A Mobile Phone Game to Prevent HIV Among Young Africans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number Reporting the Game is Valuable
研究概览
简要总结
This project will test the feasibility of an electronic game to prevent HIV among African preadolescents, delivered via inexpensive Android smart phones. In order to collect feasibility data for a future randomized controlled trial, this study involves the pilot-testing of the intervention with a sample of young people in Nyanza region, Kenya, where 11.4% of young women ages 15-24 are HIV-infected. This feasibility study will be carried out with the Kenya Medical Research Institute (KEMRI).
详细描述
This project will test the feasibility of an electronic game for preadolescents, delivered via inexpensive Android smart phones. The game is informed by socio-behavioral and pedagogical theories, evidence-based practice, and formative research on youth sexual culture in sub-Saharan Africa. It is designed to: educate young players, ages 11-14, about sexual health and HIV/AIDS; build risk-reduction skills and related self-efficacy for prevention of HIV, sexually transmitted infections (STIs), and unintended pregnancy; challenge harmful gender norms and HIV stigma; and foster dialogue with parents and caregivers.
The proposed feasibility test will be conducted in Western Kenya. Sixty preadolescents will be enrolled in the trial, 30 in the study arm and 30 in the control arm. The Kenya Medical Research Institute (KEMRI) has established community advisory boards (CABs) in Kisumu, which will be available to the proposed study.
Data collection will take place at KEMRI offices, health clinics, or in the meeting room of a local community-based organization (CBO). In addition, data on game-play will be automatically collected on mobile phones given to preadolescent study participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 11-14 at time of recruitment
- •Resident in Nyanza region, Kenya
- •Having basic literacy in English
- •Only one child enrolled per family
排除标准
- •Aged <11 or >14 at time of recruitment
- •Not resident in Nyanza region, Kenya
- •Without basic literacy in English
- •Sibling to a child already enrolled in the study
- •Participant in formative research to inform the study
研究组 & 干预措施
Tumaini Mobile Phone Game
Participants randomized to this arm will be invited to play the Tumaini game.
干预措施: Tumaini Mobile Phone Game (Behavioral)
Standard of Care
Participants randomized to this arm will receive no intervention beyond the current standard of care for sexual education.
结局指标
主要结局
Number Reporting the Game is Valuable
时间窗: Day 17 (post-intervention)
The value of the game was assessed with several questions regarding how much the participants learned and how useful the information is. The number of participants reporting that they learned a lot, found the information very useful now, and found the information very useful for the future, are presented below.
Number of Participants Playing the Game
时间窗: Day 17 (post-intervention)
Participants were asked to play the game for at least one hour per day for 16 days. The number of participants who reported playing the game everyday and the number of participants who reported playing the game for an hour or more each time are presented here.
Number Interested in Participating
时间窗: Month 1
To evaluate the feasibility of conducting a technology based intervention in a low resource area, the number of eligible individuals who were interested in participating after hearing about the study was examined. Letters were sent to 150 families inviting them to attend an informational meeting and 126 attended a meeting and were assess for eligibility.
Time to Recruitment of 60 Participants
时间窗: Month 1
The number of days needed to recruit 60 participants.
Number of Participants Feeling Very Safe
时间窗: Day 17 (post-intervention)
Personal safety associated with being in possession of the phone was assessed by the post-intervention survey. Phones provided for the intervention were set up so that all other features were blocked and only function the phone could perform was playing the game.
Number of Participants Completing the Study
时间窗: Duration of Study (Up to 4 Months)
The number of participants who completed all study visits after providing consent are presented here.
Number of Phones Returned
时间窗: Month 2
The phone retention rate (phones not lost during the intervention) was assessed by the number of phones returned at the end of the intervention.
Number Reporting Game Was Very Fun
时间窗: Day 17 (post-intervention)
Game acceptability was assessed by asking participants how fun playing the game was. The number of participants reporting that the game was "very fun" are presented here.
Number of Participants Lost to Follow Up
时间窗: Duration of Study (Up to 4 Months)
The number of participants who consented to participate but then later could not be reached prior to completing all study visits.
次要结局
- Change in Risk Assessment(Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention)
- Change in Behavioral Intention(Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention)
- Change in Knowledge(Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention)
- Change in Future Orientation(Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention)
- Change in Perceived Social Norms(Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention)
- Change in Self-Efficacy(Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention)
- Change in Attitudes(Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention)
研究者
Kate Winskell
Associate Professor
Emory University