A Mobile Phone Game to Prevent HIV Among Young Africans

Study Overview
=================
Brief Summary
-----------------
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).

Detailed Description
-----------------
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.

Official Title
-----------------
A Mobile Phone Game to Prevent HIV Among Young Africans

Conditions
-----------------
HIV/AIDS

Intervention / Treatment
-----------------
* Behavioral: Tumaini Mobile Phone Game


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Aged 11-14 at time of recruitment Resident in Nyanza region, Kenya Having basic literacy in English Only one child enrolled per family Exclusion criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 14 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tumaini Mobile Phone Game<br>Participants randomized to this arm will be invited to play the Tumaini game. | Behavioral: Tumaini Mobile Phone Game<br>* Tumaini is a scenario-based role-playing game application, optimized for use on low-cost Android smartphones. Participants will be invited to play the game for at least ten hours over a period of three weeks. The game is designed to: educate players about sexual health and HIV/AIDS; build risk-reduction skills and related self-efficacy for prevention of HIV/STIs and unintended pregnancy; challenge HIV stigma and harmful gender norms; and promote parent-child dialogue.<br>|
| No Intervention: Standard of Care<br>Participants randomized to this arm will receive no intervention beyond the current standard of care for sexual education. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number Interested in Participating | 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. | Month 1 | 
| Time to Recruitment of 60 Participants | The number of days needed to recruit 60 participants. | Month 1 | 
| Number of Participants Lost to Follow Up | The number of participants who consented to participate but then later could not be reached prior to completing all study visits. | Duration of Study (Up to 4 Months) | 
| Number of Participants Completing the Study | The number of participants who completed all study visits after providing consent are presented here. | Duration of Study (Up to 4 Months) | 
| Number of Phones Returned | The phone retention rate (phones not lost during the intervention) was assessed by the number of phones returned at the end of the intervention. | Month 2 | 
| Number Reporting Game Was Very Fun | 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. | Day 17 (post-intervention) | 
| Number Reporting the Game is Valuable | 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. | Day 17 (post-intervention) | 
| Number of Participants Feeling Very Safe | 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. | Day 17 (post-intervention) | 
| Number of Participants Playing the Game | 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. | Day 17 (post-intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Knowledge | Knowledge measures will be assessed via Yes/No survey questions and will address puberty, HIV, sexually transmitted infections (STIs), pregnancy, condoms, and alcohol and drugs. Knowledge was assessed with 15 items and responses are coded as 0 or 1. Total scores range from 0 to 15, with higher scores indicating increased knowledge. A positive value for the change from baseline score indicates an increase in knowledge from the baseline assessment. | Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention | 
| Change in Self-Efficacy | Self-efficacy was assessed via a 3-point Likert scale, and addressed self-efficacy to seek advice about puberty, sex, relationships; to communicate about protected sex; to reject peer, partner and adult pressure to engage in risk behaviors. Self-efficacy was assessed with 9 items which were scored as 0, 0.5 or 1. Total scores ranged from 0 to 9, with higher scores indicating increased self-efficacy. A positive value for the change from baseline score indicates an increase in self-efficacy since the baseline assessment. | Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention | 
| Change in Risk Assessment | Risk assessment was assessed via a 3-point Likert scale, and addressed perceived risk of certain risk situations/behaviors and of contracting HIV. Risk is assessed with 4 items and responses are coded as 0, 0.5 or 1. Total scores range from 0 to 4, with higher scores indicating increased risk assessment. A positive value for the change from baseline score indicates an increase in assessing risky situations as risky. | Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention | 
| Change in Behavioral Intention | Behavioral intention was assessed via Yes/No questions. The measure addressed intention to seek advice, to avoid risk situations, and to engage in health protective behaviors. Behavioral intention is assessed with 6 items that are scored as 0 or 1 and total scores range from 0 to 6. Higher scores in indicate more intention to partake in health protective behaviors and a positive value for the change from baseline score indicates a desirable change in intention. | Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention | 
| Change in Future Orientation | Future orientation was assessed via a single multiple-choice question (Yes/No/Maybe) and addressed perceived locus of control. Response is coded as 0, 0.5, or 1 and higher scores indicate greater understanding of future locus of control. A positive value for the change from baseline score indicates a desirable change in scores. | Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention | 
| Change in Perceived Social Norms | Perceived social norms were assessed via a 3-point Likert and addressed sex, gender, condoms, and HIV stigma. Social norms were assessed with 6 items that are scored as 0, 0.5, or 1. Total scores range from 0 to 6 with higher scores indicating perception of more desirable social norms. A positive value for the change from baseline scores indicates a desirable change. | Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention | 
| Change in Attitudes | Attitudes were assessed via 3-pt Likert survey questions relating to HIV stigma, condoms, sex, gender, and future orientation. Attitudes were assessed with 15 items and responses coded as 0, 0.5, or 1. Total scores ranged from 0 to 15, with higher scores indicating more desirable attitudes. A positive value for the change from baseline score indicates an increase in desirable attitudes. | Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV prevention, Preadolescence, Mobile phone game, Feasibility