Network HIV Prevention Intervention for Drug Users
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 746
- 试验地点
- 1
- 主要终点
- Sex Risk Behaviors: Unprotected Sex With Main Partner (Past 90 Days)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for CBT or Peer Intervention Participants:
- •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
排除标准
- •for All Participants:
- •Currently enrolled in another HIV prevention intervention
研究组 & 干预措施
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.
干预措施: Peer-oriented intervention (Behavioral)
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.
干预措施: Group cognitive behavioral therapy (CBT) (Behavioral)
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.
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.
结局指标
主要结局
Sex Risk Behaviors: Unprotected Sex With Main Partner (Past 90 Days)
时间窗: 18 months
Sex Risk Behaviors: Unprotected Sex With a Non-main Partner (Past 90 Days)
时间窗: 18 months
Sex Risk Behaviors: Any High Risk Sexual Behavior (Past 90 Days)
时间窗: 18 months
Sex Risk Behaviors: Unprotected Sex With Non-main Partner (Past 90 Days)
时间窗: 12 months
Sex Risk Behaviors: Number of Sex Partners (>=2 Sex Partners)
时间窗: 6 months
Number of participants that had 2 or more sex partners in the past 90 days.
Sex Risk Behaviors: Unprotected Vaginal Sex (Past 90 Days)
时间窗: 18 months
Sex Risk Behaviors: Unprotected Anal Sex (Past 90 Days)
时间窗: 18 month
次要结局
- HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)(18 months)
- HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)(6 months)
- HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)(12 months)