Affecting the Epidemiology of HIV in Uganda Through Older Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 203
- 试验地点
- 1
- 主要终点
- Program feasibility: Recruitment
研究概览
简要总结
The investigators propose to develop a comprehensive, text messaging-based HIV prevention program for Ugandan adolescents 18-22 years of age.
详细描述
The investigators propose to develop a comprehensive, text messaging-based HIV prevention program for Ugandan adolescents 18-22 years of age. The guiding theoretical model is the Information-Motivation-Behavioral Skills (IMB) Model of HIV Preventive Behavior.
Intervention development will be iterative: In Phase 1, the investigators will identify an intervention content "map." Then, online focus groups (FG) will be conduct online with Ugandan young adults (n = 40-80) to confirm program components (e.g., social support via Text Buddy, optimal time of delivery of daily text messages) and saliency of intended program topics.
In Phase 2, the investigation team will "translate" content into a bank of text messages that will be reviewed for comprehensiveness and inclusion of the most pertinent topics. The final pool of messages among Ugandan young adults will be tested in the Content Advisory Council (CAC; n = 30) to assess their reactions to the content, scope, style, and tone of the messages.
In Phase 3, the investigators will merge the content with the software program developed to deliver the intervention and then internally conduct a functionality test of the programmed messages. Following, the protocol and program will be tested in a beta test of 20 Ugandan adults.
In Phase 4, the investigators will test the intervention in a randomized controlled trial of 200 Ugandan young adults randomly assigned to either the intervention (n = 100) or control (n = 100) arms. The main outcome measures will focus on feasibility (e.g., recruitment and retention rates) and acceptability (e.g., Text Buddy). The primary efficacy outcome measures, measured at 3-months post-intervention, will be: (a) frequency of unprotected sex acts; (b) sustained sexual abstinence, and (c) increased HIV testing rates.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 22 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •living in Uganda
- •aged 18-22 years
- •able to read English
- •exclusive owner of a cell phone
- •using text messaging for at least 6 months
- •intended to have the same phone number or the next six months
- •able to access the Internet (to complete online surveys)
- •able to provide informed consent
排除标准
- •no other exclusion criteria will be applied
结局指标
主要结局
Program feasibility: Recruitment
时间窗: 24 weeks
The number of participants recruited for the RCT (n=200)
Program feasibility: Retention
时间窗: Through study completion, an average of 6 weeks
The number of participants that will remain in the study at program end (80%)
Program acceptability as assessed by a scale created for the RCT
时间窗: At intervention end, 6-weeks post baseline
Participant ratings of program features (e.g., Text Buddy) at intervention end
次要结局
- Percent of participants reporting condom use during sex as assessed by self-report(At intervention end, 6-weeks post baseline)
- Percent of participants reporting abstinence as assessed by self-report(At intervention end, 6-weeks post baseline)
- Percent of participants who have gotten an HIV test as assessed by self-report(At intervention end, 6-weeks post baseline)