Dataset Information

The Efficacy of a Smartphone Game to Prevent HIV Among Young Africans: Protocol for a Randomized Controlled Trial in the Context of COVID-19.

ABSTRACT:

Background

Adolescents contribute slightly less than one-third of all new HIV infections in sub-Saharan Africa. There is a need for more effective intervention approaches to help young adolescents safely navigate through adolescence and into adulthood. We are assessing the efficacy of Tumaini, a smartphone game designed to prevent HIV among young Africans. Against the background of COVID-19, meaningful alteration of the research protocol was necessary to ensure successful implementation and retention of the study participants in ongoing research.

Objective

The objective of our protocol is to determine (1) if Tumaini delays sexual debut and increases condom use at first sex and (2) whether it influences behavioral mediators of early and unprotected sex.

Methods

Participants were recruited from Kisumu County in Western Kenya. This study is a 2-arm, individual-randomized controlled trial that enrolled 1004 adolescents aged between 12 years and 15 years. The intervention arm participants are playing Tumaini, while the control arm is provided with Brainilis, a commercially available control game. The study period will last 45 months. At baseline, participants in both arms completed a baseline survey and biological testing for HIV and herpes simplex virus, type 2 (HSV-2); participants will have annual game play periods in years 1-3. They will also complete a total of 12 follow-up surveys. At endline, repeat biological testing will be conducted. Protocol adaptations were necessitated by the COVID-19 pandemic and implemented in accordance with local public health guidelines.

Results

Participants were enrolled between October 2020 and November 2020. We plan to complete study procedures in September 2024. The enrolled participant sample was 50.1% (499/996) female and had a mean age of 14.0 (SD 0.6) years.

Conclusions

This ongoing research demonstrates that, with appropriate revisions to planned protocol activities guided by the need to maintain study integrity, protect both study participants and staff, and adhere to institutional review board and local health authority guidelines, human subject research is possible in the context of a global pandemic. If the trial demonstrates efficacy, Tumaini would provide an alternative, remote means of delivering age-appropriate education to adolescents on safer sex, HIV prevention, and effective life skills on a highly scalable, low-cost, and culturally adaptable platform.

Trial registration

ClinicalTrials.gov NCT04437667; https://clinicaltrials.gov/ct2/show/NCT04437667.

International registered report identifier (irrid)

DERR1-10.2196/35117.

SUBMITTER: Mudhune V

PROVIDER: S-EPMC8896564 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

The Efficacy of a Smartphone Game to Prevent HIV Among Young Africans: Protocol for a Randomized Controlled Trial in the Context of COVID-19.

Mudhune Victor V Sabben Gaëlle G Ondenge Ken K Mbeda Calvin C Morales Marissa M Lyles Robert H RH Arego Judith J Ndivo Richard R Bednarczyk Robert A RA Komro Kelli K Winskell Kate K

JMIR research protocols 20220303 3

<h4>Background</h4>Adolescents contribute slightly less than one-third of all new HIV infections in sub-Saharan Africa. There is a need for more effective intervention approaches to help young adolescents safely navigate through adolescence and into adulthood. We are assessing the efficacy of Tumaini, a smartphone game designed to prevent HIV among young Africans. Against the background of COVID-19, meaningful alteration of the research protocol was necessary to ensure successful implementation ...[more]

