HIV Infections, Sexually Transmitted Diseases
Conditions
Keywords
Sex Education, Peer Group, Social Identity Theory, HIV Seronegativity, Intervention, women, Social Networks, Peer Education
Brief 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).
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.
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.
Sponsors
National Institute of Mental Health (NIMH)
Johns Hopkins Bloomberg School of Public Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
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 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
for All Participants: * Currently enrolled in another HIV prevention intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sex Risk Behaviors: Any High Risk Sexual Behavior (Past 90 Days) | 18 months | — |
| Sex Risk Behaviors: Unprotected Sex With a Non-main Partner (Past 90 Days) | 18 months | — |
| Sex Risk Behaviors: Number of Sex Partners (>=2 Sex Partners) | 6 months | Number of participants that had 2 or more sex partners in the past 90 days. |
| Sex Risk Behaviors: Unprotected Sex With Non-main Partner (Past 90 Days) | 12 months | — |
| Sex Risk Behaviors: Unprotected Anal Sex (Past 90 Days) | 18 month | — |
| Sex Risk Behaviors: Unprotected Vaginal Sex (Past 90 Days) | 18 months | — |
| Sex Risk Behaviors: Unprotected Sex With Main Partner (Past 90 Days) | 18 months | — |
Secondary
| Measure | Time frame |
|---|---|
| HIV Communication: Talk to Family About HIV or STIs (Past 6 Months) | 6 months |
Countries
United States
Participant flow
Recruitment details
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
Pre-assignment details
Those index participants that did not recruit a network member or did not show up to be randomized into a study condition were not assigned to a study condition. Network participants completed study interviews but were not assigned to a study condition and did not participate in the intervention.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 85 |
| 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. | 84 |
| 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. | 329 |
| 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. | 248 |
| Total | 746 |
Baseline characteristics
| Characteristic | Comparison Condition: Standard of Care | Network Participants | Intervention Condition: CHAT | Non-randomized Baseline Index Participants | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 3 Participants |
| Age, Categorical >=65 years | 0 Participants | 4 Participants | 0 Participants | 0 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 84 Participants | 323 Participants | 85 Participants | 247 Participants | 739 Participants |
| Age Continuous | 43.3 years STANDARD_DEVIATION 7 | 42.9 years STANDARD_DEVIATION 10 | 42.1 years STANDARD_DEVIATION 7 | 40.6 years STANDARD_DEVIATION 8 | 42 years STANDARD_DEVIATION 9 |
| Region of Enrollment United States | 84 participants | 329 participants | 85 participants | 248 participants | 746 participants |
| Sex: Female, Male Female | 84 Participants | 150 Participants | 85 Participants | 248 Participants | 567 Participants |
| Sex: Female, Male Male | 0 Participants | 179 Participants | 0 Participants | 0 Participants | 179 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 85 | 0 / 84 | 0 / 329 | 0 / 248 |
| serious Total, serious adverse events | 0 / 85 | 0 / 84 | 0 / 329 | 0 / 248 |
Outcome results
Primary
Sex Risk Behaviors: Any High Risk Sexual Behavior (Past 90 Days)
Time frame: 18 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Condition: CHAT | Sex Risk Behaviors: Any High Risk Sexual Behavior (Past 90 Days) | 51 participants |
| Comparison Condition: Standard of Care | Sex Risk Behaviors: Any High Risk Sexual Behavior (Past 90 Days) | 69 participants |
| Network Participants | Sex Risk Behaviors: Any High Risk Sexual Behavior (Past 90 Days) | 172 participants |
| Non-randomized Baseline Index Participants | Sex Risk Behaviors: Any High Risk Sexual Behavior (Past 90 Days) | 151 participants |
p-value: 0.0195% CI: [0.14, 0.64]Generalized Estimating Equations
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Condition: CHAT | Sex Risk Behaviors: Number of Sex Partners (>=2 Sex Partners) | 17 participants |
| Comparison Condition: Standard of Care | Sex Risk Behaviors: Number of Sex Partners (>=2 Sex Partners) | 29 participants |
| Network Participants | Sex Risk Behaviors: Number of Sex Partners (>=2 Sex Partners) | 50 participants |
| Non-randomized Baseline Index Participants | Sex Risk Behaviors: Number of Sex Partners (>=2 Sex Partners) | 53 participants |
p-value: <0.0195% CI: [0.13, 0.63]Generalized Estimating Equations
Primary
Sex Risk Behaviors: Unprotected Anal Sex (Past 90 Days)
Time frame: 18 month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Condition: CHAT | Sex Risk Behaviors: Unprotected Anal Sex (Past 90 Days) | 5 participants |
| Comparison Condition: Standard of Care | Sex Risk Behaviors: Unprotected Anal Sex (Past 90 Days) | 18 participants |
