A Mobile Phone Game to Prevent HIV Among Young Africans

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03054051

Enrollment

Registered

2017-02-15

Start date

2017-03-20

Completion date

2017-06-19

Last updated

2019-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS

Keywords

HIV prevention, Preadolescence, Mobile phone game, Feasibility

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.

Interventions

BEHAVIORALTumaini Mobile Phone Game

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

11 Years to 14 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Number Interested in Participating	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	Month 1	The number of days needed to recruit 60 participants.
Number of Participants Lost to Follow Up	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.
Number of Participants Completing the Study	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	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	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 Reporting the Game is Valuable	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 Feeling Very Safe	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 Playing the Game	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.

Secondary

Measure	Time frame	Description
Change in Knowledge	Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention	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.
Change in Self-Efficacy	Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention	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.
Change in Risk Assessment	Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention	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.
Change in Behavioral Intention	Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention	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.
Change in Future Orientation	Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention	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.
Change in Perceived Social Norms	Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention	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.
Change in Attitudes	Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention	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.

Countries

Kenya

Participant flow

Recruitment details

Participants were recruited from schools in Kisumu Town, western Kenya, Africa. Enrollment of participants occurred between March 20, 2017 and April 7, 2017. All study activities were completed by June 19, 2017.

Pre-assignment details

Letters were sent to 150 parent of age-eligible children inviting them to attend informational meetings. Of the 126 who attended a meeting, 90 were interested and eligible to participate and 60 of these were randomly selected to enroll in the study.

Participants by arm

Arm	Count
Tumaini Mobile Phone Game Participants randomized to this arm were invited to play the Tumaini game. Participants were asked to play the game for at least one hour per day for 16 days.	30
Standard of Care Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.	30
Total	60

Baseline characteristics

Characteristic	Standard of Care	Total	Tumaini Mobile Phone Game
Age, Continuous	12.6 years STANDARD_DEVIATION 1	12.7 years STANDARD_DEVIATION 1	12.8 years STANDARD_DEVIATION 1
Race and Ethnicity Not Collected	—	0 Participants	—
Region of Enrollment Kenya	30 Participants	60 Participants	30 Participants
Sex: Female, Male Female	16 Participants	30 Participants	14 Participants
Sex: Female, Male Male	14 Participants	30 Participants	16 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 30	0 / 30
other Total, other adverse events	0 / 30	0 / 30
serious Total, serious adverse events	0 / 30	0 / 30

Outcome results

Primary

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.

Time frame: Month 1

Population: This analysis includes all of the individuals who expressed interest in the study by attending an informational meeting.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
All Study Participants	Number Interested in Participating	Uninterested	2 Participants
All Study Participants	Number Interested in Participating	Did not meet inclusion criteria	34 Participants
All Study Participants	Number Interested in Participating	Eligible and interested	90 Participants

Primary

Number of Participants Completing the Study

The number of participants who completed all study visits after providing consent are presented here.

Time frame: Duration of Study (Up to 4 Months)

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
All Study Participants	Number of Participants Completing the Study	30 Participants
Standard of Care	Number of Participants Completing the Study	30 Participants

Primary

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.

Time frame: Day 17 (post-intervention)

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
All Study Participants	Number of Participants Feeling Very Safe	29 Participants

Primary

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.

Time frame: Duration of Study (Up to 4 Months)

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
All Study Participants	Number of Participants Lost to Follow Up	0 Participants
Standard of Care	Number of Participants Lost to Follow Up	0 Participants

Primary

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.

Time frame: Day 17 (post-intervention)

Population: Only participants randomized to the intervention arm are included in this analysis.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
All Study Participants	Number of Participants Playing the Game	Reported played every day	26 Participants
All Study Participants	Number of Participants Playing the Game	Reported played 1 hour or more every time	23 Participants

Primary

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.

Time frame: Month 2

Arm	Measure	Value (NUMBER)
All Study Participants	Number of Phones Returned	30 phones

Primary

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.

Time frame: Day 17 (post-intervention)

Population: This analysis includes participants in the intervention arm.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
All Study Participants	Number Reporting Game Was Very Fun	27 Participants

Primary

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.

Time frame: Day 17 (post-intervention)

Population: This analysis includes participants randomized to the intervention arm.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
All Study Participants	Number Reporting the Game is Valuable	Learned A Lot	30 Participants
All Study Participants	Number Reporting the Game is Valuable	Information Very Useful Now	29 Participants
All Study Participants	Number Reporting the Game is Valuable	Information Very Useful for Future	30 Participants

Primary

Time to Recruitment of 60 Participants

The number of days needed to recruit 60 participants.

Time frame: Month 1

Arm	Measure	Value (NUMBER)
All Study Participants	Time to Recruitment of 60 Participants	18 days

Secondary

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.