PMID: 35030090

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Project description:BackgroundThere is a pressing need to ensure that youth in high HIV prevalence settings are prepared for a safer sexual debut. Smartphone ownership is increasing dramatically in low-income and middle-income countries. Smartphone games that are appropriately grounded in behavioral theory and evidence-based practice have the potential to become valuable tools in youth HIV prevention efforts in Sub-Saharan Africa.ObjectiveTo pilot-test a theory-based, empirically grounded smartphone game for young Kenyans designed to increase age and condom use at first sex, aiming to establish directionality of effects on behavior change.MethodsTumaini ("hope for the future" in Swahili) is an interactive, narrative-based game grounded in social cognitive theory. A randomized controlled pilot study was conducted in Kisumu, Western Kenya, from April to June 2017 with 60 participants aged 11-14 (mean 12.7) years. Intervention arm participants (n=30) were provided with an Android smartphone with Tumaini installed on it and were instructed to play the game for at least 1 hour a day for 16 days; control arm participants (n=30) received no intervention. All participants completed a survey on behavioral mediators, delivered via an audio computer-assisted self-interview system at baseline (T1), post intervention (T2), and at 6 weeks postintervention (T3). The postintervention survey for intervention arm participants included questions eliciting feedback on the game. Intervention arm participants and their parents participated in 8 postintervention focus group discussions. Game log files were analyzed to calculate the length of exposure to the game. Behavioral survey data were analyzed using two-sample t tests to compare mean change from T1 to T2 and to T3 for intervention versus control arm participants. Descriptive statistics on game feedback questions were computed. Focus group transcripts were uploaded to MAXQDA software, where they were labeled with deductive and inductive codes. Data were analyzed thematically and compared across demographics.ResultsIntervention arm participants played Tumaini for a mean of approximately 27 hours. The intervention arm showed significant gains in sexual health-related knowledge and self-efficacy (both P<.001), behavioral intention for risk-avoidance strategies and sexual risk communication (P=.006), and overall survey scores (P<.001) compared with the control arm at T3. The postintervention survey revealed high subjective measures of the game's value, relevance, and appeal. Focus groups identified a wide range of knowledge and skills the participants had gained, including setting goals and planning how to achieve them, which was perceived as a key motivator for avoiding or reducing risk.ConclusionsThe study supports the need for further research to assess the efficacy of the game-based intervention. If proven efficacious, smartphone games have the potential to dramatically increase the reach of culturally adapted behavioral interventions while ensuring fidelity to intervention design.Trial registrationClinicalTrials.gov NCT03054051; http://clinicaltrials.gov/ct2/show/NCT03054051 (Archived by WebCite at http://www.webcitation.org/70U2gCNtW).

Project description:BACKGROUND:Young people aged under 25 years make up an increasing proportion of the population in emerging economies such as Kenya, where half of new adult HIV infections are among 15- to 24-year olds. Interventions targeting this age group have the potential to avert HIV infections among an increasingly large at-risk population. Interactive communication technologies offer a promising platform for reaching young people in engaging ways. OBJECTIVE:Tumaini is a narrative-based smartphone game designed to help young Africans protect themselves from HIV. The objective of this study was to pilot test the game, focusing on the data needed to inform a future randomized controlled efficacy trial, including assessments of study feasibility and safety. METHODS:The study took place in Kisumu Town, western Kenya, in spring 2017. The game-based intervention was pilot tested for 16 days with a sample of 60 preadolescents aged 11 to 14 years. Participant recruitment was initiated through schools. Participants were randomly assigned to the control or intervention arms of the study. One parent for each of the intervention arm participants was also recruited (n=30). The intervention arm participants were provided with smartphones on which Tumaini was loaded so that they could play the game at home. Youth completed behavioral surveys at baseline, posttest, and 6-week follow-up. The intervention arm participants provided quantitative feedback on their experience of the game-based intervention at posttest. They and their parents further participated in postintervention focus group discussions. Feasibility-related study metrics were collected on recruitment, enrollment, attrition, safety of participants, and return of phones. RESULTS:Recruitment and enrollment of the 60 preadolescents and parents were successfully completed within 18 days. No participants were lost to follow-up: all youth completed all 3 waves of the survey and 27 intervention arm youth and 22 parents and caregivers participated in the focus groups. No safety concerns were reported. All phones were returned after the intervention period; none were damaged or lost. All intervention arm participants initiated gameplay, recording a mean exposure time just under 27 hours. CONCLUSIONS:Findings indicate that it is feasible and safe to test a smartphone-based HIV prevention intervention for very young adolescents in urban and peri-urban sub-Saharan Africa by initiating recruitment in schools and temporarily providing youth participants with smartphones on which the game is loaded. A randomized controlled trial powered to assess the efficacy of the game-based intervention is being designed to be carried out in the same geographic area as the pilot, using similar methods. TRIAL REGISTRATION:ClinicalTrials.gov NCT03054051; https://clinicaltrials.gov/ct2/show/NCT03054051 (Archived by WebCite at http://www.webcitation.org/6wjwpX8Bg.). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/11209.

