard of CareNetwork ParticipantsNon-randomized Baseline Index Participants
Sex Risk Behaviors: Unprotected Sex With Non-main Partner (Past 90 Days)10224758
Statistical analysis
  • Intervention Condition: CHAT vs Comparison Condition: Standard of Care · Generalized Estimating Equations · p = 0.05 · Odds ratio (or): 0.36 · 95% CI 0.16 to 0.84
SecondaryHIV Communication: Talk to Family About HIV or STIs (Past 6 Months)
Time frame:
12 months
Reported as:
Number · participants
HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)
participantsIntervention Condition: CHATComparison Condition: Standard of CareNetwork ParticipantsNon-randomized Baseline Index Participants
HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)5839124104
Statistical analysis
  • Intervention Condition: CHAT vs Comparison Condition: Standard of Care · Generalized Estimating Equations · p = 0.01 · Odds ratio (or): 2.82 · 95% CI 1.41 to 5.64
PrimarySex Risk Behaviors: Unprotected Anal Sex (Past 90 Days)
Time frame:
18 month
Reported as:
Number · participants
Sex Risk Behaviors: Unprotected Anal Sex (Past 90 Days)
participantsIntervention Condition: CHATComparison Condition: Standard of CareNetwork ParticipantsNon-randomized Baseline Index Participants
Sex Risk Behaviors: Unprotected Anal Sex (Past 90 Days)5184335
Statistical analysis
  • Intervention Condition: CHAT vs Comparison Condition: Standard of Care · Generalized Estimating Equations · p = 0.01 · Odds ratio (or): 0.24 · 95% CI 0.09 to 0.68
PrimarySex Risk Behaviors: Unprotected Vaginal Sex (Past 90 Days)
Time frame:
18 months
Reported as:
Number · participants
Sex Risk Behaviors: Unprotected Vaginal Sex (Past 90 Days)
participantsIntervention Condition: CHATComparison Condition: Standard of CareNetwork ParticipantsNon-randomized Baseline Index Participants
Sex Risk Behaviors: Unprotected Vaginal Sex (Past 90 Days)3249123119
Statistical analysis
  • Intervention Condition: CHAT vs Comparison Condition: Standard of Care · Generalized Estimating Equations · p = 0.05 · Odds ratio (or): 0.47 · 95% CI 0.25 to 0.87
PrimarySex Risk Behaviors: Unprotected Sex With Main Partner (Past 90 Days)
Time frame:
18 months
Reported as:
Number · participants
Sex Risk Behaviors: Unprotected Sex With Main Partner (Past 90 Days)
participantsIntervention Condition: CHATComparison Condition: Standard of CareNetwork ParticipantsNon-randomized Baseline Index Participants
Sex Risk Behaviors: Unprotected Sex With Main Partner (Past 90 Days)3050127113
Statistical analysis
  • Intervention Condition: CHAT vs Comparison Condition: Standard of Care · Generalized Estimating Equations · p = 0.01 · Odds ratio (or): 0.41 · 95% CI 0.21 to 0.77
PrimarySex Risk Behaviors: Unprotected Sex With a Non-main Partner (Past 90 Days)
Time frame:
18 months
Reported as:
Number · participants
Sex Risk Behaviors: Unprotected Sex With a Non-main Partner (Past 90 Days)
participantsIntervention Condition: CHATComparison Condition: Standard of CareNetwork ParticipantsNon-randomized Baseline Index Participants
Sex Risk Behaviors: Unprotected Sex With a Non-main Partner (Past 90 Days)8214751
Statistical analysis
  • Intervention Condition: CHAT vs Comparison Condition: Standard of Care · Generalized Estimating Equations · p = 0.05 · Odds ratio (or): 0.33 · 95% CI 0.14 to 0.79
PrimarySex Risk Behaviors: Any High Risk Sexual Behavior (Past 90 Days)
Time frame:
18 months
Reported as:
Number · participants
Sex Risk Behaviors: Any High Risk Sexual Behavior (Past 90 Days)
participantsIntervention Condition: CHATComparison Condition: Standard of CareNetwork ParticipantsNon-randomized Baseline Index Participants
Sex Risk Behaviors: Any High Risk Sexual Behavior (Past 90 Days)5169172151
Statistical analysis
  • Intervention Condition: CHAT vs Comparison Condition: Standard of Care · Generalized Estimating Equations · p = 0.01 · Odds ratio (or): 0.30 · 95% CI 0.14 to 0.64
SecondaryHIV Communication: Talk to Family About HIV or STIs (Past 6 Months)
Time frame:
18 months
Reported as:
Number · participants
HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)
participantsIntervention Condition: CHATComparison Condition: Standard of CareNetwork ParticipantsNon-randomized Baseline Index Participants
HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)5642141113
Statistical analysis
  • Intervention Condition: CHAT vs Comparison Condition: Standard of Care · Generalized Estimating Equations · p = 0.01 · Odds ratio (or): 2.41 · 95% CI 1.25 to 4.65

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Intervention Condition: CHAT—0/85 (0%)0/85 (0%)
Comparison Condition: Standard of Care—0/84 (0%)0/84 (0%)
Network Participants—0/329 (0%)0/329 (0%)
Non-randomized Baseline Index Participants—0/248 (0%)0/248 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Intervention Condition: CHATComparison Condition: Standard of CareNetwork ParticipantsNon-randomized Baseline Index ParticipantsTotal
<=18 years00213
Between 18 and 65 years8584323247739
>=65 years00404
Age Continuous
Age Continuous(years)Intervention Condition: CHATComparison Condition: Standard of CareNetwork ParticipantsNon-randomized Baseline Index ParticipantsTotal
Mean42.1 ± 743.3 ± 742.9 ± 1040.6 ± 842 ± 9
Sex: Female, Male
Sex: Female, Male(Participants)Intervention Condition: CHATComparison Condition: Standard of CareNetwork ParticipantsNon-randomized Baseline Index ParticipantsTotal
Female8584150248567
Male001790179
Region of Enrollment
Region of Enrollment(participants)Intervention Condition: CHATComparison Condition: Standard of CareNetwork ParticipantsNon-randomized Baseline Index ParticipantsTotal
United States8584329248746
08

Study locations

1 site
  • The Lighthouse
    Baltimore, Maryland 21231, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00183456
Lead sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Sponsor
First posted
Sep 16, 2005
Start date
Sep 2005
Primary completion
Jul 2007
Completion
Dec 2009
Results posted
Oct 18, 2012
Last update
Jun 28, 2013

Study contacts

Carl A. Latkin, PhD
principal investigator · Johns Hopkins Bloomberg School of Public Health
View the source record on ClinicalTrials.gov ↗

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