A Mobile Phone Game to Prevent HIV Among Young Africans

• Sponsor: Emory University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03054051
• Collaborator: National Institute of Mental Health (NIMH) (NIH), Kenya Medical Research Institute (Other)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 3
• Patients Per Site Per Month: 20.1

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
HIV/AIDS	Behavioral: Tumaini Mobile Phone Game	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Mobile Phone Game to Prevent HIV Among Young Africans
• Actual Study Start Date: Mar 20, 2017
• Actual Primary Completion Date: Jun 19, 2017
• Actual Study Completion Date: Jun 19, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tumaini Mobile Phone Game Participants randomized to this arm will be invited to play the Tumaini game.	Behavioral: Tumaini 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.
No Intervention: Standard of Care Participants randomized to this arm will receive no intervention beyond the current standard of care for sexual education.

Outcome Measures

Primary Outcome Measures

1. 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.

2. Time to Recruitment of 60 Participants [Month 1]

   The number of days needed to recruit 60 participants.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 11 Years to 14 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kenya Medical Research Institute	Kisumu		Kenya

Sponsors and Collaborators

• Emory University
• National Institute of Mental Health (NIMH)
• Kenya Medical Research Institute

Investigators

• Principal Investigator: Kate Winskell, PhD, Emory University

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Jul 20, 2018

More Information

Publications

None provided.

• Responsible Party: Kate Winskell, Associate Professor, Emory University
• ClinicalTrials.gov Identifier: NCT03054051
• Other Study ID Numbers: IRB00081150; 5R34MH106368
• First Posted: Feb 15, 2017
• Last Update Posted: Oct 17, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Kate Winskell, Associate Professor, Emory University: HIV prevention; Preadolescence; Mobile phone game; Feasibility
• Additional relevant MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections

Study Results

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 Detail	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.

Arm/Group Title	Tumaini Mobile Phone Game	Standard of Care
Arm/Group Description	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.	Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.
Period Title: Overall Study
STARTED	30	30
COMPLETED	30	30
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Tumaini Mobile Phone Game	Standard of Care	Total
Arm/Group Description	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.	Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.	Total of all reporting groups
Overall Participants	30	30	60
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	12.8 (1)	12.6 (1)	12.7 (1)
Sex: Female, Male (Count of Participants)
Female	14 46.7%	16 53.3%	30 50%
Male	16 53.3%	14 46.7%	30 50%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
Kenya	30 100%	30 100%	60 100%

Outcome Measures

1. Primary Outcome

Title	Number Interested in Participating
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	All Study Participants
Arm/Group Description	Study participants who were randomized to either the intervention or control arm.
Measure Participants	126
Uninterested	2 6.7%
Did not meet inclusion criteria	34 113.3%
Eligible and interested	90 300%

2. Primary Outcome

Title	Time to Recruitment of 60 Participants
Description	The number of days needed to recruit 60 participants.
Time Frame	Month 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Study Participants
Arm/Group Description	Study participants who were randomized to either the intervention or control arm.
Measure Participants	60
Number [days]	18

3. Primary Outcome

Title	Number of Participants Lost to Follow Up
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tumaini Mobile Phone Game	Standard of Care
Arm/Group Description	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.	Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.
Measure Participants	30	30
Count of Participants [Participants]	0 0%	0 0%

4. Primary Outcome

Title	Number of Participants Completing the Study
Description	The number of participants who completed all study visits after providing consent are presented here.
Time Frame	Duration of Study (Up to 4 Months)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tumaini Mobile Phone Game	Standard of Care
Arm/Group Description	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.	Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.
Measure Participants	30	30
Count of Participants [Participants]	30 100%	30 100%

5. Primary Outcome

Title	Number of Phones Returned
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tumaini Mobile Phone Game
Arm/Group Description	Participants randomized to this arm were invited to play the Tumaini game.
Measure Participants	30
Number [phones]	30

6. Primary Outcome

Title	Number Reporting Game Was Very Fun
Description	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)

Outcome Measure Data

Analysis Population Description

This analysis includes participants in the intervention arm.

Arm/Group Title	Tumaini Mobile Phone Game
Arm/Group Description	Participants randomized to this arm were invited to play the Tumaini game.
Measure Participants	30
Count of Participants [Participants]	27 90%

7. Primary Outcome

Title	Number Reporting the Game is Valuable
Description	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)

Outcome Measure Data

Analysis Population Description

This analysis includes participants randomized to the intervention arm.

Arm/Group Title	Tumaini Mobile Phone Game
Arm/Group Description	Participants randomized to this arm were invited to play the Tumaini game.
Measure Participants	30
Learned A Lot	30 100%
Information Very Useful Now	29 96.7%
Information Very Useful for Future	30 100%

8. Primary Outcome

Title	Number of Participants Feeling Very Safe
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tumaini Mobile Phone Game
Arm/Group Description	Participants randomized to this arm were invited to play the Tumaini game.
Measure Participants	30
Count of Participants [Participants]	29 96.7%

9. Primary Outcome

Title	Number of Participants Playing the Game
Description	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)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Tumaini Mobile Phone Game
Arm/Group Description	Participants randomized to this arm were invited to play the Tumaini game.
Measure Participants	30
Reported played every day	26 86.7%
Reported played 1 hour or more every time	23 76.7%

10. Secondary Outcome

Title	Change in Knowledge
Description	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.
Time Frame	Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention

Outcome Measure Data

Analysis Population Description

One participant from the intervention arm was removed from this analysis at the immediate post-intervention time point due to delayed completion of the post-intervention survey.