Project description:BACKGROUND:Young people aged 15 to 24 years account for one-third of new adult HIV infections. Controlling the HIV epidemic requires effective interventions targeted toward young people and their needs. Smartphone games offer a promising avenue for reaching this population with evidence-based HIV prevention interventions. It is crucial to the effectiveness of these interventions that they be acceptable and intrinsically motivating to adolescents as well as acceptable to their parents. OBJECTIVE:Tumaini is a narrative-based smartphone game designed to help prevent HIV among young Africans aged 11 to 14 years by delaying first sex and increasing condom use at first sex. Following a 16-day feasibility study of Tumaini, we assessed the acceptability (1) of the intervention, where acceptability was operationalized as appeal, relevance, value, usability, and understandability, and (2) of this study and a planned future randomized controlled efficacy trial. METHODS:During the randomized feasibility study (n=60) of Tumaini in western Kenya in spring 2017, 30 participants used the intervention on a study-provided smartphone. The app automatically logged participant interaction with the game in time-stamped log files. All 30 participants completed an Audio Computer-Assisted Self-Interview-based game experience survey, and 27 took part in 4 focus group discussions (FGDs) about the game's appeal, relevance, value, usability, and understandability. Their parents (n=22) also participated in 4 FGDs about the acceptability of the intervention, of this study, and of a planned efficacy trial. Survey data were analyzed using SAS software (SAS Institute Inc); FGD transcripts were coded and analyzed in MAXQDA 12 (Verbi GmbH); and gameplay log files were analyzed using Microsoft Excel. RESULTS:Adolescent participants' survey responses indicated that Tumaini scored well with players on all indicators of acceptability (appeal, relevance, value, usability, and understandability). Focus group analyses aligned with these findings and emphasized a high degree of player engagement with the game, which was supported by log file analysis. Adolescent participants were eager for additional content, and parents were receptive to a longer study involving biomarkers, based on their positive experiences with this study. There is scope to improve communication with parents about their role in the intervention. As the game was tested in beta version, there is also scope to fine-tune some of the game mechanics to increase usability. CONCLUSIONS:This study shows the strong acceptability of an interactive smartphone-based game both to adolescents and their parents in western Kenya and that of the study methods used to pilot-test the intervention. It also suggests that longitudinal efficacy studies of this type of intervention, including those using biomarkers, have the potential to be acceptable among parents. TRIAL REGISTRATION:ClinicalTrials.gov NCT03054051; https://clinicaltrials.gov/ct2/show/NCT03054051 (Archived by WebCite at http://www.webcitation.org/70U2gCNtW).

Project description:The increasing availability of smartphones, including in low-income countries, offers an unprecedented opportunity to reach individuals with innovative health promotion interventions. Electronic games delivered via smartphone offer promising avenues for sexual health promotion and HIV prevention, especially for young people. By giving players real agency in a virtual and safe environment, well-designed games can provide a level of experiential learning unparalleled by many other behavioral interventions. The design of effective games for health relies on multidisciplinary insight and expertise. However, relatively few studies discuss the theoretical understanding underlying their intervention. Making explicit the theoretical grounding of a game-based intervention allows articulation of assumptions and strategies, anticipation of outcomes, and evaluation of impacts (including intermediate effects), thereby increasing understanding of pathways to change, with a view to contributing to the development of more effective games. It also helps strengthen the credibility and improve the accountability of games for health. We present the multidisciplinary theoretical framework-integrating intervention design, mediators, and behavioral outcomes-and the structure of an HIV prevention game for young African adolescents that has shown promise in a randomized pilot study in Western Kenya. The central component of Tumaini (hope for the future in Kiswahili) is an interactive role-playing narrative in which the player makes choices for characters that determine how their paths unfold. In addition, a series of mini-games reinforce skills, and the "My Story" component links the game world to the player's own life and goals, and a reward system motivates continued play. With its "choose-your-own-adventure" format, Tumaini is intended to be replayed so that players can experience the consequences resulting from different choices made in the role-playing narrative. Grounded in theories of narrative and applied communication and in social behavioral theories, especially Social Cognitive Theory, Tumaini is designed to help young adolescents acquire the information, skills, and motivation they need to avoid and reduce sexual risks. We close by situating Tumaini within discussion of the theory and practice of using interactive narrative in health promotion, with a view to furthering theoretical elaboration.

