A Secondary Prevention Empowerment Intervention for Young Women Living With HIV
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 6
- 主要终点
- Compare pre-intervention, immediate post-intervention, and 3-month post-intervention scores on sexual risk and psychological empowerment
研究概览
简要总结
This study will develop/adapt a culturally appropriate secondary prevention intervention for young, Human Immunodeficiency Virus (HIV)-positive women through intervention groups, evaluate its acceptability and feasibility, make appropriate modifications, and manualize the intervention in preparation for a full-scale randomized trial.
Once the intervention is developed/adapted, the sites will pilot the interventions twice to enable modifications. The intervention aims to address the following concerns: 1) reducing the risk of young women infected with HIV transmitting the virus to their sexual partners, and 2) preventing young women infected with HIV from re-infection with a new viral strain or co-infection with another sexually transmitted disease (STD). Data will be collected to assess the feasibility and acceptability of the newly developed intervention using both quantitative and qualitative methods at each iteration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 24 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female at birth and currently female;
- •Receives services at one of the selected ATN sites or their community partners
- •HIV-infected as documented by medical record review or verbal verification with referring professional
- •Between the ages of 16-24 years (inclusive) at the time of informed consent/assent
- •Ability to understand both written and spoken English
- •Gives informed consent/assent for study participation
排除标准
- •Presence of active, serious psychiatric symptoms (e.g., hallucinations, thought disorder) that would impair a participant's ability to meet the study requirements
- •Visibly distraught (e.g., suicidal, homicidal, exhibiting violent behavior)
- •Intoxicated or under the influence of alcohol or other substances at the time of study enrollment*.
- •Intoxication at the time of visit will exclude participation at that time. Participants cannot be visibly under the influence of substances at the time of enrollment or consent. If a participant returns to enroll while sober, enrollment can occur. Similarly, if a participant arrives to an intervention group visibly intoxicated, then she will be asked to leave. However, prior intoxication does not eliminate future participation. Thus, those who are dismissed from a session due to intoxication can return to a subsequent session as long as they are sober.
结局指标
主要结局
Compare pre-intervention, immediate post-intervention, and 3-month post-intervention scores on sexual risk and psychological empowerment
时间窗: 1 year
Compare pre-intervention ACASI scores on Sexual Activity and Sexual Risk and Psychological Empowerment Questionnaires with those collected immediately post-intervention and 3 months after intervention to determine effect of intervention on sexual risk and psychological empowerment.
次要结局
- Compare pre-intervention, immediate post-intervention, and 3-month post-intervention scores on self-efficacy, sexual negotiation, relational violence, forgiveness, anger, substance use, life goals and outcomes, and affect regulation(1 year)