Arm/Group Title	Tumaini Mobile Phone Game	Standard of Care
Arm/Group Description	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.	Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.
Measure Participants	30	30
Baseline score	7.33 (2.12)	7.93 (1.74)
Change from baseline immediately post-intervention	4.76 (2.96)	0.27 (2.07)
Change from baseline at 6 weeks post-intervention	3.80 (2.37)	0.80 (2.14)

11. Secondary Outcome

Title	Change in Self-Efficacy
Description	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.
Time Frame	Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention

Outcome Measure Data

Analysis Population Description

One participant from the intervention arm was removed from this analysis at the immediate post-intervention time point due to delayed completion of the post-intervention survey.

Arm/Group Title	Tumaini Mobile Phone Game	Standard of Care
Arm/Group Description	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.	Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.
Measure Participants	30	30
Baseline score	5.87 (2.03)	6.22 (2.41)
Change from baseline immediately post-intervention	1.95 (1.57)	0.47 (1.07)
Change from baseline at 6 weeks post-intervention	2.03 (1.83)	0.63 (1.20)

12. Secondary Outcome

Title	Change in Risk Assessment
Description	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.
Time Frame	Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention

Outcome Measure Data

Analysis Population Description

One participant from the intervention arm was removed from this analysis at the immediate post-intervention time point due to delayed completion of the post-intervention survey.

Arm/Group Title	Tumaini Mobile Phone Game	Standard of Care
Arm/Group Description	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.	Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.
Measure Participants	30	30
Baseline score	2.67 (1.25)	2.45 (1.50)
Change from baseline immediately post-intervention	0.41 (1.17)	0.00 (1.23)
Change from baseline at 6 weeks post-intervention	0.52 (0.99)	0.07 (1.03)

13. Secondary Outcome

Title	Change in Behavioral Intention
Description	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.
Time Frame	Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention

Outcome Measure Data

Analysis Population Description

One participant from the intervention arm was removed from this analysis at the immediate post-intervention time point due to delayed completion of the post-intervention survey.

Arm/Group Title	Tumaini Mobile Phone Game	Standard of Care
Arm/Group Description	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.	Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.
Measure Participants	30	30
Baseline score	4.43 (0.77)	4.83 (0.70)
Change from baseline immediately post-intervention	0.28 (0.86)	-0.12 (0.76)
Change from baseline at 6 weeks post-intervention	0.43 (0.75)	-0.15 (0.82)

14. Secondary Outcome

Title	Change in Future Orientation
Description	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.
Time Frame	Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention

Outcome Measure Data

Analysis Population Description

One participant from the intervention arm was removed from this analysis at the immediate post-intervention time point due to delayed completion of the post-intervention survey.

Arm/Group Title	Tumaini Mobile Phone Game	Standard of Care
Arm/Group Description	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.	Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.
Measure Participants	30	30
Baseline score	0.86 (0.30)	0.90 (0.24)
Change from baseline immediately post-intervention	0.05 (0.34)	0.10 (0.34)
Change from baseline at 6 weeks post-intervention	0.04 (0.31)	0.08 (0.27)

15. Secondary Outcome

Title	Change in Perceived Social Norms
Description	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.
Time Frame	Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention

Outcome Measure Data

Analysis Population Description

One participant from the intervention arm was removed from this analysis at the immediate post-intervention time point due to delayed completion of the post-intervention survey.

Arm/Group Title	Tumaini Mobile Phone Game	Standard of Care
Arm/Group Description	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.	Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.
Measure Participants	30	30
Baseline score	3.72 (1.12)	3.67 (1.24)
Change from baseline immediately post-intervention	0.47 (1.26)	-0.07 (1.30)
Change from baseline at 6 weeks post-intervention	0.37 (0.37)	-0.15 (1.35)

16. Secondary Outcome

Title	Change in Attitudes
Description	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.
Time Frame	Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention

Outcome Measure Data

Analysis Population Description

One participant from the intervention arm was removed from this analysis at the immediate post-intervention time point due to delayed completion of the post-intervention survey.

Arm/Group Title	Tumaini Mobile Phone Game	Standard of Care
Arm/Group Description	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.	Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.
Measure Participants	30	30
Baseline score	9.95 (2.30)	9.22 (2.07)
Change from baseline immediately post-intervention	0.74 (2.13)	0.82 (1.95)
Change from baseline at 6 weeks post-intervention	1.18 (1.82)	0.80 (2.25)

Adverse Events

Time Frame	Adverse events were collected from the time participants signed the consent form through the 6 week post-intervention study visit.
Arm/Group Title	Tumaini Mobile Phone Game		Standard of Care
Arm/Group Description	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.		Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.
All Cause Mortality
	Tumaini Mobile Phone Game		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)
Serious Adverse Events
	Tumaini Mobile Phone Game		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Tumaini Mobile Phone Game		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.