Project description:Sexual behaviour of adolescents is contextual, with various determinants affecting sexual activity and age of sexual debut. Insight into sexual activity among young adolescents has the potential to influence appropriate sexual and reproductive health interventions. For this analysis, adolescents were recruited as part of the Tumaini smartphone game efficacy trial. Data collection included a self-administered behavioural survey and blood test for HIV and HSV-2. Descriptive statistics were calculated for demographics and measures of sexual behaviour and behavioural intent based on gender and sexual experience, with associations assessed using chi-square tests, t-tests and Wilcoxon rank sum tests as appropriate. We enrolled 996 adolescents, mean age 14 years and 2.2% HSV-2 positivity. Overall, 15% of the adolescents were sexually experienced, this being associated with lower socio-economic status (p = 0.01), household food insecurity (p = 0.008), a living situation without both parents (p < 0.01), substance use (p = 0.02), no adult conversation about future goals (p = 0.003), conversations about condoms (p = 0.01), with some gender disparity within these factors. Among those sexually experienced, 21.7% reported unwilling sex; 17.5% had engaged in transactional sex; 57.8% had willing first sex, of whom 60.9% reported no condom use. Among those abstaining, female adolescents were less likely to contemplate condom use at first sex (p = 0.006). Our findings determine that young sexually active adolescents are likely engaging in unprotected sex and having unwilling sexual experiences. Socio-economic status, living situation and parental monitoring remain significant factors associated with sexual experience among young adolescents. In this context, early adolescence is an opportunity to provide age- and developmentally appropriate education about safer sex practices.Trial registration: ClinicalTrials.gov identifier: NCT04437667.

Project description:BackgroundDepression is the most prevalent mental disorder, with detrimental effects on the patient's well-being, high disability, and a huge associated societal and economic cost. There are evidence-based treatments, but it is difficult to reach all people in need. Internet-based interventions, and more recently smartphone-based interventions, were explored to overcome barriers to access. Evidence shows them to be effective alternatives to traditional treatments. This paper presents the protocol of a pilot study whose primary aim is to investigate the efficacy of a smartphone-based serious game intervention for patients with mild to moderate depressive symptoms.MethodsThis randomized controlled pilot trial protocol foresees two arms design: 1/ smartphone- based serious game intervention (based on Cognitive Behavior Therapy with particular emphasis on Behavioral Activation and Physical Activity), 2/ waiting list control group. The study is expected to recruit 40 participants (18+), which will be randomly assigned to one of the experimental conditions. The duration of the intervention is two months. The primary outcome measure will be depressive symptomatology. Secondary outcomes will include other variables such as physical activity, resilience, anxiety, depression impairment, and positive and negative affect. Treatment expectation, satisfaction, usability, and game playability will also be measured. The data will be analyzed based on the intention-to-treat and per protocol analyses.DiscussionThe study aims to establish initial evidence for the efficacy of a smartphone-based serious game intervention, to serve as input for a larger-scale randomized control trial. The intervention exploits advanced smartphone capabilities, such as the use of a serious game as delivery mode, with the potential benefit of engagement and treatment adherence, and motion sensors to monitor and stimulate physical activity. As a secondary objective, the study aims to gather initial evidence on the user's expectations, satisfaction, usability and playability of the serious game as a treatment.

Project description:BackgroundAntiretroviral therapy (ART) is one of the most effective ways for HIV-infected to treat AIDS. However, it is difficult to start ART among young people those newly diagnosed HIV-infection in China, and their adherence to ART is poor. We have designed an AIDS educational game called AIDS Fighter · Health Defense, which could improve the AIDS-related knowledge and has the potential to improve AIDS prevention ability of young students. In this study, AIDS Fighter · Health Defense will be used with newly diagnosed young people with HIV to evaluate the education effect of the game in improving ART adherence.DesignA stepped-wedge design randomized controlled trial will be conducted to confirm the education effect of AIDS Fighter · Health Defense on improving ART adherence of newly diagnosed young people with HIV, and to verify when to start game-based health education could be more effective for newly diagnosed young people with HIV.MethodsParticipants will receive AIDS education from health workers and start ART when diagnosed with HIV and assigned into four groups randomly. The first step group to the fourth step group will receive AIDS Fighter · Health Defense in turn at the star of ART, one week, one month and three months after the start of ART. The primary outcomes are medication adherence, CD4( +) T cell count, and HIV viral load. The secondary outcomes are ART-related knowledge, ART-related skills, psychological resilience, and self-discrimination. Assessments will be completed before the intervention and one week, first month, and third month of the intervention, and then a one-year follow-up evaluation will be conducted after the intervention.DiscussionAIDS Fighter · Health Defense may be an effective approach to help newly diagnosed young people with HIV to improve ART adherence. A stepped-wedge design randomized controlled trial of this study may find the optimal time of AIDS education to improve ART adherence of newly diagnosed young people with HIV.Registration numberChinese Clinical Trial Registry: ChiCTR2200059766, registered 11 May 2022. http://www.chictr.org.cn/showproj.aspx?proj=169420.

