Efficacy Trial for a Smartphone Game to Prevent HIV Among Young Africans
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Change in percentage of participants with recent alcohol and drug use
研究概览
简要总结
This project, funded by the National Institute of Mental Health, will test the efficacy of an electronic game to prevent HIV among African adolescents (aged 12-17), delivered via inexpensive Android smartphones. This study involves a sample of 912 young people and 500 of their parents in Kenya's former Nyanza province, where 11.4% of young women and 3% of men ages 15-24 are HIV-infected. This study will be carried out by Emory University and the Kenya Medical Research Institute (KEMRI).
详细描述
The 912 study participants (youth ages 12-14) will be randomized to the intervention or control arm upon completion of the baseline survey. The assignments will be generated with the use of a pseudo-random-number generator with permuted blocks, used to ensure a sex-balanced and age-balanced assignment to each arm. All participants will be given a low-cost (<$40) Android phone on which the study game will be loaded. Intervention arm phones will have app for Tumaini programmed on them, while control arm phones will have a commercially available game to be determined prior to the start of the randomized clinical trial. Preference will be given to a game or other app with educational content, for example, a general knowledge quiz or strategy game. Each app will be standalone and not require data access or connection to the Internet to function. All participants will be invited to play their assigned game for at least 10 hours during the November-December school holiday. While we anticipate that access to smartphones will be widespread at time of roll-out of an efficacious game, this is not yet the case: for the purposes of this study, phones need to be provided in order to ensure consistency of technology and avoid SES bias. All other phone functions aside from the alarm, will be disabled for safety reasons. The game will automatically record the time spent playing and the choices made in the context of gameplay. When returning the phones, all participants will be asked to fill out a form identifying others with whom the game or app was shared and creators of each profile on their study phones.
In line with the preferences expressed by parents during the feasibility test, the phones will be provided to participants during the long November-December school holidays and collected at the end of the holiday. Providing there is no evidence of contamination, participants will (a) keep the phone throughout the long November-December school holiday; and (b) receive the phone, loaded with the game, again during the November-December holidays of the following years.
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
- None
入排标准
- 年龄范围
- 12 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in percentage of participants with recent alcohol and drug use
时间窗: Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46
Percentage of participants that report recent alcohol and drug use.
Change in knowledge
时间窗: Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46
Knowledge measures will be assessed via Yes/No survey questions and will address HIV, sexually transmitted infections (STIs), pregnancy, and condoms. Answers to knowledge questions will be coded as 0 or 1, with higher scores indicating more accurate knowledge. A positive value for the change from baseline score indicate an increase in knowledge from the baseline assessment.
Change in behavioral intentions
时间窗: Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46
Behavioral intention will be assessed via Likert survey questions. The measure will address intention to avoid risk situations and to engage in health protective behaviors. Behavioral intention items will be scored on a 0-1 scale with higher scores indicating more intention to partake in health protective behaviors and a positive value for the change from baseline score indicating an increase in intention to engage in health protective behaviors.
Change in percentage of participants reporting recent condom use
时间窗: Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46
For participants reporting recent sexual activity, self-report of consistent condom use since previous behavioral survey.
Age at first sex
时间窗: Up to month 46
Age at first sex encounter.
Percentage of participants reporting condom use at first sex
时间窗: Up to month 46
Percentage of participants reporting condom use at first sex
Change in percentage of participants reporting recent sexual activity
时间窗: Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46
For participants reporting previous sexual intercourse, self-report of sexual intercourse since previous behavioral survey.
Binary Risk outcome of "risk" vs "low risk"
时间窗: Up to month 46
Binary outcome of "risk" group (experienced sexual debut during the study period without condom use at first sex) vs "low risk" group (not yet experienced sexual debut by the end of the study, or used a condom at sexual debut during the study period).
Change in self-efficacy
时间窗: Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46
Self-efficacy will be assessed via a Likert scale, and focus on self-efficacy to use a condom correctly; to communicate with a partner about protected sex; to reject peer, partner, and adult pressure to engage in risk behaviors; and, for female participants, to manage menstruation. Self-efficacy will be scored on a 0-1 scale with higher scores indicating stronger self-efficacy. A positive value for the change from baseline score will indicate an increase in self-efficacy since the baseline assessment.
Change in number of sexual partners
时间窗: Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46
For participants reporting any past sexual activity, number of different sexual partners
Change in risk assessment
时间窗: Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46
Risk assessment will be assessed via a Likert scale, and address perceived risk of certain risk situations/behaviors. Risk items will be scored on a 0-1 scale, with higher scores indicating higher risk assessment. A positive value for the change from baseline score will indicate an increase in assessing risky situations as risky.
Change in attitudes
时间窗: Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46
Attitudes will be assessed via Likert survey questions relating to puberty, HIV stigma, condoms, sex, and gender. Attitudes items will be scored on a 0-1 scale, with higher scores indicating more desirable attitudes. A positive value for the change from baseline score will indicate an increase in desirable attitudes.
次要结局
- Total length of gameplay(Months 3,18, 28)
- Number of participants with new HSV-2 diagnosis(Months 1 and 46)
- Number of participants with new HIV diagnosis(Months 1 and 46)
研究者
Kate Winskell
Associate Professor
Emory University