| Network Participants | Sex Risk Behaviors: Unprotected Anal Sex (Past 90 Days) | 43 participants |
| Non-randomized Baseline Index Participants | Sex Risk Behaviors: Unprotected Anal Sex (Past 90 Days) | 35 participants |
p-value: 0.0195% CI: [0.09, 0.68]Generalized Estimating Equations
Primary
Sex Risk Behaviors: Unprotected Sex With a Non-main Partner (Past 90 Days)
Time frame: 18 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Condition: CHAT | Sex Risk Behaviors: Unprotected Sex With a Non-main Partner (Past 90 Days) | 8 participants |
| Comparison Condition: Standard of Care | Sex Risk Behaviors: Unprotected Sex With a Non-main Partner (Past 90 Days) | 21 participants |
| Network Participants | Sex Risk Behaviors: Unprotected Sex With a Non-main Partner (Past 90 Days) | 47 participants |
| Non-randomized Baseline Index Participants | Sex Risk Behaviors: Unprotected Sex With a Non-main Partner (Past 90 Days) | 51 participants |
p-value: 0.0595% CI: [0.14, 0.79]Generalized Estimating Equations
Primary
Sex Risk Behaviors: Unprotected Sex With Main Partner (Past 90 Days)
Time frame: 18 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Condition: CHAT | Sex Risk Behaviors: Unprotected Sex With Main Partner (Past 90 Days) | 30 participants |
| Comparison Condition: Standard of Care | Sex Risk Behaviors: Unprotected Sex With Main Partner (Past 90 Days) | 50 participants |
| Network Participants | Sex Risk Behaviors: Unprotected Sex With Main Partner (Past 90 Days) | 127 participants |
| Non-randomized Baseline Index Participants | Sex Risk Behaviors: Unprotected Sex With Main Partner (Past 90 Days) | 113 participants |
p-value: 0.0195% CI: [0.21, 0.77]Generalized Estimating Equations
Primary
Sex Risk Behaviors: Unprotected Sex With Non-main Partner (Past 90 Days)
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Condition: CHAT | Sex Risk Behaviors: Unprotected Sex With Non-main Partner (Past 90 Days) | 10 participants |
| Comparison Condition: Standard of Care | Sex Risk Behaviors: Unprotected Sex With Non-main Partner (Past 90 Days) | 22 participants |
| Network Participants | Sex Risk Behaviors: Unprotected Sex With Non-main Partner (Past 90 Days) | 47 participants |
| Non-randomized Baseline Index Participants | Sex Risk Behaviors: Unprotected Sex With Non-main Partner (Past 90 Days) | 58 participants |
p-value: 0.0595% CI: [0.16, 0.84]Generalized Estimating Equations
Primary
Sex Risk Behaviors: Unprotected Vaginal Sex (Past 90 Days)
Time frame: 18 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Condition: CHAT | Sex Risk Behaviors: Unprotected Vaginal Sex (Past 90 Days) | 32 participants |
| Comparison Condition: Standard of Care | Sex Risk Behaviors: Unprotected Vaginal Sex (Past 90 Days) | 49 participants |
| Network Participants | Sex Risk Behaviors: Unprotected Vaginal Sex (Past 90 Days) | 123 participants |
| Non-randomized Baseline Index Participants | Sex Risk Behaviors: Unprotected Vaginal Sex (Past 90 Days) | 119 participants |
p-value: 0.0595% CI: [0.25, 0.87]Generalized Estimating Equations
Secondary
HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Condition: CHAT | HIV Communication: Talk to Family About HIV or STIs (Past 6 Months) | 58 participants |
| Comparison Condition: Standard of Care | HIV Communication: Talk to Family About HIV or STIs (Past 6 Months) | 39 participants |
| Network Participants | HIV Communication: Talk to Family About HIV or STIs (Past 6 Months) | 124 participants |
| Non-randomized Baseline Index Participants | HIV Communication: Talk to Family About HIV or STIs (Past 6 Months) | 104 participants |
p-value: 0.0195% CI: [1.41, 5.64]Generalized Estimating Equations
Secondary
HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Condition: CHAT | HIV Communication: Talk to Family About HIV or STIs (Past 6 Months) | 61 participants |
| Comparison Condition: Standard of Care | HIV Communication: Talk to Family About HIV or STIs (Past 6 Months) | 52 participants |
| Network Participants | HIV Communication: Talk to Family About HIV or STIs (Past 6 Months) | 155 participants |
| Non-randomized Baseline Index Participants | HIV Communication: Talk to Family About HIV or STIs (Past 6 Months) | 117 participants |
p-value: 0.0595% CI: [1.22, 5.89]Generalized Estimating Equations
Secondary
HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)
Time frame: 18 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Condition: CHAT | HIV Communication: Talk to Family About HIV or STIs (Past 6 Months) | 56 participants |
| Comparison Condition: Standard of Care | HIV Communication: Talk to Family About HIV or STIs (Past 6 Months) | 42 participants |
| Network Participants | HIV Communication: Talk to Family About HIV or STIs (Past 6 Months) | 141 participants |
| Non-randomized Baseline Index Participants | HIV Communication: Talk to Family About HIV or STIs (Past 6 Months) | 113 participants |
p-value: 0.0195% CI: [1.25, 4.65]Generalized Estimating Equations