Using Mobile Technology to Prevent HIV and Related Youth Health Problems: Sexual Health, Mental Health and Substance Use in Southwest Uganda
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- HIV-AIDS Test
研究概览
简要总结
Since the start of this study I have moved from NYSPI to City University of New York. The study is currently paused.
The goal of the project is to find out how the investigators can use mobile phones to prevent HIV and address related health problems such as sexual health and mental health among adolescents. The investigators will evaluate and adapt an existing text-message and interactive voice recognition (IVR) system. IVR is Interactive voice response is a technology that allows humans to interact with a computer-operated phone system through the use of voice and DTMF tones input via a keypad.
The system was designed by FHI 360 (note FHI 360 is the name of the non-profit not an acronym). FHI 360 is an international nonprofit working to improve the health and well-being of people in the United States and around the world. FHI 360 staffs more than 4,000 professionals who work in more than 60 countries. Examples of the existing content is available (https://m4rh.fhi360.org/?page\_id=191) and we have a letter of support from FHI 360, included in my funded grant proposal, stating we may use and modify this content as needed. As noted below anyone can access this content by dialing #161 when in Uganda. FHI 360 sexual reproductive health information is currently available across Uganda for free and can be accessed in by dialing #161.
The proposed research comprises two phases. Phase 1 involves two steps, (A) "theater pretesting" (includes brief interviews) (B) focus groups (or more detailed interviews depending on COVID-19 guidelines and described in detail below) that will involve asking adolescents to discuss new messages that would provide basic information about pre-exposure prophylaxis (PrEP) as well as, a set of questions about mental health, and alcohol use. We will conduct focus groups with these adolescents and elicit responses to improve the acceptability of the messages (described in detail below).
We will then modify any content as needed and conduct Phase 2 which involves (A) randomized control trial and (B) qualitative key informant interviews. Adolescents (N=200) will be randomly assigned to either the mobile phone-based intervention or to standard of care. Through this approach we will evaluate our adaptation of FHI 360's existing text message and interactive voice recognition (IVR). The adaptation will include PrEP information as well as specific mental health and hazardous alcohol use screens, promote HIV prevention for all adolescents, and support linkage to behavioral health counselors for symptomatic adolescents.
详细描述
Background This study will result in the development of one of the first mobile phone-based interventions for adolescents in East Africa that begins to address sexual health, mental health, and alcohol use. Adolescence is a developmental period associated with the increased importance of peers, increased technology use, increased mobility, initiation of sex, emergence of mental health disorders (if at risk), and initiation of alcohol use. Thus, the initial step of screening and linking adolescents with mental health or alcohol use problems to counselors, may help address these factors and also reduce the risk for HIV infection. Further, PrEP has only recently been made available to adolescents in Uganda and is not currently included in the existing FHI 360 #161 system. As described by the CDC, PrEP is a way for people who do not have HIV but who are at very high risk of getting HIV to prevent HIV infection by taking a pill every day. Studies have shown that PrEP reduces the risk of getting HIV from sex by about 99% when taken daily. Adolescents today rely heavily on mobile phones for information and services, thus the investigators believe the proposed intervention could be applied and adapted across the region, and potentially in other under-resourced settings.
Aim 1: To adapt an evidence-based mobile phone-delivered sexual health program, to include PrEP information and deliver mental health and alcohol use assessments with the goal of increasing screening and referral, as well as linkage to school-based counselors for adolescents at HIV risk.
Aim 2: Evaluate through a pilot RCT (N=200 adolescents, 15-19 years) intervention (a) acceptability and feasibility, and (b) impact on uptake of HIV prevention strategies, as well as screening and linkage to mental health and alcohol use school-based counselors.
For aim 2 the investigators hypothesize that the intervention group will uptake HIV testing and a greater rate than the control group.
Procedures There will be two phases to the study. The first will last approximately three months and include 24 subjects (15-19 years). The second phase will include 200 subjects (15-19 years) with a five week intervention and a follow-up survey within six monthhs.
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, Care Provider)
盲法说明
Participants and providers are the parties involved in the clinical trial who are prevented from having knowledge of the interventions assigned to individual participants.
入排标准
- 年龄范围
- 15 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adolescents (aged 15-19 years): Self-report during enrollment and confirmed by school personnel or local community leader.
- •Residing in the greater Masaka region in southern Uganda: Self-report during enrollment and confirmed by school personnel or local community leader.
- •Own a mobile phone: Self-report during enrollment and confirmed visually by project director or research assistant.
- •People who have the cognitive capacity to consent: A potential participant will be included if the researcher conducting the consent process determines that the potential participant has the cognitive capacity to consent. This will be determined by through the review of the consent forms.
- •For Phase II, did not participate. In Phase I: Review of study records.
排除标准
- •People who are not aged 15-19 years: Self-report during enrollment and confirmed by school personnel or local community leader.
- •People who do not reside in the greater Masaka region in southern Uganda: Self-report during enrollment and confirmed by school personnel or local community leader.
- •People who do not own a mobile phone: Self-report during enrollment and confirmed visually by project director or research assistant.
- •People who do not have the cognitive capacity to consent: A potential participant will be excluded if the researcher conducting the consent process determines that the potential participant has a mental deficit or does not have the cognitive capacity to understand the consent process and proposed research.
- •Participants in phase 1 will be excluded from phase 2: Review of study records
研究组 & 干预措施
Intervention
Participants in this arm will receive the mobile phone-based intervention.
干预措施: Youth Health SMS (Behavioral)
Standard of care
Participants in this arm will receive only standard of care.
结局指标
主要结局
HIV-AIDS Test
时间窗: 6 month
Self-report and verified at local clinic number of HIV Tests
次要结局
- Alcohol Use(6 month)
- Mental Health Counseling(6 month)
- Depression(6 month)
- PrEP Use(6 month)
- Anxiety(6 month)
研究者
Philip Kreniske
Research Scientist
New York State Psychiatric Institute