Project description:BackgroundAdolescents and young adults with HIV repeatedly demonstrate low rates of antiretroviral therapy (ART) adherence as well as low rates of viral suppression. Digital health interventions are a promising way to engage adolescents and young adults with HIV to support ART adherence. However, few digital health interventions have been developed and tested with adolescents and young adults in countries like South Africa, where the HIV burden among adolescents and young adults is greatest. Masakhane Siphucule Impilo Yethu (MASI; Xhosa for "Let's empower each other and improve our health") is a comprehensive ART adherence-supporting app for South African adolescents and young adults with HIV. It was culturally adapted using the HealthMpowerment platform.ObjectiveThe aim of this paper is to describe the protocol for a pilot randomized controlled trial examining the feasibility, acceptability, and preliminary efficacy of MASI on self-reported ART adherence and social support.MethodsWe will enroll 50 adolescents and young adults with HIV ages 15-21 years. Participants will be recruited from public ART clinics linked to a large government-funded teaching hospital in Cape Town, South Africa. Participants will be randomized 1:1 into either the intervention arm receiving a full version of MASI or the control arm receiving an information-only version of the app (n=25 per arm). Participants will be asked to engage with MASI daily for 6 months. All participants will complete baseline and follow-up assessments at 3 and 6 months.ResultsStudy screening began in May 2022 and the first participant was enrolled on June 21, 2022. As of June 12, 2023, 81 participants have completed screeners, and 36 eligible participants have been enrolled in the pilot randomized controlled trial. Recruitment is anticipated to last through August 31, 2023, with study activities anticipated through February 29, 2024.ConclusionsThere is an urgent need for innovative interventions to improve ART adherence among adolescents and young adults in settings like South Africa. If found to be feasible and acceptable, MASI could be implemented with adolescents and young adults with HIV in other parts of the country.Trial registrationClinicalTrials.gov NCT04661878; https://clinicaltrials.gov/ct2/show/study/NCT04661878.International registered report identifier (irrid)DERR1-10.2196/47137.

Project description:BACKGROUND:Young sexual minority men in the United States have a high incidence rate of HIV infection. Early intervention among this group, that is timed to precede or coincide with sexual initiation, is of critical importance to prevent HIV infection. Despite this, there are very few published randomized controlled efficacy trials testing interventions to reduce sexual vulnerability for HIV acquisition among racially/ethnically diverse, very young, sexual minority men (aged ≤18 years). This paper describes the design of a mobile app-based intervention trial to reduce sexual risk for HIV acquisition and promote health protection in this group. METHODS:This study is a randomized controlled trial of an mHealth-based HIV prevention intervention, MyPEEPS Mobile, among diverse sexual minority cisgender young men, aged 13-18 years. The mobile intervention was adapted from a prior group-based intervention curriculum with evidence of efficacy, designed to be specific to the risk contexts and realities of young sexual minority men, and to include psychoeducational and skill-building components with interactive games and activities. Participants are recruited locally within four regional hubs (Birmingham, AL, Chicago, IL, New York City, NY, Seattle, WA) and nationwide via the Internet, enrolled in-person or remotely (via videoconference), and randomized (1:1) to either the MyPEEPS Mobile intervention or delayed intervention condition. Post-hoc stratification by age, race/ethnicity, and urban/suburban vs. rural statuses is used to ensure diversity in the sample. The primary outcomes are number of male anal sex partners and frequency of sexual acts with male partners (with and without condoms), sex under the influence of substances, and uptake of pre-and post-exposure prophylaxis, as well as testing for HIV and other sexually transmitted infections at 3-, 6- and 9-month follow-up. DISCUSSION:Behavioral interventions for very young sexual minority men are needed to prevent sexual risk early in their sexual development and maturation. This study will provide evidence to determine feasibility and efficacy of a mobile app-based HIV prevention intervention to reduce sexual risk among this very young group. TRIAL REGISTRATION:ClinicalTrials.gov number, NCT03167606, registered May 30, 2017.

Dataset Information

The Efficacy of a Smartphone Game to Prevent HIV Among Young Africans: Protocol for a Randomized Controlled Trial in the Context of COVID-19.

Background

Objective

Methods

Results

Conclusions

Trial registration

International registered report identifier (irrid)

Publications

The Efficacy of a Smartphone Game to Prevent HIV Among Young Africans: Protocol for a Randomized Controlled Trial in the Context of COVID-19.

Similar Datasets

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